US20140052158A1 - Implantable support attachment system and assembly - Google Patents
Implantable support attachment system and assembly Download PDFInfo
- Publication number
- US20140052158A1 US20140052158A1 US13/765,085 US201313765085A US2014052158A1 US 20140052158 A1 US20140052158 A1 US 20140052158A1 US 201313765085 A US201313765085 A US 201313765085A US 2014052158 A1 US2014052158 A1 US 2014052158A1
- Authority
- US
- United States
- Prior art keywords
- suture
- capsule
- needle
- tissue
- clasp
- 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.)
- Abandoned
Links
Images
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
- A61B17/0469—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, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
-
- 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
- A61B17/062—Needle manipulators
- A61B17/0625—Needle manipulators the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator
-
- 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
- A61B17/0482—Needle or suture guides
-
- 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
- A61B17/06066—Needles, e.g. needle tip configurations
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00805—Treatment of female stress urinary incontinence
-
- 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
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0409—Instruments for applying suture anchors
-
- 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
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
-
- 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
- A61B17/06004—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, 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
- A61B17/06004—Means for attaching suture to needle
- A61B2017/06042—Means for attaching suture to needle located close to needle tip
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/28—Surgical forceps
- A61B17/29—Forceps for use in minimally invasive surgery
- A61B17/2909—Handles
- A61B2017/2912—Handles transmission of forces to actuating rod or piston
- A61B2017/2913—Handles transmission of forces to actuating rod or piston cams or guiding means
- A61B2017/2916—Handles transmission of forces to actuating rod or piston cams or guiding means pins in guiding slots
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Molecular Biology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Rheumatology (AREA)
- Surgical Instruments (AREA)
- Prostheses (AREA)
Abstract
A method of intracorporeally suturing a patient includes engaging tissue with a suturing head retaining a needle, forming an opening in the tissue with the needle, and pushing the needle into a through-bore formed in a capsule that is attached to a leading end of a suture and pulling the capsule and the leading end of a suture through the opening. The method additionally includes securing a clasp attached to a trailing end of the suture to an implantable support, and pulling on the suture and implanting the support inside the patient.
Description
- Intracorporeal suturing of tissue during surgery presents challenges to the surgeon in that the surgeon is called upon to manipulate suturing instruments within the confines of a relatively small incision formed in the patient's body.
- For example, in some cases a surgeon will place a suture within the pelvis of the patient without actually seeing the suture site. The challenge of placing a suture within the pelvic region is compounded when additional support structures are sutured into the pelvic region, for example when the pelvis is reinforced with a mesh-style support to address pelvic organ prolapse or urinary incontinence.
- Improved suturing instruments and improved methods of delivering intracorporeal sutures would be welcomed by the surgical staff.
- One aspect provides an attachment assembly configured to secure an implantable support within a patient. The attachment assembly includes a length of suture, an anchor, a capsule, and a clasp. The suture has a leading end half terminating in a leading end and a trailing end half terminating in a trailing end. The anchor is coupled to the trailing end half of the length of the suture. The capsule is attached to the leading end of the suture and has a through-bore extending longitudinally through the capsule. The clasp is attached to the trailing end of the suture, the clasp attachable to the implantable support.
- One aspect provides a method of intracorporeally suturing a patient includes engaging tissue with a suturing head retaining a needle, forming an opening in the tissue with the needle, and pushing the needle into a through-bore formed in a capsule that is attached to a leading end of a suture and pulling the capsule and the leading end of a suture through the opening. The method additionally includes securing a clasp attached to a trailing end of the suture to an implantable support, and pulling on the suture and implanting the support inside the patient.
- The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts.
-
FIG. 1 is a schematic view of one embodiment of an implantable support attachment system including a suture thrower and a suture attachment assembly. -
FIG. 2 is a schematic side view of one embodiment of the suture thrower illustrated inFIG. 1 . -
FIG. 3 is a cross-sectional view of a handle of the suture thrower illustrated inFIG. 2 . -
FIG. 4 is a perspective view of a shaft of the suture thrower illustrated inFIG. 2 . -
FIG. 5 is a cross-sectional view of a suture head of the suture thrower illustrated inFIG. 2 . -
FIG. 6 is a cross-sectional view of one embodiment of a capsule of the suture attachment assembly illustrated inFIG. 1 . -
FIG. 7A is a perspective view,FIG. 7B is a front view, andFIG. 7C is a side view of one embodiment of a clasp of the suture attachment assembly illustrated inFIG. 1 . -
FIG. 8A is a schematic view of the suture head of the suture thrower engaged with intracorporeal tissue. -
FIG. 8B is a schematic view of a needle of the suture had forming an opening in the intracorporeal tissue. -
FIG. 8C is a schematic view of the needle engaged with a through-bore of the capsule and pulling the capsule and the suture through the opening formed in the intracorporeal tissue. -
FIG. 8D is a schematic view of the capsule in the clasp located outside of the body with the clasp secured to the implantable support. -
FIG. 8E is a schematic view of the anchor engaged with the back side of the intracorporeal tissue and the implantable support secured relative to the intracorporeal tissue T. -
FIGS. 8F-8I are schematic views of embodiments of the suture attachment assembly employed to place another implantable fabric into intracorporeal tissue. -
FIG. 9 is a schematic view of an implantable support attachment system including the suture attachment assembly illustrated inFIG. 1 and one embodiment of a suture thrower. -
FIG. 10A is a perspective view,FIG. 10B is a front view, andFIG. 10C is a side view of one embodiment of a clasp suited for use with the suture attachment assembly illustrated inFIG. 1 . -
FIG. 11A is a top view,FIG. 11B is a side view, andFIG. 11C is a perspective view of one embodiment of a clasp suited for use with the suture attachment assembly illustrated inFIG. 1 . -
FIG. 12A is a top view andFIG. 12B is a side view of another embodiment of a suture attachment assembly. -
FIG. 13 is a side view of another embodiment of a suture attachment assembly. - In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such as “top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is used with reference to the orientation of the Figure(s) being described. Because components of embodiments can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.
- It is to be understood that the features of the various exemplary embodiments described herein may be combined with each other, unless specifically noted otherwise.
- Tissue includes soft tissue, which includes dermal tissue, sub-dermal tissue, ligaments, tendons, or membranes. As employed in this specification, the term “tissue” does not include bone.
- In this specification, end means endmost and end portion means that segment that is adjacent to and extends from the end. For example, a proximal end is that end location of a handheld instrument that is nearest a user, and a proximal end portion is that segment (e.g., a handle of the handheld instrument) that is adjacent to and extends distally away from the proximal end.
- It is desirable to implant support materials to address pelvic dysfunction. Some systems that are employed to implant support materials include a needle attached to a mesh support by a suture line. The suture line can include a tapered portion having one segment that is wider than a second statement, or the wider segment is employed as a dilator to force the tissue open wide enough to accept a portion of the mesh support. The dilation of the tissue has the potential to undesirably weaken or traumatize the tissue.
- In contrast, embodiments of a suture attachment system and assembly are described herein that obviate the dilation of the tissue and offer improved implant management that is less complex, or intuitive, and less cumbersome.
- Embodiments provide a suture attachment assembly that is configured to cooperate with a suture thrower to allow a surgeon to secure an implantable support within a patient. The suture attachment assembly includes a suture having a clasp opposite a leading end. The clasp is configured to quickly engage with the support, obviating the use of knots. The clasp allows the surgeon to conveniently place (and if desired, replace) the clasp onto the support at a location outside of the patient's body. The leading end is configured to be directed through an opening in intracorporeal tissue to pull the clasp/support along in the wake of the suture. In one embodiment, an anchor of the attachment assembly is terminated against the intracorporeal tissue to secure the implantable support at a desired location inside the patient.
- In one embodiment, a suture thrower is provided that has a movable needle that moves in a proximal direction to first form an opening in the tissue and subsequently capture the capsule, which is retracted by the needle in the distal direction to allow the surgeon to retrieve the capsule and the suture attached to the capsule to a location outside of the patient's body.
-
FIG. 1 is a schematic view of one embodiment of anattachment system 20 configured to secure animplantable support 22 within a patient. Theattachment system 20 includes asuture attachment assembly 24 and asuture thrower 50. As noted above, the components of thesystem 20 are not drawn to scale. - The
suture attachment assembly 24 has aclasp 34 that is attachable to theimplantable support 22, for example outside of the patient's body by means of a quick connect or other attachment device. Thesuture 26 is passed through tissue and retrieved to place thesupport 22 intracorporeally at a desired location within the patient. Thesuture attachment assembly 24 includes ananchor 32 that secures thesupport 22 at the desired location after the suture is retrieved through the tissue. Thesuture thrower 50 cooperates with thesuture attachment assembly 24 to form an opening in the tissue and retrieve thesuture 26 through the opening formed in the tissue. - The
implantable support 22 is sized and configured to reinforce the floor of the pelvis or support other tissues within the pelvis and suitably includes nonwoven materials such as autograft material (the patient's own tissue), allograft material (tissue from a cadaver), xenograft material (tissue from another species), or synthetic materials such as woven fabrics or meshes, nonwoven fabrics or meshes, fibrillated fibers, or spun and/or fibrillated fibers. Thesupport 22 is generally provided with voids (pores) that are configured to allow tissue ingrowth into and through thesupport 22. The pores of thesupport 22 are generally larger than, on average, about 75 μm. - In one embodiment, the
implantable support 22 is a knitted monofilament polypropylene mesh having an area of approximately 225 cm2 mesh with a basis weight of approximately 21 g/m2, a pore size of approximately 1121 μm, and a thickness of approximately 260 μm. The mesh is thin and light weight (i.e., the basis weight is less than approximately 30 g/m2) to provide a thin and comfortable mesh that is less likely to erode tissue that contacts the mesh and less likely to be sensed through the tissue layers by the patient. Other suitable materials forimplantable support 22 include fabrics formed from polyester, polyethylene, silicone, urethanes, polyurethanes, copolymers, or block copolymers of these or suitably similar polymeric materials. Suitable polypropylene mesh is available from Coloplast Corp., Minneapolis, Minn. Other suitable support material is available from, for example, HerniaMesh, Chivasso, Italy. - The
suture attachment assembly 24 includes a length ofsuture 26, acapsule 28 attached to aleading end 30 of thesuture 26, ananchor 32 coupled to thesuture 26, and theclasp 34 attached to a trailingend 36 of thesuture 26. - In one embodiment, the
suture 26 has a leading end half terminating in theleading end 30 and a trailing end half terminating in the trailingend 36, where theanchor 32 is coupled to the trailing end half of thesuture 26, thecapsule 28 is attached to theleading end 30 of thesuture 26, and theclasp 34 is attached to the trailingend 36 of thesuture 26. - In one embodiment, the
capsule 28 is a tube having a through-bore 156 formed longitudinally through thecapsule 28. - The
suture thrower 50 includes ashaft 54 coupled between ahandle 52 and asuturing head 56 that houses amovable needle 62. Thehandle 52 thus defines a proximal end of thesuture thrower 50 and is nearest a user of thesuture thrower 50. Thecapsule 28 is sized for retention within adistal end 64 of the suturinghead 56 and theclasp 34 trails behind thesuture 26 and is attachable to theimplantable support 22. - During use, the
handle 52 is activated to drive theneedle 62 in a proximal direction to form an opening in intracorporeal tissue (for example a ligament) and subsequently seat theneedle 62 into the through-bore 156 to engage thecapsule 28. Theneedle 62 retrieves thecapsule 28 through the opening in the tissue to deliver theleading end 30 of thesuture 26 outside of the patient. Theclasp 34, attached to the trailingend 36 of thesuture 26, is available outside of the patient and accessible by the surgeon for attachment of theclasp 34 to theimplantable support 22. Theclasp 34, by being accessible outside of the patient's body, permits the surgeon to more accurately attach thesuture 26/clasp 34 to theimplantable support 22 prior to implanting thesupport 22 within the patient. The surgeon pulls on thecapsule 28 end of thesuture 26 to pull thesuture 26 through the tissue and draw theimplantable support 22 into the patient. Theclasp 34 moves through the opening in the tissue formed by theneedle 62 until theanchor 32 engages with the tissue to prevent theimplantable support 22 from being withdrawn back through the opening, thus intracorporeally placing thesupport 22 in the patient. The surgeon subsequently removes thecapsule 28 and any excess length of thesuture 26 from the patient. -
FIG. 2 is a schematic side view of thesuture thrower 50. In one embodiment, handle 52 includes anactuator 58 communicating with arod 60 that is disposed withinshaft 54. When actuator 58 is activated,rod 60 moves throughshaft 54 to extend theneedle 62 that is stored within aproximal end portion 112 ofhead 56 axially outward through tissue and toward adistal end 64 ofhead 56. Theneedle 62 moves away from the user (who is holdinghandle 52 at the proximal end of suture thrower 50) towarddistal end 64 ofsuture thrower 50 for engagement with the through-bore 156 formed in the capsule 28 (FIG. 1 ). - In one embodiment, the capsule 28 (
FIG. 1 ) is retained withindistal end 64 of thehead 56 and so positioned to allow theneedle 62 to frictionally engage with the through-bore 156. Theneedle 62 thus mates with thecapsule 28, removes thecapsule 28 fromdistal end 64, and retracts the capsule into theproximal end portion 112 ofhead 56. In this manner, thesuture 26 that is towed behind thecapsule 28 is “thrown” through the tissue. Embodiments described below include a guide pin located withinhead 56 that is configured to disengage thecapsule 28 fromneedle 62 after thecapsule 28 is delivered to a location outside of the patient's body. -
Suture thrower 50 is suited for the intracorporeal suturing of tissue during surgery, and in one embodiment is provided as a sterile disposable surgical instrument that is discarded after the surgical procedure. To this end, the components ofsuture thrower 50 are selected to be compatible with gas, steam, or radiation sterilization. -
FIG. 3 is a cross-sectional view of thehandle 52. In one embodiment, handle 52 is aligned with a major longitudinal axis A and includes abody 70 extending between adistal end 72 and aproximal end 74, athumb brace 76 extending laterally frombody 70, atrigger 78 spaced apart fromthumb brace 76, and aknob 80 coupled toproximal end 74. - In one embodiment,
body 70 is fabricated from plastic, for example via molding. Suitable plastic materials for the fabrication ofbody 70,brace 76, andknob 80 include, as examples, polycarbonate, polyethylene, acrylonitrile butadiene styrene, acrylic, or nylon. In one embodiment, brace 76 is integrally molded with a clamshell-style ofbody 70 and these two components are joined together to retaintrigger 78 andknob 80.Trigger 78 is formed to have sufficient strength to resist bending when activated by the human hand. Suitable materials for formingtrigger 78 include metal such as aluminum or plastics such as polyetherimide or poly-ether-ether-ketone. -
Shaft 54 is coupled todistal end 72 ofbody 70, androd 60 is disposed withinshaft 54 and coupled to trigger 78. In one embodiment,actuator 58 includestrigger 78 attached torod 60 and aspring 82 disposed within aspring pusher 84 and biased against and aninternal rib 86.Trigger 78 is movable towardthumb brace 76 to moverod 60 in a distal direction longitudinally withinshaft 54, which compressesspring 82. Whentrigger 78 is released,spring 82 extends to pushspring pusher 84 proximally, which retracts or returnsrod 60 towardproximal end 74. Trigger is spaced apart fromthumb brace 76 by a distance of approximately 4-12 cm to enable the fingers of the user to comfortably activatetrigger 78.Trigger 78 is disposed at an angle B relative to the longitudinal axis A ofbody 70, and in an exemplary embodiment the angle B is between 70-110 degrees such thattrigger 78 is approximately orthogonal to longitudinal axis A. -
Actuator 58 is configured to moverod 60 forward in a distal direction and rearward in a proximal direction withinshaft 54. In one embodiment, it is desirable to moverod 60 rearward an additional distance to disengage the capsule 28 (FIG. 1 ) from needle 62 (FIG. 2 ). To facilitate this,rod 60 includes an insert (not shown) that communicates throughspring pusher 84 and is captured inwindow 88. Whenknob 80 is turned,spring pusher 84 turns and the insert attached torod 60 is retracted back in a proximal direction due to the angle ofwindow 88, which retractsrod 60 an additional distance intobody 70. For example, in oneembodiment knob 80 is configured such that a 180 degree clockwise ofknob 80 relative to end 74 drawsrod 60 an additional distance of about 2 mm intobody 70. Althoughknob 80 is configured to retractrod 60 further intobody 70 via a turning motion, other mechanisms such as levers or draw bars for retractingrod 60 incrementally rearward are also acceptable. -
FIG. 4 is a side view ofshaft 54. One suitable embodiment ofshaft 54 includes a substantially rigid aluminum annular tube extending between aproximal end 90 that is attachable to handle 52 (FIG. 3 ) and adistal end 92 that is attachable to head 56. Other substantially rigid materials, such as stainless steel, are also suitable selections for fabricatingshaft 54. Another embodiment ofshaft 54 includes a distal end portion associated withdistal end 92 that is flexible and configured to bend laterally relative tofirst section 96 to enable the surgeon to selectivelydirect head 56 to a desired location. - In one embodiment, the
shaft 54 includes theproximal end 90 that is attachable to handle 52 (FIG. 3 ), thedistal end 92 that is attachable to head 56 (FIG. 2 ), and acrimp 94 or aweld 94 that connects afirst section 96 to asecond section 98. In one embodiment,shaft 54 is formed as a thin-walled tube withfirst section 96 formed of a first material and asecond section 98 is formed of a different second material. In an exemplary embodiment,first section 96 is formed of 6000 series aluminum and asecond section 98 is formed of 3000 series aluminum, with these twometal sections weld 94. The 6000 series aluminum is selected to have a shear modulus of a sufficient value to preclude the user from bendingfirst section 96 assuture thrower 50 is manipulated. For example, in one embodiment the shear modulus offirst section 96 is approximately 30 GN/m2. The 3000 series aluminum is selected to have a shear modulus of a sufficient value to enable a user to bend thesecond section 98 with their hands, which enables the user to shape and guide second section 98 (which is attached to head 56) in controlling and guiding the placement of sutures withhead 56. For example, in one embodiment the shear modulus ofsecond section 98 is approximately 10 GN/m2. In another example, in one embodiment the yield strength offirst section 96 is approximately 30 GN/m2. The 3000 series aluminum is selected to have a yield strength of a sufficient value to enable a user to bend thesecond section 98 with their hands, which enables the user to shape and guide second section 98 (which is attached to head 56) in controlling and guiding the placement of sutures withhead 56. For example, in one embodiment the yield strength ofsecond section 98 is approximately 10 GN/m2. - One example of suitable lengths for
sections first section 96 to have a length between 4-24 cm andsecond section 98 to have a length from 1-10 cm. Other lengths forsections weld 94 is provided as a metal peripheral crimp securingfirst section 96 tosecond section 98. -
FIG. 5 is a cross-sectional view ofhead 56. In one embodiment,head 56 is formed of two mating components, and the view ofFIG. 5 is taken with one half of the structure removed so that the internal features ofhead 56 are visible.Head 56 is molded from plastic, for example from a polyetherimide plastic sold under the trademark Ultem, or from glass-filled polyetherimide plastics also sold under the trademark Ultem. - In one embodiment, the
proximal end portion 112 extends from aproximal end 110 of thehead 56 and includes aneck 114 that extends between theproximal end portion 112 and thedistal end 64 to form athroat 132 that is suited for engaging over or around ligament or other tissue.Head 56 is attachable toshaft 54, and in one embodiment includes anopening 120 sized to receiveshaft 54 such thatrod 60 extends intoproximal end portion 112 and couples with alink 122 that is attached toneedle 62. In one embodiment,distal end 64 is not aligned with, but is rather offset radially from longitudinal axis A, to more comfortably positionshaft 54 for manipulation by the surgeon ashead 56 is engaged with tissue. - In one embodiment, a
clevis pin 121 connects a proximal end oflink 122 torod 60 and a distal end oflink 122 is coupled toneedle 62. Movement ofrod 60 moves link 122, which movesneedle 62 into and out of aneedle exit port 123 formed inproximal end portion 112. In one embodiment, atrace 124 that is formed on aninterior surface 125 ofproximal end portion 112 ofhead 56, and link 122 is configured to translate and rotate withintrace 124 to translateneedle 62 along axis A and pitch needle up/down relative to axis A. For example, in oneembodiment link 122 includes afirst pin 126 that couples withclevis 121 and asecond pin 128 that couples withneedle 62. Axial movement ofrod 60 translates to axial movement oflink 122 andneedle 62, and link 122 rotates aboutpins needle 62 off of axis A. -
Link 122 is thus configured to translate withintrace 124 to moveneedle 62 in/out relative toneedle exit port 123, and rotate relative topins needle 62 up/down relative to longitudinal axis A. In one embodimentproximal end portion 112 includes aguide pin 130 that defines a bore sized to receiveneedle 62.Needle 62 is configured to slide through the bore formed inguide pin 130, andguide pin 130 is rotatable to allowneedle 62 to pitch relative to longitudinal axis A asneedle 62 moves axially, for example asneedle 62 moves into engagement withdistal end 64. -
Neck 114 extends betweenproximal end portion 112 anddistal end 64 and defines thethroat 132.Needle 62 is movable fromproximal end portion 112, out ofneedle exit port 123, acrossthroat 132, and into acavity 134 formed indistal end 64.Needle 62 is preferably machined from metal such as stainless steel or a shape memory alloy such as NiTiNOL (Nickel Titanium Naval Ordinance Laboratory), as examples. - In one embodiment,
distal end 64 andcavity 134 are both radially spaced away from longitudinal axis A, andguide pin 130 rotates to enableneedle 62 to move out of theneedle exit port 123, pitch upwards, and intocavity 134. In one embodiment, a top surface ofneck 114 defines an open, exposed groove configured to receive and guide suture that extends from the capsule 28 (FIG. 6 ) captured incavity 134 back to handle 52 (FIG. 1 ). - The
cavity 134 is configured to retain thecapsule 28 attached to suture 26 (seeFIG. 1 ), andneedle 62 is configured to penetrate tissue and entercavity 134, engage thecapsule 28, and pull thecapsule 28 through the tissue and intoneedle exit port 123 to “throw” the suture acrossthroat 132. Theguide pin 130 is placed to displace thecapsule 28 from theneedle 62 when the knob 80 (FIG. 3 ) is rotated, which allows the surgeon or the technician to selectively disengage thecapsule 28 from thehead 56 of thesuture thrower 50. Some embodiments ofhead 56 include mechanisms configured to linearlydirect needle 62 out ofneedle exit port 123 acrossthroat 132 and intocavity 134 for engagement with the capsule. Other embodiments ofhead 56 include mechanisms configured to shunt needle 62 (e.g.,pitch needle 62 upward relative to axis A away fromneedle exit port 123 and intocavity 134 for engagement with the capsule). -
FIG. 6 is a side view of one embodiment of theneedle 62 aligned for engagement with thecapsule 28 of thesuture attachment assembly 24. Theneedle 62 is employed to form the opening in the tissue and thecapsule 28 is retrieved through the opening in the wake of theneedle 62. - The
capsule 28 is sized to be deposited and retained in cavity 134 (FIG. 5 ) of thehead 56 of thesuture thrower 50 to position the through-bore 156 to receive aleading end 158 ofneedle 62. In contrast to pointed, solid needles that are pushed through tissue, thecapsule 28 is an annular tube segment having the through-bore 156 that configures thecapsule 28 to be captured by theneedle 62 and pulled through an opening that is pre-formed in the tissue by theneedle 62. The structure of thecapsule 28 allows the surgicallysharp needle 62 to form a uniform opening in the tissue with the desirable benefit of a minimum of tissue trauma prior to engaging with thecapsule 28 and retrieving thecapsule 28 through the opening. Thus, the structure of theannular capsule 28 and the method of retrieving theannular capsule 28 through the opening in the tissue are counter-intuitive to the current approaches of driving bullet-shaped suture ends through tissue. - The through-
bore 156 is formed as a longitudinal bore extending though the body of thecapsule 28. In one embodiment,needle 62 is shaped to promote secure engagement withcapsule 28 andleading end 158 is formed to have a conical point with ashoulder 162 that is sized to be pressed into engagement with aflange 164 of through-bore 156. For example,flange 164 that is shaped and sized to frictionally engage (e.g., snap-fit) in a “locked” manner with ashoulder 162 ofneedle 62 asneedle 62 is driven into through-bore 156.Capsule 28 is configured to be detached fromneedle 62 by guide pin 130 (FIG. 5 ) afterneedle 62 pullscapsule 28 rearward in a proximal direction intohead 56. - The conical point of
needle 62 is configured to form a channel opening when advanced through tissue, andcapsule 28 is sized to be pulled through the channel in the tissue made byneedle 62. In one embodiment, leadingend 160 ofcapsule 28 is chamfered andneedle 62 is configured to draw the chamfered (or truncated)end 160 ofcapsule 28 first through the tissue. In one embodiment, leadingend 160 ofcapsule 28 is a blunt end similar to that illustrated for the trailing end of thecapsule 28, andneedle 62 is configured to draw theblunt end 160 ofcapsule 28 blunt end-first through the tissue. - For example, in one
embodiment needle 62 has a first diameter D1 andcapsule 28 has a diameter D2, were diameter D1 is equal to or greater than diameter D2. In this manner,capsule 28 is sized to followneedle 62 and be retracted through the channel formed in the tissue byneedle 62. - Leading
end 158 ofneedle 62 is sized to frictionally engage with through-bore 156 formed incapsule 28. For example, in oneembodiment leading end 158 has a diameter D3 that is slightly greater than an inside diameter D4 formed in an opening of through-bore 156. In this manner, when leadingend 158 ofneedle 62 is inserted into through-bore 156, leadingend 158 is forced into and seats within and capturescapsule 28. - In one embodiment, the inside diameter D4 of the through-
bore 156 adjacent to theleading end 160 of thecapsule 28 is smaller than an inside diameter D5 of the through-bore 156 adjacent to the trailingend 170 of thecapsule 28. - In one embodiment, the
capsule 28 is molded from plastic integrally over thesuture 26. Suitable plastic materials for fabricatingcapsule 28 include polypropylene, polysulfone, urethane, or polyetherimide as examples.Suture 26 includes monofilament suture, braided suture, coated suture materials or the like, as examples. In one embodiment, thesuture 26 is a monofilament polypropylene suture. -
FIG. 7A is a perspective view,FIG. 7B is a front view, andFIG. 7C is a side view of one embodiment of theclasp 34. In one embodiment, theclasp 34 is formed as a single monolithic unit including afirst paddle 200 connected to asecond paddle 202 by aspine 204. Each of thepaddles sides leading end 210 of theclasp 34 and diverge to a blunt trailing end, oranchor 32, of theclasp 34. Theleading end 210 is sized to be wedged or pulled through the opening formed in the tissue by the needle 62 (FIG. 6 ), and theblunt anchor end 32 of theclasp 34 is sized to prevent theclasp 34 from being retracted back through the opening formed in the tissue. - In one embodiment, the
first paddle 200 includes aprojection 212 that is sized to frictionally engage with arecess 214 formed in thesecond paddle 202. For example, in one embodiment thefirst paddle 200 includes an exterior surface opposite an interior surface, and theprojection 212 projects from the interior surface of thefirst paddle 200. In a similar manner, thesecond paddle 202 includes an exterior surface opposite an interior surface, and therecess 214 extends between the exterior surface and the interior surface. Theprojection 212 is formed to frictionally engage with therecess 214, for example by having a diameter that is slightly larger than a diameter of therecess 214, to allow thefirst paddle 200 to snap-fit into engagement with thesecond paddle 202. - The
clasp 34 is fabricated from a material that is suitable for implantation into the human body. In one embodiment, theclasp 34 is fabricated from polypropylene. Other suitable materials for fabricating theclasp 34 include polyethylene, polymers in general, bio-absorbable polymers, biodegradable polymers, or bio-resorbable polymers. -
FIGS. 8A-8E are schematic views of embodiments of thesuture thrower 50 and thesuture attachment assembly 24 employed to place animplantable fabric 22 into intracorporeal tissue. - Embodiments of the suturing device described herein provide a method of suturing tissue useful in many surgical procedures, including the treatment of pelvic dysfunction including pelvic organ prolapse. For example, embodiments provide a suturing device suited for the surgical treatment of pelvic organ prolapse that is operable to suture a scaffold or other support to a ligament or other tissue located within the pelvis. With some surgical procedures it is desirable to apply sutures to the sacrospinous ligament and/or the arcus tendineus ligament to attach a synthetic scaffold thereto that is configured to support the pelvic floor and reduce or eliminate the undesirable effects of pelvic organ prolapse.
- During an exemplary procedure, a catheter is placed in the patient's urethra and other recommended, desirable, or preliminary surgical steps are taken in preparation for surgery. The patient is typically placed on an operating table in a lithotomy position with buttocks extending just beyond an edge of the table. With the patient under anesthesia, a vaginal incision (female) or a perineal incision (male) is made by the surgeon. Thereafter, the surgeon would typically palpate the patient to identify a desired landmark, such as the sacrospinous ligament or arcus tendineus ligament or other tissue landmark. The surgeon identifies the landmark, for example with a finger, and subsequently introduces
sterile instrument 50 and engages the throat 132 (FIG. 5 ) of thehead 56 with the identified landmark. -
FIG. 8A is a schematic view of thethroat 132 of thehead 56 engaged with tissue T. Theneedle 62 is retracted withinneedle exit port 123 ofproximal end portion 112 ofhead 56.Capsule 28 is seated incavity 134 withsuture 26 trailing distally away fromhead 56. Thehead 56 has been introduced into an incision and thethroat 132 of thehead 56 is placed to engage a portion of intracorporeal tissue T, which positions theneedle 62 to capture thecapsule 28 and pull thesuture 26 through the intracorporeal tissue T. The intracorporeal tissue T includes soft tissue in general, such as the Cooper's ligament, the sacrospinous ligament, the arcus tendineus ligament, or other pelvic tissue. - In one embodiment, prior to throwing
suture 26, it is recommended that the surgeon direct the trailingend 36 ofsuture 26 andclasp 34 overdistal end 64 ofhead 56 and back toward a proximal end ofshaft 54 for ease of managingsuture attachment assembly 24 during the procedure. To facilitate this, in one embodiment thedistal end 64 of thehead 56 includes a slot configured to enable thesuture 26 to pass throughdistal end 64 to facilitate loading/unloading capsule 28 intocavity 134. - In one embodiment,
rod 60 andneedle 62 are aligned on axis A whenneedle 62 is retracted intoproximal end portion 112 as illustrated, andcapsule 28 is aligned on an axis C that is not aligned with axis A. -
FIG. 8B is a schematic view of thesystem 20 with theneedle 62 pushed through the tissue T to form anopening 215 in the tissue T. Theneedle 62 is shunted away from longitudinal axis A bylink 122 andpin 130, moved in a second direction along axis C byrod 60, and translated through the intracorporeal tissue T to thedistal end 64 of thehead 56 for engagement with the through-bore 156 (FIG. 6 ) of thecapsule 28.Guide pin 130 has rotated counterclockwise to allow the movement oflink 122 withintrace 124 to shunt the direction ofneedle 62 out of alignment with axis A and into alignment with axis C. Additional forward movement ofrod 60 will further directneedle 62 acrossthroat 132, through the intracorporeal tissue T, and into engagement withcapsule 28. As described below,needle 62 is reversible along the paths coincident with axis C and axis A to retractneedle 62 andcapsule 28 intoneedle exit port 123. -
FIG. 8C is a schematic view ofneedle 62 retracted intohead 56 withcapsule 28 parked inneedle exit port 123 and thesuture 26 thrown through the intracorporeal tissue T. In one embodiment,needle exit port 123 is sized to receivecapsule 28 such thatport 123 forms acapsule garage 123 into whichcapsule 28 is parked after extraction fromcavity 134.Rod 60 has drawnlink 122 into full rearward engagement withtrace 124 such thatneedle 62 is aligned with axis A and retracted intohead 56.Capsule 28 is parked insideneedle exit port 123 andsuture 26 extends acrossthroat 132 and through the intracorporeal tissue T, which configures thesystem 20 to allow the surgeon to pull thehead 56 and thecapsule 28 out of the patient for subsequent manipulation of thecapsule 28. - In one embodiment, and as described above with reference to
FIG. 2 ,knob 80 is configured to be turned to incrementally retractrod 60 an additional distance intohandle 52, which separatesneedle 62 fromcapsule 28. For example, the additional retraction ofneedle 62 by the rearward motion ofrod 60 causescapsule 28 to be pressed againstguide pin 130, which shearscapsule 28 off ofneedle 62.Needle 62 is thus disengaged fromcapsule 28 to allow the surgeon to manipulate thecapsule 28 free of thehead 56 and outside of the patient's body. -
FIG. 8D is a schematic view of thesuture attachment assembly 24 engaged with the intracorporeal tissue T. Thecapsule 28 andclasp 34 reside outside of the patient's body in thesuture 26 enters the patient's body through the incision and disengaged with the intracorporeal tissue T. With reference toFIG. 7C , the surgeon may selectively attach theclasp 34 to a desired location of theimplantable support 22 by snapping thefirst paddle 200 into engagement with thesecond paddle 202 to captureimplantable support 22 between thepaddles suture 26 attached to thecapsule 28 will pull theimplantable support 22 into a desired location within the patient's body. -
FIG. 8E is a schematic view of theclasp 34 pulled through theopening 215 formed in the intracorporeal tissue T by the needle 62 (FIG. 8B ) until theanchor 32 is engaged with the back side of the tissue T to secure theimplantable support 22 relative to the intracorporeal tissue T. - Embodiments have been described providing a method of intracorporeally suturing tissue of a patient, where the method includes engaging the tissue with a suturing
head 56 retaining aneedle 62, forming anopening 215 in the tissue T with theneedle 62, passing a leading end of asuture 26 through theopening 215, securing aclasp 34 attached to a trailing end of thesuture 26 to animplantable support 22, and pulling thesuture 26 and ananchor 32 that is attached to thesuture 26 through theopening 215 formed in the tissue T, thus placing theimplantable support 22 inside the patient. - In one embodiment, the
clasp 34 is a tissue or a biologic body including attached synthetic arms, where theclasp 34 assists in placing the attached synthetic arms into the patient and the synthetic arms include a portion of, or all of, theimplantable fabric 22. -
FIGS. 8F-8I are schematic views of embodiments of the suture attachment assembly 24 (as placed by thesuture thrower 50 described above) employed to place anotherimplantable fabric 22′ into intracorporeal tissue. -
FIG. 8F is a schematic view of theclasp 34 of thesuture attachment assembly 24 positioned for engagement with asacrificial tab 216 that extends from theimplantable fabric 22′. The surgeon attaches theclasp 34 to thesacrificial tab 216 of theimplantable support 22′ by snapping thefirst paddle 200 into engagement with the second paddle 202 (FIG. 7C ) to capture thesacrificial tab 216 between thepaddles implantable support 22′ is pulled to a desired location and implanted within the patient's body when the surgeon pulls on the end of thesuture 26 that is attached to thecapsule 28. Thesuture attachment assembly 24 and thesacrificial tab 216 of theimplantable fabric 22′ are both removed from the patient's body. -
FIG. 8G is a side view of thesacrificial tab 216 portion of theimplantable fabric 22′. In one embodiment, thesacrificial tab 216 includestab material 217 that is attached to theimplantable fabric 22′ along abreak line 218. In one embodiment, thetab material 217 is sheathed inmaterial 219 that is configured to assist in pulling thesacrificial tab 216 through tissue. For example, in one embodiment thesheath material 219 is a coating of a polyvinyl alcohol film that is applied over thetab material 217 to provide lubricity between thesacrificial tab 216 and the tissue as thesacrificial tab 216 is pulled or placed in the tissue. In one embodiment, the entiresacrificial tab 216, including thesheath material 219, is removed from theimplantable fabric 22′ after implantation. However, any polyvinyl alcoholfilm sheath material 219 that remains in the patient's body after implantation is configured to dissolve and be absorbed into the patient's body. -
FIG. 8H is a schematic view of theclasp 34 attached to thesacrificial tab 216 and pulled through theopening 215 that was formed in the intracorporeal tissue T by the needle 62 (FIG. 8B ). Theimplantable fabric 22′ is secured or seated in the tissue T. -
FIG. 8I is a schematic view of theclasp 34 and thesacrificial tab 216 pulled through the tissue T and separated at thebreak line 218. Theimplantable fabric 22′ is thus implanted in the tissue T and the entiresuture attachment assembly 24, including theclasp 34 and thesacrificial tab 216, are removed from the patient and disposed of. -
FIG. 9 is a schematic view of one embodiment of anattachment system 220 configured to secure theimplantable support 22 within a patient. Theattachment system 220 includes asuture capturing device 250 and asuture attachment assembly 254. - The
suture capturing device 250 includes aneedle driver 260 having adistal tip 261 spaced apart from acatch mechanism 262. Thesuture attachment assembly 254 includes aneedle 270 or abullet 270 attached to a leading end of thesuture 26 with theclasp 34 attached to the trailing end of thesuture 26. Theimplantable support 22 is as described above. - In one embodiment, the
needle driver 260 is designed to place a sling transvaginally by throwing thesuture 26 through the Cooper's ligament, for example. Theneedle 270 is loaded into thedistal tip 261 of theneedle driver 260, and upon activation of the needle driver 260 (for example by an activation mechanism in a handle of the driver 260) thebullet 270 is delivered in an arc across the throat and retained within thecatch mechanism 262. In this manner, theneedle 270 and thesuture 26 are both thrown through the tissue and theneedle 270 is retained within the catch mechanism for retrieval to a location outside of the patient's body. Thereafter, the surgeon attaches theclasp 34 to implant 22, imposed aneedle 270 thecatch mechanism 262, and pulls thesuture 26 through the tissue to implant to support 22. -
FIG. 10A is a perspective view,FIG. 10B is a front view, andFIG. 10C is a side view of one embodiment of aclasp 294 suited for use with thesystem 20 and thesuture attachment assembly 24 illustrated inFIG. 1 . - In one embodiment, the
clasp 294 is formed as a single monolithic unit including afirst paddle 300 connected to asecond paddle 302 by aspine 304. Each of thepaddles sides leading end 310 of theclasp 294 and diverge to a blunt trailingend 311, oranchor 311, of theclasp 294. Theleading end 310 is sized to be wedged or pulled through tissue, and theanchor end 311 of theclasp 294 is sized to prevent theclasp 294 from being retracted back through the tissue. - In one embodiment, the
first paddle 300 includes aprojection 312 that is sized to frictionally engage with arecess 314 formed in thesecond paddle 302. For example, in one embodiment thefirst paddle 300 includes an exterior surface opposite an interior surface, and theprojection 312 projects from the interior surface of thefirst paddle 300. In a similar manner, thesecond paddle 302 includes an exterior surface opposite an interior surface, and therecess 314 extends between the exterior surface and the interior surface. Theprojection 312 is formed to frictionally engage with therecess 314 to allow thefirst paddle 300 to snap-fit into engagement with thesecond paddle 302. - In one embodiment, the
clasp 294 has acurved anchor end 311. Theleading end 310 of theclasp 294 is attached to the trailingend 36 of thesuture 26, and each of thepaddles curved anchor end 311 having a pair of spaced apart prongs 316, 318. Each of theprongs clasp 294 has been pulled through the tissue to ensure that theclasp 294 remains fixed at the implant site selected by the surgeon. -
FIG. 11A is a top view,FIG. 11B is a side view, andFIG. 11C is a perspective view of one embodiment of aclasp 324 suited for use with thesystem 20 and thesuture attachment assembly 34 illustrated inFIG. 1 . - In one embodiment, the
clasp 324 is formed as a single monolithic unit including afirst paddle 330 connected to asecond paddle 332 by aspine 334. Each of thepaddles sides leading end 340 of theclasp 324 and diverge to ananchor 341 of theclasp 324. Theleading end 340 is sized to be wedged or pulled through tissue, and theanchor 341 is sized to prevent theclasp 324 from being retracted back through the tissue. - In one embodiment, the
first paddle 330 includesprojections complementary recess 344 formed in thesecond paddle 332. Theprojections recesses 344 to allow thefirst paddle 330 to snap-fit into engagement with thesecond paddle 332 to capture the support 22 (FIG. 1 ) there between. - In one embodiment, the
leading end 340 of theclasp 324 is attached to the trailingend 36 of thesuture 26, and theanchor 341 is located between theleading end 340 and a trailingend 346 of theclasp 324. In this manner, when thesuture 26 is pulled through theopening 215 formed in the intracorporeal tissue T (FIG. 8B ) by theneedle 62, theleading end 340 of theclasp 324 will pass through theopening 215 and theanchor 341 will become engaged with the tissue T. The trailingend 346 of theclasp 324 and a portion of thepaddles anchor 341 is configured to engage with the tissue such that theleading end 340 projects out of one side of the ligament, for example, and the trailingend 346 of thepaddles support 22 is consequently not pulled through the tissue. Theclasp 324 thus provides amid-located anchor 341. -
FIG. 12A is a top view andFIG. 12B is a side view of another embodiment of asuture attachment assembly 350. Thesuture attachment assembly 350 includes thesuture line 26, thecapsule 28 attached to theleading end 30 of thesuture line 26, aclasp 354 attached to the trailingend 36 of thesuture line 26, and ananchor 352 that is attached to thesuture line 26 and separate from theclasp 354. Thesuture line 26 and thecapsule 28 are described above, and are employed to pull theanchor 352 and theclasp 354 to an intracorporeal location within the patient's body. - In one embodiment, the
anchor 352 is conical or bullet-shaped or converges to a pointedleading end 356 that is configured to allow theanchor 352 to be pulled through an opening formed in the tissue. A trailingend 358 of theanchor 352 is configured to be wider than theleading end 356 such that theanchor 352 prevents the leading portion of thesuture attachment assembly 350 from being pulled back through the opening in the intracorporeal tissue. In one embodiment, theanchor 352 is a conical anchor fabricated from polypropylene. - In one embodiment, the
clasp 354 is configured to open and close and includes afirst paddle 360 attached to asecond paddle 362 by aspine 364. In one embodiment,spine 364 is provided as a “living hinge” that allows thefirst paddle 360 and thesecond paddle 362 to flex relative to thespine 364. In one embodiment, thefirst paddle 360 includes aprojection 370 projecting from an interior surface that is configured to engage with arecess 372 formed in thesecond paddle 362. Theclasp 354 opens wide enough to receive the implantable support 22 (FIG. 1 ) and thepaddles implantable support 22 to secure the support inside of theclasp 354. - During implantation, and as described above, the
capsule 28 is pulled or thrown through an opening formed in the intracorporeal tissue by the needle 62 (FIG. 6 ) and retrieved a location outside of the patient's body. Thecapsule 28 allows thesuture line 26 to be pulled through the opening in the intracorporeal tissue to place the support material held within theclasp 354 at the desired intracorporeal location. - In one embodiment, the
anchor 352 slides along thesuture 26. For example, during placement of theanchor 352, theanchor 352 is pulled through the opening formed in the intracorporeal tissue and then manually pushed along thesuture 26 toward theclasp 354 to secure theclasp 354 at the desired intracorporeal location. -
FIG. 13 is a side view of another embodiment of asuture attachment assembly 380. Thesuture attachment assembly 380 includes thesuture line 26, thecapsule 28 attached to the leading and 30 of thesuture 26, and aplate 382 attached to the trailingend 36 of thesuture 26. In one embodiment, theplate 382 includesprojections 384 formed along an exterior surface of theplate 382. Theprojections 384 are configured to engage with woven or nonwoven support fabrics that are suitable for implantation into the human body. In this embodiment, theplate 382 provides a clasp with one paddle, where the one paddle includes projections that are configured to engage with threads or other portions of an implantable body support. - Embodiments of a suture attachment system and assembly have been described that allow a surgeon to secure an implantable support within a patient while offering improved implant management that is more intuitive and accurate in placement and less complex and cumbersome.
- Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present invention. This application is intended to cover any adaptations or variations of medical devices as discussed herein. Therefore, it is intended that this invention be limited only by the claims and the equivalents thereof.
Claims (10)
1. An attachment assembly configured to secure an implantable support within a patient, the attachment assembly comprising:
a length of suture having a leading end and a trailing end;
a capsule attached to the leading end of the suture; and
an anchor coupled to the trailing end of the suture, the anchor including an anchor portion and a clasp portion that is formed as a single monolithic unit with the anchor portion, with the clasp portion configured to be attachable to the implantable support.
2. The attachment assembly of claim 1 , wherein the capsule has an open through-bore extending longitudinally through the capsule.
3. The attachment assembly of claim 2 , wherein the open through-bore extends from a leading end of the capsule to a trailing end of the capsule and an inside diameter of the through-bore adjacent to the leading end of the capsule is smaller than an inside diameter of the through-bore adjacent to the trailing end of the capsule.
4. The attachment assembly of claim 1 , wherein the implantable support comprises a porous mesh and the anchor comprises at least one projection that is configured to engage with a filament of the porous mesh.
5. The attachment assembly of claim 1 , wherein the anchor portion is located between the capsule and the clasp portion.
6. An attachment system configured to secure an implantable support within a patient, the attachment system comprising:
a suture thrower comprising a suturing head housing a movable needle; and
a suture assembly comprising a length of suture, a capsule attached to a leading end of the suture, and an anchor coupled to the suture, where the anchor includes an anchor portion and a clasp portion that is formed as a single monolithic unit with the anchor portion, with the clasp portion is attachable to the implantable support;
wherein the needle is configured to form an opening in tissue prior to engaging with an open through-bore formed longitudinally through the capsule and pull the capsule through the opening to deliver the leading end of the suture outside of the patient.
7. The attachment system of claim 6 , wherein the capsule is sized for retention within the suturing head.
8. The attachment system of claim 6 , wherein the capsule is an annular tube and the through-bore is an axial bore formed through the capsule.
9. The attachment system of claim 6 , wherein the needle comprises one of a substantially straight needle and a curved needle.
10. The attachment system of claim 6 , wherein the anchor portion is located between the capsule and the clasp portion.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13/765,085 US20140052158A1 (en) | 2010-03-12 | 2013-02-12 | Implantable support attachment system and assembly |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DKPA201070096 | 2010-03-12 | ||
US12/723,854 US8398659B2 (en) | 2010-03-12 | 2010-03-15 | Method of intracorporeally suturing tissue |
US13/765,085 US20140052158A1 (en) | 2010-03-12 | 2013-02-12 | Implantable support attachment system and assembly |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US12/723,854 Continuation US8398659B2 (en) | 2010-03-12 | 2010-03-15 | Method of intracorporeally suturing tissue |
Publications (1)
Publication Number | Publication Date |
---|---|
US20140052158A1 true US20140052158A1 (en) | 2014-02-20 |
Family
ID=43971204
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US12/723,854 Expired - Fee Related US8398659B2 (en) | 2010-03-12 | 2010-03-15 | Method of intracorporeally suturing tissue |
US12/943,027 Active US8226686B2 (en) | 2010-03-12 | 2010-11-10 | Implantable support attachment system and assembly |
US13/765,085 Abandoned US20140052158A1 (en) | 2010-03-12 | 2013-02-12 | Implantable support attachment system and assembly |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US12/723,854 Expired - Fee Related US8398659B2 (en) | 2010-03-12 | 2010-03-15 | Method of intracorporeally suturing tissue |
US12/943,027 Active US8226686B2 (en) | 2010-03-12 | 2010-11-10 | Implantable support attachment system and assembly |
Country Status (4)
Country | Link |
---|---|
US (3) | US8398659B2 (en) |
EP (1) | EP2544597B1 (en) |
ES (1) | ES2476286T3 (en) |
WO (1) | WO2011110182A1 (en) |
Families Citing this family (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2014085827A1 (en) | 2012-11-30 | 2014-06-05 | The Regents Of The University Of Colorado, A Body Corporate | Medical fabric with integrated shape memory polymer |
US9820842B2 (en) | 2008-09-30 | 2017-11-21 | The Regents Of The University Of Colorado, A Body Corporate | Medical fabric with integrated shape memory polymer |
US20110046642A1 (en) * | 2009-08-21 | 2011-02-24 | Coloplast A/S | Suture assembly and system |
WO2012034126A1 (en) * | 2010-09-10 | 2012-03-15 | The Regents Of The University Of Colorado, A Body Corporate | Medical fabric with integrated shape memory polymer |
DK201170308A (en) * | 2011-06-17 | 2012-12-18 | Coloplast As | Suturing assembly providing bi-directional needle movement through uni-directional actuator movement |
US8992550B2 (en) * | 2011-07-20 | 2015-03-31 | Coloplast A/S | Suture system with capsule eyelet providing multiple suture tissue fixation |
US8752230B2 (en) * | 2011-08-01 | 2014-06-17 | Misder, Llc | Device with handle actuated element |
US9775699B2 (en) * | 2012-04-13 | 2017-10-03 | Boston Scientific Scimed, Inc. | Adjustable implant for the treatment of urinary incontinence |
CA2905345A1 (en) | 2013-03-15 | 2014-09-25 | Ams Research Corporation | Systems, tools, and methods for connecting to tissue |
USD816852S1 (en) | 2016-04-11 | 2018-05-01 | Coloplast A/S | Implantable support |
USD801539S1 (en) * | 2016-04-11 | 2017-10-31 | Coloplast A/S | Implantable support |
USD816853S1 (en) | 2016-04-11 | 2018-05-01 | Coloplast A/S | Implantable support |
USD825063S1 (en) * | 2016-04-11 | 2018-08-07 | Coloplast A/S | Implantable support |
US10849617B1 (en) | 2020-02-11 | 2020-12-01 | King Saud University | Piercing forceps |
Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5665109A (en) * | 1994-12-29 | 1997-09-09 | Yoon; Inbae | Methods and apparatus for suturing tissue |
US5792153A (en) * | 1994-03-23 | 1998-08-11 | University College London | Sewing device |
US6551330B1 (en) * | 2000-09-21 | 2003-04-22 | Opus Medical, Inc. | Linear suturing apparatus and methods |
US20080065156A1 (en) * | 2006-09-08 | 2008-03-13 | Hauser David L | Expandable clip for tissue repair |
US8226666B2 (en) * | 2003-03-14 | 2012-07-24 | Edwards Lifesciences Corporation | Mitral valve repair system and method for use |
US8313498B2 (en) * | 2005-08-08 | 2012-11-20 | Abbott Laboratories | Vascular suturing device |
US8608758B2 (en) * | 2009-03-11 | 2013-12-17 | DePuy Synthes Products, LLC | Threadable knot soft tissue defect repair system |
Family Cites Families (29)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US2006622A (en) * | 1933-01-30 | 1935-07-02 | Charles Pearis | Terminal box |
US4345601A (en) | 1980-04-07 | 1982-08-24 | Mamoru Fukuda | Continuous suturing device |
US5333624A (en) | 1992-02-24 | 1994-08-02 | United States Surgical Corporation | Surgical attaching apparatus |
US5330442A (en) | 1992-10-09 | 1994-07-19 | United States Surgical Corporation | Suture retaining clip |
GB9510624D0 (en) * | 1995-05-25 | 1995-07-19 | Ellis Dev Ltd | Textile surgical implants |
ATE371409T1 (en) | 1998-05-21 | 2007-09-15 | Christopher J Walshe | SYSTEM FOR FIXING TISSUE |
DE19964081B4 (en) | 1999-12-29 | 2005-06-30 | Ethicon Gmbh | Stripe-type implant and surgical gripping instrument |
US6582443B2 (en) | 2000-12-27 | 2003-06-24 | Ams Research Corporation | Apparatus and methods for enhancing the functional longevity and for facilitating the implantation of medical devices |
US6612977B2 (en) | 2001-01-23 | 2003-09-02 | American Medical Systems Inc. | Sling delivery system and method of use |
US7371245B2 (en) | 2002-08-02 | 2008-05-13 | C R Bard, Inc | Transobturator introducer system for sling suspension system |
JP5058969B2 (en) | 2005-04-06 | 2012-10-24 | ボストン サイエンティフィック リミテッド | System, apparatus and method for suburethral support |
WO2006119273A2 (en) | 2005-05-04 | 2006-11-09 | Ams Research Corporation | Apparatus for securing and tensioning a urethral sling to public bone |
US8864650B2 (en) | 2005-06-21 | 2014-10-21 | Ams Research Corporation | Methods and apparatus for securing a urethral sling to a pubic bone |
WO2007008209A1 (en) | 2005-07-13 | 2007-01-18 | Boston Scientific Scimed Inc. | Snap fit sling anchor system and related methods |
US7981023B2 (en) | 2005-07-25 | 2011-07-19 | Boston Scientific Scimed, Inc. | Elastic sling system and related methods |
WO2007014241A1 (en) | 2005-07-25 | 2007-02-01 | Boston Scientific Scimed, Inc. | Pelvic floor repair system |
DE102005035762A1 (en) | 2005-07-29 | 2007-02-01 | Süd-Chemie AG | Producing highly porous layers comprises providing a substrate with a surface; modifying substrate surface section to produce surface-modified sections; and applying methyl orthoformate on the surface-modified sections of the substrate |
WO2007059368A1 (en) * | 2005-11-11 | 2007-05-24 | Ams Research Corporation | Integral sling connection system and method |
EP2617385B1 (en) | 2006-03-16 | 2017-07-19 | Boston Scientific Limited | System for treating tissue wall prolapse |
AU2007257870B2 (en) | 2006-06-08 | 2013-08-15 | Boston Scientific Scimed, Inc. | Method and apparatus for levator distension repair |
EP2063790B1 (en) | 2006-10-26 | 2016-01-27 | AMS Research Corporation | Surgical articles for treating pelvic conditions |
WO2008067317A2 (en) | 2006-11-27 | 2008-06-05 | Prosurg, Inc. | Method and apparatus for supporting body organs, urethra and bladder neck |
AU2008203927B2 (en) | 2007-01-03 | 2013-10-03 | Boston Scientific Scimed, Inc. | Methods for installing sling to treat fecal incontinence, and related devices |
US20090099409A1 (en) | 2007-10-16 | 2009-04-16 | Luehrs Kirsten F | Medical sheet |
US8236013B2 (en) | 2007-10-19 | 2012-08-07 | Boston Scientific Scimed, Inc. | Apparatus for placing medical implants |
US9439746B2 (en) | 2007-12-13 | 2016-09-13 | Insightra Medical, Inc. | Methods and apparatus for treating ventral wall hernia |
US20090216072A1 (en) | 2008-02-27 | 2009-08-27 | Ralph Zipper | Urinary incontinence sling apparatus and method |
US20090222027A1 (en) | 2008-02-28 | 2009-09-03 | Lsi Solutions, Inc. | Ferrule holder with suture relief lobes |
US20090228021A1 (en) | 2008-03-06 | 2009-09-10 | Leung Jeffrey C | Matrix material |
-
2010
- 2010-03-15 US US12/723,854 patent/US8398659B2/en not_active Expired - Fee Related
- 2010-11-10 US US12/943,027 patent/US8226686B2/en active Active
-
2011
- 2011-03-11 WO PCT/DK2011/050079 patent/WO2011110182A1/en active Application Filing
- 2011-03-11 EP EP11710411.7A patent/EP2544597B1/en not_active Not-in-force
- 2011-03-11 ES ES11710411.7T patent/ES2476286T3/en active Active
-
2013
- 2013-02-12 US US13/765,085 patent/US20140052158A1/en not_active Abandoned
Patent Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5792153A (en) * | 1994-03-23 | 1998-08-11 | University College London | Sewing device |
US5665109A (en) * | 1994-12-29 | 1997-09-09 | Yoon; Inbae | Methods and apparatus for suturing tissue |
US6551330B1 (en) * | 2000-09-21 | 2003-04-22 | Opus Medical, Inc. | Linear suturing apparatus and methods |
US8226666B2 (en) * | 2003-03-14 | 2012-07-24 | Edwards Lifesciences Corporation | Mitral valve repair system and method for use |
US8313498B2 (en) * | 2005-08-08 | 2012-11-20 | Abbott Laboratories | Vascular suturing device |
US20080065156A1 (en) * | 2006-09-08 | 2008-03-13 | Hauser David L | Expandable clip for tissue repair |
US8608758B2 (en) * | 2009-03-11 | 2013-12-17 | DePuy Synthes Products, LLC | Threadable knot soft tissue defect repair system |
Also Published As
Publication number | Publication date |
---|---|
US20110224697A1 (en) | 2011-09-15 |
EP2544597A1 (en) | 2013-01-16 |
US8398659B2 (en) | 2013-03-19 |
ES2476286T3 (en) | 2014-07-14 |
WO2011110182A1 (en) | 2011-09-15 |
EP2544597B1 (en) | 2014-05-07 |
US8226686B2 (en) | 2012-07-24 |
US20110224698A1 (en) | 2011-09-15 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US8226686B2 (en) | Implantable support attachment system and assembly | |
US11529223B2 (en) | Method of attaching a surgical suture inside of a pelvis | |
US10363027B2 (en) | Suture assembly including a suture attached to a leader | |
US8852212B2 (en) | Suturing system and assembly | |
US10278691B2 (en) | Suture assembly including a suture clip | |
US8623033B2 (en) | Suture system with capsule eyelet providing multiple suture tissue fixation | |
US8591528B2 (en) | Suture system and assembly including a suture cap formed around a tubular sleeve | |
US20120197270A1 (en) | Suture system and assembly including a leader plug | |
US8562622B2 (en) | Suturing device with suturing capsule removal mechanism |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: COLOPLAST A/S, DENMARK Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:DEITCH, SARAH J.;DRAVIS, DANIEL J.;THEIRFELDER, CHRISTOPHER A.;REEL/FRAME:029959/0289 Effective date: 20100406 |
|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |