Noninvasive suture delivery devices

Abstract

Noninvasive suture delivery devices are disclosed. In accordance with an implementation, a suture delivery device includes a handle, a first arm, a second arm, and a crimp assembly. The first arm is coupled to and extends from the handle and has a distal end. The distal end of the first arm has a fastener aperture and a first suture holder having an opening and a groove. The second arm extends from the handle and has a distal end. The distal end of the second arm has a second suture holder having an opening and a groove. The fastener aperture is to carry a fastener and actuating the crimp assembly enables the crimp assembly to crimp the fastener.

Description

NONINVASIVE SUTURE DELIVERY DEVICESFIELD OF THE DISCLOSURE

[0001] This application claims the benefit of and priority to U.S. Provisional Patent Application Number 63 / 541 ,657, filed September 29, 2023, the content of which is incorporated by reference herein in its entireties and for all purposes.FIELD OF THE DISCLOSURE

[0002] This disclosure relates generally to medical devices and, more particularly, to noninvasive suture delivery devices.BACKGROUND

[0003] Preterm birth is defined as a birth that occurs before 37 weeks of gestation, which can be further categorized into extreme preterm (<28 weeks), very preterm (28-32 weeks), moderate preterm (32-24 weeks) and late preterm (34-36 weeks). Pregnancies at or beyond 37 weeks of gestation are considered “term” pregnancies. Preterm birth is the leading cause of death for children younger than 5 years of age, with more than a million infant deaths attributed to preterm birth annually. Globally, over 15 million births are preterm annually.

[0004] Preterm births may occur for a number of reasons ranging from behavioral (smoking or drinking during pregnancy) and previous uterine or cervical trauma, to physiological issues such as cervical insufficiency or “short cervix.” Cervical insufficiency (also known as cervical weakness or cervical incompetence) is an obstetric condition wherein the cervix begins to dilate and thin in the early second trimester (14-20 weeks), which can lead to miscarriage or an extremely preterm birth. Cervical shortening, which can be measured during an ultrasound exam, refers to abnormally shallow cervical tissue. A short cervical length directly correlates with risk of preterm birth. For example, cervical length less than 25 mm carries an 18% risk of preterm birth, while length less than 15 mm carries a 50% risk of preterm birth.

[0005] Depending on the potential underlying cause, there are a variety of treatments and mitigation strategies to address preterm birth risk, including: behavioral modification to minimize risk factors (smoking cessation, modified bed rest, etc.); progesterone and progesterone analogues to address shortened cervix; cervical pessary- a silicone 'cap' that seals the cervix and is designed to prevent the onset of labor; and surgical intervention to strengthen and close the cervix, a technique known as cervical cerclage.

[0006] The cervical cerclage technique, developed in the 1950s, has remained virtually unchanged since its initial development and carries significant health risks for both the mother and fetus. Cervical cerclage, which is also known as a cervical stitch, is a medical treatment in which a strong suture is sewn into and around the cervix to keep it closed and prevent miscarriage or preterm birth. The procedure includes placing a non-absorbable suture trans- vaginally through the cervix to support an ongoing pregnancy and prevent premature shortening or opening of the cervix. The procedure is then reversed at 37 weeks by removing the suture, once the pregnancy has technically made it to “term.” The major draw backs to this procedure are the potential for serious complications including rupture of membranes, premature labor, injury to the cervix or bladder, need for general or spinal anesthesia and bleeding. Another drawback is the cervical cerclage has not shown any clinical benefit in women with a multi- gestational pregnancy, which is one of the leading causes of preterm birth.

[0007] While cervical cerclage is generally effective (80% reduction of preterm birth risk in treated vs. untreated populations in clinical studies), the surgical technique carries significant risks for the mother including negative reactions to general anesthesia, blood loss, and hospital acquired infection. The procedure is also of significant risk to the fetus, as nicking the amniotic membrane or infection of the amniotic sac can lead to even earlier preterm birth or miscarriage.

[0008] Currently, obstetricians have a way to screen pregnant women for cervical insufficiency through the use of abdominal and / or transvaginal ultrasound. This practice has not gained universal acceptance because there is no clear intervention that can be offered to all women with a short cervix found on ultrasound that has been shown to be effective and safe.SUMMARY

[0009] In accordance with a first implementation, a suture delivery device includes a handle, a first arm, a second arm, and a crimp assembly. The first arm is coupled to and extends from the handle and has a distal end. The distal end of the first arm has a fastener aperture and a first suture holder having an opening and a groove. The second arm extends from the handle and has a distal end. The distal end of the second arm has a second suture holder having an opening and a groove. The fastener aperture is to carry a fastener and actuating the crimp assembly enables the crimp assembly to crimp the fastener.

[0010] In accordance with a second implementation, a suture delivery device includes a handle, a first arm, a plurality of second arms, and a crimp assembly. The first arm is coupled to and extends from the handle and has a distal end. The distal end of the first arm has a fasteneraperture. Each of the plurality of second arms extend from the first arm and each has a distal end. The distal end of each of the second arms has a suture holder having an opening and a groove. The fastener aperture is to carry a fastener and actuating the crimp assembly enables the crimp assembly to crimp the fastener.

[0011] In accordance with a third implementation, a suture delivery device includes a handle, a first arm, and a second arm. The first arm is coupled to and extends from the handle and includes a distal end. The distal end of the first arm includes a first arc-shaped suture holder including an opening and a groove. The second arm extends from the handle and includes a distal end. The distal end of the second arm includes a second arc-shaped suture holder including an opening and a groove.

[0012] In accordance with a fourth implementation, a suture delivery device includes a handle, a first arm, a second arm, a crimp assembly, and a rachet and pawl mechanism. The first arm is coupled to and extends from the handle and includes a distal end. The distal end of the first arm has a fastener aperture and a first suture holder including an opening and a groove. The second arm extends from the handle and has a distal end. The distal end of the second arm has a second suture holder that includes an opening and a groove. The rachet and pawl mechanism is carried by the handle to tighten a suture.

[0013] In further accordance with the foregoing first, second, third, and / or fourth implementations, an apparatus and / or method may further include or comprise any one or more of the following:

[0014] In an implementation, the suture delivery device includes a coupling. The second arm includes a proximal end and the coupling couples the proximal end of the second arm to the first arm.

[0015] In another implementation, the second arm is flexible.

[0016] In another implementation, the distal end of the second arm is outwardly biased away from the first arm.

[0017] In another implementation, the suture delivery device includes a suture including a loop and a tail. The loop is positionable within the groove of the first suture holder and the groove of the second suture holder.

[0018] In another implementation, the suture delivery device includes a tail handle. The tail of the suture has a distal end coupled to the tail handle.

[0019] In another implementation, the tail handle has a ring.

[0020] In another implementation, the tail handle has a clip to enable the tail handle to be coupled to the first arm.

[0021] In another implementation, the suture delivery device includes a fastener positioned within the fastener aperture. The tail of the suture passes through the fastener.

[0022] In another implementation, the fastener includes a grommet.

[0023] In another implementation, the distal end of the first arm defines a suture aperture and the tail of the suture passes through the suture aperture.

[0024] In another implementation, the fastener aperture faces the second arm.

[0025] In another implementation, the first arm has a longitudinal axis and the fastener aperture has a longitudinal axis that is substantially perpendicular relative to the longitudinal axis of the first arm.

[0026] In another implementation, the groove of the first suture holder and the groove of the second suture holder face one another.

[0027] In another implementation, the first suture holder and the second suture holder have surfaces that define the openings and an interference fit is formed between the suture and the surfaces of the first suture holder and the second suture holder that define the openings.

[0028] In another implementation, the crimp assembly has a trigger, a link, and a rod. The trigger is pivotably coupled to the handle. The rod is movably positioned within the first arm and has a distal end. The link couples the trigger and the rod.

[0029] In another implementation, movement of the trigger about the pivot linearly moves the rod within the first arm to enable the distal end of the rod to engage and crimp the fastener.

[0030] In another implementation, the first arm has a longitudinal axis and the fastener aperture has a longitudinal axis that is substantially coaxial with the longitudinal axis of the first arm.

[0031] In another implementation, the distal ends of the second arms are outwardly biased away from the first arm.

[0032] In another implementation, the second arms are movable between a collapsed position and an expanded position.

[0033] In another implementation, the suture delivery device includes an arm lock to secure the second arms in the collapsed position.

[0034] In another implementation, the first arm has a longitudinal axis and the arm lock has a ring that surrounds the first arm and the second arms and is movable along the longitudinal axis of the first arm to enable the second arms to be in the collapsed position or the expanded position.

[0035] In another implementation, the suture delivery device includes a suture including a loop and a tail. The loop is positionable within the grooves of the suture holders.

[0036] In another implementation, the suture delivery device includes a suture tensioner including a reel carried by the first arm.

[0037] In another implementation, the suture delivery device includes a suture including a loop and a tail. The loop is positionable within the grooves of the suture holders. The suture wrapped around the reel.

[0038] In another implementation, the crimp assembly has a trigger, a link, and a rod. The trigger is pivotably coupled to the handle. The rod is movably positioned within the first arm and has a distal end. The link couples the trigger and the rod.

[0039] In another implementation, the suture delivery device includes a tension gauge carried by the first arm.

[0040] In another implementation, the suture delivery device includes a tension gauge.

[0041] In another implementation, the tension gauge includes a spring and a housing including a spring housing, a U-shaped coupling extending from the spring housing, and a slider. The spring is positioned and coupled within the spring housing and the slider is positioned around and movable along the first arm.

[0042] In another implementation, the suture delivery device includes a suture tensioner including a reel carried by the first arm. The suture delivery device further includes a tether and a suture. The tether coupled to and between the suture tensioner and the U-shaped coupling. The second suture includes a loop and a tail. The loop is positionable within the grooves of the suture holders and the tail coupled to the spring.

[0043] In another implementation, the first arm includes a fastener aperture. The suture delivery device includes a crimp assembly. The fastener aperture is to carry a fastener and actuating the crimp assembly enables the crimp assembly to crimp the fastener.

[0044] In another implementation, the suture delivery device includes a tension gauge.

[0045] In another implementation, the tension gauge is carried by the first arm.

[0046] In another implementation, the tension gauge includes a spring and a housing including a spring housing, a U-shaped coupling extending from the spring housing, and a slider. The spring is positioned and coupled within the spring housing and the slider is positioned around and movable along the first arm.

[0047] In another implementation, each of the first arc-shaped suture holder and the second arc-shaped suture holder comprise an arc length that is between about 25% and about 50% of a circumference of a cervix of between about 6.2 centimeters and about 9.42 centimeters.

[0048] In another implementation, the crimp assembly includes a trigger, a link, and a rod. The trigger is pivotably coupled to the handle. The rod is movably positioned within the first arm and has a distal end. The link couples the trigger and the rod.

[0049] In another implementation, the rachet and pawl mechanism includes a trigger, a driving pawl, a locking pawl, and a rachet wheel. Actuating the trigger causes the driving pawl to rotate the rachet wheel in a first direction and the locking pawl inhibits the rachet wheel from rotating in a second direction opposite the first direction.

[0050] In another implementation, the rachet wheel includes a central cylindrical hub around which the suture is to be wound.

[0051] In another implementation, the rachet and pawl mechanism includes a first spring to bias the trigger away from an actuated position and a second spring to bias the locking pawl into engagement with the rachet wheel.

[0052] In another implementation, the fastener aperture is to carry a fastener and actuating the crimp assembly enables the crimp assembly to crimp the fastener.Brief Description of the drawings

[0053] FIG. 1 is an isometric view of a suture delivery device in accordance with the teachings of this disclosure.

[0054] FIG. 2 is a cross-sectional detailed view of the suture delivery device of FIG. 1 and a schematic representation of a cervix and a vaginal canal.

[0055] FIG. 3 is an isometric view of the suture delivery device of FIG. 1 with a portion of the handle removed to further illustrate the crimp assembly.

[0056] FIG. 4 is another cross-sectional detailed view of the suture delivery device of FIG. 1 with the loop surrounding and tightened against the cervix.

[0057] FIG. 5 is an expanded view of another implementation of an example suture delivery device.

[0058] FIG. 6 is an isometric view of another implementation of an example suture delivery device in an expanded position.

[0059] FIG. 7 is an isometric view of the suture delivery device of FIG. 6 in the collapsed position.

[0060] FIG. 8 is a detailed isometric view of the suture delivery device of FIG. 6 showing the first arm and the second arms.

[0061] FIG. 9 shows the loop placed around the outside circumference of the cervix and secured in place by the fastener.

[0062] FIG. 10A is an isometric view of another implementation of an example suture delivery device in an expanded position.

[0063] FIG. 10B is a detailed isometric view of a portion of the example suture delivery device of FIG. 10B.

[0064] FIG. 1 1 is an isometric view of a suture holder that can be used to implement the suture holder of the suture delivery device of FIG. 1 .

[0065] FIG. 12 is a cross-sectional side view of an implementation of another suture delivery device.Detailed Description

[0066] FIG. 1 is an isometric view of a suture delivery device 100 in accordance with the teachings of this disclosure. The suture delivery device 100 includes a handle 102, a first arm 104, a second arm 106, and a crimp assembly 108 in the implementation shown. The first arm 104 is coupled to and extends from the handle 102 and has a distal end 110. The distal end 110 of the first arm 104 has a fastener aperture 112 and a first suture holder 114. The first suture holder 1 14 has an opening 116 and a groove 1 18. The second arm 106 extends from the handle 102 and has a distal end 120. The distal end 120 of the second arm 106 has a second suture holder 122 and includes an opening 116 and a groove 1 18. The suture holders 114, 122 may be referred to as suture arm clips. The fastener aperture 1 12 is shown carrying a fastener 124. The crimp assembly 108 is actuatable in operation in a direction generally indicated byarrow 126 to enable the crimp assembly 108 to crimp the fastener 124. The fastener 124 may be a grommet 128. The fastener 124 may be atraumatic. The fastener 124 may additionally or alternatively be implemented by a short metal sleeve and / or a one-way plastic sleeve. The plastic sleeve may be deformable thermoplastic and / or may be melted as examples.

[0067] A coupling 130 is included in the implementation shown that couples a proximal end 132 of the second arm 106 to the first arm 104. The coupling 130 is shown having a first sleeve 134 that surrounds the first arm 104 and a second sleeve 136 that surrounds the second arm 106. The second arm 106 may be coupled to the first arm 104 and / or to the handle 102 in another way, however. The coupling of the proximal end 132 of the second arm 106 to the first arm 104 enables the second arm 106 to extend from the handle 102 as an example.

[0068] The second arm 106 is flexible in the implementation shown. The second arm 106 being flexible allows the second arm 106 to move toward and / or adjacent to the first arm 104 and for the first arm 104 and the second arm 106 to be in a collapsed position. The distal end 120 of the second arm 106 may be outwardly biased away from the first arm 104. The second arm 106 being outwardly biased away from the first arm 104 allows the first arm 104 and the second arm 106 to be in an expanded position, as shown in FIG. 1 .

[0069] The suture delivery device 100 is shown carrying a suture 138 having a loop 140 and a tail 142. The suture 138 may be implemented by monofilament, a braided suture, a band / strap such as mersilene tape as examples. The suture 138 may additionally or alternatively be extensible or inextensible. The loop 140 is positioned within the groove 118 of the first suture holder 1 14 and the groove 118 of the second suture holder 122. The tail 142 of the suture 138 has a distal end 144 and a tail handle 146 is coupled to the distal end 144 of the suture 138. The distal end 144 of the suture 138 may be tied or otherwise coupled to the tail handle 146.

[0070] A user of the suture delivery device 100 may grasp the tail handle 146 and pull the tail handle 146 in a direction generally indicated by arrow 148 to pull the loop 140 of the suture 138 out of the first suture holder 114 and / or the second suture holder 122 and pull the loop 140 closed.

[0071] The tail handle 146 includes a ring 150 as shown. The tail handle 146 may have any other configuration, however. The tail handle 146 also has a clip 152 that enables the tail handle 146 to be coupled to the first arm 104. The clip 152 is shown having opposing arms 154 that are positioned about the coupling 130 to couple the tail handle 146 to the first arm 104 via thecoupling 130. The clip 152 may alternatively be directly coupled to the first arm 104 and / or another portion of the suture delivery device 100.

[0072] FIG. 2 is a cross-sectional detailed view of the suture delivery device 100 of FIG. 1 and a schematic representation of a cervix 156 and a vaginal canal 158. The arms 104, 106 may be in a collapsed position when inserting the arms 104, 106 through a speculum, into the vaginal canal 158, and up to the cervix 156. The arms 104, 106 may be released as shown in FIG. 2 to allow the loop 140 to be opened and placed over the cervix 156.

[0073] The first arm 104 and the second arm 106 are shown positioned within the vaginal canal 158 and on either side 160, 162 of the cervix 156. The loop 140 of the suture 138 is shown positioned within the grooves 118 of the first suture holder 114 and the second suture holder 122 and surrounding the cervix 156.

[0074] The fastener 124 is positioned within the fastener aperture 1 12 and the tail 142 of the suture 138 is shown passing through the fastener 124. The distal end 1 10 of the first arm 104 defines a suture aperture 164 and the tail 142 of the suture 138 passes through the suture aperture 164. The tail 142 of the suture 138 thus passes through both the fastener 124 and the suture aperture 164 of the first arm 104 and extends rearward to the tail handle 146.

[0075] The fastener aperture 112 of the first arm 104 faces the second arm 106 in the implementation shown. Axes of the first arm 104 and the fastener aperture 112 are substantially perpendicular. The phrase “substantially perpendicular” means between about + / - 5 of parallel including perpendicular itself and / or accounts for manufacturing tolerances as set forth herein. The fastener aperture 112 may be in a different orientation, however (e.g., see, FIG. 5). For example, the fastener aperture 112 may be positioned at the distal end of the first arm 104 facing forward as an example.

[0076] The groove 118 of the first suture holder 1 14 and the groove 1 18 of the second suture holder 122 face one another. Each of the first suture holder 1 14 and the second suture holder 122 have surfaces 166 that define the openings 116. The surfaces 166 and the suture 138 may form an interference fit when the suture 138 is passing through the opening 116. The surfaces 166 may be spaced to allow the suture 138 to pass through the corresponding opening 116 if a threshold amount of force is applied to the suture 138 by pulling the tail 142 of the suture 138 in the direction generally indicated by arrow 148. In an alternative implementation, the grove 1 18 could be shaped in a wedge formation where the wedge is designed to allow the suture 138 toenter into the opening but as the suture 138 is pushed deeper into the wedge an interference fit occurs, holding the suture 138 in place (see, FIG. 11 for example).

[0077] FIG. 3 is an isometric view of the suture delivery device 100 of FIG. 1 with a portion of the handle 102 removed to further illustrate the crimp assembly 108. The crimp assembly 108 has a trigger 168, a link 170, and a rod 172 in the implementation shown. The trigger 168 may be referred to as a squeeze handle. The trigger 168 is pivotably coupled to the handle 102, the rod 172 is movably positioned within the first arm 104, and the link 170 couples the trigger 168 and the rod 172. The trigger 168 is coupled to the handle 102 at a pivot 173. The trigger 168 is movable about the pivot 173 in a direction generally indicated by arrow 174 to linearly move the rod 172 within the first arm 104 in a direction generally by arrow 176 toward the fastener 124 to allow the rod 172 to engage and crimp the fastener 124. The rod 172 may directly or indirectly engage the fastener 124 when the fastener 124 is being crimped. The fastener 124, once crimped, secures the loop 140 of the suture 138 with a threshold tension about the cervix 156 to keep the loop 140 closed and inhibit miscarriage or preterm birth.

[0078] FIG. 4 is another cross-sectional detailed view of the suture delivery device 100 of FIG. 1 with the loop 140 surrounding and tightened against the cervix 156. The suture 138 is shown displaced from and spaced from the grooves 118 of the first suture holder 1 14 and the second suture holder 122. The fastener 124 is shown positioned within the fastener aperture 1 12 and the rod 172 is shown having a distal end 178 that is linearly movable within the first arm 104 to engage and crimp the fastener 124.

[0079] The user may pull on the suture 138 until the suture 138 is released from the suture holders 114, 122 in operation after the loop 140 is placed around the outside circumference of the cervix 156. The arms 104, 106 may include depth markings 180 to help position the suture 138 at a threshold depth on the cervix 156. The second arm 106 may be pulled back out and recollapsed down enabling adequate visualization of the suture 138 wrapped around the cervix 156. The second arm 106 may alternatively be removable from the suture delivery device 100 for further visualization of the cervix once the suture loop 140 has been disengaged from the suture holder 114, 122.

[0080] The user may actuate the trigger 168 of the crimp assembly 108 to crimp the fastener 124 to lock in the circumferential tension around the cervix 156 after a threshold tension level has been achieved in the suture 138. The suture 138 may also be cut away from the tail handle 146 either by hand or intentionally using a cutter within and / or otherwise carried by the suture delivery device 100. The suture 138 may be cut at a sufficiently long length such that the end ofthe tail 142 can be readily retrieved in the vagina for subsequent removal of the cerclage later on in the pregnancy.

[0081] FIG. 5 is a detailed view of another implementation of an example suture delivery device 200. The suture delivery device 200 of FIG. 5 is similar to the suture delivery device 100 of FIG. 1 . The first arm 104 has a longitudinal axis and the fastener aperture 112 has a longitudinal axis that is substantially coaxial with the longitudinal axis of the first arm 104, however. The phrase “substantially coaxial” means between about + / -5“ of coaxial including coaxial itself and / or accounts for manufacturing tolerances as set forth herein. The suture aperture 164 of the suture delivery device 200 is shown at least partially facing the second arm 106.

[0082] FIG. 6 is an isometric view of another implementation of an example suture delivery device 300 in an expanded position. The suture delivery device 300 has a handle 102, a first arm 304, a plurality of second arms 306, and a crimp assembly 108. The first arm 304 is coupled to and extends from the handle 102 and has a distal end 110 having a fastener aperture 112. The second arms 306 extend from the first arm 304 and each have a distal end 120 including a suture holder 308. The suture holder 308 has an opening 1 16 and a groove 1 18. The crimp assembly 108 may be actuated in a direction generally indicated by the arrow 174 to enable the crimp assembly 108 to crimp the fastener 124 carried by the fastener aperture 1 12. One or more of the arms 304, 306 may be flexible in the implementation shown so that the arms 304 and / or 306 may be concentrically collapsed, reducing the cross-sectional area of the suture delivery device 300 during insertion. The arms 304 and / or 306 may spring outward to position the arms 304 and / or 306 in the expanded position.

[0083] The distal ends 120 of the second arms 306 are outwardly biased away from the first arm 304 in the implementation shown. The second arms 306 are also movable between a collapsed position shown in FIG. 7 and an expanded position shown in FIG. 6.

[0084] FIG. 7 is an isometric view of the suture delivery device 300 of FIG. 6 in the collapsed position. An arm lock 310 is included in the implementation shown to secure the second arms 306 in the collapsed position. The arm lock 310 has a ring 314 that surrounds the first arm 304 and the second arms 306 and is movable along the longitudinal axis of the first arm 304 in a direction generally indicated by arrow 316 to enable the second arms 306 to be in the collapsed position or the expanded position. The ring 324 may secure the second arms 306 in the collapsed position as shown.

[0085] The suture delivery device 300 also has a suture tensioner 318 having a reel 320 carried by the first arm 304. The suture 138 may be wrapped around the reel 320 to allow tension to be placed on the suture 138 when the loop 140 of the suture 138 is pulled and / or when the reel is rotated. The reel 320 may be referred to as a suture tensioner. The user can rotate the reel 320 until a threshold circumferential tension is created by the loop 140 around the cervix 156 as an example. The suture tensioner 318 may include a torque limiting feature and / or a torque level indicator in some implementations. Once the threshold tension level has been satisfied in the suture 138, the user may actuate the trigger 168 of the crimp assembly 108 to crimp the fastener 124 to lock in the circumferential tension around the cervix 156.

[0086] FIG. 8 is a detailed isometric view of the suture delivery device of FIG. 6 showing the first arm 304 and the second arms 306.

[0087] FIG. 9 shows the loop 140 placed around the outside circumference of the cervix 156 and secured in place by the fastener 124.

[0088] FIG. 10A is an isometric view of another implementation of an example suture delivery device 700 in an expanded position. The suture delivery device 700 of FIG. 7 is similar to the suture delivery device 100 of FIG. 1 . The suture delivery device 700 of FIG. 7 includes a tension gauge 702 carried by the first arm 104. The tension gauge 702 includes a housing 704 and a spring 706 disposed within the housing 704. The spring 706 may be a coil spring or any other type of spring. The spring 706 may alternatively be implemented by an electronic force transducer as an example. The housing 704 has a spring housing 708, a U-shaped coupling 710, and a slider 712. The slider 712 is positioned around the first arm 104 and is movable along the first arm 104.

[0089] The spring housing 708 has a distal end 714 including an opening 716, a side opening 718, and a proximal end 720 from which the U-shaped coupling 710 extends. The spring housing 708 also includes a visual indicator 722. The visual indicator 722 may be a marking on an exterior surface of the spring housing 708, for example.

[0090] The spring 706 is disposed within the spring housing 708 and is coupled at the proximal end 720 of the spring housing 708. The U-shaped coupling 710 has a first leg 724 and a second leg 726 and defines a slot 727. The first leg 724 is coupled to the proximal end 720 of the spring housing 708 and an opening 728 is defined between the second leg 726 and the proximal end 720. A tether 730 may be positioned through the opening 728 and is shown positioned in the slot 727 to couple the U-shaped coupling 710 and the suture tensioner 318.The suture tensioner 318 is shown on the side of the handle 102. The suture tensioner 318 may alternatively be positioned on the rear and / or internally within the handle 102 as examples.

[0091] The tail 142 of the suture 138 is coupled to the spring 706 and the loop 140 of the suture 138 is positioned within the suture holders 114, 122. The tether 730 is thus coupled to the suture 138 through the U-shaped coupling 710.

[0092] The suture holders 1 14 and / or 122 may have an arc length that is between about 25% and about 50% of the circumference of the cervix as an example. The suture holders 114, 122 may be referred to as arc-shaped suture holders. The circumference of the cervix may be between about 6.2 centimeters and about 9.42 centimeters. The size and / or shape of the suture holders 114, 122 enables the suture delivery device 700 to more easily deliver the loop 140 over the cervix as an example. The tether 730 may be referred to as the first suture or a coupling.

[0093] In operation, the suture 138 is coupled to the spring 706 by accessing the spring 706 through the side opening 718 of the spring housing 708 and the tether 730 is positioned within the slot 727 and coupled to the suture tensioner 318. The tether 730 may be wrapped around the reel 320 to allow tension to be placed on the sutures 138, 730 when the loop 140 of the suture 138 is pulled and / or when the reel 320 is rotated. The suture tensioner 381 may additionally or alternatively include a positionable ratchet mechanism. The slider 712 may slide on the first arm 104 toward the handle 102 as tension is placed on the suture 138, 730 and the spring 706 may expand and / or lengthen. A portion of the spring 706 being at the indicator 722 may represent that the suture 138 is at a threshold amount of tension. In an alternative implementation, the indicator 722 includes multiple markings to indicate different tension levels on the suture 138. For example, but not limited to, tensions between about 5 N and about 20 N may be indicated using the tension gauge 702. In another implementation, the indicator 722 could be a screen that reports the force read by a force transducer. The indicator 722 could also be located in other locations, such as the handle 102 in instances where the tension gauge 702 is integrated within the handle 102 rather than placed on the first arm 104.

[0094] The crimp assembly 108 may be actuated to crimp the fastener 124 when the threshold amount of tension is applied to the suture 138. The threshold amount of tension may be different depending on the situation.

[0095] FIG. 10B is a detailed isometric view of a portion of the example suture delivery device 700 of FIG. 10A. The tension gauge 702 is shown being carried by the first arm 104. The tension gauge 702 may carried by the suture delivery device 700 in a different way, however.

[0096] FIG. 1 1 is an isometric view of a suture holder 800 that can be used to implement the suture holder 114, 122 of the suture delivery device 100 of FIG. 1 . The suture holder 800 includes a base 802 and an arced arm 804 coupled to the base 802. The base 802 has a central opening 806 that receives the first arm 104 and a side opening 808 enabling access to the fastener aperture 112.

[0097] The arced arm 804 includes a groove 810 having an opening 812. The loop 140 of the suture 138 is pressed into the groove 810 in practice to create an interference fit and couple the loop 140 of the suture 138 and the suture holder 800. The arced arm 804 may have an arc length that is between about 25% and about 50% of the circumference of the cervix as an example.

[0098] FIG. 12 is a cross-sectional side view of an implementation of another suture delivery device 1200. The suture delivery device 1200 of FIG. 12 is similar to the suture delivery device 700 of FIG. 10A in that the suture delivery device 1200 includes the handle 102, first arm 104, the second arm 106, and the crimp assembly 108. In contrast to the suture delivery device 700 of FIG. 10A, the suture delivery device 1200 includes a rachet and pawl mechanism 1202 carried by the handle 102 to tighten a suture. The rachet and pawl mechanism 1202 may be used to tighten the loop 140 of the suture 138 around the cervix 156, for example.

[0099] The rachet and pawl mechanism 1202 includes a trigger 1204, a driving pawl 1206, a locking pawl 1208, and a rachet wheel 1210. The trigger 1204 may be referred to as a rachet trigger. Actuating the trigger 1204 causes the driving pawl 1206 to rotate the rachet wheel 1210 in a first direction 1212 and the locking pawl 1208 inhibits the rachet wheel 1210 from rotating in a second direction opposite the first direction 1212. The trigger 1204 may be actuated by moving the trigger 1204 relative to the handle 102 in a direction generally indicated by arrow 1216. The rachet wheel 1210 has a central cylindrical hub 1218 around which the suture is wound in operation.

[0100] The rachet and pawl mechanism 1202 also has a first spring 1220 and a second spring 1222. The first spring 1220 biases the trigger 1204 away from an actuated position and in a direction generally opposite that indicated by the arrow 1216 and the second spring 1222 biases the locking pawl 1208 into engagement with the rachet wheel 1210 in the implementation shown.

[0101] Further, while several examples have been disclosed herein, any features from any examples may be combined with or replaced by other features from other examples. Moreover,while several examples have been disclosed herein, changes may be made to the disclosed examples without departing from the scope of the claims.

Claims

What is Claimed is:1 . A suture delivery device, comprising: a handle; a first arm coupled to and extending from the handle and comprising a distal end, the distal end of the first arm comprising a fastener aperture and a first suture holder comprising an opening and a groove; a second arm extending from the handle and comprising a distal end, the distal end of the second arm comprising a second suture holder comprising an opening and a groove; and a crimp assembly, wherein the fastener aperture is to carry a fastener and wherein actuating the crimp assembly enables the crimp assembly to crimp the fastener.

2. The suture delivery device of claim 1 , further comprising a coupling, wherein the second arm comprises a proximal end and wherein the coupling couples the proximal end of the second arm to the first arm.

3. The suture delivery device of any one of the preceding claims, wherein the second arm is flexible.

4. The suture delivery device of any one of the preceding claims, wherein the distal end of the second arm is outwardly biased away from the first arm.

5. The suture delivery device of any one of the preceding claims, further comprising a suture comprising a loop and a tail, the loop positionable within the groove of the first suture holder and the groove of the second suture holder.

6. The suture delivery device of claim 5, further comprising a tail handle, wherein the tail of the suture comprises a distal end coupled to the tail handle.

7. The suture delivery device of claim 6, wherein the tail handle comprises a ring.

8. The suture delivery device of any one of claims 6 - 7, wherein the tail handle comprises a clip to enable the tail handle to be coupled to the first arm.

9. The suture delivery device of any one of claims 5 - 8, further comprising a fastener positioned within the fastener aperture, wherein the tail of the suture passes through the fastener.

10. The suture delivery device of claim 9, wherein the fastener comprises a grommet.11 . The suture delivery device of any one of claims 5 - 10, wherein the distal end of the first arm defines a suture aperture and wherein the tail of the suture passes through the suture aperture.

12. The suture delivery device of any one of the preceding claims, wherein the fastener aperture faces the second arm.

13. The suture delivery device of any one of the preceding claims, wherein the first arm has a longitudinal axis and the fastener aperture has a longitudinal axis that is substantially perpendicular relative to the longitudinal axis of the first arm.

14. The suture delivery device of any one of the preceding claims, wherein the groove of the first suture holder and the groove of the second suture holder face one another.

15. The suture delivery device of claims 13 - 14, wherein the first suture holder and the second suture holder comprise surfaces that define the openings and wherein an interference fit is formed between the suture and the surfaces of the first suture holder and the second suture holder that define the openings.

16. The suture delivery device of any one of the preceding claims, wherein the crimp assembly comprises a trigger, a link, and a rod, the trigger pivotably coupled to the handle, the rod movably positioned within the first arm and having a distal end, and the link coupling the trigger and the rod.

17. The suture delivery device of claim 16, wherein movement of the trigger about the pivot linearly moves the rod within the first arm to enable the distal end of the rod to engage and crimp the fastener.

18. The suture delivery device of any one of claims 1 - 5 and 7 - 17, wherein the first arm has a longitudinal axis and the fastener aperture has a longitudinal axis that is substantially coaxial with the longitudinal axis of the first arm.

19. The suture delivery device of any one of the preceding claims, further comprising a tension gauge.

20. The suture delivery device of claim 19, wherein the tension gauge comprises a spring and a housing comprising a spring housing, a U-shaped coupling extending from the spring housing, and a slider, the spring positioned and coupled within the spring housing and the slider is positioned around and movable along the first arm.21 . The suture delivery device of claim 19, further comprising a suture tensioner comprising a reel carried by the first arm, further comprising a tether and a suture, the tether coupled to and between the suture tensioner and the U-shaped coupling, the suture comprising a loop and a tail, the loop positionable within the grooves of the suture holders and the tail coupled to the spring.

22. A suture delivery device, comprising: a handle; a first arm coupled to and extending from the handle and comprising a distal end, the distal end of the first arm comprising a fastener aperture; a plurality of second arms extending from the first arm and each comprising a distal end, the distal end of each of the second arms comprising a suture holder comprising an opening and a groove; and a crimp assembly, wherein the fastener aperture is to carry a fastener and wherein actuating the crimp assembly enables the crimp assembly to crimp the fastener.

23. The suture delivery device of claim 22, wherein the distal ends of the second arms are outwardly biased away from the first arm.

24. The suture delivery device of any one of claims 22 - 23, wherein the second arms are movable between a collapsed position and an expanded position.

25. The suture delivery device of claim 24, further comprising an arm lock to secure the second arms in the collapsed position.

26. The suture delivery device of claim 25, wherein the first arm comprises a longitudinal axis and wherein the arm lock comprises a ring that surrounds the first arm and thesecond arms and is movable along the longitudinal axis of the first arm to enable the second arms to be in the collapsed position or the expanded position.

27. The suture delivery device of any one of claims 22 - 26, further comprising a suture comprising a loop and a tail, the loop positionable within the grooves of the suture holders.

28. The suture delivery device of any one of claims 22 - 27, further comprising a suture tensioner comprising a reel carried by the first arm.

29. The suture delivery device of claim 28, further comprising a suture comprising a loop and a tail, the loop positionable within the grooves of the suture holders, the suture wrapped around the reel.

30. The suture delivery device of any one of claims 22 - 29, wherein the crimp assembly comprises a trigger, a link, and a rod, the trigger pivotably coupled to the handle, the rod movably positioned within the first arm and having a distal end, and the link coupling the trigger and the rod.31 . The suture delivery device of claim 1 , wherein the second arm is flexible.

32. The suture delivery device of claim 1 , wherein the distal end of the second arm is outwardly biased away from the first arm.

33. The suture delivery device of claim 1 , further comprising a suture comprising a loop and a tail, the loop positionable within the groove of the first suture holder and the groove of the second suture holder.

34. The suture delivery device of claim 33, further comprising a tail handle, wherein the tail of the suture comprises a distal end coupled to the tail handle.

35. The suture delivery device of claim 1 , wherein the fastener aperture faces the second arm.

36. The suture delivery device of claim 1 , wherein the first arm has a longitudinal axis and the fastener aperture has a longitudinal axis that is substantially perpendicular relative to the longitudinal axis of the first arm.

37. The suture delivery device of claim 1 , wherein the groove of the first suture holder and the groove of the second suture holder face one another.

38. The suture delivery device of claim 1 , wherein the first arm has a longitudinal axis and the fastener aperture has a longitudinal axis that is substantially coaxial with the longitudinal axis of the first arm.

39. The suture delivery device of claim 1 , further comprising a tension gauge carried by the first arm.

40. The suture delivery device of claim 39, the tension gauge comprises a spring and a housing comprising a spring housing, a U-shaped coupling extending from the spring housing, and a slider, the spring positioned and coupled within the spring housing and the slider is positioned around and movable along the first arm.41 . The suture delivery device of claim 39, further comprising a suture tensioner comprising a reel carried by the first arm, further comprising a tether and a suture, the tether coupled to and between the suture tensioner and the U-shaped coupling, the suture comprising a loop and a tail, the loop positionable within the grooves of the suture holders and the tail coupled to the spring.

42. The suture delivery device of claim 22, further comprising a suture comprising a loop and a tail, the loop positionable within the grooves of the suture holders.

43. The suture delivery device of claim 22, further comprising a suture tensioner comprising a reel carried by the first arm.

44. The suture delivery device of claim 43, further comprising a suture comprising a loop and a tail, the loop positionable within the grooves of the suture holders, the suture wrapped around the reel.

45. The suture delivery device of claim 44, wherein the crimp assembly comprises a trigger, a link, and a rod, the trigger pivotably coupled to the handle, the rod movably positioned within the first arm and having a distal end, and the link coupling the trigger and the rod.

46. A suture delivery device, comprising: a handle; a first arm coupled to and extending from the handle and comprising a distal end, the distal end of the first arm comprising a first arc-shaped suture holder comprising an opening and a groove; a second arm extending from the handle and comprising a distal end, the distal end of the second arm comprising a second arc-shaped suture holder comprising an opening and a groove.

47. The suture delivery device of claim 46, wherein the first arm comprises a fastener aperture, further comprising a crimp assembly, wherein the fastener aperture is to carry a fastener and wherein actuating the crimp assembly enables the crimp assembly to crimp the fastener.

48. The suture delivery device of claim 46, further comprising a tension gauge.

49. The suture delivery device of claim 48, wherein the tension gauge is carried by the first arm.

50. The suture delivery device of claim 48, the tension gauge comprises a spring and a housing comprising a spring housing, a U-shaped coupling extending from the spring housing, and a slider, the spring positioned and coupled within the spring housing and the slider is positioned around and movable along the first arm.51 . The suture delivery device of claim 46, wherein each of the first arc-shaped suture holder and the second arc-shaped suture holder comprise an arc length that is between about 25% and about 50% of a circumference of a cervix of between about 6.2 centimeters and about 9.42 centimeters.

52. A suture delivery device, comprising: a handle; a first arm coupled to and extending from the handle and comprising a distal end, the distal end of the first arm comprising a fastener aperture and a first suture holder comprising an opening and a groove; a second arm extending from the handle and comprising a distal end, the distal end of the second arm comprising a second suture holder comprising an opening and a groove; a crimp assembly, and a rachet and pawl mechanism carried by the handle to tighten a suture.

53. The suture delivery device of claim 52, wherein the crimp assembly comprises a trigger, a link, and a rod, the trigger pivotably coupled to the handle, the rod movably positioned within the first arm and having a distal end, and the link coupling the trigger and the rod.

54. The suture delivery device of any one of claims 52 - 53, wherein the rachet and pawl mechanism comprises a trigger, a driving pawl, a locking pawl, and a rachet wheel, wherein the actuating the trigger causes the driving pawl to rotate the rachet wheel in a first direction and the locking pawl inhibits the rachet wheel from rotating in a second direction opposite the first direction.

55. The suture delivery device of claim 54, wherein the rachet wheel comprises a central cylindrical hub around which the suture is to be wound.

56. The suture delivery device of any one of claims 54 - 55, wherein the rachet and pawl mechanism further comprises a first spring to bias the trigger away from an actuated position and a second spring to bias the locking pawl into engagement with the rachet wheel.

57. The suture delivery device of any one of claims 52 - 56, wherein the fastener aperture is to carry a fastener and wherein actuating the crimp assembly enables the crimp assembly to crimp the fastener.

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