WO2012145349A1 - Dispositif de retrait de suture de cerclage - Google Patents

Dispositif de retrait de suture de cerclage Download PDF

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Publication number
WO2012145349A1
WO2012145349A1 PCT/US2012/034000 US2012034000W WO2012145349A1 WO 2012145349 A1 WO2012145349 A1 WO 2012145349A1 US 2012034000 W US2012034000 W US 2012034000W WO 2012145349 A1 WO2012145349 A1 WO 2012145349A1
Authority
WO
WIPO (PCT)
Prior art keywords
shaft
suture
cutter
distal end
blunt end
Prior art date
Application number
PCT/US2012/034000
Other languages
English (en)
Inventor
Alfred Z. Abuhamad
Original Assignee
Eastern Virginia Medical School
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Eastern Virginia Medical School filed Critical Eastern Virginia Medical School
Priority to EP12774531.3A priority Critical patent/EP2699170A4/fr
Priority to JP2014506494A priority patent/JP2014518656A/ja
Priority to CA2833549A priority patent/CA2833549A1/fr
Publication of WO2012145349A1 publication Critical patent/WO2012145349A1/fr
Priority to US14/056,871 priority patent/US20140046140A1/en

Links

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
    • A61B17/0467—Instruments for cutting sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods

Definitions

  • This disclosure relates to a device for removing a cerclage suture.
  • Cerclage placement is a common procedure performed in high risk pregnancies where a woman is at risk for pregnancy loss from incompetent cervix or a short cervix as identified on ultrasound examination. Cerclage placement in women with a short cervix can reduce preterm delivery. Cerclage placement is typically done in early second trimester and the procedure is performed in the hospital under regional anesthesia. The procedure involves placement of a suture around the cervix in a purse-string fashion which provides compression of the cervix and prevents the premature opening of the cervix.
  • the suture itself is typically removed at about thirty-seven weeks gestation. This length of time between placement of the suture and time for its removal can cause mucosal swelling surrounding the suture and thus makes its removal difficult. Cerclage removal typically involves trying to identity the loop of the suture and using scissors to remove it under direct visualization. This can be a difficult procedure as the free loop is buried under the cervical mucosa and can be difficult to identify.
  • the device has a shaft sized and shaped to extend from a proximal end outside a vagina to a distal end near a cervix.
  • the shaft also has a blunt end located at the distal end of the shaft and having a taper for allowing the blunt end to pass between a cerclage suture and cervical mucosa without cutting the mucosa and to move the suture away from the mucosa.
  • the device also comprises a movable cutter at the distal end of the shaft and being movable between an open non-cutting position and a closed cutting position for cutting the suture.
  • the device also comprises an actuator for causing the cutter to be moved from the open position to the closed position to cut the suture.
  • This disclosure also includes a method for removing a cerclage.
  • a shaft having a blunt end is inserted into a patient's vagina.
  • the blunt end is positioned under a cervical suture to cause the suture to move away from a cervical mucosa, wherein the blunt end that passes under the cervical suture does not have a cutting blade.
  • a retractable cutter is actuated to cut the suture. Then, the shaft is withdrawn from the patient's vagina.
  • FIG. 1 is a cross sectional view of a baby in the uterus before cerclage.
  • FIG. 2 is a cross sectional view of a baby in the uterus with a suture around the cervix.
  • FIG. 1 A is a cross sectional view of the suture pathway.
  • FIG. 2A is a cross sectional view of a suture around the cervix.
  • FIG. 3 is a cross sectional view of a shaft extending into the vaginal canal to the cervix.
  • FIG. 4 is a perspective view of the blunt end of the shaft under the cervical suture.
  • FIG. 5 is a perspective view of the tip of the shaft in an open position under the cervical suture.
  • FIG. 6 is a cross sectional view of an embodiment of the shaft in an open position under the cervical suture.
  • FIG. 7 is a cross sectional view of an embodiment of the shaft in a closed position and cutting the cervical suture.
  • FIG. 8 is a view of a cerclage with cutting locations.
  • This disclosure describes a device for removing a cerclage.
  • cerclage includes a cervical stitch and a tracheloplasty in the cervix.
  • the cervix 12 and the vaginal canal 20 are also shown.
  • a baby is in the uterus and there is a cerclage 14 at the cervix 12.
  • FIGS. 1A and 2A are cross-sections of FIG. 2, at similar locations.
  • the cerclage 14 is a cervical stitch through the cervical mucosa to close the cervix during pregnancy.
  • FIG. 1 A shows a pathway of a cervical suture.
  • FIG. 2A shows a cross section of a completed cerclage.
  • Other suitable stitch pathways for closing the cervix can also be used.
  • a speculum 18 can be used to hold open the vaginal canal 20.
  • a cerclage cutting device 22 has a handle 24 and an elongated shaft 26 with a proximal end 28 and a distal end 30.
  • Shaft 26 is held with the handle which can be designed for left and right handed use, near proximal end 28.
  • Shaft 26 can have a uniform cross sectional diameter, or as shown, can have sections, e.g., with a larger cross sectional diameter portion and a smaller cross sectional diameter portion.
  • the shaft can include plastic, metal, or any other suitable material.
  • the shaft has a suitable size and shape such that the distal end of the shaft is configured to extend into the vaginal canal to the cervix.
  • the proximal end of the shaft is configured to remain outside of the vaginal canal.
  • the distal end of the shaft has a blunt end 32 for passing into the vaginal canal and tunneling under the cervical mucosa without cutting the cervical or vaginal tissue.
  • the blunt end does not include a blade.
  • blunt end 32 has a tapered portion 34 so that the end can tunnel under the cerclage 14 and elevate the suture from the surrounding tissue 12. This elevation allows a clear visualization of the area where the cutting will be performed.
  • blunt end 32 has a curvature along its posterior aspect that allows the suture to be elevated, although other shapes typically tapered or curved can be used to move the suture away from the cervical tissue without cutting the cervical tissue. As the shaft is moved laterally under the cerclage, blunt end 32 can pass under the suture and lift the cerclage away from the cervical mucosa. This allows the cerclage to be cut without cutting the cervical or vaginal tissue.
  • the blunt end 32 of the shaft may include a lip 42 to hold the suture and to prevent the suture from slipping off of the blunt end of the shaft.
  • Other suitable configurations for holding the suture on the blunt end of the shaft may also be used.
  • the blunt end of the shaft may provide a recess for holding the cerclage before it is cut.
  • the blunt end may be smooth or may include the lip.
  • the lip 42 holds the suture in place so that it may be cut by a cutter 50 that can have a closed cutting position (FIG. 7) and an open non-cutting position (FIG. 6).
  • the cutter is in an open position in the distal end before and after the cutter is actuated.
  • a cutter blade 54 moves through an opening 56 in the distal end of the shaft to a closed position. In the closed position, a blade extends through the distal end of the shaft and cuts the suture.
  • FIG. 8 shows an example of cerclage without surrounding tissue.
  • the cutter includes a pin 64 that allows the cutter to rotate and pivot about the pin 64 to the closed cutting position when actuated.
  • the blade of the cutter could be located on a relatively movable portion or a relatively stationary portion of the cutter.
  • a movable portion 66 of the cutter is lifted by a wedge 68 that moves horizontally under operation control and slides under and lifts the movable portion when the device is actuated because of the relationship of the surfaces.
  • the movable portion returns to a prior location in the distal end of the shaft, e.g., with a spring.
  • the handle 24 of the device may include a actuator 70, for controlling the retractable cutter 50.
  • the actuator may be located on the handle to allow the device to be actuated by squeezing the handle.
  • the actuator may be a pushing element coupled to the handle or near the proximal end of the shaft that allows the user to actuate the retractable cutter 50 by pressing the pushing element with a thumb or finger.
  • the actuator may be coupled to any portion of the handle or proximal end of the shaft that allows a user to activate the cutter when the device is inserted into the vaginal canal.
  • the actuator should be easy to use and may be reused for multiple cuttings on the same patient or different patients.
  • the handle may be designed so that it is easy to guide the device through the vaginal canal and the cervical mucosa and to actuate the retractable cutter with one hand.
  • the handle should be designed so that it does not prevent clear visualization of the cervix and the cerclage.
  • a rod 72 can be coupled to the actuator and the retractable cutter.
  • the rod may be provided inside of the shaft.
  • the rod may have a distal portion that is coupled to the cutter and a proximal portion that is coupled to the actuator.
  • the distal portion of the rod may be shaped on an inclined plane.
  • the distal end of the rod may slide under the retractable cutter, thus moving the cutter into a closed position.
  • Other suitable configurations for actuating the retractable cutter to cut the suture may also be used.
  • the distal end of the rod may be coupled to the cutter.
  • the rod may be housed within a channel in the shaft.
  • the channel may have a distal end and a proximal end.
  • the distal end of the channel may form an incline.
  • the rod may move distally through the channel to the inclined region. Then, the distal end of the rod may be elevated by the inclined region, thus moving the cutter coupled to the distal end of the rod to a closed position.
  • a spring system may be coupled to the actuator. Upon actuation of the cutter by the actuator, the spring system may compress to allow the actuator to actuate the cutter into the closed position. Once pressure is released from the actuator, the spring system may expand to allow the cutter to move to an open position.
  • a light source may be coupled to the device to allow for visualization of the cerclage.
  • the light source may be coupled to the blunt end 32 of the shaft.
  • the light source may be coupled to the proximal end of the shaft and illuminate the blunt end of the shaft to allow for visualization of the cerclage and the cutting of the suture.
  • Other suitable locations for positioning the light source to allow visualization of the cerclage can also be used.
  • the light source may be on the outside of the vaginal canal and separate from the device and also allow for visualization of the cerclage.
  • the device may be a multi-use product or a single-use, disposable product. If multi-use, the design should allow for convenient cleaning and sterilization.

Landscapes

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

Abstract

La présente invention concerne un dispositif pour enlever une suture de cerclage qui a une tige dimensionnée et formée de manière à s'étendre d'une extrémité proximale à l'extérieur d'un vagin à une extrémité distale à proximité d'un col de l'utérus. La tige a en outre une extrémité mousse située à l'extrémité distale de la tige et ayant un cône pour permettre à l'extrémité mousse de passer entre une suture de cerclage et la muqueuse cervicale sans couper la muqueuse et déplacer la suture depuis la muqueuse. Le dispositif comprend un dispositif de coupe mobile à l'extrémité distale de la tige et étant déplaçable entre une position non-coupe ouverte et une position de coupe fermée pour couper la suture. Le dispositif comprend en outre un actionneur pour amener le dispositif de coupe à être déplacé de la position ouverte vers la position fermée pour couper la suture.
PCT/US2012/034000 2011-04-18 2012-04-18 Dispositif de retrait de suture de cerclage WO2012145349A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP12774531.3A EP2699170A4 (fr) 2011-04-18 2012-04-18 Dispositif de retrait de suture de cerclage
JP2014506494A JP2014518656A (ja) 2011-04-18 2012-04-18 セルクラージュ縫合糸の除去装置
CA2833549A CA2833549A1 (fr) 2011-04-18 2012-04-18 Dispositif de retrait de suture de cerclage
US14/056,871 US20140046140A1 (en) 2011-04-18 2013-10-17 Cerclage suture removal device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161476625P 2011-04-18 2011-04-18
US61/476,625 2011-04-18

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US14/056,871 Continuation-In-Part US20140046140A1 (en) 2011-04-18 2013-10-17 Cerclage suture removal device

Publications (1)

Publication Number Publication Date
WO2012145349A1 true WO2012145349A1 (fr) 2012-10-26

Family

ID=47041893

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2012/034000 WO2012145349A1 (fr) 2011-04-18 2012-04-18 Dispositif de retrait de suture de cerclage

Country Status (4)

Country Link
EP (1) EP2699170A4 (fr)
JP (1) JP2014518656A (fr)
CA (1) CA2833549A1 (fr)
WO (1) WO2012145349A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101572950B1 (ko) 2014-03-17 2015-11-30 순천향대학교 산학협력단 자궁내장치의 실 절단용 직각가위

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4128100A (en) * 1976-10-08 1978-12-05 Wendorff Erwin R Suture
US5176695A (en) * 1991-07-08 1993-01-05 Davinci Medical, Inc. Surgical cutting means
US5306284A (en) * 1992-02-19 1994-04-26 John Agee Surgical instrument
US5397333A (en) * 1993-09-24 1995-03-14 Nusurg Medical, Inc. Surgical hook knife
US5569283A (en) * 1993-09-03 1996-10-29 United States Surgical Corporation Surgical cutting instrument with guarded blade
US20050277948A1 (en) * 2004-06-14 2005-12-15 Leonard Cedars Apparatus and methods for the administration of a cerclage
US7520886B2 (en) * 2005-01-27 2009-04-21 Wilson-Cook Medical Inc. Endoscopic cutting device
US20090209994A1 (en) * 2000-06-05 2009-08-20 Boston Scientific Scimed, Inc. Methods and devices for the treatment of urinary incontinence
US20090299406A1 (en) * 2008-05-30 2009-12-03 Ethicon Endo-Surgery, Inc. Multifunction surgical device
US20100114134A1 (en) * 2006-05-01 2010-05-06 Mcintyre Jon T Device and Method for Temporary Vessel Occlusion

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3995619A (en) * 1975-10-14 1976-12-07 Glatzer Stephen G Combination subcutaneous suture remover, biopsy sampler and syringe
JPS6118882Y2 (fr) * 1978-11-20 1986-06-07
US4962770A (en) * 1987-09-18 1990-10-16 John M. Agee Surgical method
NL1013958C2 (nl) * 1999-12-24 2001-06-26 Bernhard Wilhelm Geziena Nicol Vaginaspeculum.
WO2005102179A1 (fr) * 2004-03-31 2005-11-03 Wilson-Cook Medical, Inc. Dispositif pour couper des sutures

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4128100A (en) * 1976-10-08 1978-12-05 Wendorff Erwin R Suture
US5176695A (en) * 1991-07-08 1993-01-05 Davinci Medical, Inc. Surgical cutting means
US5306284A (en) * 1992-02-19 1994-04-26 John Agee Surgical instrument
US5569283A (en) * 1993-09-03 1996-10-29 United States Surgical Corporation Surgical cutting instrument with guarded blade
US5397333A (en) * 1993-09-24 1995-03-14 Nusurg Medical, Inc. Surgical hook knife
US20090209994A1 (en) * 2000-06-05 2009-08-20 Boston Scientific Scimed, Inc. Methods and devices for the treatment of urinary incontinence
US20050277948A1 (en) * 2004-06-14 2005-12-15 Leonard Cedars Apparatus and methods for the administration of a cerclage
US7520886B2 (en) * 2005-01-27 2009-04-21 Wilson-Cook Medical Inc. Endoscopic cutting device
US20100114134A1 (en) * 2006-05-01 2010-05-06 Mcintyre Jon T Device and Method for Temporary Vessel Occlusion
US20090299406A1 (en) * 2008-05-30 2009-12-03 Ethicon Endo-Surgery, Inc. Multifunction surgical device

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP2699170A4 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101572950B1 (ko) 2014-03-17 2015-11-30 순천향대학교 산학협력단 자궁내장치의 실 절단용 직각가위

Also Published As

Publication number Publication date
CA2833549A1 (fr) 2012-10-26
EP2699170A4 (fr) 2014-11-26
JP2014518656A (ja) 2014-08-07
EP2699170A1 (fr) 2014-02-26

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