US-20260123959-A1 - CERVICAL SUPPORT SYSTEM AND METHOD OF USE

US20260123959A1US 20260123959 A1US20260123959 A1US 20260123959A1US-20260123959-A1

Abstract

An apparatus for use in a cerclage procedure includes a flexible support member and a plurality of compression members disposed along the flexible support member. Each of the compression members has a connecting feature through which a suture used during the cerclage procedure is passed. Each of the compression members transforms a radially-compressive force applied by the suture into a radial pressure applied against the cervix.

Inventors

Michael House
Errol Norwitz
Dwayne E. Hickman
Christopher McCaslin
Christopher O. Evans
Genevieve R.K. Laing
Devon C. Campbell

Assignees

TUFTS MEDICAL CENTER, INC.
CX THERAPEUTICS, INC.

Dates

Publication Date: 20260507
Application Date: 20251231

Claims (17)

1 . An apparatus for use in a cerclage procedure, said apparatus comprising: a flexible support member having a radial plane with a plurality of compression members disposed along the flexible support member, each of the compression members having a length extending in a plane substantially transverse to the radial plane of the flexible support member, wherein each of the compression members includes a connecting feature configured to receive a suture during the cerclage procedure, and wherein the compression members are configured to transform a radially-compressive force applied by the suture into a radial pressure applied against the cervix along an entire length of each of the compression members that receive a suture.
2 . The apparatus of claim 1 , wherein the flexible support member is integral with the compression members.
3 . The apparatus of claim 1 , comprising first and second flexible support members, the first and second support members being adjacent to one another and spaced from one another along a length of the apparatus, and wherein the compression members extend between the first and second flexible support members.
4 . The apparatus of claim 1 , wherein the apparatus includes at least two compression members.
5 . The apparatus of claim 1 , wherein the flexible support member is at least partially circular.
6 . The apparatus of claim 5 , wherein the compression members are substantially equally spaced along a circumference of the flexible support member.
7 . The apparatus of claim 1 , wherein the connecting feature comprises at least one of an opening or a groove configured to accommodate the suture.
8 . The apparatus of claim 1 , wherein the compression members have a shape selected from the group consisting of a plate, a rod, a bar, and a beam.
9 . The apparatus of claim 1 , wherein at least one of the flexible support member and the compression members includes a time release medication.
10 . The apparatus of claim 9 , wherein the medication is progesterone.
11 . A system for use in a cerclage procedure, comprising: a pressure transformer configured to be installed on a cervix, the pressure transformer having at least one flexible member that is generally annular in shape and having a radial plane and configured to surround the cervix, the at least one flexible member having flexible member contact area; a plurality of compression members, each having a length oriented in a plane generally perpendicular to the radial plane of the at least one flexible member and a compression member contact area along a length thereof, wherein each compression member is configured to contact the cervix along the compression member contact area; and at least one suture configured to engage with selected ones of the compression members and the cervix such that the pressure transformer is configured to exert a compressive force on the cervix along the flexible member contact area and the entire compression member contact area.
12 . The device of claim 11 , wherein the flexible support member is an elastomeric structure.
13 . The system of claim 11 , wherein the compression members have a groove or an opening configured to seat the suture.
14 . The system of claim 11 , wherein the compression members are integrally formed on the flexible member.
15 . The system of claim 11 , wherein the compression members further comprise an engagement feature to seat the suture.
16 . The apparatus of claim 11 , wherein at least one of the flexible member, the compression members, and the suture includes a time release medication.
17 . The apparatus of claim 16 , wherein the medication is progesterone.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 18/024,795, filed on Mar. 6, 2023, and entitled “Cervical Support System and Method of Use,” which is a National Stage of International Application No. PCT/US 2021/049209, filed on Sep. 7, 2021, entitled “Cervical Support System and Method of Use, which claims the benefit of U.S. Provisional Ser. No. 63/075,467 , filed on Sep. 8, 2020, and entitled “Cervical Support System and Method of Use,” the entireties of which are herein incorporated by reference. BACKGROUND Embodiments of the present disclosure relate to supporting the cervix. Cervical insufficiency is a known complication of pregnancy that can cause miscarriage or preterm birth. Preterm birth is a frequent cause of morbidity and mortality in newborn infants and is the leading cause of death in childhood. Complications from preterm birth include chronic lung disease, feeding difficulties, retinopathy and neurodevelopmental abnormalities. The rate of preterm birth in the United States in 2015 was 9.6% and a 2006 report from the Institute of Medicine estimated the cost per preterm newborn in the United States was $51,600, which translates to $26.2 billion in annual health care costs. In cases of cervical insufficiency, the cervix dilates in the absence of labor, which leads to preterm delivery. Cervical insufficiency is currently treated using a cerclage procedure in which a suture is placed around the cervix to provide support and prevent preterm dilation. Cerclage procedures are performed in 0.3% to 0.4% of pregnancies, which translates to 15,000 annual procedures in the United States. SUMMARY In a typical cerclage procedure, the cerclage is removed 1) at 37 weeks, 2) for preterm labor or 3) for preterm premature rupture of the membranes. In some cases, it can be difficult to visualize the suture below the level of the knot. When a patient presents with labor, the knot can be buried in the tissue. When the suture is difficult to visualize, clinicians can inadvertently cut the knot, which makes nearly impossible to visualize the suture. There are cases when the patient labors with a cerclage in place, which leads to cervical laceration. Accordingly, there is an ongoing need for improved systems and methods for cerclage procedures. As discussed in greater detail below, use of a knot tube provides a fastening that is more easily identifiable and locatable, for example, when the suture is to be removed, as compared to a suture fastening knot that can be buried in the tissue. If a buried knot is eliminated, the suture will be easier to cut which, minimizes the risk of laceration of patient tissue. In embodiments, in which the knot tube includes barbs or other structure for preventing the suture from passing back through the inner passage, the knot tube allows for easier tightening of the suture. In an embodiment, an apparatus comprises a body configured for use in a cerclage procedure, the body including an outer surface formed of a biocompatible material and an inner surface, the inner surface defining an inner passage having a longitudinal axis and a first dimension extending from a first end to a second end of the body, the inner passage configured to allow suture to extend therethrough. In another embodiment, a kit for use in a cerclage procedure comprises a suture, a body, and compression tubes. The body includes an outer surface formed of a biocompatible material and an inner surface, the inner surface defining an inner passage having a longitudinal axis and a first dimension extending from a first end to a second end of the body, the inner passage configured to allow suture to extend therethrough. Each compression tube is formed of a biocompatible material and has an inner surface, the inner surface defining an inner passage having a longitudinal axis and a third dimension extending from a third end to a fourth end of the compression tube, the inner passage being configured to allow suture to extend therethrough. Embodiments which include compression tubes have additional advantages. For example, cervical insufficiency can be caused by abnormally soft cervical tissue. In some cases, the soft tissue of the cervix does not maintain the position of the suture in the tissue and the suture pulls through the cervix. Over time, the cerclage is displaced and does not enclose the cervical canal. If the cerclage does not enclose the canal, it does not provide support to the cervix. Suture migration can occur because compression from the cerclage is concentrated over a small surface area. Concentrated compression over a small area leads to tissue disruption (i.e., the soft cervical tissue is unable to resist the compression force of the cerclage). When tissue disruption occurs, the cerclage tears the tissue. Use of compression tubes minimizes possible suture migration and alleviates excess stress from the suture on the wound. In particular, the compr