Therapeutic devices and methods for reducing injury caused by labor and delivery

Abstract

Systems, devices, and methods to reduce trauma and injury to tissue during labor and delivery are disclosed. In particular, the systems and methods involve devices that hold dilation support devices, dilation devices in place in the vaginal canal during certain stages of labor. These devices hold the dilation devices in a therapeutically effective position in the vaginal canal and maintain the dilation devices in such a position for a sufficient period of time to allow the dilation devices to have a therapeutic effect.

Description

Technical Field

[0001] The field relates to labor and delivery, and more specifically to improved apparatus and methods for addressing discomfort and tissue damage during labor and reducing pelvic dysfunction resulting from certain aspects of labor and delivery. Background Technology

[0002] Approximately 134 million women give birth worldwide each year, including 3 million vaginal births in the United States.

[0003] Birth most commonly occurs through the processes of labor and delivery. Labor is the physiological process by which the mother pushes the fetus from the uterus into the outside world. Labor is characterized by regular, painful contractions accompanied by changes in cervical dilation and effusion. Contractions propel the fetus through the birth canal, which includes the cervix and vaginal cavity. The birth canal provides a passage for the fetus through the mother's pelvic floor.

[0004] The pelvic floor is a vital and complex network of muscles, ligaments, and bones that support pelvic organs such as the bladder, rectum, intestines, and urethra. Thus, the passage of a fetus from the uterus to the outside world requires traversing this dense complex of pelvic floor muscles. The passage of the fetus can adversely affect the health of this muscular complex, which is crucial for daily activities. Damage to this muscular complex can lead to pelvic floor disorders, conditions that particularly affect the normal functioning of the female pelvic organs.

[0005] Although a known association exists between labor and delivery and pelvic floor disorders, the exact physiological mechanisms underlying many of these disorders remain under investigation. Damage to the pelvic floor muscles during delivery is considered one of the most significant contributing factors to pelvic floor disorders. Babies are often relatively large compared to the diameter of the birth canal, with large heads and broad shoulders. This is known to potentially cause damage to the mother, and especially to her pelvic floor, as the mother pushes the baby through the birth canal, resulting in fetal descent.

[0006] Clinically, labor and delivery are divided into three phases during vaginal delivery. The first phase begins with cervical demise and ends with full cervical dilation, which allows the fetus to pass through the birth canal. The second phase, defined by the fetus's passage through the birth canal, is described as the main movement of labor. During this phase, the fetus descends with its movement and rotation, overcoming resistance from the soft tissues of the maternal pelvis and pelvic floor. The second phase terminates with the delivery of the fetus. The third phase includes the separation and expulsion of the placenta.

[0007] During the second stage of labor, as the fetal head descends into the birth canal, it exerts direct pressure on the pelvic floor. The fetus passes through the birth canal by stretching the levator ani muscle fibers and connective tissue, abruptly opening and often damaging the pelvic floor muscles. Unlike the gradual dilation of the cervix during the first stage of labor, the pelvic floor and vaginal cavity must dilate rapidly during the second stage. For the average woman, the vaginal opening (or vaginal opening) has a baseline resting diameter of approximately 2.6 cm. During the first stage of labor, the vagina maintains this baseline diameter as the cervix dilates, but as the baby passes through the cervix, the vaginal cavity expands from 2.6 cm to 10 cm (the average head diameter of a newborn). This 3.8-fold expansion in diameter and approximately 15-fold expansion in area occurs within seconds to minutes.

[0008] Studies show that 15%–35% of labor processes, and therefore more than a third of labor processes in some years, result in damage to the pelvic floor muscles, where the mother's muscles tear from the pelvic bone or are overstretched to the point of functional impairment. Muscle tears from the supporting bones (known as avulsion injuries) are serious injuries, and complete avulsion injuries are strongly associated with the later development of pelvic organ prolapse. Repairing these injuries is invasive, and repair procedures may be ineffective. Furthermore, physicians recognize that treating such injuries can be significantly costly for the mother.

[0009] U.S. Patent 9,492,197, assigned to this assignee, discloses a system for reducing trauma during vaginal delivery, which, for this discussion, can be understood as all soft tissues involved during the second stage of labor and the delivery phase. Such systems can reduce tissue damage and injury to the patient and provide a useful protocol for improved patient recovery and reduced undesirable symptoms subsequently caused or aggravated by tissue damage during labor and delivery. While systems like those disclosed in U.S. Patent 9,492,197 can function well, there is still a need to fully utilize such systems to make them more accessible to patients and clinicians. Summary of the Invention

[0010] The systems, devices, and methods described herein reduce trauma and damage to tissues during labor and delivery. In particular, the systems and methods described herein relate to devices for holding dilators in a suitable position within the vaginal cavity during the second stage of labor. These devices hold the dilators in a therapeutically effective position within the vaginal cavity and maintain the dilators in such a position for a sufficient period of time to allow for therapeutic efficacy. Furthermore, such devices allow the dilators to remain in a suitable position within the vaginal cavity as the patient changes from the usual labor position and moves around the patient's bed.

[0011] Such dilators as those manufactured and sold by the assignee can therapeutically treat the tissues of the vaginal cavity during labor, and particularly before the fetus enters the vaginal cavity. The dilator can apply dilating forces substantially slowly to the tissue walls of the vaginal cavity, thereby progressively and therapeutically relaxing the vaginal cavity tissues and allowing them to expand elastically, thus reducing tissue tearing and separation of tissues from the pelvis. However, because the female body is generally designed to expel the baby during delivery, dilators may be difficult to retain in the vaginal cavity during labor, as the biomechanical forces that arise during the second stage of labor tend to expel the object from the vaginal cavity. The systems, devices, and methods described herein retain the dilator in the vaginal cavity for a duration sufficient to achieve a therapeutic effect, such as two hours, one hour, fifty minutes, forty-five minutes, thirty minutes, or more or less than one hour, and some other time determined by the treating clinician as appropriate for the patient receiving treatment and in the process of labor and delivery.

[0012] In one embodiment, the device includes an adapter disposed at the proximal end of a vaginal dilator (sometimes referred to herein as a dilator or speculum). The adapter may be shaped to releasably engage with the proximal end of the dilator and allow the distal end of the dilator to extend distally from the adapter. The releasable engagement of the adapter allows the adapter to engage with and disengage from the proximal end of the dilator during labor. In a typical embodiment, the adapter is sized to fit snugly over at least a portion of the proximal end of the dilator, thereby providing a frictional engagement that creates a mechanical connection between the adapter and the proximal end of the dilator. The frictional engagement is strong enough to hold the adapter on the proximal end of the dilator during the types of patient movement typically expected during labor and delivery. This may include the patient turning to their side, the patient's hips sliding across the surface of the bed and possibly even leaving the bed, and standing or squatting during portions of the second stage of labor. In any case, the frictional engagement is strong enough to allow useful attachment of the adapter to the proximal end of the dilator and to resist clinically expected forces such that the adapter does not easily disengage from the dilator during labor.

[0013] In an alternative embodiment, the adapter is integrated with the distal end of the expansion device. In such an alternative embodiment, the distal end of the expansion device may be formed of a plastic material, and it may be shaped to provide the distal end of the expansion device, and may have an adapter integrated in the shape suitable for use with the systems and methods described herein.

[0014] In some embodiments, the adapter has a mounting member for receiving the retention band. Typically, the mounting member is an outwardly extending arm that provides a recess for receiving the retention band, thereby allowing the retention band adapter to engage mechanically. The retention band may be made of fabric or some flexible material, and it will have a length sufficient to wrap around the patient's thigh and have a section that crosses the patient's thigh at a location above the patient's pubic arch. Typically, the retention band is adjustable to accommodate patients of different sizes and body types. The retention band has a fixing feature shaped to engage with the attachment feature of the adapter. Typically, the retention band has a fastening mechanism for securing the retention band to the patient's body. The fastening mechanism is typically releasable and in some embodiments includes a hook-and-loop fastener to provide an easily breakable release mechanism, thereby allowing easy release from the patient's body.

[0015] More specifically, the systems and methods described herein include, in one aspect, a device for reducing injury to a patient during labor and delivery procedures, the device comprising: an adapter shaped to engage a proximal end of a vaginal dilator and allow a distal end of the dilator to extend distally from the adapter and having an mounting element for receiving a retention band; and a retention band made of a flexible material and having a length sufficient to wrap around the patient's thigh, having a segment that crosses the patient's thigh at a location above the patient's pubic arch, and having a fixation feature shaped to engage an attachment feature of the adapter, thereby restricting proximal movement of the adapter away from the patient's birth canal.

[0016] Optionally, the retention bandage comprises one or more strips of elastic material. Further optionally, the one or more strips of elastic material include fasteners to allow the one or more strips to form a closed loop around the patient's body. Further, the one or more strips may include hook-and-loop fasteners to allow the one or more strips to form a closed loop around one or more of the patient's thighs.

[0017] In some common implementations (but not all), the fixation band includes a strip of flexible material sized to wrap around the patient’s waist and thighs to form a band, the band having two strip segments positioned between the patient’s thighs and above the patient’s pubic arch.

[0018] In some common implementations (but not all), the retention band has a release element that disconnects the band from the patient or adapter when a proximal force is applied that exceeds the expected force for the infant to travel proximally through the birth canal during delivery.

[0019] Optionally, the release element includes a hook-and-loop fastener disposed on the strap to provide an easily detachable release element for disconnecting the strap from the patient or adapter.

[0020] In some common implementations, the adapter mounting includes an arm that extends radially and proximally from the adapter to form a bend sized to engage with a retention band. Optionally, the arm is formed as a guide rail attached to a side of the adapter and provides an internal groove for receiving the retention band. Typically (but not always), the adapter includes a plastic body shaped to fit around the handle of the dilator. However, alternatively, the adapter may be an integral part of the vaginal dilator, thus being constructed into the dilator and a portion thereof. Optionally, the arm snaps into the dilator and is thus integral with it. In other implementations, the arm may be molded as part of the proximal end of the dilator.

[0021] In another aspect, a method for reducing tissue damage during labor and delivery procedures is provided, the method comprising providing a vaginal dilator of the type for providing therapeutic dilation force during at least a portion of the labor procedure, providing a wearable retention band having a length sufficient to encircle the patient's waist and at least one thigh, securing the retention band to the patient by wrapping the band around the patient's waist and at least one thigh, such that the band is secured to the patient at a first position near the pubic arch and a second position above the pubic arch, and securing the dilator to the retention band at the second position and positioning at least a portion of the dilator within the vaginal cavity and securing different portions of the dilator to the retention band, such that the retention band resists undesirable detachment of the dilator from the vaginal cavity.

[0022] Optionally, the method may include providing an adapter coupled to a proximal end of a vaginal dilator to allow a distal end of the dilator to extend distally from the adapter and having an mounting member for slidably receiving a retention band. This may include providing an adapter comprising providing a removable adapter capable of being releasably coupled to a proximal end of the vaginal dilator, and optionally may include providing a vaginal dilator having a proximal end in which the mounting member is integrated.

[0023] In some practices, securing a retention band to a patient involves using fasteners to fasten a first section of the retention band to a second section of the retention band. Fasteners may include at least one of hook-and-loop fasteners, snaps, zippers, clips, and buckles.

[0024] Typically, the method involves securing the vaginal dilator to a retaining band at a second position and placing at least a portion of the dilator within the vaginal cavity to secure the retaining band, and securing the dilator at a position within the patient's vaginal cavity such that dilating force can be applied to the patient's levator ani muscle during labor.

[0025] The method may include applying force at the location and maintaining a therapeutic effect for a duration (continuous or incremental time), and may include holding the vaginal dilator within the patient's vaginal cavity and applying dilating force to the tissue walls of the vaginal cavity for a period between 30 and 120 minutes. Optionally, the method may include temporarily removing the vaginal dilator from the vaginal cavity during the period between 30 and 120 minutes. Attached Figure Description

[0026] Figure 1 An embodiment of a retention device for securing a vaginal dilator in place during labor and delivery is shown;

[0027] Figures 2A-2F The structure of two example dilation devices for therapeutically expanding the vaginal cavity before the fetal head passes through is described in more detail;

[0028] Figures 3A-3E Depicting for fixing to expansion devices (such as Figure 1 An embodiment of the adapter at the proximal end of the illustrated example expansion device;

[0029] Figure 4 An implementation scheme for the fixation strap is described;

[0030] Figure 5 A- Figure 5 F depicts an example of a fixation band attached to a model patient;

[0031] Figure 6A and Figure 6B A fixation device is shown that is positioned appropriately around the patient's body and holds the expansion device in place for therapeutic treatment;

[0032] Figures 7A-7D Example labor poses are depicted;

[0033] Figure 8A and Figure 8B The images show undamaged and damaged pelvic floors, as well as the types of damage reduced by the device described herein.

[0034] Figure 9A and Figure 9B An expansion device is depicted at the beginning of the process and towards the end of the process;

[0035] Figure 10 An example processing procedure is described;

[0036] Figure 11A and Figure 11B Alternative implementation schemes for the adapter are described;

[0037] Figure 12 Alternative implementation schemes for the adapter are described;

[0038] Figure 13A and Figure 13B Alternative implementation schemes for the adapter are described;

[0039] Figure 14 Alternative implementations of the type of retention device described herein are depicted;

[0040] Figure 15 Alternative embodiments of the retention device of the type described herein are depicted;

[0041] Figure 16 It depicts, in part, the body positioning of the model patient. Figure 15 The retaining device; and

[0042] Figure 17 The image depicts the fixation to the expansion device and its positioning around the model patient's body. Figure 15 The retaining device. Detailed Implementation

[0043] The apparatus and methods described herein are designed to prepare and dilate vaginal and perineal tissues during labor to reduce or prevent (among other things) the late development of pelvic floor damage and pelvic floor disorders. Specifically, the apparatus and methods described herein provide a therapeutic approach to prepare the mother for the delivery phase of labor during the early stages of labor. To this end, in some embodiments, the apparatus includes a retention device that can hold a dilator within the mother's vaginal cavity during the early stages of labor, preferably in a manner that allows the mother to move through some of the typical labor positions employed during labor and delivery. The retention device described herein may be removable to allow the clinician to easily remove the retention device from the patient and optionally also remove the dilator (as needed or preferred by the clinician during the procedure). Additionally, the retention device is designed for easy reuse on the patient to allow the patient to continue the dilation procedure during labor. Therefore, as described herein, retention devices allow the dilator to be held in place for a duration sufficient to achieve therapeutic effects (whether continuous or resulting from intermittent treatment periods), while also allowing for easy and convenient removal of both the retention and dilator from the patient, enabling clinicians to focus on different aspects of labor and delivery.

[0044] In some embodiments, the device includes a retention device comprising: an adapter coupled to a distal end of the dilator; and a retention band coupled to the adapter and holding the adapter, and thus the coupled dilator, in place during labor. Typically, the retention device retains the dilator in a position within the patient's vaginal cavity for a therapeutically sufficient period of time to prepare the infant for birth. For example, the retention device described herein can retain the dilator in position for a period sufficient to stretch the patient's vaginal tissue until, for example, the diameter of the patient's vaginal opening has reached approximately 10 cm (approximately the size of the fetal head). In some embodiments, the retention device retains the dilator such that its distal end enters the vaginal opening and extends into the vaginal cavity to the anterior 3 to 4 cm of the vagina, and holds the dilator in this position to gradually expand the vagina from a resting diameter of 2 to 3 cm to a fully expanded diameter equal to the size of the delivered fetus (approximately 10 cm). The retention device described herein can work in conjunction with dilation devices that are expanded manually or via an automated actuation system, and the dilation device can be quickly folded and removed when needed. Typically, the retention device holds the dilation device in the appropriate anatomical position for a duration of approximately one to three hours, although the duration can vary and may be longer or shorter, and can be set by the attending clinician. Because the clinician may need to monitor the progress of labor during this time, and the mother may need to move around the delivery room, the retention device can be removable for periodic separation of the dilation device from the mother.

[0045] The retention device described herein can be attached to the patient during some or all of the first stage of labor and removed before delivery during the second stage, thus allowing the second stage to proceed. The retention device can be used before the second stage of labor, therefore before the baby passes through the birth canal and before the baby comes into contact with the dilator. Depending on how long it takes to achieve adequate therapeutic vaginal dilation, such as approximately 10 cm, the dilator can be inserted at some point during the first stage of labor. The target dilation diameter of 8 cm means that the device should be used in a hospital under the supervision of a trained obstetrician and nurse. The dilator and retention device can be used without any anesthesia or under local anesthesia. Tissue preparation can also be performed after administration of epidural anesthesia or other analgesia, which will eliminate any pain or discomfort that the device may cause. Local anesthesia can also be applied to the tissue contact surface of the device to minimize pain.

[0046] Figure 1An embodiment of the retaining device 100 of the type described herein is depicted. For example... Figure 1 As shown, the retention device 100 includes an adapter 110 and a retention strap 118. The adapter 110 engages with and attaches to the proximal end 108 of the dilation device 102, thereby allowing the distal end 104 of the dilation device 102 to extend outward and distally from the adapter 110 along the longitudinal axis (not labeled) of the dilation device 102. An example of a dilation device that can be used with the retention system and method described herein is disclosed in U.S. Patent 9,492,197, assigned to the assignee.

[0047] The adapter 110 includes a body 116 and two arms 112. In the depicted embodiment, the body of the adapter is generally conical, with one side of the cone open to allow access to the front of the expansion device. The two arms 112 are attached to the distal point of the body 116 and extend radially outward from the body 116 and generally along the longitudinal axis of the body 116 toward the proximal end of the body 116. The arms 112 create two recesses 114 between the two arms 112 and the body 116. A retaining band 118 of flexible material engages in the recesses 114. Although not shown, in Figure 1 The retention band 118 depicted has a length sufficient to wrap around the patient's thigh at a position above the pubic arch. This provides a mechanical connection point, with at least one contact point above the proximal end of the vaginal cavity. Since uterine contractions can push the dilator proximally and out of the vaginal cavity, the attachment above the pubic arch provides a connection for securing the retention band above the pubic arch. This connection allows the retention band to apply a force to the adapter that is opposite to the force tending to push the dilator out of the vaginal cavity and tends to retain the dilator within the vaginal cavity.

[0048] The size and shape of the depicted retention band 118 are determined to secure it to the patient's body and, during labor or at least for a portion of labor, to hold the adapter 110 in place when engaged with the dilator 102. The dilator 102 therapeutically treats the tissues of the vaginal cavity before the fetus passes through and moves toward the vaginal opening. Figure 1 In the depicted embodiment, the expansion device 102 is an electric motor-operated expansion device, the electric motor-operated expansion device including a means for extending the expansion device 102 from a contraction configuration ( Figure 1 (As shown) The motor extends to an extended configuration. Such a motorized expansion device 102 can be extended based on a clinician's access to user interface controls (such as controls 120 and 122). Such controls can cause the expansion device to activate the motor and cause the expansion device to expand or contract. Figures 2A-2CThe invention describes an alternative expansion device that is manually operated and includes a rotatable knob for expanding or contracting the expansion device. This is disclosed in U.S. Patent 9,492,197, assigned to the assignee. Figures 2A-2C An example of an expansion device of the type described.

[0049] exist Figures 2A-2C In the example, the dilator 200 is a vaginal dilator including rigid or semi-rigid pads 202, arms 204, a handle 206, and a dilating mechanism 208. In the depicted example, the dilator 200 includes four sets of pads 202 and arms 204. In other embodiments, different numbers of pads and arms may be used. For example, one embodiment includes as few as two or three sets of pads and arms, and other embodiments may include more than four sets of pads and arms, such as five, six, seven, or even eight or more sets. The sets of pads and arms may be arranged symmetrically or asymmetrically around the central axis of the device.

[0050] Pad 202 is coupled to arm 204, which can be coupled to a central rod (not shown) extending along the longitudinal axis of the device, passing through handle 206, and coupled to extension mechanism 208. Tissue contact pad 202 can be designed to maintain stability across all expansion diameters. In some embodiments, the pad can have a saddle shape that maintains a constant waist size and inclination angle during expansion. Figures 2A-2C In the illustrated embodiment, arm 204 has a scissor-like assembly and includes shafts 210 and 212 that rotate about a pivot 214. Shafts 210 and 212 can be coupled to a pad and a central rod. Figures 2A-2C In this device, the expansion mechanism 208 includes a mechanical knob configured to expand the arms of the vaginal dilator. Manual rotation of the knob causes it to move away from the handle and causes the central rod to move proximally into the handle, allowing shafts 210 and 212 to rotate about pivot 214 and push the pad 202 radially outward from the central rod of the device. Because the arm 204 includes a scissor-like assembly, the pad 202 can remain parallel to the device and to each other during expansion, which keeps the pad's orientation relative to the tissue stable during expansion. Additionally, keeping the pad in a parallel orientation helps hold the device in proper position within the tissue while maximizing the force distribution along the pad. Rotation of the knob in the opposite direction causes the central rod to move distally, causing the scissor-like assembly to fold and move the pad inward toward the central rod.

[0051] Figure 2A and Figure 2C An expansion device 200 that fits within an adapter 230 is depicted. Figure 2A An expansion device 200 in a contracted configuration is shown, and Figure 2C An expansion device in an extended configuration is shown. Figure 2B An expansion device in a substantially contracted configuration is also shown, with the distal release member 220 extending outward. For illustrative purposes, Figure 2B An expansion device 200 without adapter 230 is shown to more clearly present the proximal end of the expansion device 200. Adapter 230 includes a body 238 and two arms extending from the body 238 and forming a recess 234, the size of which is determined to receive a retaining strap (not shown).

[0052] Although Figure 1 and Figures 2A-2C Expansion devices with mechanical expanding arms that induce dilation are shown, one motorized and the other manually driven. However, it will be readily understood that other devices for dilating a patient's vaginal cavity can be used in conjunction with the retention devices described herein, including expanding balloons, expanding foam bodies, and any other mechanisms adapted to deliver outwardly directed and controlled expanding forces. Such devices can be used in conjunction with the retention devices described herein to hold such alternative dilation devices in a suitable position within the vaginal cavity for a period of time and at a position chosen by the clinician to achieve the therapeutic effect.

[0053] For the procedure described herein, the size of the dilator 200 can be determined, shaped, and configured to be inserted into the vagina at approximately the anterior third, or 3 to 4 cm, and to gradually dilate the vaginal opening from a resting diameter of approximately 2 cm to a fully dilated diameter of approximately 10 cm. The dilator 200 can be configured to... Figure 2A The compact configuration shown extends to, for example, Figure 2C The extended configuration is shown. When the expansion device 200 expands to the extended configuration, as... Figures 2B-2C As shown, pad 202 and arm 204 move radially outward from the expansion device, causing the pads to separate from each other. In some embodiments, the maximum diameter of the pad in the expansion configuration can be approximately 10 cm. In one embodiment, the maximum outer diameter of the pad in the expansion configuration is approximately 8 cm to 12 cm.

[0054] Optionally, the vaginal dilator 200 may include one or more indicators or one or more gauges 218. Figures 2A-2CIn some embodiments, gauge 218 is positioned on handle 206; however, the gauge can be positioned anywhere on the dilator, or even remotely, such as on a display monitor. In some embodiments, the gauge provides the clinician with an indication of the diameter of the dilator across pad 202. The user, such as a physician, can then use the gauge to determine the amount of tissue dilation. For example, gauge 218 may include a simple binary reading (indicating whether the diameter is above or below a certain threshold for continued dilation), or it may have a scale indicating the actual diameter of the dilator. Further optionally, dilator 200 may include a distal release mechanism configured to reduce dilator 200 from an expanded configuration to a closed configuration. The distal release mechanism may include a fetal body detection switch 220 that detects contact between the fetus and the distal release member. The distal release member can release dilator 200 from engagement with the vaginal wall and fold dilator 200 into a closed configuration, and in any case, into a reduced-size configuration that prevents dilator 200 from obstructing the passage of the infant and allows the clinician to remove dilator from the patient.

[0055] Figures 2D-2F Alternative embodiments of the expansion device 250 suitable for use with the systems and methods described herein are depicted. In particular, Figure 2D The expansion device 250 is depicted as having an adapter, the adapter including an integrated arm 252 that is directly attached to and integral with the distal end 254 of the expansion device 250. For example... Figure 2D As depicted, the distal end 254 of the expansion device 250 includes a curved arm 252 extending outwardly from the distal end 254 of the expansion device. (As shown by...) Figure 2D Further described, the distal end of the expansion device includes a user control 264, which can be operated by a patient, clinician, or other party to switch the expansion device between an expanded configuration and a folded configuration. For this purpose, Figure 2E The expansion device 250 is depicted as partially expanded, and the pad 258 is shown extending partially from the expansion device 250. Figure 2F An arm 258 is depicted, which extends and is positioned more fully outward from the expansion device 250 via a scissor arm 260, the scissor arm in Figure 2F The middle part is the scissor mechanism with drive arm 258 extending outward from expansion device 250.

[0056] return Figure 1 It can be seen that the vaginal dilator 102 is held by the retaining device 100, such that the dilator 102 fits into and engages with the adapter 110. Figure 1 In the described implementation, the distal end of the expansion device (which is Figures 2A-2CThe handle 206 of the device 200 fits into the body 116 of the adapter 110. In this depicted embodiment, the adapter 110 is a plastic housing sized to receive the handle of the expansion device 102. In one example, the adapter 110 is made of a plastic material suitable for use in medical applications, and in a specific example, the adapter 110 is made of acrylonitrile-butadiene-styrene (more commonly known as ABS) or some other suitable thermoplastic polymer. In some embodiments, the material is selected to allow for sterilization and reuse.

[0057] The adapter 110 can be sized and shaped such that the handle of the dilator 102 "clicks" into the adapter 110 and is held within the adapter by a frictional engagement. This frictional engagement allows the dilator 102 to be removable from the adapter 110 when mechanical force (typically manual force from the clinician) is applied to overcome the frictional engagement and release the dilator 102 from the adapter 110. Therefore, the clinician can easily remove the dilator from the adapter. This can be done once the therapeutic procedure is complete and the patient is ready for the final stages of labor and delivery. Alternatively, this can be done during labor to allow the clinician to attach a fetal scalp monitor or deliver and place catheters or perform other actions requiring unobstructed access to the vaginal cavity or cervix. In cases where access is required for a temporary period before the completion of the treatment procedure, the dilator 102 can be temporarily removed from the adapter 110 and then replaced back into the adapter 110 to allow the treatment procedure to continue. Optionally, this removal of the dilator 102 can be performed without removing the retention band 118 from the patient. Further alternatively, the removal of the dilation device 102 may be performed after or as part of the removal of the fixation strip from the patient.

[0058] Figure 3A and Figure 3B Alternative embodiments of the adapter 300 suitable for use with the retention device described herein are depicted. Figure 3A The adapter 300, arm 302, recess 304, body 310, curved rear wall 312 and rear wall opening 308 are depicted. Figure 3B The adapter 300 is depicted from an alternative view that shows the curved rear wall 312 and the rear wall opening 308 in more detail. Figure 3A and Figure 3BIn the depicted embodiment, arms 302 extend outward from the body 310 and along the longitudinal axis (not marked) of the adapter 300 to extend from the distal end of the adapter 300 to the proximal end. Each arm 302 is connected to the body at both its distal and proximal ends. An offset between the arm 302 and the body 310 forms a recess 304, the size of which is determined and shaped to accommodate a portion of a retention strap (not shown). The adapter 300 itself is sized and shaped to accommodate an expansion device (such as...) Figure 1 The proximal end of the depicted expansion device 102 is typically a handle. The proximal end of the expansion device can snap into an adapter 300 such that the handle of the expansion device 102 snaps into the adapter 300 and engages within a recess in the body 310 formed by a curved rear wall 312, which follows the curvature of the handle of the expansion device 102. The surface opposite the curved rear wall 312 is open to allow access to user interface controls placed on the handle 108 of the expansion device 102. The rear wall opening 308 allows the body 310 of the adapter 300 to flex, thereby facilitating reception and snapping onto the handle 208 of the expansion device 200. Additionally, the rear wall opening 308 allows a clinician to access the handle 208 when it is in place in the adapter 300, thereby facilitating pressing the handle 208 to push the handle out of the adapter 300 and release the expansion device 200 from the adapter. In some embodiments, the expansion device may have a gripping portion, such as a gripping portion formed of silicon material and positioned on one side of the distal end of the expansion device. The silicon gripping portion allows the clinician to form a more reliable manual grip on the expansion device. An opening 308 in the rear wall of the adapter 300 allows the clinician to grip the silicon gripping portion positioned on the rear side of the distal end of the expansion device, thereby providing a better grip within the expansion device even when the expansion device is mated within the adapter. Alternatively, the adapter 300 may include labels, such as the depicted “front” and “rear”, to allow the user to more easily identify which side of the adapter 300 is in front, and thus more easily insert the expansion device correctly into the adapter.

[0059] Figures 3C-3E Further alternative embodiments of the adapter 350 suitable for use with the retention device described herein are depicted. Figures 3C-3E The adapter 350, arm 352, recess 354, body 360, curved rear wall 362 and rear wall opening 358 are depicted. Figures 3C-3E The adapter 350 is depicted from an alternative perspective that shows certain features (such as the curved rear wall 362 and the rear wall opening 358) in more detail. Figures 3C-3DIn the depicted embodiment, arm 352 is shown curved and arc-shaped, giving the adapter a convex profile. Arm 352 is attached to body 360 at the proximal end of adapter 350 and is open at the distal end. Recess 354 is the space between arm 352 and body 360. Arm 352 extends outward from body 360 and along the longitudinal axis (not marked) of adapter 350, thereby extending from the distal end of adapter 350 to the proximal end of adapter 350.

[0060] Adapters 300 and 350 can be made of plastic such as ABS, and will typically be plastic bodies with sufficient elasticity to snap into place around the handle of the expansion device. However, other materials can be used, including fiberglass, aluminum, or any other material suitable for attachment to the expansion device and connection to a retention strap. Figures 3A-3E In one embodiment, the adapter 350 has a height of approximately 65.6 mm, and the adapter has a width of approximately 72 mm from arm 352 to arm 352. Each arm 352 has a width of approximately 10.00 mm.

[0061] Adapters 300 and 350 snap onto the handle of the expansion device. However, in other embodiments, the adapters may have snap rings, screws, or other mechanical fasteners to connect adapters 300 and 350 to the expansion device, and the method for securing the adapters to the expansion device may vary depending on the application, including whether the adapters need to be easily and quickly released from engagement with the expansion device, or whether the adapters need to have a more secure connection to the expansion device. Figure 3A The adapter 300 depicted in -d is one of two examples of adapters suitable for use with the retention devices and methods described herein. For example, in an alternative embodiment, the adapter may include snaps for forming a mechanical connection with the retention strap. The snaps may be attached to the body of the adapter and may be snap fasteners of the type for attachment to fabric material and are generally referred to as fabric snaps. In such a case, the adapter may allow one side of the snap fastener to be secured to the body of the adapter and the other side of the snap fastener to the fabric of the retention strap. Snapping the adapter to the retention strap releasably secures the adapter to the retention strap. In other alternative embodiments, the adapter may include arms permanently secured to the retention strap, for example by sewing the arms of the adapter into a fabric pocket formed in the retention strap.

[0062] Figure 4 Describes the use of adapters (such as Figure 3AOne embodiment of the retention band 400 used in conjunction with adapters 300 and 350 (-e). In this embodiment, the retention band 400 is a strip of flexible material (typically fabric and generally elastic). Typically, the size of the retention band 400 is determined to fit directly around the patient's body or be mounted around clothing and gowns worn by the patient. The depicted retention band 400 is secured to the patient in a location that facilitates connection of the retention band 400 to the adapter, such that the adapter is positioned to hold the dilation device in the effective therapeutic position.

[0063] The depicted retention strap 400 is made of flexible and elastic materials, such as elastic and stretchable polyurethane fabric, some of which are sold under the trademark Spandex®. Figure 4 The retention band 400 has a length from end to end sufficient to wrap around both thighs of the patient being treated. The retention band 400 may have a segment that crosses the patient's thigh at a location above the pubic arch and has a fixation feature 402 shaped and sized to engage with an attachment feature of an adapter. The retention band 400 has a lumbar band 406 sized to wrap around the patient's back at the waist. This can be... Figure 5 As seen in A, the retention strap is shown wrapped around the waist of the patient model, such that a waist band 406 extends across the model's lower back. The retention strap 400 has two thigh-wrap sections 402 and 408, each of which can wrap around the patient's thigh. A releasable attachment mechanism is provided by elements 404 and 410, in this case, corresponding portions of a hook-and-loop fastener.

[0064] like Figure 4 The depicted thigh band segments 402 and 408 and waist band 406 include hook-and-loop fastener elements 404 and 410 for allowing one or more thigh bands 402 and 408 to form a closed loop around one or more of the patient's thighs. This can be achieved by... Figure 5 B- Figure 5 As seen in Figure F, these figures illustrate the thigh straps of the fixation band being secured around the model's thighs and then to the appropriate position on the lumbar strap 406 located behind the model's lower back. In this depicted example, thigh straps 402 and 408 are secured to the lumbar strap 406 by hook-and-loop fasteners. Specifically, Figure 5 A shows a model with a retention band (such as retention band 400) positioned behind her waist, at or above her pelvis, and above her pubic arch. Figure 5In section B, the model has wrapped the right portion of the fixation band (thigh band 408) around her right thigh, so that the end of the thigh band 408 passes through her groin and wraps around and abuts against her gluteus maximus. Figure 5 C, viewed from the side, shows the end of the thigh strap 408 with a hook element 404 attached to a corresponding ring fastener (410 in this case), which is not shown but is positioned at the upper waist of the model and arranged to engage with the hook element 404. Figure 5 D depicts a model similarly securing the retention strap 400 around the model's left thigh, and Figure 5 E and Figure 5 F, viewed from the side, shows the end of the thigh strap 402 with a hook fastener 404 attached to a loop fastener 410 on the waist strap 406 at the rear section of the retention strap 400 located at the lower back of the model.

[0065] The hook-and-loop fastener elements 404 and 410 can be engaged by pressing them together, such that the hook element 404 is firmly pressed against the loop element 410 until a hook-and-loop engagement is achieved. The size of the hook-and-loop fasteners 404 and 410 can be selected such that the engagement of the hook element with the loop element is robust enough to resist separation when a force is applied to the retention band that pulls the loop element 404 away from the hook element 410, and the force applied is the type of force typically generated by the patient moving around during labor. In this way, the retention band 400 can remain secured around the patient's waist and thighs even when the patient moves around. However, the engagement force of the hook-and-loop fasteners 404 and 410 can be selected such that it will be released under a force that can be applied when a clinician intentionally attempts to remove the retention band 400 from the patient. This force can be the type of force that an obstetrician typically applies to remove a well-secured band held by the hook-and-loop fasteners from the patient. Typically, the force is generated by a strong tearing or pulling motion, which produces a shearing force that can pull the hook away from the ring.

[0066] The retention band may be made of an elastic material to facilitate stretching. The amount of elasticity is selected to provide sufficient elasticity to allow for good attachment to the patient, such that the elastic thigh bands 406 and 408 can elastically wrap around the patient's thighs and optionally provide an elastic contractile force that pulls the thigh bands in an upward direction and toward the patient's vaginal cavity. Since uterine contractions during labor can exert an outward force on the dilating device, the elasticity of the retention band should be selected to sufficiently resist this force to prevent the dilating device from dislodging from the patient. In some embodiments, the retention band may be made of medical-grade fabric. The width of the band can be selected to balance patient comfort and strength. In one embodiment, the band is approximately 1.5 inches wide, but other widths may be selected, and the chosen width will depend on the current application, including the patient's expected body shape. In some embodiments, hook-and-loop fastener attachments are provided at selected locations on the band, and at those selected locations, the retention band can be secured by attaching hooks to the loops of the fasteners. However, in some alternative embodiments, one side of the retention band is completely or substantially completely covered in the loop or hook of the hook-and-loop fastener to allow attachment at any location along the retention band. Further, in other embodiments, other fasteners may be used, including snaps, zippers, buckles, clips, fasteners, or any fastener made of a material suitable for attaching the retention band in a manner that allows it to be secured to the patient's body. If necessary, clinicians may even use strips to form knots to hold the retention band in place, and the choice of fasteners will depend in part on the clinician's preference, who may choose one retention band over another based on the fastening system employed by the band.

[0067] Figure 6A A local model of a patient of average build undergoing therapeutic treatment using the retention device described herein is depicted. Specifically, Figure 6a depicts a local model 600 of the patient, showing a retention device 608 comprising a retention band 602, an adapter 606, and an expansion device 604. Figure 6A In the image, the retention device adapter 606 is attached to the proximal end of the dilator 604, and the retention band 602 is attached to the two arms of the adapter 606 (not shown because they are covered by the retention band). The retention device 608 holds the dilator in a therapeutically effective position within the patient's vaginal cavity. Once positioned, the retention band 602 restricts the adapter 606 from proximal movement away from the patient's birth canal, even when uterine contractions and labor movements tend to expel the object from the birth canal, and even when the patient moves around as typically for a patient during labor. In Figure 6a, the adapter 606 and the dilator 640 can be similar to Figure 1The depicted adapter and dilator include a motorized dilator. The adapter 606 is shown engaging the proximal end of the dilator 640, and the distal end of the dilator 604 extends outward from the adapter 606 and into the patient's vaginal cavity. The retention band 602 may be similar to... Figure 4 The depicted retention band 400 may be made of a flexible and elastic material. The retention band 602 has a length sufficient to wrap around the patient's upper waist and both thighs and has a segment crossing the patient's thighs at a location above the patient's pubic arch. This is understood to provide mechanical support to the retention band 602, allowing it to apply an upward-pointing force opposite to the uterine contractions generated during labor and tending to move proximally and away from the patient's birth canal. The thigh strip of the retention band 602 is secured to a recess (not shown) between the arm of the adapter and the body of the adapter, such that the retention band 602 restricts the adapter 606 from moving proximally away from the patient's birth canal during treatment. Figure 6A The fixation device 600 is shown to hold the dilation device 604 in place for therapeutic effect on the patient. Clinicians can use the fixation device 608 to hold the dilation device 604 in a therapeutically effective position for a sufficient period of time to achieve a therapeutic effect.

[0068] Figure 6B An MRI model depicting the vaginal cavity of patient 600 and showing that the dilation device 604 can be held in position by the fixation device 608. For example... Figure 6B As depicted, the retention device 608 holds the dilator 604 such that the proximal end of the dilator 604 is positioned within the vaginal cavity of the patient 600. Figure 6B In this configuration, the dilator 604 is positioned within the vaginal cavity, thus approaching the pubic bone, and applies a dilating force close to the pubic bone. For example... Figure 6B As shown, in this example, the dilator is held close to the patient's urethra, across the perineal body and levator ani muscle, and away from the cervix. In one embodiment, the method described herein employs a retention device 608 to hold the dilator within the vaginal cavity and close to the perineal body and across the levator ani muscle to provide therapeutic dilation force to this muscular complex and this body during labor.

[0069] The retention device described in this article can be worn by the patient, thus keeping the dilation device in place even as the patient moves through some common labor positions. Figures 7A-7D Several examples of possible positions for the patient during labor and delivery are depicted. See Figure 7a to... Figure 7D It can be seen that patients can get up from the hospital bed during labor and orient themselves in different positions to improve comfort, facilitate the labor process, or for other reasons. Figure 7AThe patient is shown in a squatting position. Figure 7B The patient is shown lying on their side with a pillow between their legs and under their head. Figure 7C The image depicts the patient kneeling, with their torso supported by a support ball, and... Figure 7D The illustration shows a patient lying diagonally on a bed, with the bed partially raised to support the patient's back. In all four illustrations, it can be seen that labor is a physically demanding and active process, and that the retention device, even as the patient moves around the room and changes position in a manner relevant to the labor procedure, can hold the dilation device in a therapeutic position and maintain its therapeutic effect for a considerable period of time. For this purpose, retention bands (such as...) Figure 4 The described fixation band (400) is typically soft, flexible, and comfortable, allowing the patient to wear it comfortably during labor, even as she moves around the room and positions herself in different orientations. Additionally, the fixation band (such as...) Figure 4 The described fixation band (400) can be secured to the patient's body with sufficient strength so that the fixation band is not easily released from the patient, even when the patient moves to a squatting or lying position. Figure 4 In the depicted embodiment, the retention strap 400 includes a hook-and-loop fastener that can be used to secure the retention strap to the patient with sufficient strength to resist separation from the patient even when the patient moves around the room and changes their position.

[0070] The retention devices described herein can hold a dilator in place for the duration of the treatment procedure. For example, a retention device can hold a dilator in the vaginal cavity for a period of time sufficient to achieve the therapeutic effect. Typically, this therapeutic effect is a controlled and progressive stretching of the vaginal cavity, sufficient to facilitate subsequent delivery of the infant while minimizing trauma to the patient. For this purpose, the diameter of the dilator can be incrementally increased, thus increasing the size of the vaginal cavity. The incremental increase can be sufficiently progressive to allow tissue expansion without tearing or otherwise damaging. The tissue can expand gradually, allowing the tissue material to remain sufficiently elastic during expansion to avoid tearing and damage. Although not theoretically limited or constrained, the tissue walls of the vaginal cavity are part of the birth canal and are anatomically generally capable of allowing the infant to pass through. However, the tissues of the pelvic floor and vaginal cavity can be subjected to sudden outward forces during many labor procedures as uterine contractions propel the infant's head and shoulders rapidly through the birth canal and across the pelvic floor. As the infant descends through the birth canal, uterine contractions push the fetal head through the cervix and through the vaginal cavity, which forms a passage through the pelvic floor and the complex of muscles and ligaments that make up the pelvic floor. The fetal head may be large, and the average area of ​​the fetal head in the plane of minimum diameter was measured to be 70 cm². 2 Up to 100 cm 2The fetal head typically has a circumference of 300 mm to 350 mm, requiring significant stretching and deformation of the levator ani complex (the muscle complex surrounding the levator ani muscle). MRI-based computer modeling has shown that the length of the lowest and medial portion of the levator ani complex must increase more than threefold during crowning. Given this degree of rapid stretching, severe muscle damage is not particularly noteworthy, as this stretching is generally considered well beyond the approximately 150% elastic limit of tissue strain. In any case, this rapid outward expansion during delivery can be too fast for untreated tissue. The treatment device described herein allows sufficient time for the tissues of the birth canal and pelvic floor (including the levator ani complex) to adjust by allowing adequate fluid and blood flow to allow the tissues to expand as needed (e.g., to expand the diameter of the vaginal cavity to 10 cm (or 100 mm)). By allowing the vaginal walls and pelvic floor to expand between the baby's passage, the tissue walls of the vaginal cavity and the tissues of the pelvic floor are prepared to expand to allow the baby's passage without tearing and damage, or to reduce tearing and damage.

[0071] Figure 8A and Figure 8A These are magnetic resonance imaging (MRI) images of actual patients that were not processed using the systems and methods described in this paper. Figure 8A This demonstrates the patient's healthy and undamaged levator muscle complex, while Figure 8B The image shows an injured patient. Figure 8A and Figure 8B The comparison of images in the images demonstrates that significant damage to the levator fasciculus can occur during labor. Figure 8B The image illustrates a tear in tissue from the pelvic bone structure, and the patient has suffered pelvic muscle damage during labor and the passage of the fetus through the vagina. The example injury shown is significant and may be difficult to heal completely. Such injuries to the complex that makes up the pelvic floor can occur during labor and delivery and can lead to additional conditions, including bladder prolapse and loss of sphincter support, resulting in permanent or intermittent incontinence. The systems and methods described herein are designed to reduce or eliminate such injuries to the pelvic floor during labor.

[0072] Figure 9A and Figure 9B The therapeutic effect of a vaginal dilator used to therapeutically widen tissue in the birth canal is demonstrated. Figure 9A and Figure 9B An example of a vaginal dilator 900 of the type used in conjunction with the retention device described herein is depicted. Figure 9AIn the diagram, the dilator 900 is shown inserted into the vagina in a closed configuration. The outer diameter of the dilator 900 in the closed configuration can be less than 4 cm, and this can be used during the initial insertion process to provide placement with sufficient patient comfort. Figure 9B A dilator 900 in an extended configuration is shown. The outer diameter of the dilator 900 in the extended configuration can be up to approximately 10 cm. The device can be inserted into the patient at any time during the first stage of labor, and the clinician can choose when to administer the treatment. On average, women stay in the hospital for 14 hours before the second stage of labor begins. After insertion, the dilator 900 expands incrementally, such as over one to three hours, and expands in a manner deemed optimal by the clinician; in some treatments, the diameter of the device is expanded to approximately 10 cm. To provide more effective treatment using the dilator 900, the clinician can employ a retention device to hold the dilator 900 within the vaginal cavity during labor. The retention device resists uterine contractions applied to the dilator 900 and forces arising during changes in the patient's position during labor, and is operated to hold the dilator 900 in the effective treatment position for the duration of treatment.

[0073] Figure 10 This is a diagram illustrating a method for dilating vaginal tissue, which can be used at least in part with the retention device described herein. The right y-axis indicates the force applied to the patient's vaginal cavity by the dilator, the left y-axis indicates the dilation diameter of the dilator, and the x-axis indicates time in minutes.

[0074] Referring to the diagram, in this treatment, the diameter of the vaginal tissue was approximately 5.5 cm and increased to approximately 8 cm over a period of approximately 1 hour (60 minutes). The amount of force applied to the tissue was gradually increased to provide the increased diameter while avoiding tissue damage. For example, initially, force was applied using a dilator to dilate the tissue to approximately 5.5 cm (or 55 mm). After the initial dilation, the tissue relaxed, and the measured force applied to the tissue by the device was observed to decrease for approximately 4 minutes. This indicates that the tissue elastically adjusted to the initially applied force, as the increased diameter of 5.5 cm was observed to be retained even as the applied force decreased. Next, a gradually increasing and incremental force (increased in cycles of approximately 1 minute) was applied by the device to dilate the tissue to 5.6 cm, followed by a period of no further dilation that allowed the tissue to relax and the measured applied force to decrease. This incremental process was repeated until a maximum dilation of approximately 8.0 cm (80 mm) was achieved.

[0075] It should be understood that these values ​​are merely interpretable, as each woman's body and tissues may respond differently to treatment. However, typically, methods for dilating vaginal tissue may include inserting a vaginal dilator into the vagina, measuring the force applied to the vagina by the vaginal dilator, dilating the vagina with the vaginal dilator, and pausing or stopping vaginal dilation when the force applied to the vagina by the vaginal dilator increases to a first force threshold. In some embodiments, the method further includes measuring the vaginal diameter using the vaginal dilator. The method may then include resuming vaginal dilation when the force applied to the vagina by the vaginal dilator decreases to a second force threshold. For example, a user or controller may determine that the tissue is sufficiently relaxed that it is time to begin dilating the vaginal tissue to a larger diameter. In some embodiments, dilation is resumed until the force applied by the vaginal dilator increases to the first force threshold, or alternatively, until the applied force increases to a third force threshold greater than the first force threshold. In some embodiments, the first, second, and third force thresholds range from approximately less than 8 pounds of force.

[0076] Figure 11A and Figure 11B Another alternative embodiment of the adapter 1100 is depicted from a different perspective. The adapter includes a body 1102 and a pair of curved arms 1104. The curved arms 1104 form curved recesses 1108 between the arms 1104 and the body 1102. The size of the curved recesses 1108 is determined to receive a retention strap for securing the adapter 1100 to the retention strap. An opening 1110 allows access to an expansion device and facilitates removal of the expansion device from the adapter 1100. Figure 12 Another alternative embodiment of the adapter 1200 is depicted. The depicted adapter 1200 includes a body 1202 and an arm 1204. The arm extends from the body 1204 at an acute angle and a recess 1208 is provided between the arm 1202 and the body 1204. Figure 13A and Figure 13B Another embodiment of the adapter 1300 is depicted from a different perspective. The adapter includes two arms 1304 extending outwardly from a body 1302 and providing a recess 1308 into which a retention strap can engage for securing the adapter to the retention strap. An opening 1310 allows access to the expansion device and facilitates removal of the expansion device from the adapter 1300. Those skilled in the art will understand that adapters with different configurations can be used with the retention devices and methods described herein without departing from the scope of the invention.

[0077] Figure 14 Alternative implementations of the retention system described herein are depicted. In particular, Figure 14A retaining strap 1400 is depicted, comprising an adapter 1402 and two fabric loops 1404 and 1406. The adapter 1402 engages between the fabric loops, and as... Figure 14 As shown, adapter 1402 may include two arms extending outward from the body. In this example of this alternative embodiment of the retention system, adapter 1402 is comparable to the adapter depicted in Figure 13. In any case, the retention strap 1400 in this embodiment includes two fabric loops. Fabric loops 1404 and 1406 may each be formed from strips of resilient, flexible material including hook-and-loop fasteners. For this purpose, Figure 14 Each loop 1404 and 1406 is shown as a fabric strip already formed into a loop, with the ends of the fabric strips overlapping. Hook and loop fasteners (not shown) are arranged on each fabric strip such that the two ends of the fabric strips can overlap and connect together as shown to form... Figure 14 The ring depicted.

[0078] In use, each of rings 1402 and 1404 can be wrapped around the corresponding thigh of the patient and secured tightly enough to prevent the fabric ring from slipping along the length of the patient's thigh during labor. The fabric ring secured to the patient's thigh is connected to the arm of adapter 1402 by sliding into a recess formed between the body of the adapter and the arm of the adapter. Once in place, the two rings 1404 and 1406 act as retention bands that hold adapter 1402 in place so that the dilation device (not shown) mated within adapter 1402 can be held in the effective therapeutic position for the duration of treatment. The rings around the thigh can be positioned high enough to be above the patient's pubic arch.

[0079] Figure 15 Another alternative embodiment of the retention strap 1500 is described. The retention strap 1500 comprises two strips 1504 of a flexible material, in one case an elastic and flexible fabric, such as a polyurethane material like that sold under the trademark Spandex®. Figure 15 As depicted, the two strips 1504 are arranged to form an overlapping region 1502 and are joined at the overlapping region 1502, such that the two strips 1504 are connected to form an X shape. In the depicted embodiment, the connection at the overlapping region 1502 is formed by stitching the two separate strips 1504 together, such that they are joined at the location that divides each strip 1504 into a long portion and a short portion. In this embodiment, a receiving slot adapter 1506 is formed at the overlapping portion 1502 and provides an opening through the two strips 1504. The size of the receiving slot adapter 1506 is determined to receive a portion of the proximal end of the expansion device for releasably connecting the expansion device to the retention strap 1500.

[0080] Figure 16 The image depicts a model with a 1500-type retainer strap applied to her body. (As shown) Figure 16 As depicted, the retention band 1500 is positioned such that the overlapping area 1502 of the connection fits near and proximal to the pubic arch of the model patient, and the long and short portions of the band are brought together and connected such that the long and short portions form a loop around the model patient's thigh. To connect the long and short portions of the band, the retention band 1500 can use hook-and-loop fasteners of the type commonly used for connecting fabric materials or any suitable fastener.

[0081] Figure 17 Depicting Figure 15 and Figure 16 The depicted type of retention band 1700 is positioned around the thigh of a model patient (wearing trousers) and has an expansion device 1702 in a contracted form, which engages with a receiving slot adapter (of a similar type) in the retention band 1700. Figure 15 In the depicted receiving slot adapter 1506). For example... Figure 17 As depicted, the expansion device 1702 can engage a proximal portion against and slide into and through the receiving slot adapter to be releasably coupled to the retention strap 1700. The receiving slot adapter provides engagement with the retention strap 1700 without the use of a separate plastic adapter. In this embodiment, the retention strap employs a sufficiently robust fabric material to provide openings through overlapping strips in the fabric slots, wherein the openings are strong enough to resist tearing forces generated in response to downward movement of the expansion device 1702.

[0082] The embodiments described herein should not be construed as limiting, and various modifications and additions can be applied to these embodiments without departing from their scope, including retention systems that permanently attach the adapter to the retention band (e.g., by sewing the adapter to the retention band). Additionally, the retention band can have several alternative shapes, and for example, an alternative retention band can be shaped as underwear that can be worn by the patient during labor and retain the dilation device in a therapeutically effective position for the duration of therapeutic effectiveness. Furthermore, retention bands can be employed that can be attached to other locations on the patient's body, such as fabric strips surrounding the upper part of the patient's body (e.g., the patient's shoulders). Further, although the retention band has been described as a fabric strip for surrounding and securing to a portion of the patient's body, in alternative embodiments, an adhesive can be used to directly attach the fabric strip to the patient's body. For example, adhesive can be applied to the surface of the fabric strip. The strip with adhesive (very much like an adhesive bandage) can attach to the patient's body when some force is applied. This can cause the fabric strip to adhere to the patient. The adapter can then be attached to the adhered fabric strip.

[0083] For other details relating to this invention, materials and manufacturing techniques at the level of a person skilled in the art may be employed. This also applies to additional operations that are typically or logically employed, regarding the method-based aspects of the invention. Moreover, it is contemplated that any optional features of the described inventive variations may be set forth and claimed independently, or in combination with any one or more features described herein. Similarly, references to singular items include the possibility of the existence of a plural of identical items. More specifically, when used herein and in the appended claims, the singular forms “a / an,” “said,” and “the” include plural referents unless the context clearly indicates otherwise. It should be further noted that claims may be drafted to exclude any optional elements. Thus, this statement is intended as a precondition for the use of exclusive terms such as “only,” “only,” or the use of “negative” when reciting elements of the claims. Unless otherwise specified herein, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The scope of this invention is not limited by the subject matter description, but only by the ordinary meaning of the terminology used in the claims.

Claims

1. An apparatus for reducing injury to a patient during labor and delivery procedures, the apparatus comprising: An adapter, shaped to engage the proximal end of a vaginal dilator and allow the distal end of the dilator to extend distally from the adapter, and having an mounting for receiving a retention band, and A fixation band, made of a flexible material and having a length sufficient to wrap around the patient's thigh, and having a segment that crosses the patient's thigh at a location above the patient's pubic arch, and having a fixation feature shaped to engage with the attachment feature of the adapter. Therefore, the retaining band restricts the adapter from moving proximally away from the patient's birth canal.

2. The apparatus according to claim 1, wherein, The retaining band comprises one or more strips of elastic material.

3. The apparatus according to claim 2, wherein, The one or more strips of elastic material include fasteners to allow the one or more strips to form a closed loop around the patient's body.

4. The apparatus according to claim 2, wherein, The one or more strips include hook-and-loop fasteners to allow the one or more strips to form a closed loop around one or more of the patient's thighs.

5. The apparatus according to claim 2, wherein, The fixation band includes a flexible material strip, the size of which is determined to wrap around the patient's waist and thighs to form a band, the band having two strip segments positioned between the patient's thighs and above the patient's pubic arch.

6. The apparatus according to claim 1, wherein, The retention band has a release member that disconnects the band from the patient or the adapter when a proximal force exceeding the expected force for the infant to travel proximally through the birth canal during delivery is applied.

7. The apparatus according to claim 6, wherein, The release element includes a hook-and-loop fastener disposed on the strap to provide an easily detachable release element for disconnecting the strap from the patient or the adapter.

8. The apparatus according to claim 1, wherein, The mounting element includes an arm that extends radially and proximally from the adapter to form a bend, the size of which is determined to engage with the retention strap.

9. The apparatus according to claim 6, wherein, The arm is formed as a guide rail, which is attached to the side of the adapter and provides an internal groove for receiving the retaining strap.

10. The apparatus according to claim 1, wherein, The adapter includes a plastic body that is shaped to fit around the handle of the expansion device.

11. The apparatus according to claim 1, wherein, The adapter is an integral part of the vaginal dilator.

12. A method for reducing tissue damage during labor and delivery procedures, the method comprising: Provides a type of vaginal dilator for providing therapeutic dilation force during at least a portion of the labor process. A wearable retention band is provided, the wearable retention band having a length sufficient to wrap around the patient's waist and at least one thigh. The fixation band is secured to the patient by wrapping it around the patient's waist and at least one thigh, such that the band is secured to the patient at a first position near the pubic arch and a second position above the pubic arch. The dilator is secured to the retaining band at the second position, and at least a portion of the dilator is disposed within the vaginal cavity, and different portions of the dilator are secured to the retaining band such that the retaining band resists undesirable detachment of the dilator from the vaginal cavity.

13. The method according to claim 12, wherein the method further comprises: supply An adapter is attached to the proximal end of a vaginal dilator to allow the distal end of the dilator to extend distally from the adapter, and has a mounting for slidably receiving the retention band.

14. The method according to claim 13, wherein, The adapter provided includes a removable adapter that can be releasably attached to the proximal end of the vaginal dilator.

15. The method according to claim 13, wherein, Providing an adapter includes providing a vaginal dilator having a proximal end in which the mounting element is integrated.

16. The method according to claim 12, wherein, Securing the retention band to the patient includes using fasteners to secure a first segment of the retention band to a second segment of the retention band.

17. The method according to claim 16, wherein, Fasteners used include at least one of hook and loop fasteners, snaps, zippers, clips, and buckles.

18. The method according to claim 12, wherein, The vaginal dilator is secured to the fixation band at the second position and at least a portion of the dilator is disposed within the vaginal cavity, including fixing the fixation band to secure the dilator at a position within the patient's vaginal cavity such that an expansion force can be applied to the patient's levator ani muscle during labor.

19. The method of claim 16, further comprising holding the vaginal dilator within the vaginal cavity of the patient and applying dilating force to the tissue wall of the vaginal cavity for a period of time between 30 minutes and 120 minutes.

20. The method of claim 19, further comprising temporarily removing the vaginal dilator from the vaginal cavity during the time period between 30 minutes and 120 minutes.

Images