Vaginal stents, vaginal dilators, and methods of fabricating the same

One aspect of the invention provides a vaginal stent system including: an inflatable vaginal stent and a removable handle. The inflatable vaginal stent include includes: an elastomeric exterior wall and a first fitting located at a base of the inflatable vaginal stent. The removable handle is adapted and configured for insertion, inflation, and removal of the inflatable vaginal stent from a subject's vagina. The removable handle includes a second fitting complementary to the first fitting and adapted and configure to form substantially fluid tight coupling when the handle is coupled to the inflatable vaginal stent. Another aspect of the invention provides a method of fabricating a customized vaginal stent or dilator. The method includes: generating a 3D model of a vaginal stent or dilator; and controlling a 3D printer to fabricate a vaginal stent or dilator according to the 3D model.

BACKGROUND OF THE INVENTION

Vaginal dilators and stents are used after surgical neovagina creation in order to maintain the caliber of the newly created vagina and to avoid restenosis after surgery or radiation. Neovaginal creation is necessary in girls born with Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome (1/4,500), vaginal agenesis (1/5,000-7,000), cloacal anomalies, Congenital Adrenal Hyperplasia or other congenital anomalies. Additional uses include any women with vaginal stenosis from pelvic radiation or gynecology-oncology related cancer surgeries.

Currently available stents and dilators exist only in adult vaginal sizes that cannot be used safely or comfortably in the pediatric population or oncologic patients who have undergone vaginal brachytherapy.

SUMMARY OF THE INVENTION

One aspect of the invention provides a vaginal stent system including: an inflatable vaginal stent and a removable handle. The inflatable vaginal stent include includes: an elastomeric exterior wall and a first fitting located at a base of the inflatable vaginal stent. The removable handle is adapted and configured for insertion, inflation, and removal of the inflatable vaginal stent from a subject's vagina. The removable handle includes a second fitting complementary to the first fitting and adapted and configure to form substantially fluid tight coupling when the handle is coupled to the inflatable vaginal stent.

This aspect of the invention can have a variety of embodiments. At least one of the inflatable vaginal stent and the removable handle can include one or more magnets. The inflatable vaginal stent can include a magnetically-actuatable valve adapted and configured to deflate the inflatable vaginal stent when the removable handle is placed in proximity to a base of the inflatable vaginal stent. The one or more magnets can have sufficient strength to remove the inflatable vaginal stent from a subject's vagina by placing the removable handle proximate to the subject's perineum.

Another aspect of the invention provides a vaginal dilator system including: a vaginal dilator and a removable handle. The vaginal dilator includes: an exterior wall and a hollow channel extending the length of the vaginal stent. The removable handle is adapted and configured for insertion and removal of the inflatable vaginal stent from a subject's vagina.

This aspect of the invention can have a variety of embodiments. At least one of the vaginal dilator and the removable handle can include one or more magnets. The one or more magnets can have sufficient strength to remove the inflatable vaginal stent from a subject's vagina by placing the removable handle proximate to the subject's perineum.

Another aspect of the invention provides a method of fabricating a customized vaginal stent or dilator. The method includes: generating a 3D model of a vaginal stent or dilator; and controlling a 3D printer to fabricate a vaginal stent or dilator according to the 3D model.

DEFINITIONS

As used in the specification and claims, the terms “comprises,” “comprising,” “containing,” “having,” and the like can have the meaning ascribed to them in U.S. patent law and can mean “includes,” “including,” and the like.

Unless specifically stated or obvious from context, the term “or,” as used herein, is understood to be inclusive.

DETAILED DESCRIPTION OF THE INVENTION

Methods of Fabricating Vaginal Stents or Dilators

Referring now toFIG. 1, one aspect of the invention provides a method100of fabricating a vaginal stent or dilator.

Optionally in step S102, one or more measurements are obtained. The measurements can relate to the current dimensions of a subject's vagina or desired dimensions for various medical reasons. In some embodiments, the dimensions can be assessed visually by a healthcare provider. Additionally or alternatively, one or more imaging devices such as an inflatable cavity imager (e.g., as described in U.S. Patent Application Publication Nos. 2014/0272221, 2014/0276005, and 2014/0276105) or various ultrasound, magnetic resonance, computed tomography, and/or X-ray devices and techniques can be utilized.

In step S104, a 3D model of a vaginal stent or dilator is generated. The 3D model can be generated based on the one or more measurements obtained in step S102or can be generated from one or more templates or patterns. The 3D model can be generated using computer-aided design (CAD) software and can be manipulated by a healthcare provider to have a desired shape and/or dimensions. In some embodiments, a stent has an uninflated dimension of about 7 cm in length by about 2 cm in width or about 6 cm in length by about 1 cm in width. In some embodiments, dilators can have lengths and diameters as small as about 0.5 cm.

In step S106, a 3D printer is controlled to fabricate a vaginal stent or dilator according to the 3D model generated in step S104. A variety of 3D printers are available from a variety of sources. One suitable 3D printer is the OBJET30 PRO™ 3D printer from Stratasys Ltd. of Eden Prairie, Minn., which deposits layers of liquid photopolymers. One exemplary photopolymer is OBJET RGD525 acrylic photopolymer also available from Stratasys Ltd. Other suitable photopolymers include acrylonitrile butadiene styrene (ABS), polypropylene, rubber, and the like. Suitable fused deposition modeling (FDM) thermoplastics include acrylonitrile butadiene styrene (ABS), acrylonitrile styrene acrylate (ASA), nylon, polycarbonate (PC), PC-ABS blends, polylactic acid (PLA), polyvinyl alcohol (PVA), thermoplastic elastomers (TPEs), high impact polystyrene (HIPS), and the like. Other suitable extrudable materials include silicone.

Fabrication of vaginal stents and dilators can provide customized devices to fit a particular subject's anatomy and medical needs without the delays associated with manufacturing and shipping. Additionally, customized fabrication can avoid the need to purchase multiple devices that may not fit the patient's anatomy or needs, and can reduce patient frustration, pain, and non-compliance.

In addition to 3D printing one or more components of a vaginal stent or dilator, 3D printing can also be utilized to produce negative molds of one or more components that can then be used to mold or more components. For example, a negative of an uninflated exterior wall as described further herein can be printed using a 3D printer and then used to cast the exterior wall, e.g., with an elastomer such as polyurethane.

Vaginal Stents

Referring now toFIG. 2A, another aspect of the invention provide a vaginal stent200that can be inserted into a subject's vagina and inflated to a desired size to achieve a medical goal. The vaginal stent200includes an elastomeric exterior wall202and a fitting204located at the base of the vaginal stent200. When inflated, the stent200can be rigid enough to retain shape and vaginal wall support despite movement and valsalva. The stent200can be inserted intraoperatively, remain in situ, and be progressively inflated until removal at a later date when healing occurs.

The fitting204can be adapted and configured to receive a fluid (either gas or liquid) to inflate the elastomeric exterior wall202to a desired level and/or shape. In one embodiment, the fitting204is a Luer-lock-style fitting.

A central core206can maintain the length of and facilitate insertion of the stent200into the subject's vagina prior to inflation. The central core206can be pliable, while also having rebound and shape memory. The central core206can be fabricated from rubbers, plastics, or metals. In one embodiment, the central core206has a plurality of holes to facilitate flow of fluid into the region bound by the elastomeric exterior wall202. In some embodiments, the inner core206is perforated or is a plastic mesh.

Insertion and removal of vaginal stents can be challenging and/or uncomfortable for many patients and particularly for children and adolescents. In order to address this discomfort, embodiments of the invention can utilize a removable handle208as depicted inFIG. 2B. One or more of the removable handle208and the vaginal stent200can include one or more magnets (e.g., 4 or 8) such as rare-earth magnets. In some embodiments, the magnets can have sufficient strength to pull the vaginal stent200from the subject's vagina when the subject holds the removable handle208adjacent or proximal to the subject's perineum. Without being bound by theory, it is believed that between about 0 pounds and about 26 pounds of force (e.g., between about 0 pounds and about 5 pounds, between about 5 pounds and about 10 pounds, between about 10 pounds and about 15 pounds, between about 15 pounds and about 20 pounds, between about 20 pounds and about 26 pounds, and the like) would be sufficient to remove a deflated vaginal stent from a typical subject's vagina and that sufficient force can be generated across the perineum using magnets.

In order to further minimize user discomfort, the removable handle can facilitate inflation and/or deflation of the magnetic stent. For example, the vaginal stent200can include one or more fittings located on a base that engages with the removable handle208and the removable handle208can include a complementary second fitting. For example, the fittings can be located centrally to a plurality of radially-arranged magnets and/or ferromagnetic materials so that fittings will be aligned by magnetic forces. Once the vaginal stent200, the removable handle208, and the fittings therein are engaged, fluid can flow from the removable handle into the vaginal stent200for inflation. One or more valves (e.g., one-way or check valves) can seal the vaginal stent200against fluid leakage. In one embodiment, one or more of the one or more valves210can be magnetically-actuated, preferably at a relatively low magnetic force so that the vaginal stent200will deflate as the removable handle208approaches the perineum and prior to the application of sufficient forces to move and extract the vaginal stent200. In some embodiments, the removable handle208can include a pressure gauge to provide feedback to the subject regarding the degree of inflation of the coupled vaginal stent.

Referring now toFIGS. 3A and 3B, side and top views of the core206are provided showing the perforations in the outer wall and the hollow center and ends that allow for passage of vaginal secretions.FIGS. 3C-3Eprovide cross-sectional views of the core.FIG. 3Eprovides exemplary dimensions in millimeters.

Vaginal Dilator

Referring now toFIG. 4A, another aspect of the invention provides vaginal dilators400a,400b,400cthat can be composed of a rigid, durable plastic material shaped as a tapered hollow capsule. Various sizes can be produced. For example, dilator400ahas a diameter of about 20 mm and a length of about 70 mm, dilator400bhas a diameter of about 15 mm and a length of about 65 mm, and dilator400chas a diameter of about 10 mm and a length of about 60 mm. Any of the vaginal dilators disclosed herein may comprise a hollow channel for extrusion of fluid from the vagina as shown inFIG. 4A. In certain embodiments, the channel runs along the entire length of the vaginal dilator. The diameter of the channel is not restricted to any particular diameter, but should be sufficient for fluid to enter the channel and, in certain embodiments, to pass through the dilator.

Referring now toFIGS. 4B and 4C, in some embodiments, the vaginal dilator(s)400include or are compatible with the use of magnets410for engagement with a removable handle208for insertion and/or removable. The arrangement of four magnets410at 90° radial intervals is depicted inFIG. 4D. In some embodiments, the removable handle208is compatible with both the vaginal stents200and the vaginal dilators400.

EQUIVALENTS

INCORPORATION BY REFERENCE