Apparatus and methods for accessing and sealing bodily vessels and cavities

Abstract

Everting balloon systems and methods for using the same are disclosed herein. The systems can be configured to access and dilate body lumen and cavities. For example, the systems can be used to dilate the cervix and access the uterine cavity. The systems can also be used to occlude the cervix. The systems can also be used to occlude the urethra.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority to U.S. Provisional Application No. 61 / 902,742, filed Nov. 11, 2013, 61 / 977,478, filed Apr. 9, 2014; 62 / 005,355, filed May 30, 2014; and 62 / 007,339, filed Jun. 3, 2014, all of which are incorporated by reference herein in their entireties.BACKGROUND[0002]For physicians and medical professionals, accessing systems for vessels and bodily cavities in patients have typically used various guidewire and catheter technologies. In some cases, the process requires the insertion of a series of mandrels or wires to increase the lumen diameter for the eventual passage of a larger bore instrument within the vessel. This technique can be referred to as “Dottering” or in the case of accessing the cervical canal and uterus, physicians will use a series of increasing diameter mandrels known as Hegar dilators. In the techniques described above, the methods involved pushing an object, mandrel, or device through the vessel to...

AI Technical Summary

Benefits of technology

[0025]The everting balloon system can be used for insemination and can seal the cervix for a duration of time for the deposition of sperm and to allow for mobility for the patient. The everting balloon system can have a decoupling mechanism configured to decouple the outer catheter and inner catheter while maintaining hydraulic pressure in an everting balloon. The system can deflate and removal the everting balloon concurrently.

Problems solved by technology

In some cases the shear forces can result in trauma, pain for the patient, or perforation.

In addition, as the everting catheter deploys inside out, uncontaminated or untouched balloon material is placed inside the vessel wall.

This process can be particularly difficult in some nulliparous, post-menopausal women with very small diameter cervical canals.

A cervix could be difficult to traverse as a result of prior surgery, underlying stenosis, or other anatomical configuration or tortuosity that makes the passage of instruments or Hegar dilators difficult.

As mandrels or instruments get smaller in diameter, the likelihood of perforation or a false passage increases.

The security of the cervical cap is not reliable and due to its size and bulk, not as comfortable for the patient.

The pump can be worn by the woman outside of the physician's office but patient mobility is limited due to keeping the integrity of the conduit and pump.

Also, when delivering the reproductive material, such as an embryo, into the uterine cavity, vacuum effect can unintentionally remove the reproductive material from the uterine cavity.

Further, incontinence is a prevalent clinical and social issue that primarily affects women.

The choice of therapeutic options has limited reimbursement and many of the techniques lack consistent data.

Incontinence is a multi-factorial disease condition and patient satisfaction with many invasive techniques is poor.

Due to the social stigma, many patients are reluctant to seek advice and many patients decline surgical and less invasive options.

Consequently, male and female incontinence patients rely on sanitary pads and the restrictions that the presence of bulky, wet pads imposes on their daily lives.

In contrast, urethral plugs and inserts in use currently have a propensity of urinary tract infections which may be a result of the lack of cleanliness of the device that resides in the urethra or bladder.

For a patient, being able to insert a device within their own urethra is not easy and the act itself is unnatural for the patient.

Since the inserts used today require pushing a device through the urethra, the urethral passageway could become sore or tender after repeated insertions.

Hence it is understandable that the presence of a relatively stiff device that is keeping the opening of the bladder tight against the urethral opening can create an uncomfortable feeling for the patient, especially a patient that is active and mobile.

Furthermore, urinary protection and voiding could occur 3 to 7 times a day, a high cost device would not be acceptable to most patients or would limit the device usage to only the most socially challenging events.

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