IMAGING PROBE ADAPTER

Abstract

An imaging probe adapter for measuring the properties of a lumen like the vaginal canal, the rectum, or anal sphincter. The device has an adapter body with a proximal end and a distal end. The distal end of the adapter body may be formed into an insertion tip capable of easy insertion into the appropriate lumenal structure. An inflatable pressure chamber covers the distal end of the adapter body. A baseplate formed on the proximal end of the adapter body incorporates fluid channels for inflating the pressure chamber and a probe channel that receives an ultrasound probe or other suitable imaging probe. The device is used to measure and model lumenal biomechanical properties such as stiffness, compliance, elastic versus viscous contributions to overall stiffness, and total displacement.

Claims

1. An imaging probe adapter for measuring the properties of a lumen, comprising: an adapter body with a proximal end and a distal end, where the distal end is adapted for insertion into the lumen and the proximal end forms a baseplate adapted to remain outside the lumen, a pressure chamber capable of being inflated with a liquid, a probe channel formed in the adapter body for receiving an imaging probe capable of measuring the deformation and geometry of the pressure chamber, one or more flow channels in the baseplate in communication with the pressure chamber, and a system for inflating and deflating the pressure chamber.

2. The imaging probe adapter of claim 1, the pressure chamber further comprising: a balloon having two ends, with one end secured to the distal end of the adapter body and the other end secured to the baseplate.

3. The imaging probe adapter of claim 1, in which the system for inflating and deflating the pressure chamber further comprises a pump connected by tubing to the one or more flow channels in the baseplate.

4. The imaging probe adapter of claim 3, further comprising the pump being a syringe pump or peristaltic pump.

5. The imaging probe adapter of claim 1, further comprising a system for measuring the internal pressure of the pressure chamber.

6. The imaging probe adapter of claim 5, in which the system for measuring the internal pressure of the pressure chamber is pressure transmission tubing connecting the pressure chamber via a flow channel to a pressure transducer that is external to the adapter.

7. The imaging probe adapter of claim 5, in which the system for measuring the internal pressure of the pressure chamber is a pressure transducer mounted in the pressure chamber.

8. The imaging probe adapter of claim 1, further comprising channels formed in the baseplate to allow wiring or tubing to pass through the baseplate into the pressure chamber.

9. The imaging probe adapter of claim 1, where the probe channel formed in the adapter body is adapted to receive an endoanal ultrasound probe.

10. A method for measuring the structural integrity and structural health of the female pelvic floor, comprising: inserting an imaging probe into an imaging probe adapter, where the imaging probe adapter comprises an adapter body with a proximal end and a distal end, and where the distal end is adapted for insertion into the lumen and the proximal end forms a baseplate adapted to remain outside the lumen, a probe channel formed in the adapter body for receiving an imaging probe, a pressure chamber capable of being inflated with a fluid, one or more flow channels in the baseplate in communication with the pressure chamber, and a system for inflating and deflating the pressure chamber; inserting the distal end of the imaging probe adapter into a patient's vagina; inflating the imaging probe adapter pressure chamber with fluid; obtaining pressure measurements of the pressure chamber; using the imaging probe to obtain measurements of the deformation of the pressure chamber; using the imaging probe to obtain measurements of the geometry of the pressure chamber; and resolving the obtained measurements to model vaginal biomechanical properties at one or more locations within the vagina.

11. The method of claim 10, further comprising using the obtained measurements to create a graphic representation of the 3-dimensional shape of the vagina under various pressures.

12. The method of claim 10, further comprising using the obtained measurements to create a graphic representation of the 3-dimensional shape of the vagina under various pressures accompanied or overlaid by a map describing various biomechanical properties.

13. The method of claim 10, further comprising using the obtained measurements to create a map depicting biomechanical properties along the vaginal geometry.

14. The method of claim 12, where the mapped biomechanical properties may include one or more biomechanical properties such as stiffness, compliance, elastic versus viscous contributions to overall stiffness, or total displacement.

15. A method for measuring the properties of a lumen, comprising: inserting an imaging probe into an imaging probe adapter, where the imaging probe adapter comprises an adapter body with a proximal end and a distal end, and where the distal end is adapted for insertion into the lumen and the proximal end forms a baseplate adapted to remain outside the lumen, a probe channel formed in the adapter body for receiving an imaging probe, a pressure chamber capable of being inflated with a fluid, one or more fluid channels in the baseplate in communication with the pressure chamber, and a system for inflating and deflating the pressure chamber; inserting the distal end of the imaging probe adapter into a lumen; inflating the imaging probe adapter pressure chamber with fluid; obtaining pressure measurements of the pressure chamber; using the imaging probe to obtain measurements of the deformation of the pressure chamber; using the imaging probe to obtain measurements of the geometry of the pressure chamber; and resolving the obtained measurements to model lumenal biomechanical properties at one or more locations within the lumen.

16. The method of claim 15, further comprising using the obtained measurements to create a graphic representation of the 3-dimensional shape of the lumen under various pressures.

17. The method of claim 15, further comprising using the obtained measurements to create a map depicting biomechanical properties along the lumenal geometry.

18. The method of claim 17, where the mapped biomechanical properties may include one or more biomechanical properties such as stiffness, compliance, elastic versus viscous contributions to overall stiffness, or total displacement.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0015] FIG. 1. is an elevation view of the exterior of the imaging probe adapter. Dashed lines depict the interior structure of the adapter.

[0016] FIG. 2 is a cut-away view of the interior of the imaging probe adapter with an imaging probe installed in the adapter.

[0017] FIG. 3 is a cut-away view of the interior of the imaging probe adapter

[0018] FIG. 4A is a perspective views of the exterior of the imaging probe adapter with the balloon inflated.

[0019] FIG. 4B is a perspective views of the exterior of the imaging probe adapter with the balloon inflated.

DETAILED DESCRIPTION OF THE INVENTION

[0020] The invention is an imaging probe adapter 1 for measuring the properties of a lumenal structure like the vaginal canal, the rectum, or anal sphincter. The exterior of the imaging probe adapter 1 is depicted in FIG. 1. Dashed lines depict the interior structure. The adapter 1 has an adapter body 3 with a proximal end 5 and a distal end 7. The adapter body 3 may be made of rigid, semi-rigid, or flexible materials that are capable of transmitting ultrasound or other imaging waves.

[0021] The distal end 7 of the adapter body 3 may be formed into an insertion tip capable of easy insertion into the appropriate lumenal structure. In one embodiment for assessing the female pelvic floor the insertion tip is designed to insert easily and comfortably into the vagina without encouraging dilation of the cervix. The distal end 7 may comprise a piece having two rounded steps, cut so that the first step is narrow enough to easily separate the labia as would be the case with a cone, but is blunt enough to prevent cervical dilation as would be the case with a cone. In another embodiment, the anatomical tip can be cast, molded or formed in one piece.

[0022] A pressure chamber 9 may be constructed of a bag like structure that fits over the adapter body 3. The pressure chamber 9 may be configured as a balloon made of compliant materials such that the material stretches to accommodate the volume within the balloon. The balloon may be made of any suitable flexible material with known mechanical properties that is capable of stretching when the balloon is inflated. By knowing the mechanical properties of the material, the pressures resulted from the tensions and loads being placed by the lumen onto the pressure chamber 9 may resolved and mathematically separated from the pressure generated by the tension within the balloon. In another embodiment, the pressure chamber 9 may be configured as a balloon made of non-compliant materials. In this embodiment, the material of the balloon does not stretch but the balloon is constructed such that it can be filled to a volume that can distend the lumen being evaluated. In this embodiment, the minimal tension is generated within the balloon material and therefore the pressures generated within the pressure chamber 9 are due to the tensions and loads being placed by the lumen onto the pressure chamber 9. In one embodiment, the balloon is a durable polyurethane polymer of medical grade material.

[0023] One or more balloon attachment points 11 may be incorporated into the adapter body 3. In this embodiment, the balloon attachment points 11 are channels molded into the adapter body 3 that are configured to receive elastic bands or circumferential clamps 13 to hold the balloon in place. The balloon may also be attached to the adapter body 3 by adhesives or other suitable attachment methods.

[0024] The proximal end 5 of the adapter body 3 forms a baseplate 15. The baseplate 15 is the widest portion of the adapter body 3. One or more flow channels 17 are formed in the baseplate 15. The flow channels 17 communicate with the interior of the pressure chamber 9, and the channels 17 allow fluid to be pumped into the pressure chamber 9 to inflate the pressure chamber 9. A system (not shown) for inflating the pressure chamber 9 may include a pump for moving fluid into and out of the balloon by means of a tube secured to a flow channel 17. Flow of liquid or air into the pressure chamber 9 may be both controlled and monitored.

[0025] In one embodiment, a syringe pump is employed in which the flow rate of around 25-100 mL/min is achieved, and in which the flow is monitored by the position of the syringe plunger. In another embodiment a flow meter is employed. The pump controls the flow of fluid into the pressure chamber 9. The internal pressure of the pressure chamber 9 may be measured with a pressure transducer (not shown) mounted in the pressure chamber 9 or pressure transmission tubing may be attached to one of the flow channels 17 and the pressure may be measured by a pressure transducer external to the adapter 1.

[0026] FIG. 2 is a cut-away view of the interior of the imaging probe adapter 1. The interior of the adapter body 3 forms a probe channel 19 that is adapted for receiving an imaging probe 21. In FIG. 2, an imaging probe 21 is inserted into the probe channel 19. In this embodiment, the imaging probe 21 is an endoanal ultrasound probe, but the probe channel 19 may be configured to accept other types of imaging probes 21. An imaging probe 21 may be coated with ultrasound gel before it is inserted into the probe channel 19 to aid in the transmission of ultrasound waves. FIG. 3 is a cut-away view of the imaging probe adapter 1 without an imaging probe 21 inserted into the probe channel 19.

[0027] FIG. 4a is a perspective view of the exterior of the imaging probe adapter 1. In this embodiment, the baseplate 15 is in shape of a flattened, circular flange. The baseplate 15 may be configured into different shapes in other embodiments. The bottom of the baseplate 15 is visible in FIG. 4b. Two flow channels 17 are present in the baseplate 15, but other embodiments may be configured with one or more flow channels 17. One or more of the flow channels 17 may serve as a port to conduct components (such as tubes, wires, or cables) through the baseplate 15 into the interior of the pressure chamber 9.

[0028] To use the imaging probe adapter 1, an imaging probe 21 is inserted into the probe channel 19. Then the adapter 1 is inserted into the patient to a desired depth, such as the depth of the cervix when the vagina is relaxed and the patient is in a supine position with legs in stirrups.

[0029] The balloon may be inflated at a desired speed while simultaneously recording pressure, volume, and deformation data. This technique allows for creation of load-versus-displacement curves, or other derivatives thereof, such as stress-versus-strain curves, and load-versus-time curves. This data may be processed to identify specific parameters (i.e. stiffness, extensibility, bulk modulus, novel parameter(s) identified from the described device's data set) of interest to the researcher or clinician. The balloon may also be inflated to a desired volume or pressure value, and at a desired speed, and inflation may be stopped when the pressure or volume threshold is reached. The balloon is held at the above-reached volume for a desired amount of time. This may be from zero seconds up to as much as about an hour or more if stress relaxation behavior is of interest. Alternatively, the balloon may quickly be inflated to a desired pressure, then continually inflated at a very slow inflation rate in order to maintain the desired pressure. This technique would allow the observation of creep phenomenon. The balloon can then be deflated to the original volume.

[0030] The endoanal ultrasound probe 21 may be used to obtain balloon geometry at a single plane of interest or it may scan the entire length of the balloon to obtain a 3D volumetric geometry of the balloon as it is being inflated. By means of this invention, detailed vaginal biomechanical properties may be obtained with a resolution high enough to resolve for differences in the biomechanical properties throughout the various locations of the vagina. Data may be output numerically or accompanied by a graphic representation consisting of the 3D shape of the vagina under various pressures overlayed with a map representing various biomechanical properties along the vaginal geometry. The map may be in the form of a heatmap, with different colors representing different values of the mapped biomechanical properties. The biomechanical properties are not limited to but may include stiffness, compliance, elastic versus viscous contributions to overall stiffness, total displacement, etc.

[0031] The above-described techniques and procedures may be used in a number of diagnostic, preventative, and therapeutic modes including, without limitation, the following: [0032] 1. Diagnosis/characterization of lumenal strength and structural integrity. This information is directly related to the presence and severity of structural disorders of, for example, the pelvic soft tissues such as pelvic organ prolapse or other pelvic floor disorders. [0033] 2. Creation of a baseline parameter, similar to a patient's normal blood pressure, which is related to lumenal health. This allows the continuous tracking of a patient's progress allowing for a more personalized approach to prenatal care and obstetrics. [0034] 3. Diagnosis/identification of patients at high risk for obstetric or other trauma or complications. Structural data is used to evaluate the vagina's ability to accommodate the loading during childbirth, so the clinician can make more informed decisions regarding interventions (C-section, forceps, vacuum suction, for example). [0035] 4. Evaluation of surgical interventions which seek to restore structural integrity to the female pelvic floor. These surgeries employ meshes, slings, and major repair and restructure of tissues. Assessment of the structural effects of these procedures allows for better tracking of progress and better understanding of a patient's benefits/complications associated with the surgery. [0036] 5. The evaluation of therapy progress, as in physical therapy or fitness training. These therapies seek to strengthen the vaginal tissues through commonly-used methods. [0037] 6. Detection or characterization of complications associated with surgery, pelvic injury, and/or radiation which can result in narrowing of the vagina as well as fibrosis.

[0038] The terms comprising, including, and having, as used in the claims and the specification herein, shall be considered as indicating an open group that may include other elements not specified. The terms a, an, and the singular forms of words shall be taken to include the plural form of the same words, such that the terms mean that one or more of something is provided. The term one or single may be used to indicate that one and only one of something is intended. Similarly, other specific integer values, such as two may be used when a specific number of things is intended. The terms preferably, preferred, prefer, optionally, may, and similar terms are used to indicate that an item, condition or step being referred to is an optional (not required) feature of the invention.

[0039] The following detailed description is presented to enable any person skilled in the art to make and use the invention. For purposes of explanation, specific details are set forth to provide a thorough understanding of the present invention. However, it will be apparent to one skilled in the art that these specific details are not required to practice the invention. Descriptions of specific applications are provided only as representative examples. Various modifications to the preferred embodiments will be readily apparent to one skilled in the art, and the general principles defined herein may be applied to other embodiments and applications without departing from the scope of the invention. The present invention is not intended to be limited to the embodiments shown, but is to be accorded the widest possible scope consistent with the principles and features disclosed herein.

[0040] The invention has been described with reference to various specific and preferred embodiments and techniques. However, it should be understood that many variations and modifications may be made while remaining within the spirit and scope of the invention. It will be apparent to one of ordinary skill in the art that methods, devices, device elements, materials, procedures and techniques other than those specifically described herein can be applied to the practice of the invention as broadly disclosed herein without resort to undue experimentation. All art-known functional equivalents of methods, devices, device elements, materials, procedures and techniques described herein are intended to be encompassed. This invention is not to be limited by the embodiments enclosed, including any shown in the drawings or exemplified in the specification, which are given by way of example and not of limitation.

[0041] While the invention has been described with respect to a limited number of embodiments, those skilled in the art, having benefit of this disclosure, will appreciate that other embodiments can be devised which do not depart from the scope of the invention as disclosed herein. Accordingly, the scope of the invention should be limited only by the attached claims.