IL305984A - Expanding device and system - Google Patents

Description

EXPANDING DEVICE AND SYSTEM FIELD OF THE INVENTION The present invention relates to an expanding device and system and in particular, to such a device and system providing for expanding, widening and/or dilating a body lumen and/or cavity for example a cervix. BACKGROUND OF THE INVENTION Endometriosis is a condition afflicting women of child-bearing age which is characterized by the growth of endometrial tissue in areas outside the uterus. These extrauterine endometrial growths are a leading cause of pelvic pain and can also cause infertility. Endometriosis can affect any portion of the female reproductive system, however, when expressed in the cervix, it may lead to additional secondary conditions such as infertility. Endometriosis that is expressed in the cervical canal can lead to cervical blockage or cervical stenosis. Cervical stenosis is caused by cervix narrowing that may lead to a complete closing off of the passageway between the uterus and vagina. Cervical stenosis may have a variety of causes such as cervical cancer, birth condition, uterine prolapse, cancer, as a side affect of previous surgical procedures, vaginal or cervical atrophy, or any combination thereof. Such cervical stenosis may further lead to infertility, recurring infections, discomfort and pain. A treatment for cervical stenosis is provided by way of medical intervention where the cervix is urged to dilate by using pharmaceuticals or similar interventionary means. Current cervical dilation instruments cannot be easily placed in the cervix and can only be placed for a short period of time. SUMMARY OF THE INVENTION The present invention overcomes the deficiencies of the background art by providing a device and system that may be for cervical dilation and/or expanding and particularly configured for easy placement and use within the anatomy that may further allow for additional treatment of the female reproductive tract. While the foregoing description provides specific embodiment and disclosure with respect to the female reproductive tract and in particular the cervix, embodiment of the present invention are not limited for use within the cervix or the female reproductive tract. As will become evident in the ensuing description embodiments of the present invention are not limited to the cervix or female reproductive tract and may therefore be utilized to expand, open and/or dilate other tissue and/or anatomical lumen, space, volumes, canals or the like. Embodiments of the present invention provide a cervical expanding device and system configured for dilating and/or expanding a stenosis of the cervix. Unless otherwise defined, 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 belongs. The materials, methods, and examples provided herein are illustrative only and not intended to be limiting. Implementation of the method and system of the present invention involves performing or completing certain selected tasks or steps manually, automatically, or a combination thereof. BRIEF DESCRIPTION OF THE DRAWINGS The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in order to provide what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. In the drawings: FIG. 1 is a schematic block diagrams of an exemplary device and system according to embodiments of the present invention; FIG. 2A-B are schematic illustrative diagrams of an exemplary device according to an embodiment of the present invention; FIG. 2A showing a delivery configuration of the device; FIG. 2B showing an expanded configuration of the device; and FIG. 3A-B are schematic illustrative diagrams of a head portion of an exemplary device according to an embodiment of the present invention; FIG. 3A showing a delivery configuration of a head portion of the device; FIG. 3B showing an expanded configuration of a head portion the device; and FIG. 4A-C are schematic illustrative diagrams of a drive module portion of an exemplary device according to an embodiment of the present invention; FIG. 4A shows a pre use state of the drive module prior to dilation; FIG. 4B shows an in use configuration of the drive module; FIG. 4C shows a post use state of the drive module after dilation; and FIG. 5A-Bare schematic illustrative diagrams of an exemplary device in use within the cervix, according to an embodiment of the present invention; FIG. 5A showing a delivery configuration of the device as deployed within the cervix; FIG. 5B showing an expanded configuration of the device in the deployed expanded state within the cervix. DESCRIPTION OF THE PREFERRED EMBODIMENTS The principles and operation of the present invention may be better understood with reference to the drawings and the accompanying description. The following figure reference labels are used throughout the description to refer to similarly functioning components are used throughout the specification hereinbelow. 50 auxiliary devices; 100 expanding device; 102 head portion; 104 cover member; 106 support member; 108 actuating member and/or a pull rod member; 110 drive module; 110a distal end; 110b proximal end; 110r axial driving recess; 110t threaded surface; 112 driving member; 112t driving member threading; 114 interfacing conduit; 115 electronic module; 120 sensor module; 150 system; FIG. 1 shows a schematic block diagram of an expanding device 100 and a system 150 thereof, according to embodiments of the present invention. Expanding device 100 is preferably utilized to dilate a cervix or the like anatomical lumen, canal in a human or animal body. In particular device 100 may be configured to expand and/or open and/or widen and/or dilate a stenotic cervix as a result from endometriosis or the like maladies. In embodiments device 100 comprises a head portion 102, a driving module 110 and an interfacing conduit 114. In some embodiments device 100 may optionally comprise a sensor module 120, as is shown in broken line indicative that it is an optional member. In some embodiments device 100 may optionally comprise an electronics module 115, as is shown in broken line indicative that it is an optional member. Expansion device 100 comprises a controllably expandible head portion member 102 that is configured to expand once placed within the respective anatomy and in particularly the stenotic and/or occluded cervix. In embodiments head portion 102 comprises an outer cover member 104 and an internal support member 106. In embodiments, outer cover member 104 and support member 106 are preferably provided from optional pliable materials that may assume a small delivery configuration, as best seen in FIG. 3A, and an expanded in-use configuration, as best seen in FIG. 3B. In embodiments cover member 104 is optionally and preferably provided from silicone or the like materials. In embodiments, support member 106 may for example be provided from a mesh like spring material that may be stretch to expanded from a contracted state to dilate the treatment site for example including but not limited to a cervix, or the like treatment site and/or host tissue wherein device 100 is used and/or deployed. In embodiment, support member 106 may be provided from optional biocompatible materials capable of assuming at least two or more configurations, for example including supermaterial, pliable material, nitinol, smart materials the like or any combination thereof.

In embodiments head portion 102 or portions thereof particularly support member 106 may be provided from optional biocompatible materials for example including but not limited to polymers, alloys, smart materials, shape memory materials, nitinol, materials exhibiting plastic deformation, super-elastic metal alloy which transforms from an austenitic state to a martensitic state, any combination thereof or the like as is known in the art. In embodiments the expanded state the head portion and in particular the internal support member 106 is controllable with an actuating member 108 that is associated distally with head portion 102 via the support member 106 and associated proximally with drive module 110. In embodiment, actuating member 108 is functionally coupled with driving module 110 such that driving member 112 of the driving module 110 facilitates expansion of head portion 102 and in particular support member 106 to assume an expanded configuration, as best seen in FIG. 3B, from its delivery configuration, as best seen in FIG. 3A. As will be described in greater detail with FIG. 4A-C. preferably driving member 112 is functionally coupled to actuating member and provides for maneuvering actuating member 1so as to expand support member 106, wherein support member 108 is functionally coupled to support member 106. In embodiment head portion 102 in its delivery configuration may be configured to have an outer diameter of about 3mm, a non-limiting example of which is schematically shown in FIG. 5A. In embodiments head portion 102 in its deployed expanded configuration may be configured to have an outer diameter of up to about 15mm and more preferably up to about 12mm, a non-limiting example of which is schematically shown in FIG. 5B. In embodiments drive module 110 is provided for controlling the expanded state of head portion 102. In an optional and preferred embodiment drive module 110 may be a manually manipulated module, a non-limiting example of which is shown in FIG. 4A-C. In an optional embodiment drive module 110 may be provided as an electronic and/or actuator controlled and/or motorized and/or automated device for controlling the expansion configuration and/or state of head portion 102. For example, drive module 110 may comprise an electronic actuator and/or motor that is controlled with an optional electronics module 115.

In embodiments, drive module 110 preferably comprises a driving member 112 that provides for controlling the expanded configuration of head portion 102. Optionally driving member 112 may be controlled manually, for example as shown in FIG. 4A-C. Optionally driving member 112 may be controlled by electronic actuator and/or motor (not shown), that may be controlled with an electronics module 115. Most preferably driving member 112 is functionally coupled and/or associated with actuating member 108 along a distal end of actuating member 108. In embodiments actuating member 108 is preferably functionally associated with at least a portion of head portion 102 and most preferably support member 106 along a proximal end of actuating member 108. In embodiments, actuating member 108 may be housed within and/or fit internal to and/or within a lumen of an interfacing conduit 114 that is preferably provided to interface driving module 110 along a proximal end of interfacing conduit 114 and further interfaces with head portion 102 along a distal end of interfacing conduit 114. In embodiments actuating member 108 is configured to be linearly displaceable and/or maneuvered within the interfacing conduit. Preferably it is this linear movement in the distal to proximal direction that allows for expanding head portion 102 to its expanded configuration with the treatment site and/or host tissue for example including but not limited to cervix. In embodiments at least a portion of head portion 102 may feature and/or be functionally associated with at least one or more sensors of sensor module 120. In embodiments at least a portion of driving module 110 may feature and/or be functionally associated with at least one or more sensors of sensor module 120. For example, to sense the pressure applied and/or exerted along the cervical canal while expanding and/or dilating the cervix. In embodiments tissue device 100 may comprise electronic module 1comprising electronics circuitry, hardware, software to render device 100 functional and/or operational and in particular to render drive module 110 operational. In embodiments electronics module 115 may comprise a plurality of optional sub-modules for example including but not limited to a power supply module, controller and/or processor module, user interface module, and memory module. In a preferred embodiments electronics module 115 may further comprise a communication module. In embodiments electronics module 115 may be functionally associated with and/or comprise a sensor module 120. In embodiments, User Interface (UI) module may provide a user with means for interfacing with device 100 preferably via processor module . User interface may be provided in the form of an activation button, audiovisual display, the like or any combination thereof. In embodiments, UI module may be provided in optional forms for example including but not limited to buttons, dials, displays, alphanumeric display, touch screen, touch pad, buzzer, tactile pad, at least one light emitting diode (LED), at least one organic LED (OLED), speakers, microphone, or any combination thereof. In embodiments processor module provides the necessary processing hardware and/or software necessary to render device 100 functional. In embodiments controller and/or processor module may provide for controlling any portion of device 100 and in particular drive module 110 and sensor module 120. In embodiments power module provides the necessary hardware and/or software to power device 100 therein rendering device 100 operational. Power module may for example be provided in optional forms for example including but not limited to battery, rechargeable induction battery, induction coil, capacitors, super capacitors, inductors the like power source or any combination thereof. In embodiments communication module preferably provides the necessary hardware and/or software to facilitate communication for device 100 and in particular with auxiliary devices 50 forming system 150. Optionally communication module may be utilized to communicate with an optional auxiliary devices 50. For example, an auxiliary device may for example include but is not limited to a smartphone, mobile processing and communication device, imaging device, server, computer, healthcare service provider dedicated system, first respondent call center, health care call center, the like or any combination thereof. In some embodiments communications module may be utilize various communication protocols for example including but not limited to wireless communication, cellular communication, wired communication, near field communication, BLUETOOTH, ZIGBEE, optical communication, the like and/or any combination thereof.

In embodiments memory module provides the necessary hardware and/or software to facilitate operations of device 100 by enabling storing and/or retrieving stored data and/or the like as is known in the art. In embodiments sensor module 120 may provide the necessary hardware and/or software to facilitate operations of at least one or more sensor(s) associated with device 100 to enable sensing various events in and around device 1particularly in and about head portion 102. In some embodiments, for example, sensor module 120 may be configured to sense the environment surrounding head portion 102 and/or driving module 110, for example, the expansion site, for example a cervix. For example, sensor module 120 may be utilized to provide imaging of the cervix, and/or for measuring the temperature, measuring the pH, flow parameters, pressure, resistance or the like conditions in and around the treatment site particularly the cervix. In embodiments sensor module 120 may comprise at least one or more sensor selected from the group consisting of: image sensor, temperature sensor, pH sensor, flow-meter , pulse oximeter, pressure sensor, acoustic sensor, microphone, positional sensor, infrared sensor, optical sensor, wavelength specific imaging sensor, the like or any combination thereof. In embodiments sensor module 120 may be disposed along any portion of device 100, and in particular associated with driving module 110 and/or head portion 102. In embodiments, at least some sensors of sensor module 120 may be disposed adjacent to head portion 102. In embodiments an image sensor may be provided in optional forms for example including but not limited to camera, for example disposed about head portion 102. In some embodiments image sensor may be provided in the form of ultrasound sensor, that may optionally be disposed along head portion 102. In some embodiments image sensor may be provided in the form of wavelength specific imaging device such as an infrared optical sensor and infrared light source. In embodiments an image sensor, optionally in the form of a camera, may be configured to provide image processing and/or analysis so as to infer and/or obtain parametric data relating to the e treatment site and/or expansion site. For example, such image processing analysis may provide to determine at least one parameter associated with the targeted tissue expansion site, for example including but not limited to :length, width, height, area, volume, shape, surface area, tissue type, or any combination thereof. For example, the sensors and in particular image sensor utilized with device 100 to dilate a cervix, may for example facilitate to determine how much force is required to dilate the cervix and/or to determine when to stop the expansion process as the cervix has been sufficiently dilated. In some embodiments sensor module 120 may comprise at least one position sensor configured to identify the position of head portion 102 so as to convey the spatial location of head portion relative to the targeted anatomy. In embodiments position sensor may be provided in optional forms for example including but not limited to optical sensors, mechanical sensors, electromagnetic sensor, induction sensor, magnetic based sensors or the like sensor provided for determining and the relative position of device 100 within the human anatomy. In embodiments system 150 may comprise expansion device 100 that is in communication with and/or functionally coupled with at least one or more auxiliary device 50. In embodiments auxiliary device 50 may be provided in optional forms for example including but not limited to a server, computer, smartphone, or the like processing and communication device capable of receiving and/or exchanging data from device 100 so as to process the data. In embodiments, auxiliary device 50 is preferably utilized to apply big data algorithms and/or the like artificial intelligence algorithms to analyze data received from device 100. Optionally communication between auxiliary device 50 and device 100 is facilitated with an optional communication module utilizing any communication protocol for example including wireless, cellular, wired, near field, the like or any combination thereof. In embodiments system 150 and/or device 100 and/or auxiliary device may communicate with additional auxiliary devices to undertake processing of data associated with system 150 and/or device 100. For example, such auxiliary device communication devices may for example include but is not limited to a smartphone, mobile processing and communication device, imaging device, server, computer, healthcare service provider dedicated system, first respondent call center, health care call center, the like or any combination thereof. FIG. 2A-B show schematic illustrative diagrams of perspective views of device 100 in its different expanded configurations. FIG. 2A shows a perspective view of device in its un-expanded and/or delivery configuration wherein head portion 102 assumes its minimal diameter configuration. In embodiments, in the delivery configuration head portion 102 may be configured to have an outer diameter of about 3 millimeters. Optionally head portion in the low profile delivery configuration may be configured to have an outer diameter from about 1 millimeter (mm) and up to about 5 millimeters (mm). FIG. 2A further shows a schematic non-limiting embodiment of the driving module 110 in a manual configuration comprising a driving member 112 that is configured to be axially displaceable along an axis of driving module 110 wherein the driving module 110 features a threaded surface 110t. Most preferably the threaded surface 110t corresponds to threading 112t provided on driving member 112 allowing driving member to be axially displaced along the threaded surface 110t in a distal to proximal direction. In the low profile and/or delivery configuration of head portion 102, driving member 112 is disposed along a proximal end of driving module 110 and threaded surface 110t, for example as shown in FIG. 2A. FIG. 2B shows a perspective view of device 100 wherein head portion 102 is shown in the expanded configuration. In embodiments, in the expanded configuration head portion 102 may be configured to have an outer diameter of up to about 15 millimeters. Optionally, head portion in the expanded configuration may be configured to have an outer diameter of up to about 20 millimeters (mm). FIG. 2B further shows a schematic non-limiting embodiment of the driving module 110 in a manual configuration after the axial displacement driving member 112 distally along threaded surface 110t. In embodiments, the axial displacement of driving member 112 distally functions to expand head portion 102 via the actuating member 108, as will be described with respect to FIG. 4A-C. Accordingly, as driving member 112 is driven and/or axially displaced along threaded surface 110t, most preferably proximally toward a proximal end of threaded surface 110t and/or drive module 110 it causes head portion 102 to gradually expand. In the low profile and/or delivery configuration of head portion 102, driving member 112 is disposed along a proximal end of driving module 110 and threaded surface 110t, for example as shown in FIG. 2A. FIG. 3A-B are schematic illustrative diagrams of a head portion 102 in its different configurations. FIG. 3A shows a low profile and/or delivery configuration of a head portion 102, utilized to delivery and/or place and/or associate device 1within of the treatment site. For example, FIG. 5A shows head portion 102 in a non -limiting delivery site namely a cervix. FIG. 3B shows an expanded in-use configuration of a head portion 102 the device utilized to deliver and/or place and/or associate device 100 within of the treatment site. For example, FIG. 5B shows head portion 102 in a non -limiting delivery site namely a cervix. FIG. 3B shows the expanded configuration of head portion 102 revealing the cover member 104, most preferably provided from flexible materials such as silicon. The expanded configuration shown in FIG. 3B further reveals the support member 106 provided in the form of a spring like material and/or mesh material that may be manipulated with actuating member 108 transition from a small profile delivery configuration, FIG. 3A, to the expanded in-use configuration, FIG. 3B. Preferably actuating member 108 is functionally associated with driving member 112 so as that as driving member is axially displaced proximally it displaces actuating member with respect to support member therein causing support member to gradually expand. In embodiments support member 106 is preferably provided in the form of a compressed spring in its delivery configuration, FIG. 3A, that is expanded to assume its large diameter and/or expanded configuration for example as shown in FIG. 3B. FIG. 4A-C provide a close up view of drive module 110 in its different states according to embodiments of the present invention. FIG.4A shows a pre use state of the drive module 110 where driving member 112 is disposed proximally and therefore head portion 102 is in the delivery configuration and/or small profile configuration, as shown in FIG. 3A. FIG. 4C shows a post use state of the drive module 110 where driving member 112 is disposed distally at a distal end of drive module 110 after member 112 has been axially displaced, as shown by the directional arrow, along threaded surface 110t, the displacement causing actuating member 108 to displaced along with member 112 causing head portion to gradually expand, as described with FIG.3B. FIG. 4B shows a transition phase of drive module 110 as driving member 112 is displaced axially along threaded surface 110t by way of turning as depicted by the directional arrow. , FIG. 4A-C show an optional embodiment of a manual drive module 110 featuring a threaded surface 110t, an axial driving recess 110r and a driving member 112. Preferably driving module has a proximal end 110b and a distal end 110a. In embodiments, driving member 112 is configured to be axially displaced along threaded surfaces 110t from a distal end 110a to a proximal end 110b. In embodiments axial driving recess 110r disposed along at least a portion of threaded surface 110t provides an axial recess into which actuating member 108 may be fit. Accordingly, a distal end of actuating member 108 is associated with drive module 110 along axial driving recess 110r, wherein actuating member is configured to be displaced along the length of recess 110r with the displacement of driving member 112. Accordingly, as driving member 112 is displaced distally along threaded surface 110t it displaced actuating member 108 distally to cause the head portion 1to expand as previously described and shown in FIG. 3B. While the invention has been described with respect to a limited number of embodiment, it is to be realized that the optimum dimensional relationships for the parts of the invention, to include variations in size, materials, shape, form, function and manner of operation, assembly and use, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the present invention. Therefore, the foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not described to limit the invention to the exact construction and operation shown and described and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention. It should be noted that where reference numerals appear in the claims, such numerals are included solely or the purpose of improving the intelligibility of the claims and are no way limiting on the scope of the claims. It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements. Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the scope of the appended claims. Citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the invention. Section headings are used herein to ease understanding of the specification and should not be construed as necessarily limiting. While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications and other applications of the invention may be made.

Claims (6)

1. CLAIMS What is claimed is: 1) An expanding device (100), the device comprising, a head portion (102), a driving module (110) and an interfacing conduit (114), wherein said head portion is configured to have an small profile configuration during delivery and an expanded state during use; wherein said driving module is configured to control the expanded state of said head portion with a driving member (112) and an actuating member (108); and wherein said interfacing conduit provides for interfacing between said head portion and said driving module.

2. The device of claim further comprising a sensor module (120).

3. The device of claim 1 further comprising an electronic module (115).

4. The device of claim 1 wherein said head portion (102) comprises an external cover member (104) and an internal support member (106).

5. The device of any one of claims 1-4 wherein said drive module 110 comprises a driving member (112) and a threaded surface (110t) wherein said driving member is configured to be displaced distally along a length of said threaded surface to drive said actuating member (108) to expand said internal support member (106).

6. The device of claim 1 wherein said drive module (110) comprises an axial driving recess (110r) that is associated with said actuating member (108) and said driving member (112).