APPARATUS AND METHOD FOR EVERTING CATHETER FOR EMBRYO TRANSFER USING TRANSVAGINAL ULTRASOUND
Everting balloon systems and methods for using the same with an alignment element for stability and anti-rotation of the everting balloon are disclosed herein. The systems can be configured to access and deliver instruments, media, or other catheters into bodily lumens and cavities. The alignment element can eliminate the potential for the everting membrane to become twisted or rotated which could impact access or the ability of the system to deliver materials. A compliance member can facilitate internal pressurization of the everting catheter system. An everting catheter system can be configured for use with transvaginal ultrasound and a lower profile speculum is described.
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This application is a continuation of International Patent Application No. PCT/US2018/065046 filed Dec. 11, 2018, which claims priority to U.S. Provisional Application No. 62/597,353 filed Dec. 11, 2017, which are incorporated by reference herein in their entireties.
BACKGROUNDThis disclosure can be used for everting catheters that can have an inner catheter, outer catheter, and everting membrane that can be connected to both catheters. The inner catheter may contain an inner lumen to pass fluid or media, drugs or therapeutic agents, instruments or devices, and other catheters.
For physicians and medical professionals, accessing systems for vessels and bodily cavities in patients have typically used various guidewire and catheter technologies or everting catheters. Everting catheters utilize a traversing action in which a balloon is inverted and with the influence of hydraulic pressure created by a compressible or incompressible fluid or media, rolls inside out or everts with a propulsion force through the vessel. Everting balloons have been referred to as rolling or outrolling balloons, evaginating membranes, toposcopic catheters, or linear everting catheters such as those in U.S. Pat. Nos. 5,364,345; 5,372,247; 5,458,573; 5,472,419; 5,630,797; 5,902,286; 5,993,427; 6,039,721; 3,421,509; and 3,911,927; all of which are incorporated herein by reference in their entireties. These are categorized as everting balloons and are for traversing vessels, cavities, tubes, or ducts in a frictionless manner. In other words, an everting balloon can traverse a tube without imparting any shear forces on the wall being traversed. Because of this action and lack of shear forces, resultant trauma can be reduced and the risk of perforation reduced. In addition as a result of the mechanism of travel through a vessel, material and substances in the proximal portion of the tube or vessel are not pushed or advanced forward to a more distal portion of the tube or vessel.
In addition, as the everting catheter deploys inside out, uncontaminated or untouched balloon material is placed inside the vessel wall. In the inverted or undeployed state, the balloon is housed inside the catheter body and cannot come into contact with the patient or physician. As the balloon is pressurized and everted, the balloon material rolls inside out without contacting any element outside of the vessel. Another advantage of an everting balloon catheter is that the method of access is more comfortable for the patient since the hydraulic forces “pull” the balloon membrane through the vessel or duct as opposed to a standard catheter that needs to be “pushed” into and through the vessel or duct.
Everting catheters have been described as dilatation catheters. Representative examples of dilating everting catheters include U.S. Pat. Nos. 5,364,345 and 4,863,440, both of which are incorporated by reference herein in their entireties.
Everting catheters have also been described with additional elements such as a handle for controlling instruments within an everting catheter. A representative example is U.S. Pat. No. 5,346,498 which is incorporated by reference herein in its entirety. Everting balloon catheters can be constructed with an inner catheter with an internal lumen or through-lumen (or thru-lumen). The through-lumen can be used for the passage of instruments, media, materials, therapeutic agents, endoscope, guidewires, or other instruments. Representative samples of everting catheters with through-lumens are in U.S. Pat. Nos. 5,374,247 and 5,458,573. In addition, everting catheters have been described with waists or a narrowing of the balloon diameter, such as in U.S. Pat. No. 5,074,845, which is incorporated by reference herein in its entirety.
Furthermore, infertility is a condition that affects 1 out of 8 couples in the US. One of the early treatments in the infertility regime is insemination. Intrauterine insemination or IUI is a very common procedure since it is in the early work up of an infertile couple. Most assisted reproductive clinics perform at least 3 IUI cycles before trying more expensive treatment options such as IVF.
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. In existing systems, when the transfer catheter is retracted from a second outer or guiding catheter (e.g., the “inner” catheter), the retraction produces vacuum pressure within the uterine cavity. This vacuum pressure is created in the uterine cavity by the removal and backward movement of the transfer catheter within the inner catheter. After the embryo transfer is completed, an embryologist may inspect the transfer catheter to verify that the embryos or reproductive material was indeed deposited in the uterus and not pulled back into the transfer catheter because of the vacuum effect. The same procedure may be done for the outer catheter once this catheter is removed.
The passage of the embryo transfer catheter may become impeded if the everting membrane is rotated or twisted. Twists within the balloon membrane can also reduce the ability of the everting membrane to traverse a lumen or cavity or unroll as intended. A twist in the balloon membrane can occur if the inner catheter is rotated about its central axis in relation to a stationary outer catheter. By rotating the inner catheter, the balloon membrane which is connected between both the outer catheter and inner catheter becomes twisted. In this particular situation of an everting balloon, twists in the balloon membrane can significantly impact performance of the everting system.
A twist in the everting membrane can occur during use or prep of the catheter prior to inserting the device within a patient. A twist in the everting membrane can also occur when a catheter system has the requirement of multiple eversions and retractions to complete a procedure within a patient. Likewise, a twist in the balloon system can unintentionally occur as a byproduct of the manufacturing process.
In the device configuration using a handle system, an anti-rotation feature can be particularly advantageous. As described previously, handles are very useful for driving the inner catheter and controlling the advancement and retraction of instruments, other catheters, media, and materials within the inner catheter lumen. Manipulation of a handle can inadvertently rotate the inner catheter system within the outer catheter and thereby creates twists in the balloon membrane. This situation can be exasperated by the introduction and removal of multiple instruments and devices within the inner catheter lumen.
Having an everting catheter system in which twists or inadvertent rotations of the balloon membrane will enable more stable and secure use of an everting catheter. An untwisted balloon membrane provides the least obstructed passage within the everting system. Some everting catheter systems will be more prone to balloon twisting due to the length of the balloon membrane and inner catheter and type of balloon membrane material. In some clinical applications, more tortuous anatomy may instigate a greater likelihood of balloon twists as a result of the manipulations the clinician may need to perform to complete the procedure or obtain access to the desired target location in the body.
Maintaining the alignment of the inner catheter, outer catheter, and balloon membrane may be accomplished through a handle and ratchet system as described previously. The alignment feature is accomplished by the ratchet and handle that prevents rotation of the inner catheter. The systems described herein are directed towards internal catheter apparatus that provide alignment or anti-rotation capability without requiring an additional set of components like rails, tracks, ratchets, or handles on the exterior for the catheter system.
Another clinical issue with an everting catheter is that physicians may inadvertently pull or elongate the inner catheter upon inversion of the balloon membrane. Over-elongation can stretch the balloon membrane or damage the catheter components. A feature that mechanically prevents this from occurring will be a benefit to the catheter system.
Another problematic issue for everting catheters is the pressurization step in prepping the catheter. One option that is described in the prior art is the use of an inflation device with pressure gauge that indicates the internal pressure of the catheter system. Inflation devices with pressure gauges, or building an integral pressure gauge within the catheter system, can be expensive. Using a separate, reusable pressure gauge adds to the number of components required for performing the procedure. Having a simple mechanism that regulates and indicates the amount of pressure within the catheter system would be a benefit. For more specialized procedures, being able to modulate the internal pressure depending upon the medical procedure could be particularly advantageous.
For everting catheters used in IVF procedures, it is beneficial to stabilize the inner catheter when full eversion is completed for two-stage embryo transfer procedures. A two-stage embryo transfer is performed by everting the membrane across the endocervical canal and into the uterine cavity and subsequently placing the loaded embryo transfer catheter through the inner catheter and ultimately within the uterus. This operation is done in two steps and the infertility specialist will inform the embryologist that the inner catheter has been everted and is now in place within the uterine cavity. The embryologist will then aspirate and load the embryo or embryos into the distal end of the embryo transfer catheter for eventual insertion through the inner catheter for deposition in to the uterine cavity. This is the completion of the second stage of the process. During the loading step performed by the embryologist, a mechanism that stabilizes and indicates to the user that the inner catheter is in position would be a benefit.
Another problem with everting catheters is preparing the system by internal pressurization. This preparation step can vary among users and over-pressurization, and under-pressurization, of the everting system can negatively impact the performance of the device.
Accessories can be used by the embryologist and physician performing the transfer procedure to handle the embryo transfer catheter.
The embryo transfer procedure can be done with transvaginal ultrasound (TUS). In current medical practice, the significant majority of IVF procedures are performed using abdominal ultrasound over TUS, or no ultrasound visualization at all. TUS in most practitioners' hands provides greater or enhanced visibility of the IVF catheters and procedure in general than abdominal ultrasound since the ultrasound transducer is closer in physical proximity to the catheters or uterus (the visualization target) in situ. Secondly, abdominal ultrasound may need to penetrate through varying amounts or layers of adipose or fat tissue. To overcome this situation in more obese women, the ultrasound technician needs to push the abdominal probe deeply into the tissue of the female patient's stomach to obtain sufficient views which can be uncomfortable or painful for the patient. Thirdly, to facilitate the visualization of the catheters in the uterine cavity, women are instructed prior to the procedure to maintain a full bladder for the entire procedure. In some cases if the visualization is not sufficient, female patients are asked to consume more fluids and the procedure is delayed to allow for time for urine to be created, instilled, and visible in the bladder. And finally, abdominal ultrasound requires an ultrasound technician, nurse, physician, or additional pair of hands to manipulate the abdominal ultrasound during the actual IVF procedure. In some situations the IVF physician will need to obtain the abdominal ultrasound image and then pass off or release the abdominal ultrasound probe to the technician, nurse, or other physician so that the IVF catheterization procedure can be performed. As such, for all of the reasons mentioned above, the ability to perform IVF procedures more easily using TUS would be a benefit to patients and physicians. Another area to facilitate IVF procedures would be to allow the physician to use both instruments without requiring or necessitating an additional pair of hands to complete the procedure. This is particularly true with TUS since it would enhance the procedure if the physician manipulating the catheters, and directing the ultrasound imaging, was the same physician. Having a mechanism that allows the physician performing IVF with TUS to couple the everting catheter, or IVF catheter in general, to the TUS probe so that the contralateral hand of the physician could advance the embryo transfer catheter would be advantageous.
Another area of improvement would be to automate the translation and/or retraction of the inner catheter without requiring the physician to use two hands to complete the movements. A manual controller that is operated by one hand can be coupled to the everting catheter system or a mechanism that automatically translates and/or retracts the inner catheter.
Another area of improvement for IVF and uterine procedures in general would be a modified type of speculum that is more comfortable for the patient. This is particularly true for IVF procedures since it has been reported in medical literature that the act of placing a speculum in a patient by itself create the nidus for uterine contractions. For IVF, the ability to perform the procedure with a specific speculum that is easily adjustable for directed viewing of the exocervix, can be directed for specific lateral wall viewing, can become low profile for the insertion of other devices like TUS probe, and facilitates the use of an everting IVF catheter, or any IVF catheter in general, would be a benefit. This specific speculum can work as a system with the IVF catheter or any intravaginal or transvaginal procedure separately without an everting catheter or catheters in general and instead would provide a lower profile speculum for visualizing the vagina.
SUMMARYAn everting balloon system is disclosed that can be used for uterine access procedures. The everting balloon system can be used for IVF and intrauterine insemination procedures, urinary incontinence diagnostic and therapeutic procedures, delivering intra-fallopian tube inserts, media, or diagnostic instruments, dilation of a body lumen, for access and sealing within a body cavity, or combinations thereof. The system can have a handle for insertion. The everting catheter system can be used for TUS IVF procedures. The everting catheter system can have mechanisms that automatically translate and/or retract the inner catheter which is coupled to the everting membrane. A speculum can be used with everting catheters and other transvaginal catheter procedures.
The everting balloon system can be used to access the uterus, bladder, ureters, kidneys, ducts, vessels of the vasculature, nasal passageways, other bodily lumens, or combinations thereof. Devices, tools, instrumentation, endoscopes, drugs, therapeutic agents, sampling devices (brushes, biopsy, and aspiration mechanisms), or combinations thereof can be delivered through the inner catheter lumen to the target site.
The everting balloon system can have an internal alignment mechanism that prevents rotation and spinning of the balloon membrane.
The everting balloon system can have an internal mechanism that prevents over-elongation of the inner catheter during balloon inversion.
The everting balloon system can have a compliant pressurization apparatus that's provides a pre-determined pressure within the catheter system with an indicator to the user that system is at the appropriate operating pressure.
Another embodiment can automatically pressurize the everting balloon system to a predetermined amount.
The everting balloon system can have an integral pressurization system that provides an indicator and the ability to quickly shift the pressurization state of the balloon system from pressurized to non-pressurized. Intermediate degrees of pressurization can also be selected.
The everting balloon system can have a mechanism that stabilizes the inner catheter at the full eversion stage and provides an indicator to the user that catheter system is at the appropriate step in the process for embryo transfer.
The everting balloon system can have a proximal hub connector that aids the physician and embryologist in delivering the embryo transfer catheter to the delivery catheter.
The everting balloon system can be shaped with distal end features that facilitate uterine access without the need for a speculum and/or tenaculum.
The everting catheter system can have accessories that make the handling of the embryo transfer catheter easier.
The everting catheter system can be coupled to the TUS probe to allow for simultaneous ultrasound visualization of the catheterization procedure in situ and manipulation of the catheters.
The everting catheter system can have mechanisms that automatically translate and/or retract the inner catheter coupled to the everting membrane.
The everting catheter system that can couple to a speculum that facilitates handling of the catheter system in the vagina. The speculum itself can be used with or without the everting catheter system for other transvaginal procedures.
The everting catheter system can have controllers for both the inner catheter coupled to the everting membrane and a controller for the embryo transfer catheter, or the same controller can perform both functions.
The everting catheter system can have an acorn tip at the distal end that can be malleable or articulate to enter into the exocervical os. The acorn tip can also be detachable or retractable to reveal a penetrating tip to further guide the everting membrane into the exocervical os.
The TUS IVF procedure can have a specific speculum which provides a stable platform for the physician to hold and position the IVF catheters or devices.
The IVF procedures can use an everting catheter, a handle mechanism can be incorporated that can allow for one-handed advancement or translation of both the inner catheter coupled to the everting balloon, and the advancement of the embryo transfer catheter. Such a system can allow the physician to maintain control of the TUS at all times for both the advancement of the everting balloon catheter and the advancement of the embryo transfer catheter.
The distal end of the everting catheter which engages the exocervix can be a distal tip acorn tip that articulates or can be malleable to be directed towards the exocervix os or opening. A detachable or retractable acorn tip that exposes a more guiding or penetrating distal nozzle of the outer catheter that facilitates entry into the cervix can be used.
The embryo transfer procedures can be performed with transvaginal ultrasound. The disclosed systems and methods can be used and performed without a speculum, for example, for patient comfort.
An everting balloon system 8 (also referred to as an everting catheter system 106) that can be used to traverse a vessel, such as the cervical canal is disclosed. The everting balloon system 8 can be used to access the uterine cavity via the cervix. The cervical canal is a single lumen vessel that can stretch or dilate. The everting balloon system 8 can have a control system that can be operated with one hand. The pressurization states or configurations of the everting catheter system 106 can be changed and controlled with one hand of the user.
The everting balloon system 8 can have a media volume 4. The media volume 4 can be the contiguous open volume between the inner catheter 10 and outer catheter 2 that is proximal to the balloon membrane 6. A radially outer terminal perimeter of the balloon membrane 6 can be attached to the distal terminal end of the outer catheter 2. A radially inner terminal perimeter of the balloon membrane 6 can be attached to the distal terminal end of the inner catheter 10.
The balloon membrane 6 can inflate and be in tension. The balloon membrane 6 can block the distal port of the inner catheter lumen 12.
The everting catheter system 106 can have an everting catheter system distal end 210 and an everting catheter system proximal end 214.
In the fully inflated configuration, the balloon membrane 6 can form an inflated everting balloon 22. The everting balloon 22 can have a balloon outer diameter 20 and balloon length 18 in the inflated and fully everted configuration.
The balloon outer diameter 20 can be from about 2 mm to about 20 mm, more narrowly from about 2 mm to about 7 mm, for example about 3.0 mm. The outer diameter can be constant or vary along the length of the everting balloon 22. For example, for use in the cervical canal, the most proximal portion of the everting balloon outer diameter 22 could be configured with a smaller outer diameter than the remainder of the everting balloon membrane 6. As an example, the first proximal portion of the everting balloon 22 can have a smaller balloon outer diameter 20 such as from about 2 mm to 4 mm for a length of from about 5 mm to about 10 mm from the distal terminal end of the outer catheter 2, and the remainder of the length (e.g., from about 4 cm to about 7 cm along the everting balloon 22) of the everting balloon 22 can have a balloon outer diameter 20 from about 4 mm to about 7 mm.
The interior surface and lumen of the balloon can be coated with a lubricious material to facilitate rolling and unrolling of the interior surfaces of the everting balloon membrane 6.
The exterior surface of the balloon membrane 6 can be configured with ridges, projections, bumps, grooves, and additional surface or mechanical features, or combinations thereof, for example for increased friction or holding power within the vessel.
The everting balloon 22 length 18 can be from about 2 cm to about 10 cm, more narrowly from about 3.5 cm to about 8.5 cm (e.g., for use in a longer uterine cavity lengths), yet more narrowly from about 5 cm to about 7.5 cm.
To retract and reposition or remove the balloon membrane 6, the inner catheter 10 can be pulled proximally to pull the balloon membrane 6 back within the outer catheter 2. The balloon membrane 6 can be deflated or have media pressure 14 reduced and the entire system can be withdrawn from the target site.
The transfer catheter can attach to or inserted through the inlet port. The transfer tube can hold an embryo, for example for in vitro fertilization or IVF. The embryo transfer catheter 28 can deliver embryos through the system and to the uterine cavity and other agents that help facilitate embryo implantation such as materials that promote adherence of the embryo to the uterine endometrium. The embryo transfer catheter 28 can have a distal end configuration that can promote implantation of the embryo(s) within the endometrial wall or within the sub-endometrial surface.
The embryo transfer catheter 28 can hold spermatozoa and deliver the spermatozoa through the system and to the uterine cavity for intrauterine insemination procedures. The transfer catheter can hold and deliver or deposit materials, such as drugs, therapeutic agents, instruments, endoscopes, cytology brushes, other catheters, or combinations thereof through the system and into the uterine cavity. The transfer catheter can be connected to a vacuum source for the aspiration of materials from the uterine cavity or other bodily cavities and lumens.
The transfer catheter and/or materials can be loaded in the inner catheter lumen 12 prior to everting the everting balloon 22 within the vessel or bodily cavity. For example in the case of delivery of reproductive material in the uterine cavity, the transfer catheter can be loaded with washed and prepared semen in the transfer tube and the transfer catheter can be placed in the inner catheter lumen 12.
The inner catheter 10 can be extended and the everting balloon 22 can evert and unroll through the cervix and into the uterine cavity. Concurrently or subsequently, the transfer catheter can be advanced through the inner catheter lumen 12 into the uterine cavity. Once fully everted or when the transfer catheter becomes extended or exposed from the inner catheter 10 and beyond the everting balloon membrane 6, the reproductive material in the transfer catheter can be deposited by a syringe 66, squeeze bulb, piston, or other pressure system. A second delivery catheter 32, such as a second insemination, IVF, or drug delivery catheter 32 can be concurrently inserted into the inlet port or a second inlet port. The second delivery catheter 32 can be deployed to the target site concurrent with or subsequent to the transfer catheter. The embryo transfer catheter 28 can advance distally within the everting balloon 22 and the inner catheter lumen 12. The transfer catheter can deposit the reproductive material (e.g., sperm) within the uterine cavity.
The delivery catheter 32 system can be used, for example, when a defect, such as a C-section defect or scar, cul-de-sac 40, or crypt is present within the endocervix. Such defects can be visualized before, during or after delivery of the flexible tip guidance wire 44, via transabdominal or transvaginal ultrasound. The echogencitiy of the delivery catheter 32 is enhanced by pressurization fluid, or air, or a combination of both that creates echogenic density differences that are visualized by ultrasound. The flexible tip guidance wire 44 can be introduced beyond the cul-de-sac 40 opening and towards the uterine cavity or target site, for example, to avoid the defect or cul-de-sac 40. The internal balloon pressure can be reduced or eliminated, for example, to advance the flexible tip guidance wire 44 beyond the everting balloon distal end 46. With everting balloon pressure low or at zero, the flexible tip guidance wire 44 can be threaded through the deflated balloon membrane 6 and advanced beyond the cul-de-sac 40 opening. Once the flexible tip guidance wire 44 is advanced beyond the opening and towards the target site, the everting balloon membrane 6 pressure can be re-established and the advancement of the inner catheter 10 can continue until the everting balloon distal end or leading end moves past or distal to the cul-de-sac 40 opening.
The D-shape can alternatively be an oval or elliptical shape, with a mating oval or elliptical shape on the alignment piece that restricts or eliminates the rotation of the inner catheter 10 in relation to the outer tubing 54.
Alternatively, the alignment piece shape can be configured as the external surface throughout the entire inner catheter 10 tubing body. The shape of the external surface would in this configuration mate with the internal geometry of the outer tubing 54. The surfaces can “key” into each or interference fit against each other, for example, to restrict or eliminate the rotation of the inner catheter 10 to the outer tubing 54 and the stasis valve would need to conform or fit to the external surface of the inner catheter 10 to maintain pressurization during the eversion process. As an example, the inner catheter 10 tubing can be configured with a rail surface or protrusion that mates or “keys” with receptacle within the outer tubing 54 internal geometry.
As a representative example, one embodiment of the everting catheter system 106 can operate in a pressure range from about 2 to about 4 atmospheres of pressure with a nominal pressure of about 3 atmospheres. For advancement within the cervical canal and into the uterine cavity, any residual air within the everting balloon system 8 can be removed before, during and/or after the eversion process. This can be particularly advantageous in situations with tight or stenotic cervices. One method to achieve a working pressure of 3 atmospheres is to connect a pressure gauge to the everting balloon system 8. In practice pressure gauges and inflation devices are expensive to the overall cost of the system. Another method to achieve a working pressure of 3 atmospheres is to prescribe an exact fluid volume amount to the everting balloon system 8 that must be instilled by the end user prior to use. In practice this can accomplish a working pressure of 3 atmospheres but requires diligence by the end user to both fluid volumes and the amount of air in the everting balloon system 8. The attachment of the compliant member 68 to the everting balloon system 8 can accomplish consistent fluid pressures within a wider range of fluid volumes that provides a larger tolerance to end user diligence during the catheter preparation process. This is demonstrated with a compliant member 68 attached to an everting balloon system 8 with a recommended fill volume of 3 cc of fluid 70. For test purposes while measuring preparing the everting catheter system 106 with varying amounts of fluid volume, the internal pressure of the system does not alter (much) beyond the nominal pressure of 3 atmospheres and in all fluid volumes, even when the fluid volume is intentionally doubled beyond the instructed amount, the internal pressure of the everting balloon system 8 can remain within the operating working range of the system. For this test, the complaint member is constructed with 50 durometer silicone tubing with a 0.250″ ID and a 0.500″ OD and a 1.5 cm length of silicone tubing. At the ends of the compliant member 68 (e.g., silicone tubing) can be male and female luer connectors with attachment rings to mechanically adhere the silicone tubing to the luer connectors. As the silicone tubing is filled with fluid 70, the radial walls can expand and the overall length of the silicone tubing can increase in response to the increasing volume of fluid 70. The internal fluid pressure of the everting balloon member can plateau at or near the desired nominal pressure amount, for example since the additional fluid volume is accommodated by the compliant member.
As seen in the above exemplary data table, the resultant internal pressure can remain within the specification range from about 2 to about 4 atmospheres and at or near the nominal pressure of 3 atmospheres. In this set of experiments and with this configuration of the complaint member, a fluid volume of about 2× the amount yielded a 10% increase in internal pressure. By altering the durometer, elastormeric properties, length and wall thickness of the compliant, other nominal pressure amounts can be obtained. One of the additional benefits of the compliant member 68 is that it provides a safety margin against over-pressurization that can either damage the balloon system, or provide an everting balloon system 8 that operates outside of its operational working parameters. The complaint member can be used in combination with a pressure relief valve in everting balloon systems 8 that have more critical or tight pressure tolerances, or where internal pressure changes due to operator or anatomical factors can create internal pressures that go beyond the normally-expected performance specification.
The entire compliant member 68 can be held by the physician during use. The entire complaint member can be grasped and squeezed while maintaining positional control of the everting balloon system 8.
Squeezing (i.e., applying external mechanical pressure) the complaint member circumferentially can create small rises in the internal pressure of the everting balloon system 8 that can advance the everting balloon 22 through tight or narrow anatomical passages. Relaxing the grasp (i.e., external mechanical pressure) on the complaint member would instantly return the complaint member and the everting balloon system 8 to the pervious operating pressure range. The complaint member can be pulsed or vibrated (e.g., with external mechanical pressure), for example, providing pulsatile fluid pressure spikes within the everting balloon system 8, for example for advancement through tight or narrow passageways and/or advancement of the everting balloon 22 in small and discrete steps, and/or with minor increases in internal pressure.
The everting balloon system 8 can have a syringe plunger 74 and air pressure canister 72 (e.g., in combination with or in place or the syringe plunger 74 and spring assembly 76 shown in
As another embodiment, the constant pressure source 84 could be configured to supply varying amounts of force for providing the internal pressure of the everting catheter system 106. The constant pressure source 84 can be supplied with a constant pressure regulator 92 that can modulate the amount of internal pressure being supplied to the everting balloon system 8. Pressure modulation can provide change from 3 atmospheres of pressure to 2, 1, or 0.5 atmospheres of pressure which can still provide the everting balloon 22 with structural shape but reduces the amount of eversion force, or the overall diameter of the everting balloon 22. In practice, as an example, the everting balloon 22 may have its internal pressure modulated from 3 atmospheres of pressure at a point of nearly complete eversion but would then have the internal pressure modulated to 0.5 or 1 atmospheres of pressure as the embryo transfer catheter 28 is being loaded by the embryologist, or when the embryo transfer catheter 28 is being traversed through the inner catheter 10, or at as the entire everting catheter 218 is inverted or removed from the uterine cavity without inverting the balloon back into the delivery catheter 32. Other degrees of pressure are possible with fingertip control of the physician without having to use an inflation device hooked up to the everting catheter system 106.
The everting balloon system 8 can have a fill port 94, for example to fill and/or empty the everting balloon system 8 (e.g., the everting balloon 22, constant pressure source 84, fluid reservoir 82, catheter inner volumes, connector inner volumes, or combinations thereof) with fluid 70.
As an example, working space needed to place a handle 120 within an everting catheter system 106 can increase the overall length to the delivery catheter 32, inner catheter 10, and the embryo transfer catheter 28 that needs to be placed within the system. Adding length to these systems can create handling issues within the embryology laboratory, especially in labs in which the loading of embryos within the embryo transfer catheter 28 is performed within a small incubator with side walls that will encroach on the handling of the embryology syringe 66 and placement of the distal end of the embryo transfer catheter 28 within the embryo dish within the incubator. The added length in these situations would create handling and manipulation challenges for the embryologist. The handle 120 can reduce the amount of working length occupied by the handle 120 and controller 118 mechanism while still providing a one-handed operation to the advancement of the inner catheter 10 during use. The handle 120 contains gear wheel controller 118 mechanism for engaging and translating the inner catheter 10 during use. The handle 120 can have a posterior section that can be curved to fit the palm and fingers of the physician without requiring the inner catheter 10 to be placed through the handle 120 portion for engagement with the controller 118 mechanism. The handle 120 can have a pistol grip with gear wheels actuated by the thumb. The handle 120 can be incorporated into an everting catheter system 106 for use with transvaginal ultrasound.
The system can have a Rotation Wheel 172 to guide advancement and retraction of the inner catheter 10. The Traction Wheel 182 can be connected to Motor Gear Wheel 180 for advancement and retraction of the inner catheter 10. The motor gear wheel 180 can be connected to the motor and the battery. The motor and the battery can be connected to a toggle wire 174. The toggle wire 174 can be connected from a toggle switch 176 to the motor and battery to turn the motor on and off and reverse its direction. The toggle switch 176 can turn the motor on and off and reverse its direction for the advancement and retraction of inner catheter 10.
The everting balloon membrane 6 can be connected to the inner catheter 10 distal end.
The traction wheel 182 can engage the inner catheter 10 for automatically translating and retracting the inner catheter 10. A guide wheel can secure the contact of the inner catheter 10 to the traction wheel 182. Once the everting balloon membrane 6 is pressurized, a forward push on the toggle switch 176 can activate the motor and battery 178 to advance the gear wheel to rotate the traction wheel 182. Once the deposition of reproductive matter to the uterine cavity is completed, the toggle switch 176 can be pushed in the opposite or backward direction to initiate retraction of the inner catheter 10.
The most common vaginal speculums have arms or blades 186 for displacing the anterior and posterior walls of the vagina. The standard vaginal speculum is bi-valved with two blades 186 and has a duckbill appearance. These vaginal speculums come in multiple sizes and lengths with ratcheting mechanisms to maintain the opening of the vagina 200. Some vaginal speculums have a continuous circumferential housing to contain the mechanism for opening or separating the blades 186 and applying pressure on the anterior and posterior walls of the vagina. Some speculums have a side-opening housing that allows the speculum to be slipped out of the vagina while allowing the devices to remain in place. In practice, IVF specialists need to remove the vaginal speculum to effectively operate the TUS probe which becomes increasingly difficult with embryo transfer catheter 28 systems that require two hands for effective operation. Alternatively Sims speculums, or single arm or single blade 186 speculums, have a separate posterior arm component that has a separate anterior arm component for opening the vagina. The Sims speculum used in the posterior aspect of the vagina can be inserted sideways to minimize the insertion profile. Secondarily, the arm can be rotated so that the flat portion of the Sims speculum arm is horizontal to the vaginal opening to thereby open the bottom portion of the vagina. The flat arm provides pressure on posterior vaginal opening and conversely, an anterior Sims speculum or single-arm speculum will provide pressure on the anterior opening of the vagina 200. When using Sims speculum arms on both the anterior and posterior walls, this requires two physicians or operators and the arms can be slipped out separately to allow for devices to remain in place in the vagina. Another type of vaginal speculums are designed to open only the lateral walls of the vagina as opposed to the anterior and posterior walls of the vagina. Yet another type of vaginal speculum contains four arms that opens the anterior, posterior, and both lateral walls of the vagina. In addition, some speculums are configured with 3 blades. For all of these vaginal speculums, they are designed to open the vagina to provide visual and manual access to the cervix 202 for transvaginal procedures.
For clinical practice, the IVF specialist will wash the exocervix prior to the insertion of the embryo transfer catheter 28 system. Besides clearly visualizing the cervical opening, the IVF specialist does not want vaginal fluids or bacteria on the cervix 202 or within the vagina to come into contact with the embryo transfer catheter 28 system during the insertion of catheters within the endocervix and then the uterine cavity. An additional purpose of the vaginal speculum is to keep tissues from the vaginal walls away from the cervix 202 so that the embryo transfer catheter 28 system does not come into contact with the labia or inner vaginal walls during the insertion process. The size and physical presence of the vaginal speculum does not facilitate the insertion and operation of a TUS probe in combination with standard embryo transfer catheter 28 systems that require multiple hands to effectively operate. In particular, TUS probes are designed to be placed at back wall of the vagina at the anterior fornix next alongside the cervix 202. And further, it has been reported in medical literature that the physical manipulation of the vaginal speculum can incite uterine contractions which are not desirable for IVF procedures which require the implantation of embryos. In addition, female patients have reported discomfort with the manipulation of vaginal speculums in the process of retracting the vaginal walls to expose the cervix 202. Using smaller, lower profile vaginal speculums or pediatric speculums would be more comfortable for the patient and reduced physical size and reduced vaginal manipulations will thereby lower the incidence of subsequent uterine contractions. Unfortunately the operation of existing embryo transfer catheter 28 systems require two hands and necessitate greater vaginal openings. As well as room to avoid inadvertent contact with the vaginal walls during the catheter insertion process.
Use of Sims single-arm speculums and flat arms on outermost opening of the vagina 200 provoke pressure on the posterior or anterior openings of the vagina. To summarize, a vaginal speculums that are designed to function with a lower profile and can be used in conjunction with an embryo transfer catheter 28 system would be a benefit.
U.S. Provisional Application Nos. 61/902,742, filed Nov. 11, 2013, 61/977,478, filed Apr. 9, 2014; 62/005,355, filed May 30, 2014, 62/007,339, filed Jun. 3, 2014, 62/528,422, filed Jul. 3, 2017, and 62/553,057, filed Aug. 31, 2017; U.S. patent application Ser. No. 16/029,305, filed Jul. 6, 2018; International Patent Application No. PCT/US18/49234, filed Aug. 31, 2018; and U.S. Pat. No. 9,028,401, issued May 12, 2015 and U.S. Pat. No. 10,034,986, issued Jul. 31, 2018, are incorporated by reference herein in their entireties, and any elements described therein can be used in combination with any of the elements in this application.
Any elements described herein as singular can be pluralized (i.e., anything described as “one” can be more than one). Any species element of a genus element can have the characteristics or elements of any other species element of that genus. The media delivered herein can be any of the fluids 70 (e.g., liquid, gas, or combinations thereof) described herein. The patents and patent applications cited herein are all incorporated by reference herein in their entireties. Some elements may be absent from individual figures for reasons of illustrative clarity. The above-described configurations, elements or complete assemblies and methods and their elements for carrying out the disclosure, and variations of aspects of the disclosure can be combined and modified with each other in any combination. All devices, apparatuses, systems, and methods described herein can be used for medical (e.g., diagnostic, therapeutic or rehabilitative) or non-medical purposes.
Claims
1. A method for delivering matter into a uterine cavity comprising:
- positioning an everting balloon system adjacent to a cervical canal, wherein the everting balloon device comprises a first catheter and an everting balloon attached to the first catheter, and wherein the first catheter has a catheter lumen and a distal port at the distal end of the catheter lumen, and a delivery catheter attached to opposite end of the everting balloon from the first catheter;
- everting the everting balloon in the cervical canal, wherein the everting comprises pulling the first catheter distally through the cervical canal, wherein the first catheter has a fixed alignment with the delivery catheter and everting balloon, the and wherein the everting comprises inflating the balloon distal to the first catheter.
2. The method of claim 1, wherein the fixed alignment prevents twisting of the everting balloon during the eversion and inversion process.
3. The method of claim 2, wherein the fixed alignment prevents over extension of the everting balloon during the inversion process.
4. A method for delivering matter into a uterine cavity comprising:
- everting a balloon in a cervical canal, wherein the balloon is attached to a first catheter, and wherein everting comprises pulling the first catheter distally through the cervical canal;
- transporting a flexible tip guidance wire through the first catheter into the uterine cavity to direct the distal end of the everting balloon towards a targeted region;
- transporting an catheter of the reproductive material once access to the targeted region is reached.
5. A method for delivering matter into a uterine cavity comprising:
- everting a balloon in a cervical canal, wherein the balloon is attached to a first catheter, and wherein everting comprises pulling the first catheter distally through the cervical canal;
- pressurizing balloon system with complaint member to facilitate keeping internal pressure within an operating range.
6. A method for delivering matter into a uterine cavity comprising:
- everting a balloon in a cervical canal, wherein the balloon is attached to a first catheter, and wherein everting comprises pulling the first catheter within a delivery catheter and distally through the cervical canal;
- and distal end of delivery catheter can adjust the working length of the everting balloon.
7. A system for delivering matter into the reproductive tract of a female comprising:
- a first catheter having a lumen and a distal lumen port, wherein the first catheter has a retracted configuration and an extended configuration;
- an everting balloon attached to the first catheter, wherein at least a length of the everting balloon extends past the distal end of the first catheter when the first catheter is in the extended configuration;
- a second catheter slidably located in the first catheter; and
- second catheter comprises an alignment piece to prevent rotation of the second catheter in relation to the first catheter.
8. The system of claim 7, further comprising a stopping piece to prevent over extension of the everting balloon when the second catheter is retracted in the first catheter during inversion of the everting balloon.
9. A method for delivering matter into a uterine cavity comprising:
- positioning an everting balloon system adjacent to a cervical canal, wherein the everting balloon device comprises a first catheter and an everting balloon attached to the first catheter, and wherein the first catheter has a catheter lumen and a distal port at the distal end of the catheter lumen, and a delivery catheter attached to opposite end of the everting balloon from the first catheter;
- everting the everting balloon in the cervical canal, wherein the everting comprises pulling the first catheter distally through the cervical canal, wherein the first catheter has an attachment for coupling the first catheter to a transvaginal ultrasound probe, the and wherein the everting comprises inflating the balloon distal to the first catheter.
10. The method of claim 9, wherein the attachment for coupling the first catheter to the transvaginal probe maintains the position of the everting balloon system during the eversion and inversion process.
11. The method of claim 10, wherein the attachment for coupling the first catheter to the transvaginal probe maintains the position of the everting balloon during the process of inserting a transfer catheter within the everting balloon system for delivering matter into the uterine cavity.
12. A method for delivering matter into a uterine cavity comprising:
- everting a balloon in a cervical canal, wherein the balloon is attached to a first catheter, and wherein everting comprises pulling the first catheter distally through the cervical canal;
- pressurizing the balloon;
- placing stored energy to act on the first catheter;
- and wherein the advancement of the balloon is performed by a stored energy applied to the first catheter in combination with the pressurization of the balloon;
- and advancement of the first catheter is initiated by releasing the stored energy connected to the first catheter.
13. A method for delivering matter into a uterine cavity comprising:
- an everting catheter system with an everting a balloon in a cervical canal, wherein the balloon is attached to a first catheter, and wherein everting comprises pulling the first catheter distally through the cervical canal;
- applying a rotationally opening speculum with coupling mechanism;
- attaching everting catheter system to the speculum using coupling mechanism.
14. A method for delivering matter into a uterine cavity comprising:
- everting a balloon in a cervical canal, wherein the balloon is attached to a first catheter, and wherein everting comprises pulling the first catheter within a delivery catheter and distally through the cervical canal;
- and an acorn tip at the distal end of delivery catheter can adjust from a soft rounded profile to a penetrating distal tip profile.
Type: Application
Filed: Jun 10, 2020
Publication Date: Sep 24, 2020
Applicant: CrossBay Medical, Inc. (San Diego, CA)
Inventors: Steven R. BACICH (Half Moon Bay, CA), Matthew Thomas YUREK (San Diego, CA), Cristiano Danilo Maria FONTANA (Milan), Piush VIDYARTHI (San Rafael, CA)
Application Number: 16/898,090