Patent Application
20100087798
1. Field of the Invention
The present invention relates to systems, methods, apparatus and devices for performing one or more arthroscopic, gynecologic, urologic, and laparoscopic procedures. More particularly, devices and combinations of devices provide simplified use and enhanced safety to support performance various diagnostic and therapeutic procedures in the doctor's office setting.
2. Description of the Related Art
Currently available gynecologic products are difficult to use and often have limited use and functionality. Treatment of gynecologic disorders and ailments is most often performed in a hospital and bears a large cost due to the setting and the support personnel required. Treatment options and modalities are also limited, such that the patient may not be offered the best option for her particular condition.
There is therefore a need for improved gynecologic systems, methods and devices that simplify use, offer improved functionality and enhanced safety.
According to a first aspect of the invention a hysteroscopic morcellator for performing a gynecologic procedure is disclosed. Hysteroscopic morcellator system (
According to another aspect of the invention, the morcellator system can comprise two independent subassemblies such that they operate together as a single tool that combines one or more functions of cervical distention, uterine distention, visualization, and therapy is disclosed. The first subassembly provides the power means for the morcellation means. The second subassembly contains the aspiration and irrigation ports and the morcellation means. The second subassembly contains all of the body fluid and tissue contacting elements and reduces the interface for the two subassemblies to a single rotating shaft. By separating these two elements, sterilization will only be required for the second subassembly allowing it to be manufactured as a single use disposable device. The power subassembly, which may be battery operated or driven by an electric motor, can be cleaned and reused. The tool or tools combined OD is to be less than 9 mm but preferably less than 8 mm, and preferably less than 7 mm, and preferably less than 6 mm, and preferably less than 5 mm such as to prevent painful and potentially destructive dilation of the cervix. In a preferred embodiment, second subassembly includes a sterile bag which can surround power subassembly such as when second subassembly is attached to power subassembly. In another preferred embodiment, the second subassembly includes an elongate shaft with one or more lumens. These one or more lumens may include a mechanical key such as to orient one or more inserted devices, such as visualization means.
According to another aspect of the invention, the morcellator configuration for the aforementioned system is composed of two or more members with cutting edges and each of these members connected together on a shaft such that they that rotate together as a single tool but one that permits two or more cuts to be made with each rotation of the assembly. By creating multiple cutting elements the speed of the tissue resection will be improved reducing the procedure time. By reducing the procedure time, the risks for anesthesia, fluid intravasation, injury, perforation and distention will be reduced. The morcellator outer diameter is to be less than 7 mm but preferably less than 6 mm, and preferably less than 5 mm, and preferably less than 4 mm, and preferably less than 3 mm, and in some instances less than 2 mm in size, such as to prevent painful and potentially destructive dilation of the cervix.
According to another aspect of the invention, an introducer or morcellator system for performing a gynecologic procedure is disclosed. The introducer or hysteroscopic morcellator system includes a working sheath having an inner diameter (ID) greater than the combined OD of the tool or tools used through it, and this OD can generally be less than 9 mm, preferably less than 8 mm, preferably less than 7 mm, and preferably less than 6 mm, and preferably less than 5 mm, and preferably less than 4 mm, and preferably less than 3 mm such as to prevent painful and potentially destructive dilation of the cervix.
In certain embodiments, the morcellator system is powered by a linear actuation means 121 such that the cutting motion will reflect a guillotine type of action. By utilizing a guillotine type of cutting motion, the morcellation means will allow for a distal cutting block to be used whereby the cut is terminated in a definitive manner. By cutting the tissue with a definitive edge the ability to cut tougher tissues will be enhanced. The morcellator outer diameter can be less than 7 mm, and preferably less than 6 mm, and preferably less than 5 mm, and preferably less than 4 mm, and preferably less than 3 mm, such as to prevent painful and potentially destructive dilation of the cervix.
According to another aspect of the invention, a wireless hysteroscope for viewing the female reproductive tract is disclosed that includes a fiber optic bundle or wires for LED's, camera, integral light source, image capture card and viewing means whose construction includes a rechargeable battery pack to power the system. The advantage of providing a wireless and unconstrained hysteroscope is the freedom to move and rotate the scope without wires or cables impeding the motion. The wireless hysteroscope system having an OD typically less than 6 mm, and preferably less than 5 mm, and preferably less than 4 mm, and preferably less than 3 mm, and preferably less than 2 mm such as to prevent painful insertion and movement through the cervix.
According to another aspect of the invention, an operative sheath for a hysteroscopic system is disclosed that includes a distal lens assembly, integral irrigation/working channel, and retaining means to attach the sheath to the hysteroscope. The use of an operative sheath will enable the sheath to be a single use disposable device that is sterilized while the hysteroscope can be cleaned and reused. The irrigation/working channel ID is preferably 5 Fr. and preferably less than 4 Fr. to enable easy insertion through the cervix. The operative sheath system having an OD typically less than 6 mm, and preferably less than 5 mm, and preferably less than 4 mm, and preferably less than 3 mm, and preferably less than 2 mm such as to prevent painful insertion and movement through the cervix.
According to another aspect of the invention, a scaffolding device or combined system that distends the uterine cavity to a volume equivalent to that of which could be accomplished via a liquid distention media at a pressure of at least 40 mm of HG but not greater than 100 mm HG preferably equivalent to 70 mm Hg, is disclosed. Distension of the uterine cavity is necessary to facilitate the detection and/or the treatment of various conditions including, but not limited to, the presence of fibroids, polyps, tumors, adhesions, or other abnormalities within a uterus; endometriosis or other abnormal bleeding; uterine prolapse; ectopic pregnancy; and fertility issues (both the inability to conceive and the desire to avoid pregnancy). To facilitate the detection and/or the treatment of the above and like conditions, there should be ample space within the gynecological cavity to perform various procedures; however, adequate space does not typically exist naturally in the uterine cavity because the uterus is a flaccid organ. Therefore, distention of the uterus is often necessary. Other distention devices and means are also possible, for example, injecting or disposing a gel in the uterus.
According to another aspect of the invention, a dilation device such as an inflatable balloon with a fully distended size to be less than 9 mm, and preferably less than 8 mm, and preferably less than 7 mm, and but preferably less than 6 mm, and preferably less than 5 mm, and preferably less than 4 mm, and preferably less than 3 mm, preferably less than 2 mm in size, such as to prevent painful and potentially destructive dilation of the cervix.
For purposes of this summary, certain aspects, advantages, and novel features of the invention are described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment of the invention. Thus, for example, those skilled in the art will recognize that the invention may be embodied or carried out in a manner that achieves one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various embodiments of the present invention, and, together with the description, serve to illustrate and not to limit the principles of the invention. In the drawings:
To facilitate an understanding of the invention, a number of terms are defined immediately herebelow.
As used herein, the term “trans-vaginal-wall” refers to devices or procedures which enter the vaginal opening, travel down the vaginal canal, and exit through the vaginal wall proximal to the cervix.
As used herein, the term “trans-cervical” refers to devices or procedures which enter the vaginal opening, travel down the vaginal canal, pass through the cervical canal and enter the uterus.
As used herein, the term “trans-uteral” refers to devices or procedures which pass through the wall of the uterus.
As used herein, the term “drug” refers to all drugs and other agents that may be included in the systems, methods apparatus and devices of the present invention; either by including the drug into a coating or an integral reservoir of a component; or by provided to the patient through other means such as via a lumen and exit port which is in fluid communication with a supply of the drug such as an infusion pump or syringe. Drugs shall include not only pharmaceutical compounds such as anesthetics, anti-thrombotics, thrombotics, anti-bacterial drugs and chemotherapeutics, but also other agents such as ionic solutions, hormones, genes, vitamins, clotting agents, naturally occurring substances such as extracts from plants, and any other compound or agent applicable to the procedures contained herein.
As used herein, “patient” refers to any animal, such as a mammal and preferably a human. Specific examples of “patients” include but are not limited to: individuals requiring medical assistance and healthy individuals.
As used herein, the term “distension media” refers to any liquid or gel suitable for distending a hallow organ, such as a uterine cavity.
Systems, methods, apparatus and devices are disclosed herein to provide improved diagnostic and therapeutic gynecologic, gastrointestintinal tract, lung, spine and urologic procedures and outcomes. The simplified, safer use provided allows these procedures to be performed in locations such as a doctor's office or a health clinic, eliminating the high costs associated with a hospital setting. Specific devices of the present embodiments reduce the pain encountered by the patient during and after the associated diagnostic or therapeutic procedure. The devices and apparatus provide to the clinician operator precision in both manipulation and device actions, and often allow reversibility of one or more steps of the procedure without undesirable consequence. Inadvertent tissue trauma is avoided with blunting of tips and other tissue-contacting surfaces. Simplified mechanisms, miniaturized geometries and improved methods reduce procedure times and trauma, and also the associated infection risk and blood loss. Intravasation, the entry of foreign matter in a blood vessel, is also reduced.
A hysteroscopic morcellator (or an introducer) is provided which can be placed into the patient to provide a stabile, working platform to support simplified introduction of one or more diagnostic, treatment or other devices. The hysteroscopic morcellator can comprise an elongate shaft with one or more internal lumens. The proximal end of the shaft may include one or more access ports, such as fluid access ports and device entry ports, as well as one or more controls such as buttons, knobs or levers used to manipulate the hysteroscopic morcellator or activate a mechanical or electronic module of the hysteroscopic morcellator. The hysteroscopic morcellator preferably accepts devices comprising elongate shafts, sequentially or simultaneously. The hysteroscopic morcellator system also permits the administration and or removals of fluid from the patient, such as fluid administered to the uterus, while also providing fluid stasis or maintaining stasis to a maximum pressure at which fluid can be automatically evacuated. The hysteroscopic morcellator system also permits the administration of one or more drugs, such as anesthetic drugs or clotting agents. The hysteroscopic morcellator system may be introduced through the cervix and into the uterus, through the vaginal wall to a location outside the uterus (trans-vaginal-wall), or through another entry path to a specific anatomical location within the patient.
Systems are provided that enable and/or perform diagnostic, therapeutic or combined diagnostic and therapeutic arthroscopic, gynecologic, laparoscopic and urologic procedures. The systems preferably include one or more of the hysteroscopic morcellator, a treatment device, a tissue removal device, a subsonic treatment device, a drug delivery device, a dilating device, a vaginal-wall-crossing device, a distension device, a volume occupying device, a stabilizing device, a visualization apparatus and a navigation apparatus, all of the present invention, and other devices applicable to gynecological procedures. The systems of the present invention are simple to use, and provide reduced risks while enhancing outcomes.
Treatment Devices are provided which allow a clinician to perform, individually or in combination with additional devices, one or more arthroscopic, gynecologic, gastrointestintinal tract, lung, spine and urologic procedures. The treatment devices provided include but are not limited to: devices which remove, denature or otherwise treat undesired tissue; devices which modify the structure of a vessel such as a fallopian tube or blood vessel occlusion device; drug delivery devices; and other therapeutic or diagnostic devices. The treatment devices preferably include an elongate shaft, and the shaft may include one or more internal lumens. The proximal end of the shaft may include one or more access ports, such as fluid access ports and device entry ports. A handle may be included on the proximal end, the handle including one or more controls such as buttons, knobs or levers used to manipulate the elongate shaft or activate a mechanical or electronic module of the device. The treatment devices of the present invention may additionally or alternatively perform a diagnostic function. These treatment devices may provide multiple functions, such as diagnostic or treatment functions including applying a tamponade force to bleeding tissue or distending tissue such as uteral wall tissue.
Treatment devices include tissue removal devices which can be inserted through the hysteroscopic morcellator of the present invention and be subsequently operated to remove tissue. Tissue removal device are often arranged with vacuum assemblies which provide a vacuum proximate a tissue removal element and evacuate the tissue to be removed to a site outside of the patient's body.
Treatment devices include subsonic treatment devices which also can be inserted through the hysteroscopic morcellator of the present invention and subsequently deliver subsonic energy to disrupt or otherwise modify tissue such as a fibroid.
Treatment devices include drug delivery devices which can be placed into the patient and controllably deliver a drug to a specific area of tissue or space, such as the vaginal wall, cervix, uterus, uteral wall or fallopian tube as well as a specific fibroid, polyp, tumor or other tissue mass. These drug delivery devices may provide additional functions, such as diagnostic or treatment functions including applying a tamponade force to bleeding tissue or distending tissue such as uteral wall tissue.
Dilating devices are provided which can be used to dilate the cervix, a penetration tract in the vaginal wall, or other tissue. The dilating devices preferably include an elongate shaft, and the shaft may include one or more internal lumens. The proximal end of the shaft may include one or more access ports, such as fluid access ports and device entry ports. A handle may be included on the proximal end, the handle including one or more controls such as buttons, knobs or levers used to manipulate the elongate shaft or activate a mechanical or electronic module of the device. Specific embodiments include “smart” dilation systems and methods which measure one or more parameters (e.g. device parameters such as strain or pressure or patient parameters such as EKG, EEG, blood pressure or respiration). One or more algorithms are applied to the measured parameters and used to control one or more dilation parameters such as rate, force and magnitude. These dilation devices may be integrated into another device, such as an hysteroscopic morcellator, a treatment device, or other device of the present invention. These dilation devices may provide additional or alternative functions, such as diagnostic or treatment functions including applying a tamponade force to bleeding tissue, distending tissue such as uteral wall tissue, or delivering a drug to tissue. The dilating devices of the present invention are typically configured to dilate to a diameter less than 9 mm, preferably between 5 and 8 mm, and more preferably between 2 and 5 mm. The dilating devices of the present invention are typically dilated to a pressure not to exceed 300 psi (e.g. balloon dilation pressure), and preferably less than 150 psi.
Vaginal-wall-crossing devices are provided that permit safe introduction of one or more devices, such as the hysteroscopic morcellator of the present invention, from inside the vaginal canal, through the vaginal wall to various anatomical locations including but not limited to: the outer wall of the uterus; the outer wall of the fallopian tubes; the ovaries; intra-abdominal locations; other locations and combinations thereof. The crossing devices preferably include an elongate shaft, and the shaft may include one or more internal lumens. The proximal end of the shaft may include one or more access ports, such as fluid access ports and device entry ports. A handle may be included on the proximal end, the handle including one or more controls such as buttons, knobs or levers used to manipulate the elongate shaft or activate a mechanical or electronic module of the device. In a preferred embodiment, a guidewire is first placed through the vaginal wall, and one or more devices are placed over-the-wire. These crossing devices may provide additional or alternative functions, such as diagnostic or treatment functions including delivering a drug to tissue.
Distension devices are provided which can be introduced into a space, such as the uterus, and apply a force to tissue. The distension devices include without limitation, for example, scaffolding devices or the like. The distension devices are preferably inserted through the hysteroscopic morcellator of the present invention. The distension devices preferably include an elongate shaft, and the shaft may include one or more internal lumens. The proximal end of the shaft may include one or more access ports, such as fluid access ports and device entry ports. A handle may be included on the proximal end, the handle including one or more controls such as buttons, knobs or levers used to manipulate the elongate shaft or activate a mechanical or electronic module of the device. These distension devices may provide additional or alternative functions, such as diagnostic or treatment functions including applying a tamponade force to bleeding tissue or delivering a drug to tissue. These distension devices are preferably inserted into the uterus of a patient such that the distension assembly preferably distends the uteral cavity to a volume equivalent to that which would be attained via a liquid distention media at a pressure of at least 40 mm of HG but not greater than 100 mm HG and preferably approximating 70 mm Hg.
Volume Occupying devices are provided which can be introduced into a space, such as the uterus, and occupy space within the uterus. The volume occupying devices are preferably inserted through the hysteroscopic morcellator of the present invention. The volume occupying devices preferably include an elongate shaft, and the shaft may include one or more internal lumens. The proximal end of the shaft may include one or more access ports, such as fluid access ports and device entry ports. A handle may be included on the proximal end, the handle including one or more controls such as buttons, knobs or levers used to manipulate the elongate shaft or activate a mechanical or electronic module of the device. These volume occupying devices provide the function of taking up space in a cavity, such as taking up space in the uterus to reduce the amount of fluid delivered to the uterus in a diagnostic or therapeutic procedure. These volume occupying devices may provide additional or alternative functions, such as diagnostic or treatment functions including applying a tamponade force to bleeding tissue, distending tissue such as uteral wall tissue, or delivering a drug to tissue.
Stabilizing devices are provided which are used to stabilize one or more separate devices, such as a treatment device of the present invention. Stabilizing devices may include magnets which attract a corresponding magnet integral to the separate device such as to position a treatment device proximate to tissue to be treated. The stabilizing devices preferably include an elongate shaft, and the shaft may include one or more internal lumens. The proximal end of the shaft may include one or more access ports, such as fluid access ports and device entry ports. A handle may be included on the proximal end, the handle including one or more controls such as buttons, knobs or levers used to manipulate the elongate shaft or activate a mechanical or electronic module of the device such as an electromagnet located in the distal portion of the shaft. These stabilizing devices may provide additional or alternative functions, such as diagnostic or treatment functions including applying a tamponade force to bleeding tissue, distending tissue such as uteral wall tissue, or delivering a drug to tissue.
Visualization apparatus are provided which provide enhanced imaging of target anatomical locations within the patient. The apparatus include one or more of: miniaturized cameras; infrared cameras; deployable light sources; stabilizing mechanisms; image stabilizing modules and processing; and improved and cost-reduced displays (e.g. a laptop screen display). The visualization apparatus preferably include one or more devices comprising an elongate shaft, and the shaft may include one or more internal lumens. The proximal end of the shaft may include one or more access ports, such as fluid access ports and device entry ports. A handle may be included on the proximal end, the handle including one or more controls such as buttons, knobs or levers used to manipulate the elongate shaft or activate a mechanical or electronic module of the device. These visualization apparatus may provide additional or alternative functions, such as diagnostic or treatment functions including applying a tamponade force to bleeding tissue, distending tissue such as uteral wall tissue, or delivering a drug to tissue.
Navigating apparatus are provided which enable a clinician to navigate one or more diagnostic or therapeutic devices to perform a gynecologic procedure. The navigation apparatus preferably include one or more of: an electro-magnetic (EM) beacon and/or receiver; a light emitter and/or detector; and a magnetic source and/or a detector. The navigation apparatus preferably include one or more devices comprising an elongate shaft, and the shaft may include one or more internal lumens. The proximal end of the shaft may include one or more access ports, such as fluid access ports and device entry ports. A handle may be included on the proximal end, the handle including one or more controls such as buttons, knobs or levers used to manipulate the elongate shaft or activate a mechanical or electronic module of the device. These navigation apparatus may provide additional or alternative functions, such as diagnostic or treatment functions including applying a tamponade force to bleeding tissue, distending tissue such as uteral wall tissue, or delivering a drug to tissue.
Shape-modifying wires are provided which are slidingly received by one or more lumens of a device of the present invention, such as a morcellating or other treatment device used to access and treat a fibroid. Shapes on the one or more shaping wires can bias the elongate shaft of the device, such as at a distal portion, to a pre-determined shape. In a preferred embodiment, multiple shaping wires with varied shapes are provided to accommodate different procedures and/or access to different anatomical locations.
Numerous devices of the present invention include an elongate shaft, similar in construction to shafts used in laparoscopic and percutaneous devices. The shafts may be manufactured in a “lay up” process including multiple layers of similar or dissimilar materials, such as layers of flexible biocompatible material separated by a braided material such as metal wire or plastic filament. The construction is chosen to provide adequate column strength and torqueability to access the desired anatomical locations and perform the desired actions. Each shaft preferably has a blunt or otherwise atraumatic distal tip. The shafts may include one or more lumens, such as a lumen configured to slidingly receive an elongate device such as a treatment catheter or guidewire, a lumen configured to allow fluid delivery and/or fluid sampling or removal; an inflation lumen configured to allow inflation of a balloon; a mechanical linkage lumen configured to slidingly receive a cable such as to transmit force through the shaft (e.g. from a lever on a handle on the proximal end of the shaft); a lumen configured to slidingly receive a shaping wire of the present invention; other lumens and combinations thereof. Each lumen may include one or more mechanical keys, such as to orient an inserted device such as to orient a tissue treatment element or camera device toward a window. Alternatively or additionally, each lumen may be a blind lumen which has an entry port near the proximal end of the shaft, but terminates within the shaft without exiting the distal tip or an exit hole along the shaft. A blind lumen may be incorporated which includes a “window” through which a camera element may be positioned to view outside the elongate shaft. Alternatively or additionally, each lumen may include a mechanical stop, such as to limit the travel of an inserted device.
The elongate shafts of the present invention may include a reinforced section such as a section located at the portion of the shaft that, when inserted into the body, is in proximity to the cervix. The reinforced section can provide the function of preventing collapse of an internal lumen of the shaft (enhanced radial strength) as well as prevent undesired perforation out of the shaft and into tissue such as cervical tissue. The reinforced section may comprise the braiding process described here above, and may be provided along a majority of length of the shaft, or a small portion. The shaft may include variable stiffness along its length, and may allow the stiffness to be adjusted, such as through the insertion of a stiffening wire, or by pressurizing an internal (blind) lumen of the shaft. The shaft may include along its length one or more clinician inflatable balloons, such as compliant or non-compliant nylon or PET balloons configured to dilate, deflect the device or neighboring tissue; deliver a drug; or perform another function. The elongate shafts of the present invention are typically less than 9 mm in diameter, and preferably between 5 to 8 mm in diameter, and more preferably between 2 and 5 mm in diameter.
The elongate shafts of the present invention may include clinician controlled deflection means, preferably one or more pull wires attached at their proximal end to a control in a handle on the proximal end of the shaft, and attached on their distal end to a portion of the shaft, such as a distal portion of the shaft. Advancement and retraction of the pull wire causes a portion of the shaft to deflect, such as to bring a treatment element of the present invention in proximity to tissue to be treated. The shafts may further include one or more internal conduits, such as wires or optical fibers which do not need to be advanced or retracted. These conduits may be embedded in the wall of the shaft, fixed to an internal lumen, or sandwiched between to layers present in a layered construction. Wires can be used to transmit electrical signals or energy, in either direction in the shaft. Fiber optic cables can be used to transmit light energy (e.g. laser energy) or signals (e.g. images from a lens), in either direction in the shaft. In the preferred embodiment, the shafts of the present invention include a handle on their proximal end, and the handle includes on or more controls to activate one or more portions of the device. In another preferred embodiment, a “kill-switch” control is included to allow the clinician to quickly stop an ongoing action.
The shafts and other components of the devices of the present invention are constructed of biocompatible materials. The devices may be configured for one-time use or be resterilizable. The materials include medical grade metals, plastics and other materials. Shaped memory metals such as Nitinol and shaped memory polymers may be used to provide controllable material properties or meet specific elasticity and/or resiliency requirements. The shafts and other components may include one or more coatings, such as coatings selected from the group consisting of: anti-infective drugs, anti-thrombogenic drugs; clotting agents; chemotherapeutics; anesthetics such as lidocaine; other drugs; and combinations thereof. Alternatively, the shafts and other components may include drug delivery means, such as drug reservoirs (e.g. connected to a supply of drug internal or external to the device) or drug depots (e.g. containing a supply of drug) One or more markers may be integral to a component of the device, such as a marker selected from the group consisting of: visible and non-visible markers; radiopaque markers; magnetic markers; ultrasonically reflective markers; and combinations thereof.
A functional element may be mounted to the shafts or other components of the devices of the present invention. These functional elements may include a sensor or transducer and/or another functional element such as a camera or marker as described here above. Applicable sensors include but are not limited to: electrodes such as electrical mapping electrodes; temperature sensors; pressure sensors; strain gauges; accelerometers; force sensing resistors; position sensors such as linear or rotary encoders; magnetic sensors such as hall effect transistors; optical sensors such as phototransistors; physiologic sensors such as EKG; EEG; respiration; blood sensors such as a blood gas sensors such as an O2 saturation sensors; glucose sensors; blood pressure sensors; pH sensors; other physiologic sensors; and combinations thereof. Applicable transducers include but are not limited to: magnets; electrodes such as radiofrequency electrodes; heat generators; cryogenic generators; force or space-occupying generators such as an expandable balloon or solenoid; drug delivery elements such as iontophoretic elements; sound transducers such as acoustic transducers, ultrasound transducers and subsonic transducers; radiation sources; light sources such as visible or infrared light sources configured to provide a beacon for navigation and ultraviolet light sources configured to treat infection or kill bacteria; visualization elements such as cameras, lenses, fiber optics and ultrasound crystals; other functional elements; and combinations thereof. Functional elements may further include elements to cause dissection of tissue, such as blunt dissection projections and fluid jets.
The systems, methods, apparatus and devices of the present invention are applicable to patients with one or more of the following conditions:
The systems, methods, apparatus and devices of the present invention are applicable to performing one or more therapeutic or diagnostic gynecologic and urologic procedures. These procedures may be performed inside or outside the uterus. Applicable primary procedures include but are not limited to:
In the performance of one or more gynecologic and urologic procedures, such as one or more of the procedures listed above, the systems, methods, apparatus and devices of the present invention may be used to perform one or more additional procedures, including but not limited to:
The systems, methods, apparatus and devices of the present invention may provide and/or utilize various means and routes of access to an internal location within the patient. Routes of access include but are not limited to:
The devices and apparatus of the present invention may comprise an elongate shaft that includes one or more lumens such as to slidingly receive one or more separate devices also comprising an elongate shaft. The device lumens may be configured to support over-the-wire insertion over a standard guidewire, or alternatively a side-car mounted near the distal end of the shaft may be provided to support monorail (also known as rapid exchange) insertion. The device lumens, such as the hysteroscopic morcellator of the present invention, may be sized and be otherwise configured to slidingly receive one or more devices including but not limited to:
The device lumens may be sized and include access elements such as luer fittings to attach to drug delivery devices such as syringes and infusion pumps. The device elongate shaft may be sized and otherwise configured to be passed through one or more devices including but not limited to:
Reference will now be made in detail to the present embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
Referring now to
Sheath 110 is manufactured from medical-grade plastics, metals and other biocompatible material such as a sheath including a Teflon outer layer. One or more portions of sheath 110 may be radiopaque, such as by inclusion of a barium sulfate in plastic material or inclusion of one or more metal portions which provide sufficient radiopacity. In a preferred embodiment, distal end 111 includes a radiopaque marker. Sheath 110 is preferably of a braided construction as has been described here above, and includes a reinforced portion, reinforcement 115 (e.g. consisting of a metal or plastic braided patch or embedded tube as has been described here above) near its distal end, configured to maintain the patency of one or more lumens within sheath 110 when external pressure is exerted (e.g. cervical or vaginal wall pressure) on that portion of sheath 110. Alternatively or additionally, reinforcement 115 may be configured to prevent a device inserted into sheath 110 from inadvertently puncturing out the side of sheath 110, such as to prevent a puncture that would damage cervical or other patient tissue unexpectedly. On the proximal end of sheath 110 is device insertion port 120, which provides access to an internal lumen of sheath 110 and has been configured to maintain fluid stasis with or without a device inserted through it. Port 120 preferably has an “X” cut opening through one or more diaphragms that maintain that fluid seal. The thicknesses of the diaphragms and the materials chosen preferably maintain pressure up to a predetermined level (e.g. 50 mm Hg) after which fluid is automatically evacuated to prevent damage to the patient's internal tissue.
Mechanically attached and in fluid communication with device insertion port 120 are input valve 121 and output valve 122, each of which includes a standard luer connector for attachment to standard fluid infusion lines. Input valve 121 and output valve 122 may include simple one-way valves or more sophisticated valves that open (in either direction or both) at pre-determined pressures. In combination with port 120, fluid infusion and fluid evacuation means (not shown but preferably gravity driven or pump driven fluid movement means), can be attached to port 121 and port 122 and control the level of fluid introduced into the patient via hysteroscopic morcellator 100a. In a preferred embodiment, sheath 110 is a single lumen and the fluid is introduced through that lumen. In an alternative embodiment, sheath 110 includes multiple lumens and fluid can be delivered or evacuated through one or more lumens, simultaneously or independently. In the various gynecological procedures described herein, a volume of liquid and level of liquid pressure are used to visualize the internal space and/or provide space to manipulate one or more devices. In an alternative embodiment, a gel or gas is delivered into the patient.
Hysteroscopic morcellator 100a may include a handle, not shown, on its proximal end. The handle may include one or more controls, as has been described here above. Sheath 110 may include one or more valves within one or more lumens of sheath 110, such as a valve near the distal end 111. hysteroscopic morcellator 100a may include a balloon along sheath 110, such as a balloon configured to dilate tissue such as the cervix or the vaginal wall. In an alternative embodiment, multiple balloons are employed, such as a balloon on a balloon configuration. Each balloon integrated into sheath 110 may have an integrally mounted functional element, as has been described here above but preferably a pressure or force sensor used to provide information to the clinician or a system component regarding dilation conditions (reference
Hysteroscopic morcellator 100 of
Referring now to
On the proximal end of sheath 110 is device insertion port 120, which provides access to an internal lumen of sheath 110 and is in fluid communication with fluid transfer port 123 configured to introduce and/or remove fluid or other media through sheath 110 and into the patient as has been described here above. Port 120 includes a rotating collar 124, which can be rotated to permit devices to pass through port 120 as well as seal around those devices, such as via a diaphragm which seals around inserted devices similar to a Tuohy Borst valve configuration. Port 120 further provides fluid stasis when no device is inserted through it.
Guidewire 131 may be replaced with a different guidewire, such as with a guidewire with different stiffness or lubricious properties. Guidewire 131 may remain in place for a majority of the procedure, or may be removed early on.
In certain embodiments, a balloon catheter approximately 40 cm in overall length and having an uninflated cross-section diameter of less than 4 mm but preferably less than 3 mm having two or more lumens, one extending to the distal tip for a fiber optic or guidewire and one extending to and exiting within the balloon itself for inflation and deflation. Both lumens exit at the proximal end of the catheter. The “through-lumen” used for passing the guidewire or fiber optic can be open ended or have a capped end to keep the fiber optic from touching body fluids. The balloon having a length preferably 12 cm is available in several inflated diameters to dilate the cervix to the appropriate size for the desired instrument. The preferred balloon inflation diameters measured at the midpoint of the balloon are 10 mm, 9 mm, 8 mm, 7 mm, 6 mm, 5 mm and 4 mm. The desired inflation pressure may be greater than 25 atm and in some embodiments greater than 40 atm.
The balloon, having been made of a non-compliant material such as polyethylene terephthalate (PET) is configured with specific attributes that enable the balloon to inflate distally and proximally similar to a dumbbell or dog bone shape as it grows to its fully distended sausage shape. The purpose of the evolving shape from a dumbbell or dogbone shape to a fully distended shape allows the balloon to remain anchored in its intended location throughout the inflation process. If the balloon preferentially inflated proximally first or distally first the balloon would squirt out from the structure it is trying to dilate.
There are several methods to achieving preferential inflation.
A proximal inflation port 1012 is provided for placing the proximal zone 1006 in fluid communication with the inflation media source 1004 by way of an elongated inflation lumen extending through the catheter body 1016. A distal inflation port 1014 places the distal zone 1008 in fluid communication with the source of inflation media 1004 by way of either the first inflation lumen or a second inflation lumen extending throughout the catheter body 1016. Expression of inflation media from the source 1004 will therefore inflate the proximal zone 1006 and the distal zone 1008 under approximately the same inflation pressure, which, in combination with the radially constricted force applied by the cervix in the central zone 1010, will cause the balloon to expand in an initial dog bone configuration.
Alternatively, the balloon 1002 may be configured with an internal baffle (not illustrated) to isolate the proximal section 1006 from the distal section 1008. As a further alternative, each of the proximal section 1006, distal section 1008 and intermediate section 1010 may comprise distinct inflatable balloons. In one implementation of this design, the proximal balloon 1006 and distal balloon 1008 will be coupled to a common inflation lumen enabling simultaneous inflation. The central balloon 1010 is placed in communication with a source of inflation media by way of a unique inflation lumen. In this manner, the inflation of the proximal and distal balloons may be controlled separately from the inflation of the central balloon. One or more additional lumen may be provided in the catheter 1016, depending upon the desired functionality. For example, an elongate central lumen may be provided, extending all the way to the distal tip of the balloon 1002 and further provided with a distal opening. This central lumen may be utilized for any of a variety of purposes, such as for advancing the catheter over a guidewire, and/or for the introduction of fluids and/or tools through the balloon catheter and into the uterus.
Once the balloon is dilated completely, it is left in place for several minutes to stretch the muscles that surround the cervix. Once sufficient stretching is accomplished, the balloon is deflated by drawing back on the plunger of the syringe to remove the inflation media from the balloon.
In an alternative embodiment, the balloon catheter has a third lumen to allow the user to distend the uterus with distension media while the balloon catheter is in place. The balloon catheter thereby provides a stopper function on the uterus to prevent the uterine distension fluid from leaking out. The third lumen can be used for both inflow and outflow of fluid from the uterus.
In yet another embodiment, the balloon can be made of a compliant material such as silicone or latex. In this configuration, the balloon can be used both within the cervix as well as within the uterus to act as a tamponade against uncontrolled bleeding. Using a compliant balloon material allows the balloon to take on the shape of the organ in which it is placed and provides uniform pressure when compared to a non-compliant balloon. This balloon may also have hydrophilic coatings that can carry drugs such as hemostatic agents to aid in the cessation of blood flow or chemotherapeutic agents to treat cancer or ablative agents to sclerose the lining of the uterus.
Referring now to
Hysteroscopic morcellator 100c includes a force measuring element, strain gauge 113, which is used to monitor forces exerted on sheath 110 (and the corresponding resultant forces exerted on the neighboring tissue). Wires, not shown but attached to strain gauge 113 and traveling proximally through sheath 110, attach to an electronic module, also not shown, and provide pressure or other force information to the clinician or a system component which processes the information.
Hysteroscopic morcellator 100c further includes drug delivery element 114, such as a drug delivery mechanism. Drug delivery element 114 may be a simple drug coating, or may be a depot that stores a drug such as an anesthetic and delivers the drug via osmosis, iontophoresis or other drug delivery mechanism. In a preferred embodiment, drug delivery element 114 is a pressure releasable sack, such as a sack with a duck bill valve, and when sufficient pressure is applied to the sac, such as via the cervix, a drug, such as lidocaine, is delivered. In another preferred embodiment, drug delivery element 114 includes multiple pressure-driven sacks, such as multiple sacks in different locations and/or multiple sacks with different delivery pressure properties.
Hysteroscopic morcellator 100c further includes a visualization apparatus, visualization element 112 preferably a forward looking visualization tool such as forward looking ultrasound, or a lens that provides an image to a camera, not shown, but preferably a camera system that receives an image from a fiber optic in optical communication with the lens. A display, not shown but preferably integrated into a laptop computer via a USB or video connection, provides the camera image to the clinician and/or patient.
Referring now to
Tissue removal device 200, a morcellating device, has been advanced through port 120, through a lumen of sheath 110, and into the uterus U of a patient. Tissue removal device 200 includes an elongate shaft, tube 201, which includes on its distal end 203 a cutout, window 202. A cutting element 210 is present within window 202 such that as the distal end of tube 201 is manipulated near tissue, cutting element 210 will cut that tissue. Vacuum means, not shown put in fluid communication with a lumen of tube 201 and window 202, evacuate the pulverized, cut or otherwise detached particles to a location outside of the patient. In a preferred embodiment, vacuum and evacuation means are integral to a handle of device 200. In another preferred embodiment, vacuum and evacuation means are connected to a port which is integral to a handle of device 200. Cutting element 210, of one or more configurations such as the configurations described below in reference to
Referring additionally to
Referring now to
System 10 of
Referring now to
Referring additionally to
In one embodiment, a device 332 for dislodging a fibroid 330 from the wall of the uterus 334 is illustrated in
Once the fibroid is exposed, the distension media (such as saline) would be drained from the uterine cavity allowing the fibroid to become avulsed from the wall of the uterus (
Once sufficiently coupled, the vibrational catheter 340 or wire would be vibrated at a frequency that places the fibroid 330 in opposite (or dissimilar) motion to the surrounding tissue similar to a sine wave. The specific frequency of the vibrational device could be set manually or through a feedback mechanism which measures the energy needed to keep the target tissue in a motion offset from the surrounding tissue. The vibrational frequency could be high or low and could be adjusted using the distension pressure within the uterus. Referring to
Once free of the uterine wall the fibroid 330 can be removed similar to other tissue freed or excised during laparoscopic surgery. Referring to
In an alternate embodiment, the vibrational catheter 340 or wire is used coaxially within another catheter (not illustrated). The inner device is coupled to the fibroid as stated above but the outer catheter has extendable tines, feet or a cone shaped tip that can couple with the uterine wall such that the outer catheter maintains stability while the inner vibrational member oscillates at a frequency in opposition to that of the outer stabilizing catheter. The shear stress caused by the opposing motion of the two devices will cause the fibroid to detach from the uterus along the outer capsule of the fibroid.
Referring now to
Balloon 116, which can be configured to perform one or more functions such as to dilate tissue, to anchor sheath 110 in place and to maintain one or more lumens of sheath 110 in an open state under high loading conditions. Balloon 116 is in fluid communication with inflation lumen 152 and injection port 153 such that a syringe or endoflator attached to the luer of port 153 can be used to inflate balloon 116. Balloon 116 includes a miniaturized, integral pressure sensor 154, which is preferably attached to one or more wires, not shown but traveling proximally and attaching to an electronic module which processes the received signal and provides pressure information to the clinician and/or utilizes the information in one or more ways such as to reduce patient pain such as via the “smart” dilation system and method described in detail in reference to
Pull wire 171 is fixedly attached at its distal end to a distal portion of sheath 110, and it is operably attached at its proximal end to knob 172, such that rotation of knob 172 causes sheath 170 to deflect. As shown in
Hysteroscopic morcellator 100e includes a tissue penetrating assembly comprising needle 161, an elongate hollow needle preferably constructed of stainless steel or Nitinol, which has fixedly attached on its proximal end, knob 162. Needle 161 resides within a lumen of sheath 110, and is in place when hysteroscopic morcellator 100e is advanced through tissue. Needle 161 has an internal lumen sized to slidingly receive guidewire 131. Guidewire 131 can be placed trough needle 161 after needle 161 has been advanced through tissue (guidewire loaded from proximal end of needle 161). Alternatively, guidewire 131 can be placed to a target location, such as through the vaginal wall of a patient via another needle device, and then passed through needle 161 (guidewire loaded from distal end of needle 161). In a preferred embodiment, needle 161 can be used to deliver anesthetic to tissue prior to needle 161 and/or sheath 110 advancement.
Hysteroscopic morcellator 100e may have one or more functional elements, such as a functional element described here above and integrated into sheath 110. In a preferred embodiment, a functional element comprising a visualization apparatus or a portion of a visualization apparatus, such as a camera lens and fiber optic or an ultrasound crystal and associated wiring are contained within sheath 110. Advancement of sheath 110e, such as through the vaginal wall to a location neighboring the outside of a patient's uterus, may require dissection of tissue. In a preferred embodiment, hysteroscopic morcellator 100e includes a functional element such as a blunt dissector, a fluid jet, or other dissection element. In another preferred embodiment, a blunt dissection device, such as a blunt tipped probe, electrocautery probe, or fluid-jet probe, is advanced through a lumen of sheath 110 prior to and/or during advancement of sheath 110 through tissue. Once inserted into the body of the patient, the distal portion of sheath 110 may need to be tracked, such as it is advanced through the vaginal wall at the preferred location of the anterior or posterior culdesac of the vagina, to a location outside the uterus. Tracking means, such as visualization systems and navigation systems of the present invention, may be used such as by incorporating one or more visualization or navigation elements in hysteroscopic morcellator 100e and/or by using separate devices to navigate and/or visualize. In a preferred embodiment, a visible light source is placed in a fallopian tube and a camera integral to hysteroscopic morcellator 100e or a device inserted through sheath 110 is used to locate the visible light source and access the associated fallopian tube. In another preferred embodiment, an electromagnetic transmitting antenna is placed in a fallopian tube and a receiving antenna is integral to hysteroscopic morcellator 100e or a device inserted through sheath 110 and is used to locate the transmitting source and access the associated fallopian tube.
Referring now to
Treatment catheter 500a includes shaft 501, which includes near its distal end treatment element 510, such as a morcellating assembly, a subsonic generator, an excisor, a cutter, an ablation element, or other tissue removal or denaturing element as has been described in detail here above. Also located near the distal end of shaft 101 is visualization element 520 which is preferably a camera lens connected to a fiber optic cable and configured to produce an image on display 525 of laptop 526 via a cable, wire bundle 527. Alternatively, visualization element 520 is an ultrasound crystal or crystals such as a rotating crystal or phased array of crystals, configured to produce an image on display 525 of laptop 526 via cable 527. Visualization element 520 further includes orientation apparatus 521, a nanoscale mechanism, such as a MEMS gyroscope, accelerometer or series of mercury switches, that is configured to provide movement information to an image processing unit such that the image provided to the clinician does not move as the visualization element moves. The image processing unit may be integral to laptop 526 and/or another component of system 10.
Shaft 501, which extends beyond the proximal end of hysteroscopic morcellator 100f and exits port 120, preferably includes on its proximal end a handle with one or more clinician controls (e.g. on-off buttons, pull wire rotational knobs, etc) and/or connections such as electrical connections to laptop computer 526, or mechanical connections such as to motor assemblies which provide motion to visualization element 520 (e.g. to a rotating ultrasound crystal) or treatment element 510 (e.g. to a spinning or reciprocating cutting blade).
Anesthetics, such as lidocaine, may be administered peri-procedurally (prior to, during and post procedure), via a separate device, or via one or more functional elements of hysteroscopic morcellator 100f. Numerous gynecological procedures are applicable to the system 10 and method of
In an alternative embodiment, an additional device is inserted through port 120 and sheath 110, either sequentially or simultaneously with treatment catheter 500a. The additional device may perform one or more functions such as that of a treatment device, navigation device, stabilizing device, visualization device or other device as has been described as performing a function related to the intended gynecologic and urologic procedures described throughout this application. In another alternative embodiment, treatment catheter 500a includes a second treatment element, of similar or dissimilar functionality to treatment element 510.
Referring now to
A treatment or diagnostic device, as have been described in detail here above, treatment catheter 500b, has been advanced through a lumen of sheath 110, and further advanced, such as with manipulation via pull wires integral to hysteroscopic morcellator 100f and/or treatment catheter 500b, neither pull wires shown, such that the distal end of treatment catheter 500b is proximate a fibroid F located in the wall of uterus U. Treatment catheter 500b includes shaft 501, which includes near its distal end treatment element 510, such as a morcellating assembly, a subsonic generator, an excisor, a cutter, an ablation element, or other tissue removal or denaturing element as has been described in detail here above. Also located near the distal end of shaft 101 is magnet 502, such as a rare earth magnet or clinician activatable electromagnet configured to allow the distal portion of shaft 501 of catheter 502 to be manipulated by one or more clinician-controllable magnetic fields. System 10 further includes stabilizing device 550, inserted into the uterus through the vagina V and cervix C of the patient (outside of hysteroscopic morcellator 100g). At the distal end of shaft 551 of stabilizing device 500 is a second magnet, magnet 552, preferably a rare earth magnet or clinician activatable electromagnet similar or dissimilar (such as a difference in size and/or magnetic field strength) to magnet 502 of treatment catheter 550b. Manipulation of the distal ends of either or both stabilizing device 550 or treatment catheter 500b such that magnet 552 is in relative proximity to magnet 502 will enable the magnetic force to pull the two magnets and associated distal ends together. In a preferred embodiment, either or both magnet 552 and magnet 502 are electromagnets such that one or both magnetic fields can be deactivated for initial manipulation(s), and activated to achieve final position, such as at a location where treatment element 510 is in close proximity to uteral fibroid F, as shown in
Shaft 501, which extends beyond the proximal end of hysteroscopic morcellator 100g and exits port 120, and shaft 551 both preferably include on their proximal end a handle with one or more clinician controls (e.g. on-off buttons, pull wire rotational knobs, etc) and/or connections such as electrical connections to a laptop computer (not shown but similar to laptop computer 526 of
Referring now to
A second treatment device 500d is inserted through the vaginal canal of the vagina V, through the cervix C, through the uterus U and through a fallopian tube FT2 to a location outside the fallopian tube FT2 and proximate subserosal fibroid F. In an alternative embodiment, the hysteroscopic morcellator of the present invention is placed into the cervix C, and first treatment device 500c and/or second treatment device 500d are passed into the uterus U via the hysteroscopic morcellator. In another alternative embodiment, one or more of the previous devices resides outside of the hysteroscopic morcellator, such as to stabilize that device in the uterus. Second treatment device 500d includes an elongate shaft, shaft 501d which includes on its distal end treatment element 510d, a fibroid treating element such as a morcellator, an ablative element, a lysing or excising element, or another device used to remove or denature fibroid tissue. Shaft 501d preferably includes one or more pull wires, for manipulation, and alternatively or additionally may be advanceable over a previously placed guidewire. Shaft 501d preferably includes a handle on its proximal end, not shown but preferably including one or more controls such as pull wire controls and a control to activate fibroid treating element 510d.
Treatment catheter 500c and/or treatment catheter 500d may include one or more functional elements as has been described in detail here above. Preferably, a navigation and/or visualization element is employed to introduce the ends of the devices, especially to the target location once exiting the fallopian tube. Preferably treatment catheter 500c and/or treatment catheter 500d include one or more visualization markers, such as visible and non-visible markers; radiopaque markers; magnetic markers; ultrasonically reflective markers; and combinations thereof. Similar to the trans-vaginal-wall methods of
Referring now to
Referring now to
Referring now to
Occluding rings 416 are sized to form a seal in the cervix, such as to allow elevated pressure delivery of drugs and/or to provide a vacuum seal in the area surrounding drug delivery element 410c. In an alternative embodiment, shaft 401 includes a single occluding ring 201, such as at a location of the proximal occlusion ring shown. In another alternative embodiment, occluding rings 201 may have a controllable diameter, such as rings comprising an inflatable balloon, balloon inflation lumen and inflation port not shown.
Drug delivery element 410c further includes one or more suction ports 414. Suction ports 414 and occluding rings 416 are configured such that when a vacuum is applied to suction ports 414, the cervical (or other neighboring) tissue is pulled toward the exit holes 412 of drug delivery element 410c, such that the efficacy of drug delivered through exit holes 412 is enhanced. Exit holes 412 and suction ports 414 are connected to independent hollow conduits that travel from drug delivery element 410c to port 420 on the proximal end of drug delivery device 400c. Port 420 fluidly connects to drug reservoir 430, which in turn is pressurized by pressure reservoir 440 (such as a CO2 pressure source) such that fluid can flow through shaft 401 to exit holes 412. Port 420 is also fluidly connected to vacuum generator 450 such that suction can be transferred through shaft 401 (in a separate conduit than is connected to drug reservoir 430) to suction ports 414.
In an alternative embodiment, drug delivery element further includes an iontophoretic element, not shown but configured to enhance drug delivery into the tissue surrounding drug delivery element 410c. In another alternative embodiment, shaft 401 includes a lumen to support over-the-wire delivery.
Referring now to
Referring now to
Referring now to
Referring now to
Referring now to
Basket 611 may include a covering, on the inside or the outside of the resiliently biased structure, and the covering may be a partial covering. In a preferred embodiment, a clinician places a tamponade force on a bleeding tissue location with a covered portion of basket 611. In another preferred embodiment, a clinician reduces the amount of fluid used in a procedure by inserting a scaffolding device 600 that includes a covering of basket 611 (i.e. the basket occupies space in the uterus and/or limits fluid transfer from the portion of the uteral wall in contact with the balloon). Basket 611 and any associated coverings may be coated, impregnated or otherwise include one or more drugs, such as clotting agents and anesthetics. In a preferred embodiment, the drug may be “released” by the clinician on demand, such as by an integral iontophoretic delivery element (e.g. integral to basket 611), or by applying a force to an integral pressure activated drug depot (e.g. integral to basket 611). Basket 611 and any associated coverings may be coated or treated with one or more compounds to change a property such as lubricity and radiopacity. Avoiding or reducing the need for distension with fluid subsequently reduces the risk factors (e.g. intravasation) associated with that fluid delivery.
Referring now to
In a preferred embodiment, basket 611 can be expanded in the uterus (or other body cavity), and a procedure such as a tissue removal or denaturing procedure be performed “through” the weave of basket 611. Numerous one or more treatment or other devices, can be used by the clinician while scaffolding device 600 is in place in the uterus. In particular, tissue treatment devices (e.g. morcellators; radiofrequency, laser and cryogenic ablaters; and subsonic treatment devices) and drug delivery devices can perform their intended function, such as to treat tissue present in between the filaments (tissue in “window) of basket 611. In another preferred embodiment, scaffolding device 600 is used to treat uteral prolapse. In yet another preferred embodiment, a separate balloon catheter is inserted within balloon 611, such as to occupy space and/or apply additional force to the uteral wall. In yet another alternative embodiment, one or more portions of basket 611 can be energized (e.g. deliver RF energy to tissue) in order to treat tissue, which may avoid the need for a second device.
Referring now to
Referring now to
Referring now to
Scaffolding device 600a, of similar construction to the scaffolding device of
In an alternative embodiment, treatment catheter 500, scaffolding device 600a and/or hysteroscopic morcellator 100 include a visualization apparatus such as a camera to visualize inside uterus U, such as when clear fluid is introduced into uterus U via port 123. Light may be provided, as has been described in detail here above, from a functional element integral to the distal portions of treatment catheter 500 (e.g. proximate a camera which is proximate treatment element 510), scaffolding device 600a (e.g. in one or more of arms 621 and 622) and/or hysteroscopic morcellator 100 (e.g. a forward beam light source) such as to improve the image provided to the clinician via the integral camera. In one embodiment, the camera is an infrared camera and heated and/or cooled solutions are utilized to increase the contrast in the infrared image (tissue temperature differences) and reduce or eliminate the need for an external light source.
In the performance of one or more gynecologic and urologic procedures, such as a tissue removal or other treatment procedure, scaffolding device 600a and treatment device 500 are repositioned, such as to scaffold a different part of the uterus or to access a different portion of tissue, respectively. In a preferred embodiment, a second scaffolding device is inserted through hysteroscopic morcellator 100, simultaneous with or at a different time than scaffolding device 600a resides within hysteroscopic morcellator 100. In another preferred embodiment, a second treatment device is inserted through hysteroscopic morcellator 100, simultaneous with or at a different time than treatment device 500 resides within hysteroscopic morcellator 100.
Referring now to
The visualization apparatus of
The visualization apparatus of
Camera device 700, first light source 710 and second light source 720 have had their distal ends placed through the cervix C and into the uterus C of a patient. In an alternative embodiment, the hysteroscopic morcellator of the present invention is placed into the cervix C, and camera device 700, first light source 710 and/or second light source 720 are passed into the uterus U via the hysteroscopic morcellator. In another alternative embodiment, one or more of the previous devices resides outside of the hysteroscopic morcellator, such as to stabilize that device in the uterus. Each device preferably includes a handle on their proximal end, not shown but preferably including one or more controls including but not limited to: knobs or levers to manipulate one or more pull wires configured to manipulate the distal portions of the associated device; a control to zoom in or zoom out an image; a control to focus an image; a control to stabilize an image; a control to energize a light source; a control to change the light intensity of a light source (e.g. via change to energy supplied); a control to deliver a drug; a control to change the speed of a tissue removal assembly; a “Kill-switch” control to stop motion of a component immediately; other controls and combinations thereof.
In addition to the above controls, each handle may include one or more ports, such as ports selected from the group consisting of: a valved port such as a cracking pressure valved port, a two-way valved port and a duckbill valved port; a Tuohy-Borst valve; a fluid stasis valve; a device insertion port such as a port configured to accept a treatment device of the present invention; an infusion lumen access port such as an infusion lumen in fluid communication with a drug reservoir, exit port or other component of a drug delivery element; a balloon inflation lumen access port; other ports and combinations thereof. In a preferred embodiment, camera device 700, first light source 710 and/or second light source 720 include one or more integral functional elements such as a drug delivery element or other functional element as have been described here above. In a preferred embodiment, the functional element is an integral inflatable balloon, not shown but preferably in a distal portion of the device and configured to: occupy space in the uterus, deflect the distal end of the associated device by applying a force to the uteral wall; apply tamponade force to the uteral wall, or distend the uterus.
The distal portions of camera device 700, first light source 710 and second light source 720 may be manipulated in the uterus U such as to perform a secondary function including but not limited to: applying a tamponade force to a portion of the uteral wall (e.g. a perforation or bleed); to distend the uterus; and combinations thereof. The distal portions of camera device 700, first light source 710 and second light source 720 have an “effective” outer diameter (e.g. the ID of an appropriate sheath 110 of the present invention) less than 9 mm, preferably between 5 and 8 mm, and more preferably less than 6 mm.
Referring now to
Also shown in
In an alternative embodiment, the hysteroscopic morcellator of the present invention is placed into the cervix C, and volume occupying device 800 and/or treatment catheter 400 are passed into the uterus U via the hysteroscopic morcellator. In another alternative embodiment, one or more of the previous devices resides outside of the hysteroscopic morcellator, such as to stabilize that device in the uterus.
Referring additionally to
Referring now to
Step 10 involves placing one or more devices to dilate the cervix of a patient. Prior to, during and/or shortly after the dilation of Step 10, Step 11 may be performed which is the measurement of one or more patient parameters, such as patient physiologic parameters. Patient physiologic parameters include but are not limited to: force exerted by or on tissue such as force exerted by or on the cervix as measured by a transducer integral to a cervical dilator; EKG; EEG; blood and blood gas parameters such as cell counts and O2 saturation levels; glucose parameters; pH; blood pressure; respiration; and combinations thereof.
Subsequent to Step 10, Step 20 involves the dilation of the patient's cervix. The dilation is performed per a set of dilation parameters, such parameters including but not limited to: pressure of dilation such as balloon pressure; amount of dilation per unit time; pressure increase per unit time; rate of change of dilation per unit time; rate of change of pressure increase per unit time; duty cycle of discontinuous dilation (e.g. on and off times if dilation performed in discrete time segments); frequency of discontinuous dilation; other dilation parameters and combinations thereof.
Simultaneous with the performance of the dilation of Step 20, Step 30 is performed in which one or more patient parameters, as have been listed above in reference to Step 11, are taken. Step 40 is performed, in which the one or more parameters are analyzed and the results of the analysis is compared to a threshold. If a threshold is exceeded, that information is fed to the parameter modifying algorithm of Step 50, which in turn modifies one or more of the dilation of parameters of Step 20 (such as to decrease dilation pressure or stop dilation entirely). If the threshold is not exceeded, that information is fed back to the dilation control of Step 20 and no change is made.
For example, if one of the patient parameters collected in Step 30 is blood pressure, which may be an acceptable surrogate for pain level, when a previously determined blood pressure threshold is reached, dilation is reduced or stopped. The parameter analysis may be more sophisticated that comparing the physiologic measurement to a direct threshold, other analysis made additionally or alternatively be performed such as to look at rate of change of the parameter, or to analyze two or more parameters in combination: such as two or more of EKG, blood pressure and respiration.
In a preferred embodiment, a system is provided to automatically perform the parameter analysis of Step 40 and automatically modify the dilation parameters of Steps 50 and 20. In an alternative embodiment, the clinician may perform one or more steps, or perform a portion of one or more steps manually. In another preferred embodiment, one or more thresholds involved with the analysis are programmable by the clinician. In another preferred embodiment, the mathematical formulas of the analysis are programmable by the clinician.
The dilation performed in Step 20 may be accomplished with continuous application of pressure or discontinuously in discrete time segments. These discrete dilation time segments may be fractions of seconds, multiple seconds or even minutes. In a preferred embodiment, the analysis of the physiologic measurement is performed between dilation time segments, such that the subsequent dilation time segment is potentially modified (Step 50) due to the analysis performed in the previous “off” or no-dilation period.
The “smart” dilation system and method of
In an alternative embodiment, the “smart” dilation system and method of
It should be understood that numerous other configurations of the systems, devices and methods described herein could be employed without departing from the spirit or scope of this application. While the procedures described above have been described in terms of gynecological procedures, other applicable procedures can be incorporated without departing from the spirit and scope of the invention, particularly procedures applicable to both male and female patients.
The scaffolds and volume occupying element of the present invention comprise shapes and sizes that preferably allow both visualization (such as via an internal camera) and treatment (the performance of the intended clinical procedures, such as a tissue treatment procedure). Preferred shapes of these devices include but are not limited to: spherical; conical; trapezoidal; hemispherical; scallop-shaped; and combinations of the above such as a scaffolding device with a spherical portion and a conical portion. The size of the volume occupying elements of the present invention should be more than 5% of the volume of the cavity into which it is inserted (e.g. the uterus) and up to 100% of that space (e.g. to allow maximum viewing and working area without damaging tissue such as uteral wall or neighboring tissue).
The devices of the present invention may be provide in kits, such as kits that offer various size and shape scaffolding and volume occupying devices.
Each device (e.g. treatment device) could be used in various areas, not just in the uterus.
Each device (e.g. treatment device) could be used in various procedure types such as: percutaneous, laparoscopic, MIS, open surgery, or the like.
The foregoing embodiments can be used in combination with any type of morcellator tip embodiment (with or without a vacuum), tissue removing devices, fibroid treating elements, tissue treatment devices, or tissue treatment elements, morcellator systems, morcellation means, denaturing devices, or other morcellating or other treatment devices.
With reference to
Once the drug has been placed into the target tissue, the uterus is distended by means of fluid or gas or balloon containing a fluid or gas. A catheter preferably less than 10 mm, preferably less than 8 mm, preferably less than 6 mm, preferably less than 4 mm preferably less than 3 mm containing a light source is placed into the uterine cavity preferably through the vagina and cervix although it could be done percutaneously, through the bowel or bladder, or laproscopically. Once in place the light is activated for a period of time activating the photodynamic drug which ultimately caused a tissue response that prevents abnormal bleeding within the uterus. Such a device could also be used to control abnormal bleeding of the cervix and vagina.
In an alternative embodiment, the distension and light source are housed together in a balloon catheter. This catheter may have more than one lumen such as an inflation lumen to inflate the balloon with a fluid or gas and a second lumen to house the light source used to activate the drug. The balloon material must be of sufficient material that it does not block the light waves emanating from the light source and interacting with the drug. The catheter diameter would be preferably less than 10 mm, preferably less than 8 mm, preferably less than 6 mm, preferably less than 4 mm and preferably less than 3 mm.
In an alternative embodiment the catheter would have yet another lumen extending to and exiting the tip of the catheter to distribute a drug locally before or after the balloon is inflated by gas or fluid. The drug exiting from the tip of the balloon would be forced to the wall of the uterus upon dilation of the balloon and then become activated once the light source within the balloon is activated.
In another embodiment the balloon would contain holes allowing for the weeping of the drug from the balloon so that it could interface with the wall of the uterus before during and after light therapy is administered.
With reference to
Some embodiments provide a method of performing a procedure in a uterus. The method comprises providing a distension media having a viscosity in the range of about 1 to about 20,000,000 cPs, about 100 to about 20,000,000 cPs, about 100 to about 10,000,000 cPs, about 100 to about 5,000,000 cPs, about 1 to about 1,000,000 cPs, about 1 to about 500,000 cPs, about 1 to about 200,000 cPs, about 100 to about 200,000 cPs, about 300 to about 200,000 cPs, about 500 to about 200,000 cPs, about 1 to about 150,000 cPs, about 1 to about 100,000 cPs, about 1 to about 50,000 cPs, about 1 to about 10,000 cPs, about 1 to about 5,000 cPs, about 100 to about 4,000 cPs at body temperature, and infusing the distension media into the uterine cavity so that the uterine pressure is between about 10 to about 150 mmHg, about 35 to about 120 mmHg, or about 50 to about 100 mmHg, thereby create a working space. Different gynecologic procedures may be performed in the working space created by the distension media. Suitable gynecologic procedures may include diagnostic and/or therapeutic procedures. In some embodiments, both diagnostic and therapeutic procedures may be performed in the working space created by the same distension media. In some embodiments, no aspiration of the distension media is needed between performing a diagnostic procedure and a therapeutic procedure.
To minimize intravasation, the uterine pressure may be kept low when a distension media with a lower viscosity is used. If higher uterine pressure is desired, a distension media having a higher viscosity may be used.
In some embodiments, when a more viscous distension media (i.e., having a higher viscosity) is used, the distension media would stay within the uterine cavity without spontaneously exiting through the cervix, even without a seal or a balloon plug at the cervix, In some embodiments, when a distension media with a lower viscosity is used, additional distension media may be added through an influent lumen or tube, while an effluent lumen may be provided to allow draining of the distension media.
In some embodiments, it is desirable for the distension media to have a pH within the range of about 4 to about 8, preferably about 6 to about 8, and more preferably about 7.35. The distension media may be selected from bio-compatible liquid or gel, and preferably be water-based or water soluble. In some embodiments, the distension media is selected from ultrasound transmission gels, gynecologic lubricating liquids and gels, silicone gel, poly vinyl pyrrolidone (PVP), hyaluronic acid (HA) solution, and carboxymethylcellulose (CMC).
The ultrasound transmission gel may comprise polymer, humectants, propylparaben and methylparaben in bacteriostatic concentration, and reverse-osmosis water, and may have has a pH of about 6.5 to about 7.0 and a viscosity of about 100,000 to about 170,000 cPs. Examples include Aquasonic® 100 ultrasound transmission gel, which has a pH of about 6.5 to about 7.0 and a viscosity of about 100,000 to about 170,000 cPs, and Aquasonic® Clear ultrasound transmission gel, which has a pH of about 6.5 to about 7.0 and a viscosity of about 130,000 to about 195,000. An example of gynecologic lubricating gel is KY Jelly®, which comprises purified water, glycerin, hydroxyethylcellulose, chlorhexidine gluconate, gluconolactone, methylparaben, and sodium hydroxide. It has a pH of about 4.5 to about 5.5 and a viscosity of about 90,000 to about 100,000 cPs. Endosgel, another example of gynecologic lubricating gel, comprises chlorhexidine digluconate, methyl hydroxybenzoate, propyl hydroxybenzoate, sodium lactate, hydroxyethylcellulose and purified water. It has a viscosity of about 2,200 to about 2,500 cPs. All the distension liquids described above are water soluble. One example of gynecologic lubricating liquid is KY liquid®, which comprises purified water, glycerin, propylene glycol, sorbitol, hydroxyethyl cellulose, benzoic acid, methylparaben, sodium hydroxide. It has a pH of about 5 and a viscosity of about 170 cPs.
In some embodiments, a high viscosity distension media may provide additional advantages. For examples, mixing of the highly viscous liquid and the blood is impeded, which helps to keep the distension media clear or transparent and allows for easier visualization inside of the uterus during therapeutic procedures. Highly viscous distension media can also reduce its flow rate into the circulation (i.e. intravasation), which may be likely to occur if a vein is injured. In some embodiments, the distension media is capable of distending the uterus without the cervix being plugged. However, infusion of a highly viscous distension media into uterus may present some challenges. In some cases, continuous application of 15-30 lb of pressure on a 50-mL syringe may be needed to instill the distension media.
In some embodiments, a high-molecular-weight polymer solution may be the preferred highly viscous distension media. Such a distension media would be strongly pseudoplastic or shear-thinning. That is, the viscosity of a high-molecular-weight polymer solution may fall by orders of magnitude when it goes from low to high shear rates. If key variables such as molecular weight, the concentration, pH and ionic strength are chosen appropriately, then the viscosity will be low enough at high shear rates for easy infusion of the distension media. On the other hand, the viscosity of the distension media would be high enough in the uterus under the relatively low shear rate to achieve the benefits of high viscosity as described above.
In some embodiments, a high viscosity distension media that is pseudoplastic or shear-thinning is preferred. Such distension media would have a viscosity profile such that the viscosity is high at a low shear rate and the viscosity is low at a high shear rate. In some embodiments, the distension media may have a viscosity of greater than about 1,000,000 cP, about 100,000 to about 20,000,000 cPs, about 100,000 to about 10,000,000 cPs, about 100,000 to about 5,000,000, about 500,000 to about 5,000,000, about 800,000 to about 5,000,000 cPs, about 1,000,000 to about 5,000,000 cPs or about 2,000,000 to about 5,000,000 cPs at zero shear rate.
Due to long relaxation times for high-molecular-weight polymers, a high-molecular-weight liquid exhibits elastic properties that may present further benefits. In some embodiments, under transient deformations such as pulsatile blood flow from an artery, a high-molecular-weight polymer liquid may exhibit a degree of solid-like behavior to resist the deformation and recover once the stress is removed. In some embodiments, a high-molecular-weight polymer solution would exhibit the “wineglass” flow pattern (
One example of the high-molecular-weight polymer liquid is the HA solution. Since HA is a natural component of the human body, it is naturally biocompatible. HA is a linear polysaccharide having the following molecular structure:
The number of repeats, n, dictates the molecular weight of the polymer, and can be 10,000 or higher. HA solutions demonstrate strong shear-thinning behavior due to its high molecular weight and excellent compatibility with water.
In some embodiments, a HA solution having a molecular weight of about 1 to about 1.5 million and a concentration of about 10 mg/mL may be suitable as a distension media. The molecular weight should be high enough to give strong shear-thinning and elasticity but not so high as to be very expensive. If a given HA solution is too viscous, the concentration may be adjusted lower to reduce the viscosity. In other words, the viscosity of HA solution can be tuned by picking the molecular weight and the concentration. In some embodiments, the HA distension media may be formulated by mixing HA solutions and phosphate-buffered saline solution.
In some embodiments, the high-molecular-weight polymer liquid may be PVP. It was developed as a blood thinner and its viscosity may be adjusted based on the mix fraction with saline. The PVP (0.45 g/mL) has an average molecular weight of 1,300,000, a viscosity of about 110,000 to about 125,000 cPs and a pH of about 3 to about 7.
In some embodiments, the high-molecular-weight polymer liquid may be CMC. The CMC is also a polysaccharide, and has some similarity with HA. The CMC has been widely used in food and personal care products, and is also an excipient in drug formulation. It has also been listed as an inactive ingredient for a number of injection routes. The CMC may have a molecular weight of about 300,000. To achieve a high viscosity, it requires a higher concentration of CMC.
In some embodiments, BD Visc™ (1.4% sodium hyaluronate) may be used as the high-molecular-weight polymer liquid. BD Visc™ has been used as a nonpyrogenic ophthalmic vidsosurgical device (OVD). It is prepared in a highly purified, molecular weight of sodium hyaluraonate, and has a pH of about 7 to about 7.5. It has a viscosity of 4.8M mPaS at zero shear rate and 25° C. The BD Visc™ has a viscosity profile such that the viscosity decreases as the shear rate increases, and thus making it possible to be introduced into a patient's hollow organ. Its average molecular weight is about 5-6M Daltons. The BD Visc™ OVD solution is clear and may provide good visibility. Examples of other similar OVDs that may be useful as extension media include, but not limited to, HealonGV® (1.4% sodium hyaluronate, MW=5.0M D, zero-shear viscosity=2.0M mPaS), BD MultiVisc™ (2.5% sodium hyaluronate, MW=3.0M avg. D, zero-shear viscosity=16.0M mPaS), Healon5® (2.3% sodium hyaluronate, MW=4.0M D, zero-shear viscosity=7.0M mPaS), Healon® (1.0% sodium hyaluronate, MW=4.0M D, zero-shear viscosity=230 k mPaS), Provisc® (1.0% sodium hyaluronate, MW=2.0M D, zero-shear viscosity=280 k mPaS), Amvisc Plus™ (1.6% sodium hyaluronate, MW=1.0M D, zero-shear viscosity=100 k mPaS), and Amvisc® (1.2% sodium hyaluronate, MW=1.0M D, zero-shear viscosity=100 k mPaS).
In some embodiments, the distension media may further comprise at least one additive. The additives may be selected from pH modifiers (i.e., pH adjusting agents), buffers, stabilizers, viscosity modifiers, therapeutic agents and colorants. A wide variety of biocompatible pH modifiers, buffering agents, stabilizers and the like is known in the art and need not be discussed in detail herein. Suitable additives include those that are acceptable excipients for pharmaceutical formulation, and have been described in a variety of publications, including, for example, A. Gennaro (2000) “Remington: The Science and Practice of Pharmacy,” 20th edition, Lippincott, Williams, & Wilkins; Pharmaceutical Dosage Forms and Drug Delivery Systems (1999) H. C. Ansel et al., eds., 7th ed., Lippincott, Williams, & Wilkins; and Handbook of Pharmaceutical Excipients (2000) A. H. Kibbe et al., eds., 3rd ed. Amer. Pharmaceutical Assoc.
The therapeutic agent may be selected from antibiotics, antiseptics, anesthetics, sclerosing drugs, cancer drugs, chemotherapeutic agents, vasoconstrictors, and endometrial ablation chemicals. In one embodiment, the endometrial ablation chemical may be trichloroacetic acid. In some embodiments, adding a colorant may allow certain intrauterine pathology to become more readily apparent under direct visualization. All additives may be mixed with or added to the distension media prior to or after its infusion into uterus.
In some embodiments, the distension media comprises a liquid or gel that flows through a 1 mm pinhole under a pressure of 40 mmHg at a rate of no more than about 0.6 ml/min at a normal body temperature. In some embodiments, the distension media comprises a liquid or gel that flows through a 1 mm pinhole under a pressure of 120 mmHg at a rate of no more than about 7 ml/min at normal body temperature.
It is to be understood that one of skill in the art is capable of modifying the physical properties of the various distension liquids or gels for optimization in accordance with the invention. For example, if a commercially available gel exhibits a desirable optical performance but its viscosity is too low, a variety of thickening agents or viscosity modifiers that don't affect the optical transmission of the gel may be added to elevate the viscosity. Examples of thickening agents include, but not limited to, polyethylene glycol, synthetic polymers such as carbomer (i.e., polyacrylic acid), biocompatible polymer microspheres or beads, and vegetable gums. One example of polymer microspheres is micro-porous beads (BioSphere Medical) made of an acrylic co-polymer (such as trisacryl), which is then cross-linked with gelatin. If the viscosity is too high, the distension media may be diluted to lower the viscosity. In some embodiments, lower molecular weight base material may also be used to form a distension media with a lower viscosity.
Similarly, if the commercially available gel has a pH that is too low or too high, a biocompatible pH modifier may be added to adjust the pH. For example, NaOH or other hydroxel contributor solution may be added to a distension liquid to adjust the pH upward, and HCl or otherH+ contributor solution may be added to adjust the pH downward.
A person skilled in the art would also understand that the useful viscosity or the flow rate of the distension media may also be determined by the intravasation limit of a particular distension media, and the amount of the time and the pressure needed for the distension for a particular procedure. The intravasation limit defines the maximum amount of distension media uptake that would be tolerated by the body. The uptake of the distension media can occur through a severed vein in the uterus.
In some embodiments, the distension media may have a viscosity that is high enough to sustain a 40 minute procedure at a uterine distension pressure of 120 mmHg. A person skilled in the art would also understand that the higher the viscosity of a distension media, the slower the flow rate through a 1 mm hole would be. For example, assuming a distension media has an intravasation limit of 300 mL. In order to distend the uterus long enough for a 40 minute procedure at the distension pressure of 120 mmHg, the flow rate of the distension media through a 1 mm hole should be less than about 6 mL/min at 120 mmHg. If a lower distension pressure is needed for the procedure, the same distension media with the same viscosity would provide a longer working time because the flow rate through a 1 mm hole would be slower at a lower distension pressure. At the lower distension pressure, the same distension media with a lower viscosity may be use to provide the same amount of working time as at the higher distension pressure with the distension media having a higher viscosity.
In some embodiments, the distension media may also be used in conjunction with the acoustic generator device 300 as shown in
In some embodiments, the distension media may be mixed with dextrose, and may be excited with microwave energy to quickly heat up and act as an ablative force to intentionally scar the uterus similar to other heat related ablative technologies. Likewise, the distension media can be super cooled to provide a localized ablative effect on the endometrial tissue.
Some embodiments provide a device for infusing distension media into the uterus. With reference to
With reference to
With reference to
Various distension liquids have been tested for the rate of intravasation. The test provides a way to identify a target viscosity range of a suitable distension media. Different pressures were applied to a volume of each distension liquid at a set temperature of 72° F. and 98.6° F. for up to 10 minutes, and the rate of the distension liquid exiting a Ø1 mm hole (0.040″) under defined pressure intervals was measured by recording the displaced volume.
As expected, a distension liquid with higher viscosity has a slower flow rate through a 1 mm hole. The flow rate also increases as the pressure on the liquid increases. The change in temperature from room temperature to body temperature did not seem to have a significant impact.
Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims. In addition, where this application has listed the steps of a method or procedure in a specific order, it may be possible, or even expedient in certain circumstances, to change the order in which some steps are performed, and it is intended that the particular steps of the method or procedure claim set forth herebelow not be construed as being order-specific unless such order specificity is expressly stated in the claim.
The present application claims the benefit under 35 U.S.C. 119(e) of U.S. Provisional Patent Application Ser. No. 61/099,716, filed Sep. 24, 2008, which is incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 61099716 | Sep 2008 | US |
