Patent Application
20050288551
This invention relates generally to endoscopes and endoscopic assemblies for delivery of medical devices for therapeutic or diagnostic procedures, particularly for such procedures within a female patient's fallopian tubes.
This invention generally relates to the field of occluding devices, delivery systems for such devices and the method of using such devices and systems in the occlusion of body passageways. The invention is particularly useful for the occluding reproductive lumens such as a female patient's fallopian tubes or a male patient's vas deferens to affect contraception.
Conventional contraceptive strategies generally fall within three categories: physical barriers, drugs and surgery. While each have certain advantages, they also suffer from various drawbacks. Barriers such as condoms and diaphragms are subject to failure due to breakage, displacement and misplacement. Drug strategies, such as the pill and Norplant™, which rely on artificially controlling hormone levels, suffer from known and unknown side-effects from prolonged use. Surgical procedures, such as tubal ligation and vasectomy, are very effective, but involve the costs and attendant risks of surgery, and are frequently not reversible.
Recently, minimally invasive treatments have be proposed which deploy stent-like devices within reproductive lumens for obstructing such lumens as a contraceptive alternative to tubal ligation (See for example U.S. Pat. No. 6,432,116). These stent like devices are deployed by delivery catheters having a pushing or holding element disposed within the inner lumen of the delivery catheter proximal to the stent-like device. Typically, the delivery catheter is advanced through a working lumen of a endoscope such as a hysteroscope, preferably a flexible hysteroscope. Such delivery catheters are described in co-pending application Ser. No. 10/746,131, filed on Dec. 24, 2004.
This invention is generally directed to methods, devices and assemblies for delivering a medical device to an intracorporeal location within a patient for performing a therapeutic or diagnostic procedure, particularly, for delivery of occlusive contraceptive or sterilization devices using an endoscope such as a flexible hysteroscope.
An endoscope assembly embodying features of the invention has an endoscope, for example, a hysteroscope, and an outer sheath disposed about a length of the endoscope having an expandable element such as an inflatable balloon for sealing the assembly within a lumen or cavity of the patient during the procedure.
The outer sheath of the endoscopic assembly has an elongated shaft, a proximal end, a port in the proximal end, a distal end, a port in the distal end and a first inner lumen which extends to and in fluid communication with the ports in the proximal and distal ends and which is configured to receive the shaft of an endoscope. The outer sheath is configured to be disposed about the elongated shaft of the endoscope and has an expandable member, preferably an inflatable member such as a balloon, located on a distal portion of the sheath to seal a lumen or cavity in which the assembly is disposed when the device is in an expanded configuration. When the expandable member is an inflatable member, the outer sheath has a second inner lumen which extends between the proximal end and the interior of the inflatable balloon to deliver inflation fluid to deliver inflation fluid thereto. A distal portion of the elongated shaft of the sheath distal to the expandable member, is preferably provided with one or more fluid discharge or fluid receiving ports for the withdrawal of fluid from or the delivery of fluid to the cavity or body lumen in which the assembly is disposed for drainage, insufflation, or irrigation during delivery of the medical device or during the procedure. A third lumen may extend within the shaft of the outer sheath which is in fluid communication with the ports located in the shaft of the sheath distal to the expandable member. The third lumen extends to the proximal extremity of the sheath and is configured for delivery of fluid to or withdrawal of fluid therefrom. Alternatively, the ports in the shaft of the sheath may be in fluid communication with the first lumen for the same purposes.
The endoscope disposed within the first inner lumen of the elongated sheath may be conventional design and is preferably a flexible hysteroscope. Suitable hysteroscopes are commericially available from sources such as Olympus. The endoscope generally has an elongated shaft and a working channel extending through the elongated shaft for advancement of an elongated medical device. The proximal portion of the endoscope has a loading port for loading a medical device into the working channel. Flexible endoscopes usually have a lever or other element on their proximal extremities for deflecting the distal tip of the hysteroscope to facilitate placement of the distal end within the patient's body lumen or cavity.
When the expandable member on the outer sheath is expanded to an expanded configuration within the patient's body cavity or lumen, the expandable member contacts the inner surface of the body cavity or lumen and at least partially seals the assembly therein. Fluid which may build up within the body cavity or lumen, such as the patient's uterus, drains through the ports in the shaft of the sheath through the sheath and out of the patient.
In another embodiment having other features of the invention, the endoscope has a medical device driver for contacting and manipulating a medical device within the working channel. The device driver, which may be motorized or manually operated, contacts the working channel to advance or withdraw the medical device within the working channel.
The endoscope may also be provided with a pistol grip handle-on the proximal portion of the endoscope to facilitate operation by the physician. The pistol grip handle has a palm engaging portion, a lever to deflect the distal portion of the elongated shaft and a trigger mechanism for delivery or manipulation of a medical device within the working channel. The device driver may be located on the pistol grip handle.
In yet another embodiment having other features of the invention, the endoscope may further comprise an elongated medical device delivery cassette having a housing which receives a coiled length of the medical device and which is sized to fit within a loading port of the endoscope. The coiled length of the medical device within the delivery cassette may be spring biased to unwind and pass out of the delivery cassette and has a releasable restraining element for preventing the coiled length from unwinding. Preferably, when the cassette is inserted into the loading port of the endoscope, a length of the elongated medical device extends out of the cassette to facilitate guiding the medical device into the working channel when. When the coiled length of the medical device is unwound an engaging device contacts the protruding length of the elongated medical device and acts to urge the elongated medical device down the working channel.
In another embodiment, the endoscope may further comprise a specialized tool including dual action trigger mechanism for use with an endoscope such as a hysteroscope. This dual trigger mechanism may be in the form of two triggers, each with different and specialized function, e.g. where one trigger advances and retracts the entire catheter assembly and the other trigger activates the extention of the occluding device from the catheter lumen, or the dual action may be provided in the same trigger where one attachment configuration moves the entire catheter assembly forward and backward for positioning the catheter, and the other attachment configuration acts to extrude the occluding device. The one trigger/two action embodiment may be switched from the one attachment configuration to the other in any number of means including a switch, moving pins, detachment and reattachment in a different configuration or the like.
These and other advantages of the various embodiments of the invention will become more apparent from the following detailed description and the accompanying exemplary drawings.
The present invention provides methods, devices, and systems for delivering medical devices into a patient, particularly occlusive contraceptive or sterilization devices within a female patient's fallopian tube.
The sheath 11 is preferably provided with ports 24 distal to the balloon 17 which is in fluid communication with third inner lumen 25 which extends to the port 26 at the proximal end of the shaft 11. The one or more ports 24 may be employed to withdraw fluid from or inject fluid into the patient's body cavity or lumen in which the sheath 11 is deployed. Alternatively, the at least one port 24 may be in fluid communication with the first lumen 16. Ports 24 facilitate drainage out of the patient's uterus and fluid flow into the uterus. The distal end of the elongate sheath 11 may have a seal 27 around the shaft of the endoscope 30 to prevent fluid from entry into the first inner lumen 16 of the sheath 11.
The sheath 11 has a first inner lumen 16 which encases the elongate shaft 31 of the endoscope 30 when the endoscope 30 is delivered to the patient's body cavity or lumen, e.g. uterus. The inflatable member 17 may be in an deflated configuration when the endoscope assembly 10 is inserted through the patient's cervix to the interior of the patient's uterus. When the assembly is deployed within the patient's uterus, inflation fluid is introduced through the proximal end of the second inner lumen 19 through port 20, the to expand inflatable member 17 to contact and seal against the patient's uterine cervix as shown in
The inflatable member 16 is formed of relatively non-compliant biocompatible polymeric material such as polyethylene terephthalate, nylon and the like. to facilitate inflation to a predetermined size or it is formed of a more compliant material such as polyethylene Hytrel and the like to adjust the size of the balloon by the amount of inflation pressure used.
One of the advantages of a flexible, small diameter hysteroscope is the ability of the scope to be used in examining most uteruses without the need to pull the cervix with a tenaculum to straighten the uterus. That is, typically when a stiff, generally larger diameter scope is used, the cervix must be grasped and pulled, for example by a tenaculum, to straighten the uterus sufficiently to insert the scope and view the uterus interior without being blocked by the uterus wall of a curved uterus. This is a very uncomfortable procedure and in order to do it, the gynecologist generally must hospitalize and anesthetize the patient. In these situations, the relative rigid, large diameter scope shaft itself might provide sufficient blockage of the cervix to facilitate insulation or irrigation. If so, however, drainage of the uterus might not be possible with the large diameter shaft in place. A suitable flexible hysteroscope is the hysteroscope sold by Olympus America, Inc. (model HYF-XP).
The endoscope assembly 10 provides the ability to perform insulation and drainage using a small diameter and flexible hysteroscope, which in turn allows the procedure to take place in the doctors office or a medical suite without the need for hospitalization. The endoscope assembly 10 may come in a variety of sizes in length, inflatable member size, and diameter that may be selected as appropriate for the individual patient or for the particular procedure.
The embodiment shown in
A cover may be provided on the loading port 43 that may be closed and sealed tightly so that the working channel 42 may be securely closed to form a fluid tight channel if desired. The working channel 42 may also be in fluid communication with a proximal access port. Thus if the working channel 42 is not being used for an instrument or medical device such as a delivery catheter 42, it may be supplied with an irrigation fluid or fluid may be drained from the uterus. The endoscope 40 is provided with fiber optics 50 and 51 for transmission of light to the distal tip of the scope and fiber optic 52 for image transmission to the proximal end. Eye-piece 53 is provided on the proximal end to facilitate viewing the site distal to the distal end of the scope. The delivery catheter 45 has a stabilizer wire 54 with a plunger 55 on the distal end to hold the occlusion elements 46 and 47 while the delivery catheter sheath 57 is withdrawn so as to deploy the occlusion elements.
As shown in
The delivery catheter 80 may be coiled about spring loaded shaft 81 within the cassette 82 urging the delivery catheter to be expelled from the cassette, but releasably retained, for example by a restraining element (not shown) which is broken by the act of installing the cassette into the scope. When the cassette 81 is installed in the endoscope 83, the restraint is removed (eg. A paper tape is broken or a sticky tape is removed) the catheter is released so that it is free to unwind. As it uncoils, the catheter is projected down the working channel of the scope.
Alternatively, the delivery catheter 80 may be wound onto a central hub (not shown) which has a crank which moves the delivery catheter and the operator may project the catheter assembly down the working channel by turning the crank.
As seen in
The trigger mechanism may be built into the scope, or may be designed to clip onto the scope if the scope is not provided with a built in multi-trigger mechanism.
Referring to
In the two-trigger configuration, one trigger 168 is attached so that moving the trigger forward and back moves the entire catheter and stabilizing wire assembly forward and back. Moving the other trigger 166 moves only the catheter outer wall 162 backwards while the stabilizing wire is held stationary. As previously described, this relative motion between the catheter outer wall and the stabilizing wire acts to lay down the occluding device into the desired location by withdrawing the sheath from over the occluding device.
In the device with only one trigger, the trigger has two configurations and is transformable between the two configurations to facilitate different actions by the same trigger motion. Reference is made to
Initially, as shown in
In the second configuration, as shown in
In practice, the catheter is placed into the working channel of the scope with the proximal portion of the catheter snapped into barbed retaining surface features in an inner cylinder, and the stabilization wire with a terminal button 186 fed through the outer cylinder and the terminal button snapped into retaining block 188. The trigger is hinged at hinge pin 190, and attached to the outer cylinder by attachment pin 194 in slot 195. When the scope is inserted into the uterus of a patient and the tip approaches the fallopian tube, the trigger mechanism may be used to advance and retract the catheter assembly as a whole to place the catheter shaft properly into the fallopian tube. When properly placed, the configuration of the trigger mechanism is transformed to the second configuration, for example, the hinge point at 190 is unattached, the trigger lever is reattached at pin 202 in slot 203, the pin 194 is unattached, and the trigger lever reattached at hinge point 200. Pulling the trigger lever then breaks the releasable attachment between the inner and outer cylinder and pulls the inner cylinder with the catheter sheath backward relative to the stabilizing wire. This then has the effect of sliding the catheter sheath back from over the occluding device and depositing the occluding device into the fallopian tube at the desired location.
The transfer of the attachment points and hinge points may be done in one motion by, for example, a toggle switch that pulls the attachment pin 194 and hinge pin 190 and inserting hinge pin 200 and attachment pin 202. Thus the trigger mechanism may be in the first configuration initially, and once the catheter is located with the occluding devices at the desired location, the switch can be thrown placing the trigger mechanism in the second configuration. The trigger can then be used to deposit the occluding devices.
Besides a toggle switch, another scheme for switching from catheter advancement to device deployment configuration would be to have the two different sides of the trigger fitted with pins that fit the holes in the first configuration (e.g. pins 190, 194) pointing out one direction and the pins that fit the holes for the other configuration (e.g. pins 200, 203) pointing out the other direction. The trigger could change function merely by turning it over and thus removing the pins pointing out in that direction from their mating holes and then inserting the pins pointing in the other direction into their mating holes. This functionality is not specifically illustrated in the attached drawings although it may be achieved using the elements illustrated.
Similarly, the dual trigger function may be provided by two separate trigger levers, which may be provided in a clip-on catheter delivery system as shown in
Once the catheter is in position, it may be fastened to the scope to prevent further sliding within the cylinders, by example using a setscrew, 348. The second trigger 350 may then be pulled back to withdraw the catheter 352 relative to the stabilizing wire 354 to deploy an occluding device or devices as previously described.
The slider ring 326 is attached to the trigger 356 by means of a pin on the slider ring passing through a slot 356 so that rotating motion of the trigger may be translated into longitudinal motion of the slider ring. A similar attachment between trigger 340 and the handle using slot 358 allows the straight longitudinal motion by rotation of trigger 340.
In use, as shown in
Once the handle has been secured against any further longitudinal motion, the other trigger 350 may be employed to cause relative longitudinal motion between the catheter shaft, acting as a sheath over the occluding device at the distal end, and the stabilizing wire 354 which holds the occluding device in place while the sheath is withdrawn. The trigger 350 is pulled, rotating it around rotation point 351 and thus pulling it proximally to slide the sheath from over the occluding device, thus depositing it in the fallopian tube of the patient
A number of equivalent embodiments may be made without departing from the spirit of the invention. For example, in
A pull wire 366 or the like is attached between the base arm 368 of the instrument and the sliding ring 326. The delivery catheter is inserted through the side port of the scope into the working channel of the scope, and moving the instrument forward and back will push entire catheter assembly forward and back within the working channel. The instrument be attached to a channel in the scope handle and ride forward and backward in a longitudinal direction (not shown) or be otherwise guided in a longitudinal direction, or may be freestanding. When the delivery catheter tip has been located as desired, the operator may firmly attach the instrument to the scope, for example by clipping or otherwise attaching the instrument body 363 onto the scope handle. The operator may then squeeze the scissor handles 362,364 together thus pulling the pull wire 366 which pulls the slider ring 326 proximally relative to the stabilizing wire 354. This pulls the distal catheter sheath from over the occluding device and it is thus laid down in the desired location as previously detailed. Since the occluding device may be a self expanding stent-like device, it is desirable not to try to push it longitudinally in the fallopian tube once it has be uncovered from the catheter lumen since it will then expand to contact the interior surface of the fallopian tubes, and the fallopian tubes tend to be rather delicate and could be injured by pushing the occluding device longitudinally along the fallopian tube.
If more than one occluding device is loaded into the delivery catheter, the scissor like handles on the instrument may be provided with two stops 371, 372 such that the handle can be activated twice, once only as far as permitted by stop 372, then the stop can be removed, and the next time the instrument is operated by squeezing the finger levers as far as permitted by stop 371, a second relative movement of the catheter tube and the stabilizing wire will lay down the second occluding device. In this way the amount of movement for the deployment of each occluding device may be pre-set. Although illustrated with two stops, as many stops may be employed as required for the number of occluding devices pre-loaded into the delivery catheter.
A similar embodiment is depicted in
Scopes as currently configured generally allow visualization of the surface of the tissue near the end of the scope. They transmit light out the distal end of the scope, for example by light transmitting fibers illuminated at the proximal end of the scope, and provide a lens and light transmitting fiber to carry the illuminated image at the distal end of the catheter to an eyepiece or camera at the proximal end of the scope. However this allows the operator to visualize only the surface of the tissue at the distal end of the scope. It would be advantageous to be able to obtain information about the tissue features below the surface.
One method that would provide this, especially for hysteroscopes, would be an ultrasound transducer designed for use through the working channel of the hysteroscope. However, one of the problems with the ultrasonic transducers is that the expensive portion of their mechanism may not be disposable. Moreover, generally the ultrasonic transducers should not encounter tissue in use, because the complex electronics involved is difficult to sterilize. The method generally used to overcome this problem is to place the device in a sterile, disposable sheath. Such a sheath could be provided that covers the transducer within the working channel, and still allows movement within the working channel of the scope. Alternatively, the delicate parts could be built in to the scope so that direct contact with the tissue is not necessary, i.e. the scope itself acts as the sterile sheath over the device Alternatively, if the scope is a clip-on digital scope as described immediately below, the portion with the ultrasonic transducer can be programmed to function based on the multi-purpose electrical conductors, and be removed for convenient sterilization.
If the scope is a digital device, the distal end portion may be a clip-on portion that may provides a very specific function. The proximal portion has conductors running therethrough and terminates in ends in electrical connections. These conductors carry electrical signals only, and thus can send different signals to the end of the scope depending on the desired function and the programming being used to generate those signals, and can receive and process any number of different signals, again depending on the programming of the receiving device.
For example, one type of distal portion may contain light emitting diodes and an image-sensing portion. For example, the scope may be programmed to send an electrical signal down electrical conductors one and two to activate the LEDs. A light sensing device may then generate a signal and transmit that signal back to a microprocessor attached to the scope, and the microprocessor interpret the image from that signal. Thus a “visual” image may be received from that type of clip-on distal end.
The same three electrical conductors may clip on to a different end, for example the ultrasonic transducer mentioned above. The proximal portion is programmed to send a signal to activate the ultrasonic transmitter, and perhaps another signal to move the transducer if appropriate, and a third electrical conductor is attached to the receiver to receive the return ultrasonic signal. That signal is transmitted to the microprocessor to form an image that can be viewed and interpreted.
As illustrated in
To the extent not otherwise described herein, the various components of the partitioning device and delivery system may be formed of conventional materials and in a conventional manner as will be appreciated by those skilled in the art.
While particular forms of the invention have been illustrated and described herein, it will be apparent that various modifications and improvements can be made to the invention. Moreover, individual features of embodiments of the invention may be shown in some drawings and not in others, but those skilled in the art will recognize that individual features of one embodiment of the invention can be combined with any or all the features of another embodiment. Accordingly, it is not intended that the invention be limited to the specific embodiments illustrated. It is intended that this invention to be defined by the scope of the appended claims as broadly as the prior art will permit.
Terms such a “element”, “member”, “component”, “device”, “section”, “portion”, “step”, “means” and words of similar import, when used herein shall not be construed as invoking the provisions of 35 U.S.C. §112(6) unless the following claims expressly use the term “means” followed by a particular function without specific structure or the term “step” followed by a particular function without specific action. Accordingly, it is not intended that the invention be limited, except as by the appended claims. All patents and patent applications referred to herein are hereby incorporated by reference in their entirety.
This application is based upon and claims the priority of Provisional Application Ser. No. 60/566,190, filed on Apr. 28, 2004, which is incorporated herein in its entirety by reference.
| Number | Date | Country | |
|---|---|---|---|
| 60566190 | Apr 2004 | US |
