The present invention relates to the field of minimally invasive medical devices and procedures and, in particular, to devices and methods for transcervical gynecological procedures.
Female contraception and/or sterilization may be affected by transcervically introducing an object (e.g. a coil) into a fallopian tube to inhibit conception. Devices, systems and methods for such a contraceptive approach have been described in various patents and patent applications assigned to the present assignee. For example, PCT Patent Application No. 99/15116, U.S. Pat. No. 6,526,979 and U.S. Pat. No. 6,634,361, which are hereby incorporated herein in their entirety, describe devices that are transcervically inserted into an ostium of a fallopian tube and mechanically anchored within the fallopian tube. The devices described in these patents and patent application may promote a tissue in-growth around and within the inserted device, which may be referred to as an implant or an insert. One example of such devices is the device known as “Essure” from Conceptus, Inc. of Mountain View, Calif. This tissue in-growth tends to provide long-term contraception and/or permanent sterilization without the need for surgical procedures.
U.S. Pat. No. 6,709,667 and U.S. Publication No. 2008/0041394, which are hereby incorporated herein in their entirety, and which are assigned to the present assignee, describe delivery systems and methods for these devices. The delivery system is typically formed of a handle, a delivery catheter system, and a guidewire onto which is held the contraceptive implant to be placed within the fallopian tube. The delivery catheter system contains the guidewire, a release catheter and the contraceptive implant and the guidewire within the release catheter.
The delivery catheter system is transcervically positioned into the uterus and the fallopian tubes via a hysteroscope. The delivery catheter system and guidewire enter the hysteroscope through a working channel of the hysteroscope. A distention valve is typically positioned at the tip of the working channel. The distention valve seals the entrance of the working channel to prevent a distention fluid, such as saline, to flow out of the hysteroscope as a device, such as the delivery catheter system and guidewire of the intrafallopian contraceptive delivery device, is introduced into the working channel. The opening into the distention valve is designed to prevent the leakage of any fluid out of the hysteroscope and therefore has the smallest opening possible to allow a very tight fit between the device and the valve opening. To prevent damaging the tip of the guidewire or the contraceptive implant to be inserted into the fallopian tube, the guidewire and delivery catheter system are introduced into the distention valve through an introducer sheath. The introducer sheath is formed of a soft flexible material such as plastic or Teflon and has a slit to aid in grasping and in the removal of the introducer sheath. The introducer sheath must therefore be inserted into the opening of the distention valve while on a stiff mandrel. Once the mandrel is placed within the distention valve and the channel to the desired depth the mandrel is removed, leaving the introducer sheath within the working channel and the distention valve. After placing the introducer sheath into the distention valve the tip of the guidewire and the delivery catheter system may be inserted into the introducer sheath and introduced into the distention valve and the working channel. The introducer sheath may then be removed. The distention valve may have a tight opening that places pressure on the delivery catheter and causes friction. The distention valve prevents fluid leakage from the working channel. When the introducer sheath is inserted through the distention valve, fluid can spray out of the valve and onto the physician or physician's assistant. The amount of fluid spray-back can be significant depending on the fluid pressure during the procedure. In addition, friction between the introducer sheath and distention valve can be problematic.
Once a physician has positioned the delivery catheter system and the guidewire at a position within the fallopian tube where the contraceptive implant may be deposited, it may be awkward and difficult for the physician to maintain the position and may require the physician to use an assistant to aid in the proper stabilization of the system relative to the hysteroscope. In addition, some of the contraceptive implant devices in the above references require disengaging from a delivery catheter by using an axial torque. In practice this requires the delivery catheter and endoscope in combination to be fully rotated to disengage a contraceptive implant device from the delivery catheter in order to deposit the contraceptive implant device into a fallopian tube. This maneuver may be difficult and cumbersome to perform considering that the device must also remain axially aligned in the fallopian tube.
A stabilization device may be used to help with this awkwardness. One such stabilization device includes a handle that includes a contoured holster to couple the hysteroscope and the handle of the control device, creating a fixed distance between the hysteroscope and the control device. The stabilization device may also be coupled to an endoscope.
Once the delivery catheter system is positioned at the fallopian tubes, the implant is positioned in the fallopian tube, expanded, and released from the delivery catheter system by rotating a wheel on the handle. One problem with this wheel is that the wheel sometimes sticks causing the doctor to look away from the hysteroscope.
Various different embodiments are disclosed below and the following summary provides a brief description of only some of these embodiments. According to one aspect of the invention, certain embodiments described below relate to a medical device that provides a transcervical pathway and also stabilizes a device for a minimally invasive gynecological procedure. The device for the minimally invasive gynecological procedure may be an intrafallopian contraceptive delivery device.
One embodiment of the present invention relates to an implant delivery device having a housing; an expandable implant; a release catheter, the expandable implant releasably coupled with the release catheter; a delivery catheter, the release catheter and the expandable implant slideable through the delivery catheter; a spool in the housing, at least a portion of the delivery catheter wound around the spool in a first position; a first actuator coupled with the housing and the spool to rotate the spool to unwind the delivery catheter from the spool in a second position; and a second actuator coupled with the housing and the spool to release the implant from the release catheter.
Another embodiment of the present invention relates to a system for delivering an implant to an ovarian pathway of a female body including a delivery sheath having a first longitudinal opening and a second longitudinal opening; a visualization system deliverable through the first longitudinal opening; and an implant delivery device deliverable through the second longitudinal device, the implant delivery device having an enclosure, a delivery catheter within the enclosure in a first position, at least a portion of the delivery catheter extending out of the enclosure through the second longitudinal opening in a second position.
In a further embodiment, the present invention relates to a method for delivering a contraceptive device to an ovarian pathway including in response to actuation of a first actuator, unwinding a catheter wound around a spool in an enclosure to deliver the contraceptive device near the ovarian pathway; and in response to actuation of a second actuator, releasing the contraceptive device from the catheter.
Various other devices and methods for using devices, including kits for use in treating patients, are also described below. Other features of the present invention will be apparent from the accompanying drawings and from the detailed description that follows.
The invention is described by way of example with reference to the accompanying drawings, wherein:
Embodiments of the present invention relate to an implant delivery device and a method of delivering the implant to an ovarian pathway. In one embodiment, the implant delivery system includes a housing, an expandable implant, a release catheter, a delivery catheter and first and second actuators. The expandable implant releasably coupled with the release catheter, and the release catheter and the expandable implant are slideable through the delivery catheter. The housing also includes a spool. In a first position, the delivery catheter is entirely within the housing and at least a portion of the delivery catheter is wound around the spool. Actuation of the first actuator rotates the spool to unwind the delivery catheter from the spool and deliver the distal end of the delivery catheter to the ovarian pathway (in a second position). Actuation of the second actuator expands the implant and releases the implant from the release catheter.
Referring now to
Referring now to
The method 100 begins at block 104 by identifying the anatomy and target location. The operator determines a preferred placement of the contraceptive device within the ostium, and also determines if any special circumstances are present for a particular device placement procedure. Anatomy and target location identification can be facilitated using a variety of known visualization modes, including hysteroscopy, sonography (ultrasound), fluoroscopy, and the like.
The method 100 continues at block 108 by positioning the device at the target location. A wide variety of techniques may be used to assist a healthcare professional in positioning the device in the correct location, including visualization techniques, providing high-contrast markers (such as radiopaque markers, echogenic markers, or the like), providing tactile indication of the placement position by including physical stops or “bumpers” (which may be adapted to engage reference tissues in such a tactile way as to send a signal to the healthcare professional), or the like.
The method 100 continues by deploying and/or expanding the device at the target location (block 112), and detaching the device from the deployment system (block 116). The method 100 may continue by confirming the position of the device at the target location (block 120). Confirmation may be provided by visualizing at least a portion of the device after detachment, often using the same visualization modality used during placement. In addition to optical visualization techniques, confirmation of delivery may be provided by including radiopaque markers for fluoroscopic placement confirmation, sonographic markers for ultrasound placement confirmation, or the like.
The method 100 may include anchoring and stabilizing the device at the target location (block 124) and efficacy (block 128). Efficacy may be provided by incorporating a lumen/space filling design in the implant, such as polyester fibers to incite a tissue reaction (i.e., tissue in-growth fibers), that sufficiently alters the function and architecture of the fallopian tube so as to inhibit conception. This tissue reaction results in the incorporation of the contraceptive device into the tubal lumen tissues, so that the device is firmly embedded into the surrounding tissue structure.
The elongate body 204 includes a proximal end 224 and a distal end 228. As shown in
The length of the elongate body 204 is configured to provide a transcervical pathway. For example, the length of the elongate body may be about 29-30 cm. In one embodiment, the elongate body 204 includes a working length 204a that extends through the cervix C and uterus U to or near the ostium O, and a manipulating length 204b that extends away from the cervix C and out of the female patient. In one embodiment, the working length 204a may be about 19-20 cm. It will be appreciated that the length of the elongate body may be less than 29 cm or greater than 30 cm and the working length may be less than 19 cm or greater than 20 cm.
The first lumen 208 extends from the proximal end 224 to the distal end 228 of the elongate body. The first lumen 208 is configured to receive a visualization tool, such as, for example, a hysteroscope. The visualization tool may be secured to the sheath 200 through a locking mechanism, such as, for example, a groove and tab, at a proximal end of the first lumen 208. Alternatively, the visualization tool is not secured to the sheath 200.
The hysteroscope is positioned in the sheath so that an operator can view the fallopian tube sufficiently to deliver the implant in the fallopian tube. In one embodiment, the distal end of the hysteroscope is aligned with the distal end of the sheath 200 (i.e., the distal end of the hysteroscope is flush with the distal end of the sheath 200). In another embodiment, the hysteroscope extends just beyond the distal end 228 of the elongate body 204. For example, the hysteroscope may extend less than about 1 cm beyond the distal end 228 of the elongate body.
The second lumen 212 also extends from the proximal end 224 to the distal end 228 of the elongate body. The second lumen 212 is configured to receive a device delivery system. The device delivery system may be secured to the sheath 200 through a locking mechanism, such as, for example, a groove and tab at a proximal end of the second lumen 212. As shown in
The first lumen 208, second lumen 212, both the first lumen 208 and second lumen 212 or neither the first lumen 208 nor the second lumen 212 may include a distension valve to prevent fluid leakage through the sheath 200.
The optional third lumen 216 and fourth lumen 220 are configured to be fluid lumens. For example, the third lumen 216 may be a fluid inlet and the fourth lumen 220 may be a fluid outlet, or vice versa. Alternatively, a single lumen (e.g., only third lumen 216) is provided. When a single lumen is provided, the single lumen may be both a fluid inlet and fluid outlet, or the single lumen may be a fluid inlet, while the second lumen 212, for example, serves as the fluid outlet as well as a working channel.
In one embodiment, one or more tendons are connected to the distal end of the sheath 200 to allow the operator to deflect the sheath 200 to direct the distal end of the sheath 200 toward the ostium O.
As shown in
The device delivery system 404 may be interlockable with the second lumen 212 of the sheath 200. For example, the device delivery system 404 may include a groove (not shown) to engage with the tab 232 in the second lumen 208.
As shown in
The inner drum 608 sits within the outer drum 610 and shares the same axis of rotation as the outer drum 610. An outer sheath (not shown) of the catheter 420 is wound around the inner drum 608 through the opening 614 in the outer drum 610, between the feed rollers 668, 672 to approximately the opening 690 in the housing 600. The outer sheath of the catheter 420 is connected to the groove 654 in the outer sheath arm 648. The release catheter, which may be a delivery wire, of the catheter is secured to the inner drum 608 at groove 644.
The housing 600 also includes a first gear 656, a second gear 660, a third gear 662 and a spring motor 664. In one embodiment, the spring motor 664 includes two torsion springs, each torsion spring set in opposite directions. One end of one of the torsion springs is connected to a wall of the housing and the other end is connected to a post on the outer drum. One end of the other torsion spring is connected to a post on the inner drum and another end of the torsion spring is connected to a post on the outer drum. The main axis of both of the torsion springs is the same as the axis of rotation of the inner drum and outer drum. The torsion springs are both tensioned prior to actuation of the actuators 412, 416. The housing 600 also includes a first feed roller 668 and a second feed roller 672. The first actuator 412 is connected to a first rack 676 that has a curved end 680. The second actuator 416 is connected to a second rack 684 that includes a connector 688. The connector 688 is connected with the release catheter arm 652.
The curved end 680 of the first rack 676 is connected to the second feed roller 672 and first gear 656 such that the spring motor 664 cannot rotate the outer drum 610, until the first actuator 412 is actuated. For example, as shown in
The connector 688 of the rack 684 is connected to the release catheter arm 652. When the second actuator 416 is actuated, the release catheter arm 652 disengages a detent from a slot in the inner drum 608 to separate the inner drum 608 from the outer drum 610. This separation allows the inner drum 608 to rotate in an opposing direction from the rotation of the outer drum 610 by releasing tension on the other torsion spring. When the inner drum 608 is rotated in the opposite direction, the release catheter arm 652 catches on the projection 640. When the release catheter arm 652 catches the projection 640, the inner drum 608 then rotates by itself until the projection 620 catches on the projection 616.
It will be appreciated that variations to the mechanisms within the housing 600 may be different than described above. For example, one or more motors may be provided to rotate the separate drums, the actuators powering the motors. In another example, a drum is provided to unwind the catheter, while a rack system is provided to retract the outer sheath, release catheter and/or delivery wire.
In
The contraceptive device 820 includes an outer coil 824 which is attached at attachment mechanism 812 to an inner coil 828 shown in
The contraceptive device 820 shown in
Referring back to
The contraceptive device 820 shown in
It will be appreciated that other contraceptive devices and/or delivery device configurations may be used. For example, the contraceptive devices described in copending U.S. application Ser. No. 10/866,493, filed Jun. 10, 2004, entitled Medical Devices and Methods of Making and Using Such Medical Devices, the entirety of which is hereby incorporated by reference, may be used as an alternative to the contraceptive device 820 described above. Other exemplary contraceptive devices include spider-like, stent-like, coil-like, or other implantable contraceptive devices.
As shown in
The guide 1604 includes a body 1700, an interlock 1704, a sheath 1708, a rail 1712 and a stopper 1716. The delivery device system 1608 is coupled to the guide 1604, such that the handle of the delivery device system 1608 can slide along the rail 1712.
The interlock 1704 has a diameter that is smaller than the body 1700 and is configured to be inserted into the second lumen 212 of the sheath 200. The shape and size of the interlock 1704 is complementary to the shape and size of the second lumen 212 of the sheath. The interlock 1704 includes a groove 1720. The groove 1720 is configured to engage with the tab 232 in the second lumen 212 to lock the guide 1604 to the sheath 200.
The hard sheath 1708 is configured to protect the outer sheath of the delivery device system 1608 from damage. The sheath 1708 is configured to be inserted into the second lumen 212 at the proximal end and extends to the distal end 228 of the sheath 200. In one embodiment, the distal end of the hard sheath 1708 is aligned with the distal end 228 of the sheath 200 (i.e., the distal end of the hard sheath 1708 is flush with the distal end 288 of the delivery sheath 200). Alternatively, a portion of the hard sheath 1708 may extend beyond the distal end 228 of the sheath 200.
An exemplary length of the sheath 1708 is about 29-30 cm. It will be appreciated that the length of the sheath 1708 may be less than 29 cm or greater than 30 cm. In one embodiment, the sheath 1708 includes a distension valve to prevent fluid leakage through the sheath 1708.
An exemplary material for the sheath 1708 is stainless steel. It will be appreciated that the sheath 1708 can be formed from other materials, such as, for example, other metals, hard plastics or composites.
The rail 1712 is configured to allow the handle of the delivery device system 1608 to slide along the rail 1712. Thus, the rail 1712 is a slider assembly. The shape of the rail 1712 is generally complementary to the shape of the handle of the delivery device system 1608. For example, if the handle is curved, the rail 1712 may be also be curved, the curve of the rail 1712 having a diameter that is slightly larger than the diameter of the handle. In another example, if the handle is rectangular, the rail 1712 may also be rectangular, the width of the rail being slightly larger than the width of the handle.
The rail 1712 extends distally away from the body 1700. The stopper 1716 is provided at a distal end of the rail 1712 to limit movement of the handle relative to the body 1700. In one embodiment, the length of the rail 1712 is any value or range of values between about 1 and 10 cm in length to allow for about 1-10 cm of corresponding movement of the handle. Thus, the rail 1712 both allows longitudinal movement of the handle but also limits its longitudinal movement.
The rail 1712 is sufficiently deep to allow for movement of the handle without the handle coming off the rail 1712, but sufficiently shallow to allow for removal of the handle from the rail 1712. The rail 1712 may have openings (not shown) to allow an operator to more easily remove the handle from the rail 1712. In addition, the rail 1712 may have a track (not shown) to improve movement along the rail 1712.
The guide may also allow for rotational movement of the rail relative to the delivery sheath 200. For example, the body of the guide may include a ball and socket joint.
A cross sectional view of the entire delivery device is shown in
In
When the expandable implant 2304 is correctly positioned within the ovarian pathway it is separated from the release catheter by any one of a number of means such as a trigger mechanism (not shown), a manual rotation of the release catheter, or an automatic release caused by a quick pullback of the release catheter.
The foregoing description with attached drawings is only illustrative of possible embodiments of the described method and should only be construed as such. Other persons of ordinary skill in the art will realize that many other specific embodiments are possible that fall within the scope and spirit of the present idea. The scope of the invention is indicated by the following claims rather than by the foregoing description. Any and all modifications which come within the meaning and range of equivalency of the following claims are to be considered within their scope.
The present application is a divisional of U.S. patent application Ser. No. 12/562,065 filed on Sep. 17, 2009, which is incorporated herein by reference.
Number | Date | Country | |
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Parent | 12562065 | Sep 2009 | US |
Child | 13741289 | US |