1. Field of the Invention
Embodiments of this invention relate generally to the field of medical devices and procedures for engaging material in a body. More particularly, embodiments of the instant invention relate to retrieval assemblies, such as baskets, graspers, forceps, or screens, for holding and/or entrapping material, such as a stone, in a body tract.
2. Background of the Invention
As known in the art, various specialized medical devices, such as graspers, balloons, and baskets, can be used to entrap an object, such as a stone, and drag it through an anatomical lumen to remove it. None of the existing devices can address all of the requirements of some procedures, for example, kidney stone removal procedures. Thus, a device that encompasses the functionality of graspers, balloons, and baskets is desirable.
Embodiments of the invention provide a medical device and procedure for engaging material within a body. Methods in accordance with various embodiments of the present invention involve using the apparatus to grasp, move, remove, loosen, occlude, release, and/or sweep material in a body tract of a patient.
In accordance with an aspect of the present disclosure, a medical device may include: a sheath having a proximal end, a distal end, and a lumen extending longitudinally between the proximal and distal ends; an actuation handle disposed at the proximal end of the sheath; an end-effector loop adjacent a distal end of the sheath and operably connected to the actuation handle for actuation of the end-effector loop between a deployed position and an undeployed position; and a connecting member also disposed within the lumen of the sheath and connected to the actuation handle and the end-effector loop, wherein actuation of the connecting member deflects the end-effector loop when the end-effector loop is in the deployed position.
Various embodiments of the invention may include one or more of the following aspects: the deployed position is an expanded position and the undeployed position is a collapsed position; the end-effector loop is in the collapsed position when retracted into the sheath; the end-effector loop is extendable from and retractable within the lumen of the sheath; actuation of the connecting member deflects the end-effector loop when the end-effector loop is extended from the lumen of the sheath; an elongate actuation member connects the end-effector loop to the actuation handle for actuation of the end-effector loop; the elongate actuation member attaches to a proximal end of the end-effector loop, and the connecting member attaches to a distal end of the end-effector loop; the elongate actuation member is selected from a group comprising a wire and a cable; the connecting member moves within the lumen of the sheath; the end-effector loop comprises an outer periphery that defines a space including webbing; the webbing includes a plurality of wires; the webbing defines a plurality of spaces between the wires; the end-effector loop comprises an outer periphery that defines a space including a plurality of wires; actuation of the connecting member deflects the end-effector loop up to 180 degrees.
Another aspect of the present disclosure includes a method of entrapping an object within a body. The method includes inserting a medical device into a body lumen, the medical device having a sheath having a proximal end, a distal end, and a lumen extending longitudinally between the proximal and distal ends, an actuation handle disposed at the proximal end of the sheath, an end-effector loop adjacent a distal end of the sheath and operably connected to the actuation handle, and a connecting member disposed within the lumen of the sheath and connected to the actuation handle and the end-effector loop. The method further includes advancing the medical device to a desired body location within a body lumen, extending the end-effector loop distally relative to the sheath to deploy the end-effector loop into a deployed position, with the end-effector loop in the deployed position, actuating the connecting member to deflect the end-effector loop, and entrapping the object with the end-effector loop.
Various embodiments of the invention may include one or more of the following aspects: the step of removing the medical device and entrapped object from the body; the step of deploying the end-effector loop includes expanding the end-effector loop; an elongate actuation member operably connects the end-effector loop to the actuation handle; the elongate actuation member attaches to a proximal end of the end-effector loop, and the connecting member attaches to a distal end of the end-effector loop; the elongate actuation member is selected from a group comprising a wire and a cable; the connecting member moves within the lumen of the sheath; the end-effector loop comprises an outer periphery that defines a space including webbing; the webbing includes a plurality of wires; the webbing defines a plurality of spaces between the wires; the end-effector loop comprises an outer periphery that defines a space including a plurality of wires; the step of actuating the connecting member deflects the end-effector loop up to 180 degrees; the end-effector loop is extended distally relative to the sheath from a collapsed position; the step of prying an object from an embedded position within a body; the step of prying an object from an embedded position within a body is performed prior to entrapping the object with the end-effector loop; the end-effector loop is in the collapsed position when retracted into the lumen of the sheath.
Additional objects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate one embodiment of the invention and together with the description, serve to explain the principles of the invention.
Reference will now be made in detail to the present exemplary embodiments of the invention, an example of which is 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.
As shown in
Sheath 12 may further include at least one lumen 16 extending therethrough. In some embodiments, lumen 16 may be defined as an internal passageway with an entrance and an exit, and may be formed by any suitable process such as, for example, extrusion. Alternatively, the sheath 12 may include a plurality of lumens (not shown) that may or may not differ in size. In such embodiments, the plurality of lumens may provide passageways useful in delivering, or removing, for example, medical devices, fluids, and/or other structures to or from a treatment site. The lumen 16 provided within sheath 12 may have any cross-sectional shape, dimension, and/or configuration. For example, in some embodiments lumen 16 may have a substantially circular cross-section.
End-effector loop 14 may extend within lumen 16 of sheath 12, and may be disposed at a distal end of sheath 12 for longitudinal movement relative to the sheath 12. The end-effector loop 14 may have any desired shape and/or configuration. For example, the end-effector loop 14 may have a substantially circular shape. The end-effector loop 14 may include an outer periphery made from any suitable material. Such materials may include, but are not limited to, metals or metal compounds, such as stainless steel or nitinol. For example, end-effector loop 14 may be made from a wire. The wire may have any desired cross-sectional shape and or configuration. For example, the wire may have a round cross-section. The end-effector loop 14 may also have one or more shapes and/or configurations along its length, and any desired dimensions suitable for deployment in a desired body lumen. For example, end-effector loop 14 may have dimensions adapted for placement in the human urinary tract having a particular size. For instance, the end-effector loop 14, in an expanded state, may have an outer periphery that is substantially the same size as the inner periphery of the human urinary tract having a particular size. In addition, the end-effector loop 14 may have a configuration or dimensions, or have material properties, that permit longitudinal movement of the end-effector loop 14 relative to the sheath 12, and extension and retraction into and out of the sheath 12. The overall length D and diameter A of the end-effector loop 14 may vary depending on the application. For example, a relatively small diameter A may be advantageous for retrieving stones or other objects from restricted passageways within the human urinary tract. The end-effector loop 14 may also be collapsible so that it may be more easily advanced through body lumens in its collapsed state, and, when desired, self-expandable for deployment.
In the embodiment shown in
The webbing 13 may define a plurality of cells or spaces 19 between the wires 20. The spaces 19 may be of any suitable shape, size, and/or configuration. For example, the spaces 19 may be sized to act as a filter that allows material smaller than a pre-determined size to pass through the filter. In certain embodiments, the size of the spaces 19 may vary depending on the application in which the medical device 1 will be used. For example, the size of the spaces 19 may be in the range of approximately 0.5 mm to approximately 3 mm.
The end-effector loop 14, shown and described in
As shown in
The end-effector loop 14 may be retracted into and/or advanced out of lumen 16 of the sheath 12 using any known method in the art. For example, a proximal end of the end-effector loop 14 may be integral with two elongate actuation members 14a, such as wires, that extend through the sheath 12 to an actuation handle 11 for actuation purposes. In other embodiments, a proximal end of the end-effector loop 14 may be attached to the distal end of a single wire strand or cable (not shown) extending from the actuation handle 11, and thereby connecting the end-effector loop 14 to the actuation handle 11. Connection of the end-effector loop 14 to the single wire strand or cable and of the single wire strand or cable to the actuation handle 11 may be accomplished through any suitable means of connection. For example, possible connections may include, but are not limited to, welding, soldering, tying, and/or crimping. Additionally, any suitable known handle assemblies may be used at the proximal user end for actuation. The actuation handle may be made from any suitable material including, but not limited to, thermoplastics, stainless steel, or nitinol. The user may achieve the two basic positions, collapsed (retracted) and expanded (extended), by actuating the actuation handle 11 to move the end-effector loop 14 translationally in the lumen 16 relative to the sheath 12.
In the embodiment of
As shown in
According to an embodiment of the present invention,
In reference to
The medical device 1 may be advanced to a treatment site in a number of different ways. For example, the medical device 1 may be advanced to a desired body location with the aid of a guidewire (not shown), wherein the desired body location may correspond to the vicinity of a stone, or another object targeted for removal. The medical device 1 may also be advanced to the treatment site through an access sheath or any other access device known in the art.
Alternatively, the medical device 1 may be fed to the desired body location by means of an imaging device, and may travel through the body without the use of a guidewire or access sheath. To facilitate such feeding, the sheath 12 may include radiopaque marker bands (not shown) detectable by x-ray or other imaging means. Thus, the user may monitor the position of the medical device 1 and movement thereof through the use of an imaging device.
As yet another alternative, the medical device 1 may be used in conjunction with an endoscope (not shown) or any other type of intracorporeal scope known in the art. The endoscope may travel through the body to the treatment site in any conventional manner. Once the endoscope is positioned adjacent to the treatment site, the medical device 1 may be fed through an access port of the endoscope to gain access to the object targeted for removal, such as a stone.
As shown in
With the end-effector loop 14 in the collapsed position shown in
Once the distal end of the sheath 12 is advanced past a targeted object, the end-effector loop 14 may then be advanced distally out of the sheath 12, so that the end-effector loop 14 self expands. This may be achieved by, for example, sliding actuator 17 distally in slot 18. When fully deployed, end-effector loop 14 may be substantially circular in shape or have any other configuration suitable to the particular size and shape of both the targeted object 3 and/or the environment it is located in. The proximal end of the end-effector loop 14 may remain in a collapsed state and/or disposed within the sheath 12, and may be the narrowest portion of the end-effector loop 14. Alternatively, the proximal end of the end-effector loop 14 may extend out of the distal end of the sheath 12.
Once the end-effector loop 14 is at least partially deployed, the user may manipulate the end-effector loop 14 to change its position within the tract or lumen. The user may rotate or otherwise change the orientation of the end-effector loop 14 of various embodiments about the axis defined by the sheath 12 by manipulating the actuation handle 11. In addition, the end-effector loop 14 of the medical device 1 is capable of being deflected up to 180 degrees, at degree intervals in the open position, by manipulation of the connecting member 15 by, for example, the actuation handle 11. Thus, the medical device is capable of achieving a variety of positions and, therefore, performing a variety of functions in a patient's body tract or lumen.
In accordance with an embodiment of the present invention,
Alternatively, and as shown in
As yet another alternative, and as shown in
For example, in various embodiments of the invention, a user can manipulate the actuation handle to control the loop and to pry out lodged or embedded objects to free them from impaction; occlude anatomical tracts and lumens of appropriate inside diameters to prevent migration of foreign objects; sweep the tract or lumen to remove foreign object(s); wrap the loop around a foreign object to move or remove the object; and/or straighten the loop to release it from the foreign object from the loop.
Embodiments of the invention may be used in any medical or non-medical procedure, including any medical procedure where removal of an object from within a body lumen is desired. In addition, at least certain aspects of the aforementioned embodiments may be combined with other aspects of the embodiments, or removed, without departing from the scope of the invention.
Illustrative descriptions of the invention are provided above. However, it is to be understood that the present invention encompasses variations that will be evident to those of ordinary skill in the art from the foregoing descriptions.
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.
This patent application claims the benefits of priority under 35 U.S.C. §§119, 120 to U.S. Provisional Patent Application No. 60/503,994, entitled MEDICAL DEVICE WITH FLEXIBLE DISTAL END LOOP, filed on Sep. 18, 2003, the entirety of which is incorporated herein by reference.
Number | Date | Country | |
---|---|---|---|
60503994 | Sep 2003 | US |