Endoscopic retrieval or removal devices are known in the art and are conventionally used to recover objects from inside a human subject. Such objects may include severed human tissue, foreign objects, or food bolus. Some typical devices include forceps or clasps to grab objects. Certain devices of this type are not well-suited for retrieving heavy, rounded or blunt objects such as large tissue masses, a food bolus, coins, marbles and batteries because the objects are difficult to hold secure. Further, if an object is dropped near the trachea during the removal process, the results can be catastrophic for the patient. Other devices include a variety of net support and net operating structures.
Many retrieval devices are used within an instrument channel of an endoscope during endoscopic medical procedures. These devices are generally expandable and collapsible relative to a tube inserted into the instrument channel. For example, a wire loop at the distal end of the device may expand and collapse relative to the tube by action of a handle at the proximal end of the device. Further, a net may be secured to the expandable and collapsible wire loop.
In an illustrated embodiment of the invention, a device for retrieving objects, such as for example, impacted food bolus, foreign objects, and severed human tissue, is disclosed. The device is for use within an instrument channel of an endoscope during endoscopic medical procedures.
The device includes a support assembly, a transmitting assembly, a wire defining a loop portion and two leg portions, and a net element having a distally protruding portion and a proximally protruding portion. The support assembly includes a base and an elongated tubular member. The transmitting assembly includes a handle movable relative to the base, and a link having a first end fixed to the handle and a second end remote from the base. The link extends through at least a portion of the tubular member. Each leg portion is disposed proximal from the loop portion. A proximal end of each leg portion is secured to the second end of the link by a first connection. The two leg portions are secured to each other by at least a second connection at a location between the first connection and the loop portion. The distally protruding portion is secured to a distal end of the loop portion. The proximally protruding portion is secured between the two leg portions at a location proximal from the second connection.
Further features and advantages of the invention will become apparent from the following detailed description made with reference to the accompanying drawings.
The Detailed Description merely describes preferred embodiments of the invention and is not intended to limit the scope of the invention or claims in any way. Indeed, the invention as described by the claims is broader than and unlimited by the preferred embodiments, and the terms used have their full ordinary meaning.
A device for retrieving an object from within a human subject is disclosed. In discussing the device, the terms distal and proximal are used with respect to the operator's hand. In other words, when the device is used within the instrument channel of an endoscope or similar device, the proximal and distal orientation are relative to the position of the surgeon or operator of the device. Further, it should be noted that the terms first connection, second connection, third connection, and the like do not imply a manufacturing order.
It should also be noted that for the purposes of this application, the terms attach (attached), connect (connected), and link (linked) are not limited to direct attachment, connection, or linking but also include indirect attachment, connection, or linking with intermediate parts, components, or assemblies being located between the two parts being attached, connected, or linked to one another. In addition, the terms attach (attached), connect (connected), and link (linked) may include two parts integrally formed or unitarily constructed.
For exemplary purposes only, the invention will be discussed in regard to a device designed for use within an endoscope for retrieving objects within relatively tight passages, such as for example, impacted food bolus from the esophagus. It should be apparent to others with ordinary skill in the art that the discussion and Figures included in this application are by way of example only, and that the invention can be utilized with endoscopic retrieval devices having a wide variety of structures, shapes, strengths, or purposes. One of many other exemplary uses for the invention is to remove polyps from the colon.
Several exemplary devices for endoscopic retrieval of an object from within a subject are disclosed in U.S. Pat. No. 6,814,739 to Secrest et al.; application Ser. No. 10/965,542, entitled “Retrieval Device” and filed Jul. 28, 2005; and application Ser. No. 11/137,763, entitled “Retrieval Device” and filed Dec. 1, 2005, each of which incorporated herein by reference in its entirety, to the extent that any do not conflict with the present application.
As mentioned, devices using netting have been developed to capture rounded or blunt objects. In the use of devices having netting, and it is believed in the use of other devices, physicians have experienced difficulty in recovering certain objects, such as for example, impacted food bolus from the esophagus. A bolus is a mass of masticated or chewed food. In some cases, the bolus becomes impacted in the esophagus due to disease or other disorders and consequently does not pass into the stomach. It may be more difficult to position a net over an object of this type or the object may be heavier than the human tissue or foreign object for which a typical net device was originally designed. This problem is especially apparent when manipulating the device in relatively tight places within the body. As a result, netting support collapses and does not retain its shape in a deployed position when holding the captured object. Further, the netting may tear or net connections may fail causing reliability concerns.
To solve these and other problems, the retrieval device of the invention is more reliable, structurally simpler, and less costly to manufacture than prior devices. For example, in some embodiments, the proximal portion of the net element is secured to the wire that forms the loop and leg portions of the retrieval net using a shorter tether or anchor than previous designs which anchor the net element at a more proximal location. In other embodiments, no tether or anchor is used to secure the proximal portion of the net element and instead the net element is routed between welds, or other similar connections, connecting the leg portions of the wire together. Where no tether is used to secure the proximal portion of the net element, the chances of the net element breaking or tearing are reduced because the forces are distributed more evenly over a greater area instead of at an isolated point of contact.
Further, in some embodiments, the proximal portion of the net element at least partially surrounds the connection of the leg portions to the cable and/or the connection securing the leg portions together. As such, the proximal portion of the net element inhibits damage to the connections and the inside of the tubular member. The proximal portion of the net element also provides a damping effect on the cable movement toward the distal end of the tubular member when the handle is activated. This also provides more control over the deployment of the net and cable and controls the portion of the device that exits the opening of the tubular member when the retrieval net is in the deployed position. The proximal portion of the net element also helps to center the leg portions of the wire and the cable within the tubular member.
The retrieval net generally collapses and expands relative to a tube inserted through the instrument channel of the endoscope. In the collapsed position, the retrieval net is small enough in diameter to fit inside at least the distal end of a lumen of the tubing. Further, any connection securing the net element to the loop should be small enough to fit within the lumen and allow the retrieval net to collapse and expand repeatedly. The connection should also be able to hold the net element in place relative to the loop during the expansion and collapse of the retrieval net. Further, the loop is generally connected to a motion transmitting link. The motion transmitting link allows the loop to be manipulated by a handle at the proximal end of the device. As such, any connection or connections securing the loop to the motion transmitting link must also be small enough to fit within the lumen and allow the retrieval net to collapse and expand repeatedly. If either of these connections is too large, the connection may drag or catch on the inside wall of the lumen. The friction between the connection and the inside wall of the lumen may prohibit essentially a 1:1 ratio between the movement of the handle and the movement of the distal end of the loop or retrieval net.
The net element is generally supported by the loop by threading, or weaving, the flat wire through the holes in the net element. However, the net element may be supported by the loop by any suitable method known in the art. For example, the net element may wrap around the loop, like a sleeve, or be tied to the loop. Further, the net element may be secured to the wire by tethers, anchors, adhesives, or the like such that the net element is held in place relative to the loop during the expansion and collapse of the retrieval net. For example, tethers or anchors may be used to secure the net element to the distal end and the proximal end of the loop. In an embodiment of the invention, the proximal portion of the net element is attached adjacent a connection securing the two leg portions together, by a tether or anchor, such as for example, a string tie. The proximal portion of the net element may be attached using a tether or anchor to the proximal side of the connection securing the two leg portion together. The proximal portion of the net element may be attached using a tether or anchor to a 360 degree curved portion of at least one leg portion. The distal portion of the net element may also be attached using a tether or anchor to a 360 degree curved portion of the loop portion. In another embodiment, the proximal portion of the net element may be secured to the leg portions by routing the net element through connections securing the two leg portions together. The size and smooth or curved contour of these connections reduce the drag or friction on the inside wall of the lumen, permitting essentially a 1:1 ratio between the movement of the handle and the movement of the distal end of the loop or retrieval net.
Referring now to the drawings,
The device 10 includes an elongated introducer member or tubular member 24 having a first end 26 fixed to the body 14 and a second end 28 remote from the body. The tubular member 24 and the body 14 are a fixed support assembly for the moving parts of the device 10. The tubular member 24 may be any suitable, small-diameter tube formed of a non-reactive low-friction flexible material, such as for example, polytetraflourethylene. The tubular member 24 defines a lumen with an opening 30 at the tubular member second end 28, as best seen in
A motion transmitting link 34 is connected to the handle 18. The link can be a solid cable, a hollow tube, or any suitable elongated object or combination of objects for transferring axial motion from the handle 18 to other parts of the device. The link 34 has a first end 36 fixed to the handle 18 and a second end remote from the body 14. As shown in the drawings, the link extends substantially through the tubular member 24 lumen. The link may be constructed of any suitable rigid material. The link may be one piece or formed from a series of pieces and connections, such as for example, hypodermic tubes, swage connections, and cables.
Still referring to
As shown in
As discussed, the retrieval net 50 is designed for movement between two positions.
Referring again to
As discussed, the retrieval net 50 shown in
Referring now to
The device 10 as illustrated in
As shown in
Several other embodiments include alternative shapes and structures of the distal end of the loop.
Referring to
Referring now to
The net element 54 is shown in
In a second position, the outer edge of the net element 54 now becomes line or outer edge 108. The second position shows net element 54 after it is woven on the loop 52. As can be seen, after the net element 54 is woven on the loop 52, the outer edge 106 of the net element 54 is now closer in position to the loop 52. This change in position creates the receiving pouch 58. As shown in
Two tethers or anchors are shown anchoring the net element 54 to the loop 52 in
Referring now to
In the exemplary device shown in
A net element 254 is shown in
The retrieval net 250 of device 200 is designed for movement between two positions.
Referring again to
As shown in
As shown in
Further, as shown in
In another embodiment of the invention, the net element has a distally protruding portion and a proximally protruding portion. The protruding portions are shaped and adapted to permit an operator at assemble and secure the net element directly to a corresponding segment of the wire without the use of a tether. The distally protruding portion is secured directly to a distal end of the loop portion. The proximally protruding portion is secured between the two leg portions at a location proximal from the second connection.
Referring now to
The distally protruding portion 350 is connected directly to the distal end of the loop 52. In the illustrated example, the strings alternate in position, extending either above or below the polygon segments 65a, 65b. For example, illustrated string 340 is over an external portion of the curved portion 64 and below an internal portion of the curved portion 64, while illustrated 336 is under an external portion of the curved portion 64 and above an internal portion of the curved portion 64, with portions of several strings 340, 336 woven into and through a center opening within the 360 degree curved portion 64. As such, the distally protruding portion 350 is secured to a distal end of the loop 52 at the curved portion 64. It should be apparent to others with ordinary skill in the art that the string pattern of
Specifically,
A top view of the net element 354 is illustrated in
The edge 306 is illustrated as the size of the net element 354 in relation to the loop 252 prior to the net element being woven on the loop. Further, as shown, the proximal portion of the net element 354 includes a tail portion 290. As discussed in regard to the device of
In an exemplary operation using the device, the patient is intubated with an endoscope. The device 10 is inserted through an instrument channel of the endoscope, either before or after intubation. The device is inserted with the retrieval net in a stored position. The surgeon or operator utilizing the optical features of the endoscope will identify the object for removal. After identification of the object, the surgeon or operator will move the handle with respect to the base to deploy the retrieval net into the deployed position. The surgeon or operator will manipulate the object into the receiving pouch by one of a variety of techniques, including the use of additional endoscopic tools. For example, the surgeon or operator may manipulate the snare over the top of the object and enclose the net, or manipulate the snare under the object and enclose the net. Further, the surgeon or operator may use the net as a scoop, relying on the lateral stability of the device. Once the object is within the pouch, the surgeon or operator may manipulate the handle with respect to the body to slightly close the net around the object.
While several embodiments of the invention has been illustrated and described in considerable detail, the present invention is not to be considered limited to the precise construction disclosed. Various adaptations, modifications and uses of the invention may occur to those skilled in the arts to which the invention relates. It is the intention to cover all such adaptations, modifications and uses falling within the scope or spirit of the claims filed herewith.
This application is a continuation of U.S. Non-Provisional patent application Ser. No. 14/061,395 entitled “Retrieval Device,” filed Oct. 23, 2013, which is a continuation of U.S. Non-Provisional patent application Ser. No. 13/213,689 entitled “Retrieval Device,” filed Aug. 19, 2011, and issued as U.S. Pat. No. 8,591,521 on Nov. 26, 2013, which is a continuation-in-part of U.S. Non-Provisional patent application Ser. No. 12/135,473, entitled “Retrieval Device,” filed Jun. 9, 2008, and issued as U.S. Pat. No. 8,016,838 on Sep. 13, 2011, which claims priority to, and benefit of, U.S. Provisional Application No. 60/942,788, entitled “Retrieval Device,” filed Jun. 8, 2007, the entire disclosures of which are incorporated herein by reference.
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Office Action from U.S. Appl. No. 10/965,542 dated Dec. 27, 2013. |
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Office Action from U.S. Appl. No. 10/965,542 dated Aug. 11, 2014. |
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Amendment from U.S. Appl. No. 10/965,542 dated Jan. 12, 2015. |
Office Action from U.S. Appl. No. 10/965,542 dated Feb. 20, 2015. |
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Office Action from U.S. Appl. No. 11/137,763 dated May 25, 2010. |
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Office Action from U.S. Appl. No. 11/137,814 dated Feb. 12, 2009. |
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Office Action from U.S. Appl. No. 11/404,345 dated Mar. 11, 2010. |
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Advisory Action from U.S. Appl. No. 11/404,345 dated May 27, 2010. |
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Office Action from U.S. Appl. No. 11/404,345 dated Dec. 29, 2010. |
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Interview Summary from U.S. Appl. No. 12/021,903 dated Mar. 21, 2012. |
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Interview Summary from U.S. Appl. No. 12/135,473 dated Feb. 15, 2011. |
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Supplemental European Search Report from European Application No. 02729222.6 dated Aug. 20, 2009. |
Response from European Application No. 02729222.6 dated Nov. 17, 2009. |
Office Action from European Application No. 0279222.6 dated Sep. 23, 2010. |
Response from European Application No. 02729222.6 dated Jan. 28, 2011. |
Office Action from European Application No. 02729222.6 dated Sep. 7, 2011. |
Response from European Application No. 02729222.6 dated Jan. 10, 2012. |
Search Report from European Application No. 05757183.8 dated Oct. 4, 2012. |
Office Action from European Application No. 05757183.8 dated Feb. 11, 2013. |
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Office Action from European Application No. 06112733.8 dated Feb. 19, 2009. |
Office Action from Japanese Application No. 2007-511105 dated Sep. 3, 2009. |
Response from Japanese Application No. 2007-511105 dated Mar. 5, 2010 along with English translation of claims and relevant portion of remarks made in Amendment. |
Office Action from Japanese Application No. 2007-515282 dated Jan. 7, 2011. |
Response from Japanese Application No. 2007-515282 dated Apr. 7, 2011 along with English translation of claims and relevant portion of remarks made in Amendment. |
Office Action from Japanese Application No. 2007-515282 dated Jul. 27, 2011. |
Response from Japanese Application No. 2007-515282 dated Mar. 5, 2012 along with relevant portion of remarks made in Amendment. |
Office Action from Japanese Application No. 2009-548397 dated Sep. 28, 2012. |
Response from Japanese Application No. 2009-548397 dated Mar. 28, 2013 along with English translation of claims and relevant portion of remarks made in Amendment. |
Office Action from Japanese Application No. 2010-511374 dated Dec. 28, 2012. |
Response from Japanese Application No. 2010-511374 dated Jul. 5, 2013 along with English translation of claims and relevant portion of remarks made in Amendment. |
Advanced Lin Retrieval Devices Brochure, issued by US Endoscopy 760204, Rev. A, dated at least as early as the filing date of the subject application. |
Cook Medical brochure pages, Esophageal/Gastric Colonic: Snares, 3 pgs., date is at least as early as Jul. 1, 2013. |
Juan-Marie et al. Double-Lumen Snare Injector: Introducing the Double-Lumen Concept in Ancillary Pollypectomy Equipment, Gastrointestinal Endoscopy, vol. 57, No. 5, 2003. |
MTW Endoskopie, brochure, one page, date is at least as early as Jul. 1, 2013. |
Olympus, EndoTherapy, Polypectomy, brochure, 3 pgs., date is at least as early as Jul. 1, 2013. |
English translation of Office Action in Japanese Application No. 2014-004359 dated Jan. 20, 2015. |
Extended European Search Report in European Application No. 08756773.1 dated Feb. 23, 2015. |
International Preliminary Report on Patentability from PCT/US2014/053828 dated Mar. 8, 2016. |
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Notice of Allowance from U.S. Appl. No. 10/965,542 dated Jul. 11, 2016. |
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Office Action from U.S. Appl. No. 14/016,906 dated May 31, 2016. |
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Advisory Action from U.S. Appl. No. 14/565,024 dated Apr. 14, 2016. |
Amendment from U.S. Appl. No. 14/565,024 dated Jul. 28, 2016. |
Search Report from European Application No. 12162767.3 dated Dec. 23, 2015. |
Office Action from U.S. Appl. No. 14/565,024 dated Dec. 9, 2015. |
Office Action from European Application No. 05757183.8 dated Nov. 16, 2015. |
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Extended European Search Report in European Application No. 08714094.3 dated Jan. 27, 2016. |
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Communication Pursuant to Artile 94(3) EPC from European Application No. 12162767.3 dated Nov. 12, 2018. |
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Number | Date | Country | |
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20160045210 A1 | Feb 2016 | US |
Number | Date | Country | |
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60942788 | Jun 2007 | US |
Number | Date | Country | |
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Parent | 14061395 | Oct 2013 | US |
Child | 14875028 | US | |
Parent | 13213689 | Aug 2011 | US |
Child | 14061395 | US |
Number | Date | Country | |
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Parent | 12135473 | Jun 2008 | US |
Child | 13213689 | US |