US20150196361A1 - Apparatus and method for fragmenting and aspirating materials from a body lumen - Google Patents

Abstract

A device for insertion into a body lumen includes an operator unit which may be hand held by an operator. A cannula is operatively associated with the operator unit and the cannula includes two parallel lumens. At least one of two lumens terminates at its distal end before the distal end of the other lumen and wherein one of the two lumens is contained at most partially within the other lumen.

Description

RELATED APPLICATIONS
• This application is related to and claims priority to U.S. Provisional Application No. 61/927426, filed Jan. 14, 2014, the entirety of which is herein incorporated by reference.
FIELD OF THE INVENTION
• This invention relates to medical devices and in particular to devices which are adapted to fragment materials contained within a body lumen, including urinary tract stones, bladder stones, kidney stones and the like, using optical energy, especially lasers, and removing fragmented materials from the body lumen.
BACKGROUND
• Medical devices which are used to fragment and remove stones and other materials from, for example, the urinary tract, the bladder and the kidneys (hereinafter referred to as “stones”), are known in the art. An example of such a device is shown in U.S. Pat. No. 6,517,531. In this patent, a dual lumen elongated member is used, respectively, for the purposes of providing a first lumen for an optical fiber and a second lumen to aspirate fragmented stones or other materials.
• One of the problems associated with the foregoing patent as well as other prior art is that a balance must be struck between the overall size or diameter of the device to be introduced into the urinary tract of a human being and to fit the working channel of an urethascope. The size should preferably be chosen not only so that it will fit within the space constraints above but also be of a size to be able to incorporate an aspiration lumen as well as a lumen to contain an optical fiber which is used to break apart, in this example, stones or other materials in urinary tract. As can be seen,FIG. 1 represents the prior art and it can be seen that the optical fiber lumen is contained within the aspiration lumen. This arrangement, of course, decreases the size of the aspiration lumen and limits the size of the degree of the stones or other fragmented materials which can be suctioned through the aspiration lumen to outside the body. BothFIGS. 1A and 1B show two variations of prior art systems which include the optical fiber lumen within the aspiration lumen. Thus, there is a need for a two lumen device which maintains the maximum size of the aspiration lumen so that larger pieces of fragmented stones or other materials may be aspirated while still containing sufficient space for the optical fiber lumen.
• Another problem associated with dual lumen devices of the type of the present invention is that, as can be seen in prior artFIGS. 1A and 1B, the fiber lumen and the aspiration lumen terminate at the same plane. This results in the inability of the physician or other operator to visualize the optical fiber tip unless it is pushed out of the optical lumen. In a known procedure, in addition to the use of the device such as is described in the above patent and in the present invention an additional device named a urethascope is positioned in the body lumen and provides, among other things, a visualization lumen to the physician to visualize the materials sought to be removed and to guide the optical fiber. It is also known that during the process and procedure of fragmenting stones and other materials that the tip of the optical fiber may itself fragment due to the intense energy delivered through and at the tip of the optical fiber. Because the optical fiber lumen and the plane of the aspiration lumen terminate at the same plane, it is often difficult for the physician to inspect the tip of the optical fiber. Thus, what is needed is a dual lumen device which allows for easy visualization of the optical fiber tip.
• Another issue associated with such devices described in the above patent and the present invention is the control of the optical fiber into the body cavity and its advancement within the body cavity to stones or other materials which are sought to be fragmented. Thus, what is needed is a simple and accurate means to move and control the position of the optical fiber and its tip in the urinary tract to better be able to aim the optical fiber tip at the stones to be fragmented.
• Yet another issue associated with such devices is the ability to provide a handpiece that is easily gripped and manipulated by the operator of the device in use and which provides all controls for various functions, such as advancement of the optical fiber at gross movement levels and fine movement levels and control over the function of aspiration and irrigation within easy reach of the operator during a procedure.
SUMMARY OF THE INVENTION
• In an aspect, a device for insertion into a body lumen includes an operator unit adapted to be held by an operator; a cannula operatively associated with the operator unit. The cannula includes at least two parallel lumens. At least one of the at least two lumens terminates at its distal end before the distal end of the other of the at least two lumens.
• In another aspect, the at least one lumen which terminates before the distal end of the other of the at least two lumens is contained at most partially within the at least one other lumen which extends beyond the distal end of the at least one lumen which terminates before the distal end of the at least two lumens.
• In yet another aspect, a device for insertion into a body lumen includes an operator unit adapted to be held by an operator; a cannula operatively associated with the operator unit. The cannula includes at least two parallel lumens. The at least two lumens is contained at most partially within the at least one other lumen.
• In a further aspect, the cannula is operatively associated with the operator unit at the proximal end of the cannula.
• In yet another aspect, one of the at least two parallel lumens is adapted for receiving an optical fiber and the other of the at least two parallel lumens is adapted for one or more of aspiration and irrigation of materials within the body lumen.
• In yet a further aspect, the operator unit includes one or more controls to manipulate one or more of the optical fiber and the one or more of the aspiration and irrigation of materials within the body lumen.
• In yet a further aspect, the at least one lumen terminating before the distal end of the other of the at least two lumens is wholly outside of the other of the at least two lumens.
• In an aspect, the control to manipulate the optical fiber includes a wheel operatively associated with the operator unit which one of directly or indirectly engages the optical fiber to advance the optical fiber within the operator unit. Furthermore, at least two rollers are operatively connected with the wheel, the at least two rollers being engageable with the optical fiber therebetween and wherein movement of the wheel causes the optical fiber to move due to contact with the moving at least two rollers. At least one of the at least two rollers is of a resilient material.
• In another aspect, the control to manipulate the optical fiber includes a mechanism to disengage the wheel from the optical fiber such that the operator may manually advance the optical fiber.
• In yet another aspect, the one or more controls for one or more of aspiration and irrigation of materials includes a mechanical switch and a flexible tube operatively associated with the mechanical switch, wherein the mechanical switch, when depressed, engages and at least partially collapses the flexible tube to stop one of: aspiration or irrigation of materials in the body lumen.
• In a further aspect, the mechanism includes a tube for containing the optical fiber, and wherein the tube is movable from a first position to a second position, in the second position being interposed between the at least two rollers such that an optical fiber within the tube is not engaged with the at least two rollers and may be advanced by the operator without movement of the wheel.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIGS. 1A and 1B illustrate prior art dual lumen apparatuses.
• FIG. 2 illustrates overall views of the apparatus of the present invention.
• FIG. 3 illustrates the distal portion of a dual lumen elongated device of the present invention.
• FIGS. 4A to 4C illustrate other embodiments of the device illustrated inFIG. 3.
• FIG. 4D illustrates another view of a prior art device.
• FIG. 5 illustrates an exploded view of the handpiece of the present invention.
• FIGS. 6 and 7 illustrate the handpiece and the contained mechanisms for advancing an optical fiber and controlling an aspiration/irrigating apparatuses.
• FIGS. 8A,8B,9A and9B illustrate two of the devices for controlling the insertion and advancement of an optical fiber into the optical fiber lumen.
• FIGS. 10A to 10H illustrate the overall design of the handpiece.
DETAILED DESCRIPTION
• Turning now toFIG. 2, this figure illustrates the overall structure of the device of the present invention. This can be seen as ahandpiece10, which will be described in greater detail below, having acannula12 with at least two lumens, the first lumen for the aspiration and irrigation of materials and the second a lumen for containing and guiding an optical fiber. Thehandpiece10 also containscontrols14 as seen inFIG. 2 and as will be described below in detail in reference toFIGS. 7 to 9 below, to control the aspiration/irrigating means as well as the advancement of the optical fiber. Thus, inFIG. 2, the proximal end of thehandpiece10 includes anoptical fiber port16 and avacuum port18, to be described below. In addition, aremovable pin20 is included to control the release of the mechanical vacuum switch, to be described below.
• Thecannula12 may be constructed of any number of materials including metal. While thecannula12 is shown as being more or less orthogonal to thehandpiece10, it is feasible to orient the angle between thehandpiece10 and thecannula12 in any desired angle. The shape of the handpiece is ergonomically designed to allow easy handling and operation of the handpiece during a procedure.FIGS. 10A through 10H provide additional various views of thehandpiece10.
• Turning now toFIG. 3, that figure illustrates another aspect of the present invention. As can be seen inFIG. 3, the distal end of thecannula12 includes the distal end of theoptical fiber lumen22 as well as thedistal end24 of the aspiration/irrigation lumen. It is noted that the cannula which encompasses both the fiber lumen and the aspiration/irrigation lumen may be made of a metal material or any other suitable material such as a polymeric material and may be translucent or even transparent depending on the use to which it will be put. It can be seen inFIG. 3 that the distal end of the optical fiber lumen is not in the same plane as the distal end of the aspiration andirrigation lumen24. The distal end of the optical fiber lumen is set back from the plane of the distal end of the aspiration and irrigation lumen by adistance26 and this is for the purpose of allowing better visualization by the operator of the distal tip of the optical fiber than would be feasible if the distal tip of theoptical fiber lumen22 terminated on the same plane as the aspiration/irrigation lumen24. The fiber tip and its jacket are very much visible to the physician during a procedure due to the “set back” of the optical fiber lumen, so that the position of the fiber tip and the condition of the fiber tip are readily viewable. Turning now toFIGS. 4A to4C, these figures illustrate a number of alternative embodiments of the relationship between the optical fiber lumen and the aspiration/irrigation lumen.FIG. 4D represents the prior art discussed above in reference toFIGS. 1(a) and1(b).
• FIG. 4D illustrates the relationship between the optical fiber lumen and the aspiration and irrigation lumen as seen in the prior art devices ofFIGS. 1A and 1B. In this embodiment, the optical fiber lumen is shown as being contained wholly within the aspiration/irrigation lumen. This results in a reduction in the maximum size of stones and other materials which may be aspirated through that lumen. For example, in the structure of the devices of prior artFIGS. 1A,1B and1D, if D is in diameter of the aspiration/irrigation lumen and d is the diameter of the optical fiber lumen, then the maximum stone or other material size which can be evacuated is D−d. However, in the devices illustrated inFIGS. 4A to 4C, the maximum stone or other material size which can be evacuated is D−½d, thus allowing the aspiration of larger stones and other materials while maintaining the same overall diameter of the combined lumens as in the prior art devices.
• FIG. 5 illustrates thehandpiece10 ofFIG. 2 viewed from a perspective exploded view. Thetop section11 of thehandpiece10 includes a wheel orroller control30 which controls the advancement of the optical fiber. It also includes amechanical switch32 which controls the opening and the closing of the aspiration/irrigation lumen. It further includes a lockingswitch34 which may be used to lock the aspiration/irrigation lumen in either an open or closed position to free the physician's fingers for other operations, such as manipulating the optical fiber to the vicinity of the stones or other materials which are thought to be fragmented by the optical fiber energy. Finally, a lockingpin35 is operatively connected to the mechanical switch to prevent activation of operation of the aspiration/vacuum function. A second opticalfiber handling mechanism36, as can be seen inFIG. 5 as210 inFIG. 9, on the proximal portion of the handpiece provides further controls over the optical fiber advancement.
• FIGS. 6 and 7 illustrate different views of the mechanisms to which thecontrols30,32,34 and36 are connected. Themechanical switch32 may have astopper40 which presses onto a silicone or other material flexible aspiration/irrigation tube42 so that the aspiration/irrigation tube42 may be in either a normally collapsed/closed position or moved to an open position. Thelock mechanism34 may be used to keep the aspiration/irrigation channel in an open position, the default position being the position in which thestopper40 presses against the tube to keep it closed. The lockingswitch34 may be designed in any number of desired default orientations: always off so that no vacuum is in operation unless actuated; always on so that the vacuum is always on unless the operator disengages the operation; and a mode in which the vacuum is turned on any time the laser is activated so that aspiration occurs while fragmenting stones. The lockingpin35 when inserted into handpiece, interacts with themechanical switch32 to either prevent its depression and the depression of thestopper40 or to hold thestopper40 against thetube42 to prevent actuation of the vacuum/aspiration function. In order to use themechanical switch32, the locking pin must be removed.FIGS. 7 and 8 show the device100 (orbutton30 inFIG. 5) positioned distally of the device200 (or36 inFIG. 5). As will be detailed below, each of these devices accepts and is capable of advancing (or retracting for that matter) an optical fiber that is inserted in the proximal portion of the handpiece in the vicinity of the vacuum fitting18 shown inFIG. 2 as well.
• Now to be discussed is the operation and structure of themechanisms100 and200 which are utilized to control and advance the position of the optical fiber. Turning now toFIG. 8, that figure shows the “main” mechanism for controlling and advancing an optical fiber controlled more or less precisely by the wheel orroller102. As can be seen the wheel orroller102 is attached to ageartrain104,106 and108 and that turning of the wheel orroller102 will in turn cause rotation ofshafts110 and112.Shafts110 and112 have mounted on them tworollers114 and116. There may be made of a resilient material and are spaced a distance that is slightly apart but sufficiently close that an optical fiber placed therebetween is constrained against movement or is moveable by rotation of the wheel orroller102 and throughgeartrain106 and108. Distally of therollers114 and116 is acurved tube120. Thetube120 receives an optical fiber that has passed through therollers114 and116. The distal end of thetube120 is connected to or at least in the vicinity of opening37 (best shown inFIG. 5). Thus, an optical fiber advanced through thedevice100 under action of the wheel orroller102 will exit the distal end oftube120 and enter thelumen39 which constitutes the fiber lumen as shown inFIGS. 3 and 5.
• Turning now toFIG. 9, that figure illustrates theassembly200 assembled towards the proximal portion of thehandpiece10 as may be seen inFIG. 6. Anentry port202 best seen in the exploded view ofFIG. 9A includes atube section204. That section is further connected totubes206 and208. An optical fiber inserted through theentry port202 is advanced throughtubes204,206 and208 and will exit the distal end oftube208 and enter, upon its advancement, into an entry port of theassembly100 discussed above, then through the assembly to enter betweenrollers114 and116. AS described above, rotation of the wheel orroller102 will advance the fiber throughtube120 and finally intofiber lumen39 as seen inFIG. 5. Due to the geartrain, very precise movements of the advancing optical fiber may be made. However, when the optical fiber is first “loaded” into theentry port202, to save time a more “gross” movement of the fiber through the handpiece and then through the fiber lumen may be desirable. This is achieved by theassembly200 ofFIG. 9.Assembly200 includes anactuatable button210 which is operatively connected to thelever train212 and214 such that lifting upward thebutton210 results in thetube208 moving in the distal direction towards theassembly100. Such distal movement causestube208 to enter betweenrollers114 and116. Once this is accomplished, therollers114 and116 will be in contact with the outer surface of thetube208. As a consequence, an optical fiber will be able to be “pushed” through theassembly100 and theassembly200 and through thefiber lumen39 so that the operator may began the procedure. After such advancement, the operator may push the button down, which cause withdrawal in a proximal direction of thetube208 so that therollers114 and116 contact the optical fiber, thus assuring advancement by way of the wheel orroller102.
• Alternatively, one or both of therollers114 or116 may be made to be constructed such that they is retractable away from the plane in which it engages the optical fiber during initial advancing of the fiber through the device. A potential issue with a handpiece which is orientated at an angle with respect to the aspiration/irrigation lumen and the fiber lumen is that, with respect to the aspiration/irrigation lumen, that stones and other material can get “hung up” within that lumen in the case of sharp turns within that lumen and, with respect to the fiber lumen, the fiber gets “hung up” on its advancement into the device due to sharp turns. As can be seen by reference toFIGS. 5 through 9, however, both thesilicone tube216 seen inFIG. 9B and thetube120 seen inFIG. 8B are gently curved which minimizes if not eliminates the “hang up” problems. This allows for the handpiece to be orientated at a more convenient angle to the lumens for the operator's use.
• Turning now back toFIG. 9, the aspiration/irrigation lumen'sproximal end218, as shown may be connected by well-known means to either a source (not shown) of vacuum to allow for evacuation and aspiration of materials and fluids within the body cavity or to a source (not shown) of irrigation to allow for irrigating the body cavity. It is possible during a procedure for a stone or other material object to become lodged within the aspiration/irrigation lumen or even at the distal end of such lumen. Further vacuum may not dislodge such stone or other material. In that event, the operator may switch from a vacuum operation to an irrigation operation to force the materials lodged in the lumen to be expelled for further treatment and fragmentation.
• In the operation and use of the apparatus disclosed in the present invention, a physician or other user inserts the combined optical fiber and aspiration/irrigation lumen through the urinary tract into the body cavity of the human, such as the bladder or the kidneys. After the device has been placed in the desired position, the physician or other operator inserts an optical fiber into the proximal end of the apparatus and pushes it through the metal tubes within the apparatus and through the optical fiberlumen using roller102 until the optical fiber exits the optical fiber lumen and can be observed through a urethascope. The physician or other operator then advances the tip of the optical fiber to the stone or other materials sought to be fragmented and turns on the optical fiber activation device which may operate in high energy and long pulse mode (up to 6 joule/per pulse and up to 1700 ms per pulse) in order to reduce stone or other material repulsion and movement. Other potential parameters for the present invention include a range of about 0-6 joule/per pulse, a frequency of about 5-100 Hz, and a pulse width in the range of about 200 to about 1700 microseconds. Once a sufficient amount of material has been fragmented, the material may be withdrawn through the aspiration lumen by the physician or other operator by activating a vacuumsource using switch32. The setback of the distal tip of the fiber lumen allows the physician or other operator to observe the condition of optical fiber tip and advance the tip further to continue fragmentation of stones or other materials. Stones or other materials lodged within the aspiration/irrigation lumen may be dislodged by reversing the operation to an irrigation mode to expel the lodged material or other debris.

Claims (13)

What is claimed is:

1. A device for insertion into a body lumen comprising:

a operator unit adapted to be held by an operator;

a cannula operatively associated with the operator unit;

the cannula including at least two parallel lumens;

wherein at least one of the at least two lumens terminates at its distal end before the distal end of the other of the at least two lumens.

2. The device ofclaim 1, wherein the at least one lumen which terminates before the distal end of the other of the at least two lumens is contained at most partially within the at least one other lumen which extends beyond the distal end of the at least one lumen which terminates before the distal end of the at least two lumens.

3. A device for insertion into a body lumen comprising:

a operator unit adapted to be held by an operator;

a cannula operatively associated with the operator unit;

the cannula including at least two parallel lumens;

wherein at least one of the at least two lumens is contained at most partially within the at least one other lumen.

4. The device ofclaim 1 wherein the cannula is operatively associated with the operator unit at the proximal end of the cannula.

5. The device ofclaim 4, wherein one of the at least two parallel lumens is adapted for receiving an optical fiber and the other of the at least two parallel lumens is adapted for one or more of aspiration and irrigation of materials within the body lumen.

6. The device ofclaim 5, wherein the operator unit includes one or more controls to manipulate one or more of the optical fiber and the one or more of the aspiration and irrigation of materials within the body lumen.

7. The device ofclaim 2 wherein the at least one lumen terminating before the distal end of the other of the at least two lumens is wholly outside of the other of the at least two lumens.

8. The device ofclaim 6, wherein the control to manipulate the optical fiber includes a wheel operatively associated with the operator unit which one of directly or indirectly engages the optical fiber to advance the optical fiber within the operator unit.

9. The device ofclaim 8 wherein at least two rollers are operatively connected with the wheel, the at least two rollers being engageable with the optical fiber therebetween and wherein movement of the wheel causes the optical fiber to move due to contact with the moving at least two rollers.

10. The device ofclaim 9 wherein at least one of the at least two rollers is of a resilient material.

11. The device ofclaim 9, wherein the control to manipulate the optical fiber includes a mechanism to disengage the wheel from the optical fiber such that the operator may manually advance the optical fiber.

12. The device ofclaim 5, wherein the one or more controls for one or more of aspiration and irrigation of materials includes a mechanical switch and a flexible tube operatively associated with the mechanical switch, wherein the mechanical switch, when depressed, engages and at least partially collapses the flexible tube to stop one of: aspiration or irrigation of materials in the body lumen.

13. The device ofclaim 11, wherein the mechanism includes a tube for containing the optical fiber, and wherein the tube is movable from a first position to a second position, in the second position being interposed between the at least two rollers such that an optical fiber within the tube is not engaged with the at least two rollers and may be advanced by the operator without movement of the wheel.

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