APPARATUS AND METHOD FOR FRAGMENTING AND ASPIRATING MATERIALS FROM A BODY LUMEN
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.
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 INVENTIONThis 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.
BACKGROUNDMedical 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,
Another problem associated with dual lumen devices of the type of the present invention is that, as can be seen in prior art
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 INVENTIONIn 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.
Turning now to
The cannula 12 may be constructed of any number of materials including metal. While the cannula 12 is shown as being more or less orthogonal to the handpiece 10, it is feasible to orient the angle between the handpiece 10 and the cannula 12 in any desired angle. The shape of the handpiece is ergonomically designed to allow easy handling and operation of the handpiece during a procedure.
Turning now to
Now to be discussed is the operation and structure of the mechanisms 100 and 200 which are utilized to control and advance the position of the optical fiber. Turning now to
Turning now to
Alternatively, one or both of the rollers 114 or 116 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 to
Turning now back to
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 fiber lumen using roller 102 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 vacuum source using switch 32. 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
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 of claim 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 of claim 1 wherein the cannula is operatively associated with the operator unit at the proximal end of the cannula.
5. The device of claim 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 of claim 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 of claim 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 of claim 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 of claim 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 of claim 9 wherein at least one of the at least two rollers is of a resilient material.
11. The device of claim 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 of claim 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 of claim 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.
Type: Application
Filed: Jan 13, 2015
Publication Date: Jul 16, 2015
Inventors: Assaf Preiss (Shimshit), Moshe Elazar (Tzoran), Alon Shacham (Yokneam Ilit)
Application Number: 14/595,312