The present disclosure relates to medical devices and more specifically to electrohydraulic lithotripsy probes.
The statements in this section merely provide background information related to the present disclosure and may not constitute prior art.
Electrohydraulic lithotripsy is a procedure used as a means to break up stones within the biliary tree and urinary tract. While many stones may naturally pass through and out of the patient, some stones are too large to be passed on their own. These stones may become stuck in the biliary tree or urinary tract, thereby requiring medical intervention. A common way to remove stones is with lithotripsy: a medical procedure that involves breaking up the stones into smaller pieces that are then able to be passed naturally out of the patient's body. One specific subset of lithotripsy is electrohydraulic lithotripsy, which employs high energy shock waves to fragment the stones. These shock waves can be generated and targeted at the stone from outside of the patient's body or with a device that is inserted into the patient's body—either percutaneously or through a natural body cavity.
Electrohydraulic lithotripsy can use a shock wave generating device that is inserted into the patient's body. The device, or probe, is most commonly passed through an accessory channel of a scope or other similar introducer device until the probe is adjacent to the stone. A shock wave is then generated through the probe towards the stone. Eventually, the shock waves cause the stone to fragment and the probe and scope may then be removed while the stone fragments naturally pass through and out of the patient's body. Alternatively, the fragments may be removed by a vacuum, basket, or other fragment collection device inserted through or with the scope.
The scope, which is often a cholangioscope, must have an outer diameter small enough to allow it to be safely advanced through a body lumen of a patient. Sometimes, the cholangioscope is advanced through a working channel of a larger duodenoscope that also must have a diameter small enough to allow it be safely advanced through a body lumen of a patient. Since the probe is passed through a working channel of one of these scopes, the outer diameter of the probe must be fairly small. However, these probes are generally quite long, with lengths often exceeding 230 centimeters. Because of the high length to diameter ratio, one common problem associated with electrohydraulic lithotripsy is the buckling or kinking of the probe as it is advanced through the working channel of the scope and into a patient's body lumen. Kinking and buckling of the probe can be caused by the friction generated between the probe and the working channel of the scope or various structures in the patient's body lumen. As the physician advances the probe further into the scope, the friction between the scope and probe increase, thus requiring a greater force to further advance the probe. However, as the physician applies more force to the proximal end of the probe, the probe is more likely to kink or buckle, as it cannot withstand a large force due to its small diameter and low strength. When the probe kinks or buckles, the physician may have increased difficulty in advancing the probe towards the stone. Additionally, the probe must also maintain sufficient flexibility as it must be navigated through the twists and turns of the patient's body lumen.
Thus, it is desirable to provide a lithotripsy probe that is resistant to kinking and buckling while maintaining a small outer diameter with sufficient flexibility that may be passed through the working channel of a scope.
In one form of the present disclosure, a lithotripsy probe is provided. The lithotripsy probe comprises an elongate body comprising a proximal end, a distal end, and a lumen extending therethrough. The lithotripsy probe also comprises a stiffening element comprising a proximal end, a distal end, and a length extending from the proximal end to the distal end. The stiffening element is disposed within the lumen of the elongate body. Further, the stiffening element comprises a stiffness that varies along the length of the stiffening element, wherein the stiffness of the proximal end of the stiffening element is greater than the stiffness of the distal end of the stiffening element.
The lithotripsy probe may further comprise first and second conductive wires extending through the lumen of the elongate body, the first and second conductive wires configured to deliver electrical energy to the distal end of the elongate body. Also, the stiffening element of the lithotripsy probe may increase along the length of the stiffening element from a lower stiffness at the distal end of the stiffening element to a greater stiffness at the proximal end of the stiffening element. Additionally, the proximal end of the stiffening element may be substantially coterminous with the proximal end of the elongate body and the distal end of the stiffening element may be substantially coterminous with the distal end of the elongate body. The stiffening element may also comprise a proximal portion and a distal portion, the proximal portion comprising a substantially constant outer diameter and the distal portion comprising a substantially constant outer diameter that is smaller than the outer diameter of the proximal portion, the stiffening element further comprising a step at a transition point between the proximal and distal portions. The stiffening element may include a proximal portion, a distal portion, and a first and second stiffener, the first stiffener extending from the proximal end of the stiffening element to the distal end of the stiffening element, the second stiffener extending through the proximal portion of the stiffening element. The stiffening element could also comprise a proximal portion comprising a first material and a distal portion comprising a second material, the first material having a greater stiffness than the second material. Alternatively, the stiffening element may comprise a proximal portion and a distal portion, the proximal portion being heat treated to increase the stiffness of the proximal portion, the proximal portion having a stiffness that is greater than the stiffness of the distal portion.
In another form of the present disclosure, a lithotripsy kit is provided. The lithotripsy kit comprises a scope comprising a proximal end, a distal end, and a working channel extending therethrough, the scope further comprising a proximal entrance to the working channel. The lithotripsy kit further comprises a probe comprising an elongate body comprising a proximal end, a distal end, and a lumen extending therethrough, the probe further comprising a stiffening element comprising a proximal end, a distal end, and a length extending from the proximal end to the distal end, the stiffening element disposed within the lumen of the elongate body. The probe is advancable through the working channel of the scope, the stiffening element comprising an adjacent point that is adjacent to the proximal entrance of the working channel, the adjacent point varying in position along the length of the stiffening element as the probe is distally advanced through the working channel, the probe further comprising a force required to advance the probe through the working channel of the scope, the force increasing as the adjacent point moves proximally along the length of the stiffening element. Also, the stiffening element further comprises a stiffness that varies along the length of the stiffening element, the stiffness increasing along the length of the stiffening element from the distal end to the proximal end, wherein the stiffness of the stiffening element at the adjacent point is proportional to the instant force required to advance the probe through the working channel of the scope at the adjacent point's current position along the length of the stiffening element.
Further areas of applicability will become apparent from the description provided herein. It should be understood that the description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.
The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way.
The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses. It should be understood that throughout the drawings, corresponding reference numerals indicate like or corresponding parts and features. It should also be understood that various cross-hatching patterns used in the drawings are not intended to limit the specific materials that may be employed with the present disclosure. The cross-hatching patterns are merely exemplary of preferable materials or are used to distinguish between adjacent or mating components illustrated within the drawings for purposes of clarity.
As the probe 10 is advanced through the working channel 13 of the cholangioscope 11, the frictional resistance between the working channel 13 and the probe 10 steadily increases the further the probe 10 is advanced due to the increasing amount of surface area contact between the probe 10 and working channel 13. Therefore, as the probe 10 is advanced the physician must apply an increasingly larger force to the proximal end of the probe 10 to overcome the increasing frictional forces. Due to the increasingly larger force that the physician must apply, the probe 10 may be at risk of kinking or buckling throughout this procedure. Further, the probe 10 is at a significant risk of buckling when the distal end 17 of the probe 10 reaches and then extends past the side port 28 of the duodenoscope 14 (
When all or part of the probe 10 is disposed within the working channel 13, the portion of the probe 10 that is within the working channel 13 may be less prone to kinking or buckling due to the additional support provided by the low tolerance between the working channel 13 and the probe 10. However, at any point in the procedure, an exposed portion 34 of the probe 10 (which varies in length based on the position of the probe 10 with respect to the cholangioscope 11) that has not yet been advanced into the working channel 13 of the cholangioscope 11 does not have the benefit of the support provided by the working channel 13. Thus, when the physician applies an increased force to the exposed portion 34 of the probe 10 to advance the probe 10 past the elevator and deflection point 30, the exposed portion 34 is prone to buckling, especially immediately proximal to the proximal entrance 36 to the working channel 13. A rough graph showing the relationship between the force required by the physician to distally advance the probe 10 and the position of the distal end 17 of the probe 10 is shown in
To help minimize the risk of buckling, a stiffening element 46 may be used with the probe 10. As shown in
However, the addition of a stiffening element 46 may be accompanied by the sacrifice of probe 10 flexibility. The flexibility of the probe 10 is an important design consideration since the probe must be advanced through the twists and turns of the gastrointestinal tract and then deflected 90 degrees or more at the elevator of the duodenoscope 14. Therefore, it may be preferable to design the stiffening element 46 in such a way that minimizes the loss of flexibility while still providing the necessary added stiffness to prevent or limit kinking and buckling of the probe 10 during advancement through the cholangioscope 11. As shown in the graph in
Therefore, it may be desirable to use a stiffening element 46 with a varying diameter or thickness along the length of the probe 10. For example, as shown in
Further, rather than varying the thickness of the stiffening element 46 to vary the stiffness along the length 54 of the stiffening element 46, the material properties of the stiffening element 46 may be varied instead as shown in
While the above embodiments describe stiffening elements 46 that extend along the entire length of the probe 10, the stiffening element 46 may extend along only a portion of the probe 10. For example, the stiffening element 46 may extend from the proximal end of the probe 10 to a point proximal the distal end of the probe 10. Alternatively, multiple separate stiffening elements 46 may be used within a single probe 10, each with properties similar to the stiffening elements 46 described above. Further, various design features of the stiffening element 46 in the above mentioned embodiments may be mixed and matched with other embodiments as desired.
The probe 10 and stiffening element 46 may be used in a variety of applications with varying lengths and designs. In one example, the probe 10 may be around 200-300 centimeters in length. The length of the working channel 12 of the duodenoscope 14 may be about 140-160 centimeters and the length of the working channel 13 of the cholangioscope 11 may be around 200-250 centimeters. The proximal portion 60 of the stiffening element may be 15 centimeters in length or greater. It may be preferable for the distal portion 58 to range from 5-35 centimeters in length; however, it may extend as far as or greater than half the length of the working channel 13 of the cholangioscope 11. The central portion 62 may extend between the proximal and distal portions 60, 58, and may vary widely in length. In one example, the central portion 62 may range from 30-120 centimeters in length. These dimensions are merely exemplary, and the lengths of the probe 10, stiffening element 46, and the portions 58, 60, 62 of the stiffening element 46 may be further varied.
The embodiments described above show just several potential designs of a stiffening element. Many other stiffening elements with varying diameters or thicknesses may be used. Further, the stiffening element need not be cylindrical in shape with a circular cross section. For example, the stiffening element may have a rectangular, square, ovular, or other shaped cross-section. The cross-section of the stiffening elements may also include grooves configured to accommodate the conductive wires 42, 44, thus allowing for an overall reduction in the diameter of the probe 10. The grooves may also aid in preventing the conductive wires from contacting each other, thereby reducing the possibility of electrical shorting.
Additionally, while the stiffening elements 46 may be made of a metallic material, they may also be made of a non-metallic, or non-conductive material. Non-conductive stiffening elements 46 may be desirable to prevent or limit the risk of shorting the conductive wires. Similarly, the stiffening elements 46 may instead or also be coated or wrapped in a non-metallic material to limit the risk of shorting the conductive wires.
While the present disclosure describes the embodiments in terms of a lithotripsy probe used during a biliary procedure, the stiffening element 46 may be used in any lithotripsy procedure to limit kinking and buckling of the probe when inserted into a patient. Further, the anti-kinking and buckling improvements may be used with a variety of other medical devices unrelated to lithotripsy, such as catheters used in a variety of medical procedures. Also, the improvements described above may be used in a variety of non-medical applications.
The description of the disclosure is merely exemplary in nature and, thus, variations that do not depart from the substance of the disclosure are intended to be within the scope of the disclosure. Such variations are not to be regarded as a departure from the spirit and scope of the disclosure.
The present patent document claims the benefit of the filing date under 35 U.S.C. §119(e) of Provisional U.S. Patent Application Ser. No. 62/371,437 filed Aug. 5, 2016, which is hereby incorporated by reference.
Number | Date | Country | |
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62371437 | Aug 2016 | US |