This application relates to a percutaneous puncture systems and methods for creating a tract for endourologic procedures and to methods and systems to facilitate endourologic procedures after creation of the tract.
A nephrostomy creation procedure is the creation of a communication between the skin and kidney to provide for endourologic procedure and therapy. The objective in nephrostomy tract creation is to have the wire from outside the flank directed down the ureter to provide therapeutic endourologic management or treatment of a renal system. The setting of percutaneous endourologic procedures, including but not limited to percutaneous nephrolithotomy, allows for subsequent dilation of the tract, such as by a nephrostomy dilating balloon, between the kidney and the skin over a wire that extends down the ureter. The catheter and tract can also be used to facilitate stenting of a narrowed ureter or removal or treatment of stones obstructing the ureter. Current nephrostomy tract creation is based on x-ray exposure or ultrasound to guide the physician where to locate the nephrostomy puncture wire tract.
Two widely used techniques for nephrostomy tract creation are currently utilized. One technique utilizes an antegrade approach. The antegrade approach holds increased bleeding risk due to the puncture needle puncturing the interlobar arteries as it passes into the collecting system. This antegrade approach is also skill intensive because it requires advancing from the flank to the calyx using two dimensional imaging or targeting aids. In fact, studies have shown that recent urology resident graduates often do not continue to perform the antegrade nephrostomy technique after graduating due to difficulty of this procedure. The fluoroscopy based antegrade puncture procedures require a relatively large amount of radiation exposure.
The other technique commonly utilized is the retrograde puncture technique. This technique is used to create a nephrostomy tract in a retrograde fashion. The original system for this was called the Lawson technique. The Lawson technique is performed under fluoroscopy utilizing a deflecting wire inside a ureteric catheter to select the renal calyx to be entered. That is, fluoroscopy is used to identify the renal calyx for nephrostomy access. The Lawson technique is described for example in Smith's Textbook of Urology, 2007, BC Decker Inc., “Retrograde Access” by Dennis H. Hosking and is commercially available by Cook Urological, Inc. as the “Lawson Retrograde Nephrostomy Wire Puncture Set.”
In the Lawson technique, a stainless steel 145 cm long guidewire (0.038 inches in diameter) having a 3 cm flexible tip is passed retrograde up the ureter into the renal pelvis under fluoroscopy. A 7 Fr catheter is passed over the guidewire into the renal pelvis and the guidewire is removed. A J-tipped wire in certain instances might be used to facilitate passage past an obstruction. Then the surgeon selects the optimal calyx for nephrostomy placement, optimization usually being defined by allowing easiest access to the renal calculi and the shortest tract. Once the calyx is selected, the 0.045 inch diameter deflecting wire guide is inserted through the lumen of the catheter and twist locked to the proximal end of the catheter. Deflection of the wire tip deflects the tip of the catheter, and the catheter and attached wire can be advanced into the selected calyx. However, it is recognized that due to obstructions, e.g., presence of calculi, it may not be possible to advance the catheter into the optimally desired calyx and consequently a less optimal calyx is selected by the surgeon.
After insertion of the catheter into the selected calyx, the deflecting wire guide is removed from the lumen of the catheter, while maintaining the inner-calyx position of the catheter tip. A puncture wire and sheath as a unit are inserted through the catheter lumen, with the puncture wire sharp tip shielded by the sheath. During insertion through the catheter, the wire remains retracted within the sheath, and locked to the sheath by a pin vise lock, so its puncture tip is not exposed. The puncture wire and sheath are connected/locked to the proximal portion of the catheter. The puncture wire is then unlocked from the sheath, by untwisting the cap of the pin vise actuator to loosen the vise pin grip on the puncture wire, and then incrementally advanced from the distal end of the sheath through the flank, fascia and skin. After puncturing the skin, the puncture wire is advanced from below until approximately 15 cm of wire is externally visible.
The pin vise lock securing the puncture wire to the insulating sheath is then re-locked. A fascial incising needle may or may not be passed over the puncture wire at the flank to incise fascia, and is then removed. As the 7 French catheter is advanced through the cystoscope below, the puncture wire is drawn further out of the flank, until the tip of the 7 French catheter is delivered out of the flank. At this time, the 7 French catheter is unlocked from its connection to the puncture wire assembly, and the puncture wire and insulating sheath are removed from below. A 0.038″ guidewire is then passed antegrade through the 7 French catheter from the flank, until it emerges out the lower end of the 7 French catheter at the cystoscope end. With this wire ‘through and through’ the body, the cystoscope and 7 French catheter are removed, leaving the guidewire in place.
The retrograde Lawson approach has several advantages over the antegrade approach including providing the surgeon an anatomic approach to the renal pelvis, increased likelihood of avoiding the interlobar arteries during puncture, and inherently having a wire down the ureter, an important step in securing control over the nephrostomy tract. It is also less skill intensive, due in large part to the fact that it enables travel from the “known kidney” to the “unknown flank/skin,” which better respects the principles of surgery.
However, despite its advantages over the antegrade approach, there are several disadvantages to the Lawson technique. First, it is often difficult to navigate the ureteric catheter beyond large obstructive stones in the renal pelvis. This inability to direct the catheter to the desired site (calyx) often leads the surgeon to access a less optimal calyx. Second, fluoroscopy provides only a two dimensional view of the renal anatomy, thereby limiting the ability to confidently select the calyx for tract dilation. Sometimes, there is even uncertainty as to which calyx is actually chosen due to the limited visibility provided by fluoroscopy.
Consequently, it would be advantageous to provide a system and method that enables more precise calyx location, improves access to the calyx of choice, improves visualization, permits “fluoroscopy-free” calyx selection, and allows for preliminary laser lithotripsy of a portion of a stone that may block access to calyx of choice for nephrostomy creation. Also of significance is that nephrostomy tube creation procedures are usually performed by interventional radiologists, which can further compound the risks and problems since urologists usually have better success rates for selecting the calyx for such procedures. Thus, it would be advantageous if such improved system and method could be more commonly performed by urologists.
In an attempt to address some of the disadvantages of the Lawson technique, Dr. Larry C. Munch in an article entitled “Direct-Vision Modified Lawson Retrograde Nephrostomy Technique Using Flexible Ureteroscope” and published in the Journal of EndoUrology, Volume 3, Number 4, 1989, described a technique utilizing a flexible ureteroscope.
In this “Munch technique,” a flexible steerable ureteroscope was utilized to inspect the renal pelvis and calices. As described, a flexible cystoscopy is performed and a 0.035 inch, 145 cm guidewire is passed into the ureteral orifice. Position within the ureter is assessed with fluoroscopy. The cystoscope is removed and a ureteral access sheath with its obturator is advanced over the guidewire, and the obturator is then removed and the ureteroscope is passed through the sheath into the renal pelvis. An appropriate calyx is chosen visually, and then the 0.0017 inch Lawson puncture wire and protective 3Fr radiopaque Teflon sheath is passed through the working channel of the ureteroscope. The calyx is entered and the sheath embedded in the wall of the calyx, and then the pin-vise lock which locks the puncture wire and sheath together is opened and the puncture wire is advanced through the skin under visual and fluoroscopic control. The puncture wire protective sheath and ureteroscope are then withdrawn, leaving the puncture wire and ureteral access sheath in place. At the skin, an 18 gauge needle is passed over the puncture wire into the kidney and then removed. A 9 French fascial dilator is then passed over the 0.017 inch puncture wire into the kidney, whereafter the puncture wire is removed and a 0.038 inch guidewire is passed through the 9 French dilator until it passes down the ureter through the access sheath, and exits through the urethra. Thus, Munch was the first to describe retrograde nephrosotomy via retrograde puncture from “inside to outside” though a flexible ureteroscope pre-positioned in a renal calyx.
Although the Munch technique solves some of the problems associated with the Lawson technique, it still has several deficiencies. Munch's technique of antegrade wire exchange is ineffectual and risks cutting the puncture wire with passage of 18 gage hollow bore needle over the wire. After passage of this needle, a 9 French fascial dilator is passed over the 0.017″ puncture wire, representing a wire-catheter mismatch which can result in tearing of internal tissues. This large jump from an 18 gauge needle to a 9 French fascial dilator is also cumbersome and has a high chance of failing to grant access to the kidney. In addition to employing a wire that could both kink during regular use and “shear” through the kidney and ureteropelvic junction if exposed due to wire thickness, Munch's wire exchange system has been ineffectual, with a reported use of a rigid needle cannula which could not direct the wire into the ureter.
Consequently, it would be advantageous to provide a system and method that would enable urologists to more economically and efficiently perform the nephrostomy procedure to obtain access for nephrostomy tube creation. Such procedure would have the above-noted advantages over the Lawson technique, e.g., improving calyx access, visualization etc., while also providing the advantages of reducing the number of surgical steps and reducing the possibility of tearing tissue, thereby providing advantages over the Munch technique.
In U.S. Pat. Nos. 8,771,287 and 8,888,787 (common inventor and owner as the present application), systems and methods are disclosed which provide improvements to the foregoing deficiencies and overcome the disadvantages of Lawson, Munch and other prior systems. The systems of these patents use a coaxial catheter to effect wire exchange as well as a dual diameter puncture wire to provide a thicker portion of wire over the ureteropelvic junction if exposed to this anatomic region. These features are incorporated into the commercialized RetroPerc* Flexible Ureteroscopy Guided Retrograde Nephrostomy Wire Puncture Set. In this setting, the puncture wire performs both a) renal puncture and b) serves as a bridge over which the wire exchange catheters are advanced at the flank, where the tip protector sheath over the puncture wire does not emerge from the flank. The RetroPerc* system employs a coaxial microintroducer advanced over the puncture wire at the flank to permit placement of a larger diameter second nephrostomy wire. These systems have several advantages which are described in these patents.
The inventor of these systems recognized that alternative systems could be utilized to achieve the same and in fact additional advantages, and conceived and designed unique variations which enable endourologic procedures. These are described in commonly assigned U.S. application Ser. No. 17/180,176, filed Jul. 8, 2022, the entire contents of which are incorporated herein by reference. The inventor of these systems recognized that alternative systems could be beneficial in certain applications.
The inventor of these systems also recognized that systems to facilitate endourologic procedures after nephrostomy tract creation could be beneficial in meeting the needs in certain clinical applications. Thus, the present inventor developed systems and methods to satisfy the need in the art for improved access to the renal system for performing endourologic procedures after establishment of the nephrostomy tract.
The present invention in some aspects provides methods of wire exchange at the flank, over an emergent puncture wire for nephrostomy tube creation. Each of the two systems/methods of the present invention employ single lumen exchange catheters and are described in detail herein. The catheters are configured and dimensioned to facilitate wire exchange and ureter access. One system utilizes a single catheter; another system utilizes two catheters. The catheters are sized to accommodate standard sized puncture wires and endourology working wires, and the methods utilize such sizing to obtain desired access.
The present invention also provides in some embodiments a puncture wire construction which advantageously reduces kinking of the wire. This is discussed in detail below.
The present invention also provides in some aspects improved methods of access to the renal system for endourologic treatment after nephrostomy tube (tract) creation to facilitate the endourologic procedures. The tube creation prior to the treatment can be in accordance with the methods disclosed herein or in accordance with other methods.
In accordance with one aspect of the present invention, a surgical method is provided comprising the steps of:
In some embodiments, the puncture wire is slidable within the sheath and releasingly lockingly engageable therein, and the puncture wire is released from the sheath prior to the step of advancing the puncture wire through the flank.
In some embodiments, the endourology wire is advanced through the catheter and terminates in a kidney of the patient; in other embodiments, the endourology wire is advanced through the catheter and terminates in a ureter of the patient.
In some embodiments, the puncture wire has a proximal segment with an outer diameter larger than a distal segment of the puncture wire to add stiffness to enable insertion of the catheter over the puncture wire and reduce or prevent kinking of the wire during advancement of the catheter. In some embodiments, the proximal segment of the puncture wire is flexible to permit endoscope deflection of an endoscope positioned over the puncture wire.
In some embodiments, the radiopaque portion comprises a radiopaque band extending around at least a portion of a circumference of the catheter; in other embodiments, the radiopaque portion comprises a radiopaque filler extending within a wall of the catheter along at least a portion of a length of the catheter.
In accordance with another aspect of the present invention, a surgical method is provided comprising the steps of:
In some embodiments, the outer member comprises a nephroscope having a working channel for insertion of a surgical instrument for performing an endourologic procedure. In some embodiments, the outer member comprises a sheath, and the method further comprises inserting an endoscope through the outer member, wherein the endoscope has a working channel for insertion of a surgical instrument for performing an endourologic procedure. In some embodiments, the outer member comprises a balloon dilation catheter, and the method includes i) inflating a balloon of the balloon dilation catheter; ii) advancing a sheath over the balloon into the kidney; iii) deflating the balloon; iv) removing the balloon catheter leaving the outer sheath in place; and v) inserting an endoscope with a working channel through the outer sheath into the kidney. In some embodiments, the outer member comprises a catheter having multiple lumens and a mechanism to curl the catheter to secure the catheter in the kidney.
In some embodiments, the dilator is removably positioned within the outer member; in other embodiments the dilator is integral with the outer member and extends distally. In some embodiments, the outer member is an endoscope.
In accordance with another aspect of the present invention, a surgical method is provided comprising the steps of:
In some embodiments, the clamping member is inserted directly through the skin of the patient.
In some embodiments, the method includes the step of inserting a port through the skin of the patient at a site spaced from the intended or desired site of puncture wire emergence and the step of inserting the clamping member comprises the step of inserting the clamping member through a lumen of the port, the port including illumination and visualization.
In some embodiments, the method further comprises the step of either a) releasing the puncture wire from the clamping member and positioning an exchange catheter over the puncture wire; or b) inserting an endoscope or catheter directly over the puncture wire into the kidney.
Various nephrostomy tube creation methods are also disclosed. In accordance with one aspect of the present invention, a method for creating a tract in retrograde fashion for nephrostomy tube creation is provided comprising the steps of:
In some embodiments, the puncture wire is slidable within the sheath and releasingly lockingly engageable therein, and the puncture wire is released from the sheath prior to the step of advancing the puncture wire.
In some embodiments, the second wire expands the distal tip of catheter when passed through the second section of the lumen.
In some embodiments, the puncture wire has a proximal segment with an outer diameter larger than a distal segment of the puncture wire to add stability to manual advancement of the catheter and prevent kinking of the puncture wire during advancement of the catheter. In some embodiments, the distal segment has a larger diameter than a distalmost puncture point of the penetrating tip. In some embodiments, the proximal segment is positioned outside an entry point to the ureteroscope when the puncture wire is inserted into the ureteroscope.
In some embodiments, the puncture wire has a distalmost puncture point, a first segment adjacent and proximal of the distalmost puncture point and a second segment proximal of the first segment, wherein the first segment has an outer diameter larger than an outer diameter of the puncture point and smaller than an outer diameter of the second segment to allow flexion of the first segment, and the second segment serves as a bridge over which the catheter is passed and limits kinking of the puncture wire during advancement of the catheter thereover.
In some embodiments, the puncture wire has a proximal segment with an outer diameter larger than a distal segment to prevent kinking during both advancement of the puncture wire through the ureteroscope and advancement of the catheter over the puncture wire in the second direction opposite the direction of advancement through the ureteroscope.
In some embodiments, the second section of the lumen of the catheter has little or zero clearance over the puncture wire.
In accordance with another aspect of the present invention, a method for creating a tract in retrograde fashion for nephrostomy tube creation is provided comprising the steps of:
In some embodiments, the second wire has an outer diameter larger than the inner diameter of the first catheter.
In some embodiments, the second catheter has an inner diameter substantially equal to the outer diameter of the second wire.
In some embodiments, the puncture wire is slidable within the sheath and releasingly lockingly engageable therein and the puncture wire is released from the sheath prior to the step of advancing the puncture wire.
In accordance with another aspect of the present invention, a system for creating a tract for nephrostomy tube creation is provided comprising:
In some embodiments, the system further comprises a second wire having an outer diameter larger than an outer diameter of the proximal segment of the puncture wire and larger than an inner lumen of the reduced diameter tip region to expand the reduced diameter tip region when received therethrough.
In some embodiments, the second catheter has an inner diameter equal to or larger than an outer diameter of the second wire.
So that those having ordinary skill in the art to which the subject invention appertains will more readily understand how to make and use the surgical systems disclosed herein, preferred embodiments thereof will be described in detail hereinbelow with reference to the drawings, wherein:
The present invention in some aspects provides methods of wire exchange at the flank, over an emergent section of the puncture wire section of the puncture wire extending from the flank and skin. In general, two systems/methods are disclosed, both utilizing a puncture wire and a protective sheath. Each of the two systems employ single lumen exchange catheters and are described in detail below. It should be appreciated that multiple lumen catheters could also be utilized provided they meet the dimensional aspects advantages of the single lumen catheters as used in the methods disclosed herein.
In the first system described herein, a single lumen catheter/dilator is used for insertion of an endourology working wire. This simplifies the components and procedural steps of the surgery. In the second system described herein, two single lumen catheters are utilized: a first catheter dilates the tissue around the puncture wire to ease passage of the second catheter over the puncture wire, the second catheter then provides for passage of the larger endourology working wire. More specifically, in the first system, a single lumen catheter is passed over the emergent puncture wire, followed by removal of the puncture wire and insertion of a larger wire, followed by removal of the single lumen catheter leaving the larger wire in place. In the second system, two single lumen catheters are utilized wherein a first catheter is passed over the puncture wire, followed by removal of the first catheter, then insertion of a second larger catheter over the puncture wire, and then removal of the puncture wire and advancement of a second wire into the second catheter, followed by removal of the second larger catheter, leaving the second wire in place.
The present invention also provides in some aspects in some embodiments a puncture wire construction which advantageously adds stability to advancement of an exchange catheter thereover and/or reduces kinking of the wire. This is also discussed in detail below.
The present invention in some aspects provides accessing as well as selecting a calyx under direct visualization utilizing an ureteroscope in order to create a nephrostomy tract.
In accordance with some embodiments of the present invention, a puncture wire is advanced through a working channel of an ureteroscope which has been passed into the kidney in retrograde fashion. The puncture wire is then deployed from the ureteroscope working channel through a surgeon selected calyx and through the kidney and out the flank and skin in a retrograde fashion. This technique obviates the need for antegrade access to the calyx as antegrade access disadvantageously requires significant technical skill due to limited targeting systems which typically function in two dimensions and creates potential risks for the patient including relatively high radiation exposure. This retrograde approach provides improved three-dimensional endoscopic targeting and protects the renal anatomy to prevent tissue damage during the procedure.
The present invention also provides methods for renal access after nephrostomy tube creation. Various methods for such renal access are described in detail below.
Additionally, the present invention provides various kits containing the components for practicing the various methods disclosed herein.
In the drawings, like reference numerals identify similar or like components throughout the several views.
As used herein the term “proximal” denotes the region closer to the user and the term “distal” denotes the region further from the user.
With reference to
The sheath 20 preferably has a length of between about 70 cm to about 170 cm, and more preferably between about 85 cm to about 115 cm. With this length, the sheath 20 has sufficient length for insertion through the entire working channel 42 of the ureteroscope 40, which typically has a length of approximately 85-95 cm including the portion of channel within the ureteroscope handle. The sheath is preferably a 2.5-2.7 French sheath, having an internal diameter that is sufficient to receive the puncture wire. Other dimensions are also contemplated such as sheath diameters of between about 0.038 inches and about 0.07 inches. The sheath is preferably composed of PTFE (e.g., polyimide or similar), although other materials are also contemplated. The sheath can be constructed with braiding or high durometer materials.
The puncture wire 30 and sheath 20 are releasably locked together by a conventional vise lock 50.
Note the locking mechanism depicted in
The system also can also in some embodiments include a sheath locking mechanism, such as a circumferentially tightening O-ring mechanism for locking the sheath 20 to a working channel of the ureteroscope 40 as described in U.S. Pat. Nos. 8,888,787, and 8,771,287, the entire contents of each of these patents incorporated herein by reference.
The puncture wire 30 of
The puncture wire 80 of the alternative embodiment of
The segment 82 of wire 80 can have a uniform diameter or have an increased diameter at a more proximal region. The segment 82 serves as a bridge over which an exchange catheter is passed. This segment 82 being thicker prevents kinking of the wire 80 during advancement of the exchange catheter from “outside to inside” over the wire. This segment 82 is also thicker than the distal segment 86 of the puncture wire 80 and prevents kinking of the exposed segment above and outside the ureteroscope during advancement. The proximalmost segment of wire 80 can be of the same diameter as the remaining segment 82 or can be of a larger diameter to provide an even thicker kink preventive segment. The proximalmost segment could also in alternative embodiments be a little smaller in diameter that the segment 82 but larger than the diameter of segment 86. The proximalmost segment of the puncture wire 80 is exposed outside the flexible ureteroscope as shown for example in
The puncture wire 90 (as well as the other puncture wires disclosed herein) has a diameter less than a diameter of the endourology working wire, also referred to herein as the replacement wire. This can be appreciated by reference to
It should be appreciated that puncture wire 90 is shown side by side with replacement wire 96 (also referred to herein as the endourology wire, working wire or the second wire) by way of example. The other puncture wires 30, 70 and 80 would also preferably have an outer diameter in the ranges set forth above (diameter “a”) and function in the same manner as puncture wire 90. Also, as should be appreciated, in the methods described below, puncture wire 90 is described and shown by way of example, it being understood that other puncture wires, e.g., puncture wire 30, 70 and 80, can also be used in the same manner as puncture wire 90.
A conventional ureteroscope 40 is shown in
The puncture wire 90 preferably has a length of between about 130 cm to about 185 cm, and more preferably a length of about 160 cm. With this length, the puncture wire 90 has sufficient length for insertion through the entire working channel 42 of the ureteroscope 40 as well as sufficient length to exit therefrom and extend through the flank and skin. The puncture wire can be composed of stainless steel, although other materials are also contemplated. Note that other wire lengths and diameters are also contemplated.
The puncture wires of the
As noted above, there are two different systems/methods of the present invention. One system (referred to herein as the “first” system solely for convenience) includes a single lumen dilator catheter 100 with a lumen 111 as shown in
In the illustrated embodiment, the catheter 100 has an inner diameter “a” at the distal tip which is the same (or substantially the same) as the outer diameter “a” of the puncture wire 90. Catheter 100 has an inner diameter “b” which is greater than the outer diameter “a” of the puncture wire and equal to (or slightly larger than) the outer diameter “b” of working wire 96 as shown in
In the first system, the single lumen dilator/catheter in preferred embodiments is about 12 cm to about 50 cm in length, and preferably about 20 to about 40 cm. This catheter preferably has an inner diameter of at least 0.025″ and less than 0.055″. It could also have an inner diameter between about 0.035″ and about 0.045″ to accommodate the larger diameter second endourology working wire after removal of the narrower puncture wire from within.
Note
The second catheter of the second system, designated by reference numeral 118, has a larger inner diameter and larger outer diameter than catheter 114. Catheter 118 has a lumen 119 at distal tip 120 tapering distally to a reduced diameter lumen 119a at the second section of the lumen at the distal tip. The inner diameter at tip 120, i.e., the diameter of lumen 119a, at the distalmost entry into the catheter 118 has a diameter “b” which matches or substantially matches the diameter “b” of the working wire 96 so the second catheter 118 is large enough to pass over the larger second wire 96.
Thus, in this two-catheter embodiment, while the inner diameter of the first catheter 114 is smaller than the outer diameter of the larger wire 96, the outer diameter of the first catheter 114 is larger than the outer diameter of the second wire 96. This means that the catheter 114 passes snugly over the thin first puncture wire 90 and its outer diameter will stretch fascia larger than the second wire 96 so that when the second catheter 118 is loaded over the puncture wire 90, the clearance/space between the puncture wire outer diameter and the tip inner diameter won't prevent advancement as the tissues will have been stretched already.
Note the size/diameter relationship is discussed above with respect to puncture wire 90, but is also applicable to the other puncture wires disclosed herein.
Turning now to the method of use, and with reference to
If during insertion of the ureteroscope 40 a stone is encountered under visualization that is blocking the path to the desired calyx C, e.g., calyx C1, C2, C3 etc., a laser fiber (not shown) can be inserted through the working channel 42 of the already positioned ureteroscope 40 to perform laser lithotripsy to reduce the size of the stone to allow access by the ureteroscope 40 to the desired calyx. The laser fiber can then be removed from the working channel 42.
After placement of the ureteroscope 40 at the desired location, e.g., into calyx C1 of
The puncture wire 90 and sheath 20 are then advanced in the first direction through the working channel exiting just distal of the tip 45 of the ureteroscope 40 (beyond distal opening 47 as shown in
To next advance the puncture wire 90 further through the scope 40 and sheath 20, actuator 23 of pin vise lock 21 is rotated as described above, thereby releasing the locking engagement of the puncture wire 90 and sheath 20. This enables advancement of the puncture wire 90 (see arrow in
It should be appreciated that alternatively the sheath 20 and puncture wire 90 can be locked together by the pin vise locking mechanism 50, with the puncture tip 94 slightly protruding from the sheath 20, and advanced together through the flank tissues rather than only the puncture wire 30 being advanced through the flank tissues.
At this point, one of two methods/systems for insertion of the working wire can be utilized. One method is shown in
The first method is a single catheter system and utilizes catheter 100 of
In this way, the catheter 100 can be easily slid over the puncture wire and the tip of the catheter is not expanded during insertion of the puncture wire. The catheter tip has zero or close to zero clearance over the puncture wire. The narrower tip permits easy passage of the catheter tip through the flank fascia and renal capsule over the puncture wire, and the larger inner diameter (
The diameter of the lumen of catheter 100 closely matches (is substantially equal) the OD of the working (urology) wire 96, except at the tip:
Therefore, when the urology wire 96 is inserted through the catheter 100, it will expand (dilate) the tip as described below in reference to
The second method utilizes two catheters as shown in
In this manner, the puncture wire does not expand the distal tip of the first catheter 114.
However, the lumen of the first catheter 114 (CT 1) is less than the OD of the working wire 96:
In this manner, the first catheter 114 cannot receive (pass over) the working wire.
The second catheter 118 (referred to herein as CT 2) of the second system has a lumen equal to the outer diameter of the working wire 96:
In this manner, the second catheter 118 can receive the working wire 96.
Note CT2 can have in alternate embodiments a tapered tip less than the OD of the working wire which would be expanded by the working wire. In other embodiments, the lumen at the tapered tip and proximal of the tapered tip is greater than the OD of the working wire.
Turning to the first method of
In the next step, illustrated in
After the catheter 100 is advanced far enough over the puncture wire 90 into the patient to be positioned in the ureter as shown in
Next, the catheter 100 is removed in the direction opposite the direction of its insertion (in the retrograde direction of the arrow of
An alternate embodiment of the “wire exchange” system and method of the present invention is illustrated in
In
The first catheter 114 is then removed in a direction opposite its direction of insertion (
Once the second catheter 118 is advanced antegrade into the ureter (
It is also contemplated that in an alternate embodiment, the puncture wire can be utilized without a protective sheath and inserted directly into the ureteroscope 40. The working channel 42 of the ureteroscope in this embodiment would thereby protect the puncture wire during insertion. This would reduce the number of components. Such sheathless puncture wire can be utilized with either method disclosed herein.
In these sheathless embodiments, the puncture wire can be locked to the operating (working) channel 42 of the ureteroscope 40 during insertion of the ureteroscope 40 into the calyx, and then the puncture wire released from locking engagement with the ureteroscope 40 to enable advancement distal of the end of the ureteroscope through the flank and skin. Such locking can be achieved with a vise lock or a locking mechanism similar to locking mechanism 60 described above, with the O-ring clamping on the puncture wire. Such embodiments enable a larger diameter puncture wire to be utilized, which could enable passage of a dilation balloon or other treatment devices directly over the puncture wire, thereby obviating the need for an exchange catheter and a second wire.
It is also contemplated that the characteristics of the puncture wire can be altered. For example, a coating can be applied to improve lubriciousness, and such coating can extend on a portion of or the length of the wire proximal of the tissue puncturing region. Coating with a low friction coefficient material could increase the wire caliber without significantly changing its handling properties. Preferably, the coating would not be applied to the distal 20-30 cm of the wire that is used to puncture the kidney, flank and skin.
The protective sheath for the puncture wire may be constructed to be thin walled to permit the entire puncture wire/protective sheath duo to maintain a small enough total diameter for passage through the working channel of ureteroscope. Use of materials such as PTFE (Teflon) or polyimide for sheath construction may have beneficial properties for this application.
The sheath may be constructed or post-processed to have enhanced visibility under ultrasound imaging. This may be achieved by any number of techniques, which may include but are not limited to placing a ceramic, graphite, Teflon, tungsten, Nitinol or platinum tip or outer coating on all or part of sheath or creating with or post-processing the sheath using laser or other abrasing or cutting technology to create small or microscopic grooves or indentations/dimples in the outer surface of the sheath to increase echogenicity.
It is also contemplated that all or part of the puncture wire and/or the exchange wire may be designed to have enhanced ultrasound visibility. This may allow for reduced radiation exposure during nephrostomy creation by allowing ultrasound guided confirmation of wire location during deployment. Options to achieve this include, but are not limited to the following: 1) Constructing the puncture wire and/or the exchange wire entirely of, or with a component of, a highly ultrasound-visible metal or other material. Examples include, but are not limited to, cobalt/chromium, graphite, Teflon, platinum or tungsten. These components may be mixed with stainless steel as an alloy or simply the distal tip of the wire can be made of these materials. 2) Coating the puncture wire and/or exchange wire with ceramic material, graphite, Teflon, tungsten, platinum, other metals or polymers, or material impregnated with microbubble technology such as glass microspheres, air microbubbles, or other adherent echogenic polymeric films. 3) The puncture wire and/or exchange wire may be constructed with or post-processed to create uneven surface(s) such as by brushing, lasering, creating indentations or cutting the outer surface of the wire. This would increase echogenicity of the wire.
Note the distal tip of the catheters can be radiopaque for localizing by fluoroscopy. To enhance imaging, additional regions of the catheter can be composed of radiopaque material, and even the entire length of the catheter.
The catheter may be constructed or post-processed to have enhanced visibility under ultrasound imaging. This may be achieved by any number of techniques, which may include but are not limited to placing a ceramic, graphite, Teflon, tungsten, Nitinol or platinum tip or outer coating on all or part of the catheter or creating with or post-processing the catheter using laser or other abrasing or cutting technology to create small or microscopic grooves or indentations/dimples in the outer surface of the catheter to increase echogenicity.
To create a nephrostogram to identify renal pelvis anatomy during balloon dilation of nephrostomy tract, the ureteral safety guidewire placed during the ureteroscopy portion of the procedure can be exchanged for a ureteric catheter through the urethra. Retrograde nephrostogram is performed through the ureteric catheter. A Foley catheter is placed in the bladder.
The sheath and catheters of kits 140 and 150 could also be packaged in a different configuration than the illustrated L-shape and in different locations than that shown.
In the setting of retrograde nephrostomy creation for endourologic surgery the retrograde nephrostomy wire is typically deployed through a flexible ureteroscope positioned in a renal infundibulum, with the ureteroscope tip facing the renal papilla. The puncture wire travels straight, through the renal capsule, perinephric fat, and flank musculature.
After successful retrograde nephrostomy renal puncture with the puncture wire tip emergent from the flank skin, typically the segment of the puncture wire that bridges the outside flank skin to the kidney is not optimal to effect the subsequent endourologic surgery; typically the puncture wire segment is of smaller diameter and more prone to kinking than a standard endourology working wire. The reason this is not optimal is that advancement of instrumentation over this emergent wire in the direction opposite to the puncture may cause a kink of the wire serving as a guide/bridge to the kidney, or ‘slicing’ of kidney/fascia if tension is applied to the emergent wire tip during advancement of instrumentation.
Upsizing and exchange of the puncture wire for a standard endourology working wire in accordance with devices and methods of the present invention is described above, wherein an exchange catheter (or two catheters in the two-catheter systems) is advanced (in a direction opposite the retrograde nephrostomy puncture) over the emergent puncture wire at the flank into the kidney and possibly the ureter. After removal of the inner puncture wire and possible an inner dilator of the exchange catheter (if a coaxial catheter system is used), a new endourology working wire is next advanced into position in the collecting system.
In an embodiment of the present invention, a modification to the exchange catheter system (whether a single catheter system or a coaxial catheter system is used) is provided to create a radiovisible tip. With reference to
In the alternate embodiment of
This ability to discern clearly the tip of the exchange catheter 200, 210 advantageously allows the surgeon to determine where desired to deploy the new, second endourology wire in the renal portion of the collecting system to avoid positioning the second wire in the ureter, or in the ureter itself.
More specifically, as shown in
One example of the method of use of the catheter 200 will now be described, it being understood that catheter 210 can be used in the same fashion. The method steps in this example are as follows:
In one embodiment of this system, the nephrostomy puncture wire has various properties along its length as shown in
A kit is contemplated containing a nephrostomy puncture wire with a tip-protective sheath and releasable clamp for securement of the wire and sheath, and an exchange catheter with the feature of a radiovisible tip (e.g., platinum band at the tip or doping of the partial or the entire exchange catheter itself so that tip is visible along with the portions of the catheter or the entire catheter).
Nephrostomy tracts are generally created to permit placement directly into the kidney from the flank typically of endoscopes of various configurations to perform an endourologic procedure (typically renal stone removal, but also cancer treatment, reconstruction, stricture treatment, robotics, etc.). This class of endoscopes typically has an illumination function, a video function, a fluid channel for fluid flow, such as for irrigation, drainage, etc., and a working channel for instrumentation insertion (such as a laser, basket, etc.)
The range of diameters of these endoscopes (or catheters) are generally between 8 French and 27 French. These mini-perc and micro-perc sets for minimally invasive percutaneous techniques can be between 10 French and 24 French to allow the physician to perform a percutaneous endourology procedure through smaller diameter tracts than the historically popular 30 French tracts. The mini-perc and microperc sets reduce the size of the skin incision, fascial defect, and renal defect to reduce trauma to the tissues while allowing effective endourologic surgery to be performed.
In the setting of retrograde nephrostomy creation for endourologic surgery. the retrograde nephrostomy wire is typically deployed through a flexible ureteroscope positioned in a renal infundibulum, with the ureteroscope tip facing the renal papilla. The puncture wire travels straight, through the renal capsule, perinephric fat, and flank musculature.
The present invention provides in some embodiments a retrograde nephrostomy puncture wire with two functions: 1) retrograde nephrostomy puncture and 2) bridge over which endourology scopes or sheaths, with tapered dilating tips, are advanced into the kidney. This dual function nephrostomy puncture wire eliminates the need to exchange the puncture wire for an endourology working wire, and in some applications may permit elimination of the need for a wire exchange catheter e.g., coaxial or single lumen wire exchange catheter systems.
The dual function nephrostomy puncture wire can be of single diameter and stiffness along its length or may have different properties along its length.
Described below are several examples of methods of use of the dual puncture wire. Note the puncture wire 220 shown in these dual function puncture wire examples has a single diameter along its length except for the distal pointed/sharp tip. However, it should be appreciated that other puncture wires, such as puncture wire 250 having varying stiffnesses along its length, can be utilized. Therefore, the methods described in the examples below are fully applicable to use of puncture wire 250 as well as fully applicable to other puncture wires having other dimensions, properties, penetrating tips, etc. Note the ureteroscope shown in the dual function puncture wire examples is the ureteroscope 40 of
The steps of this procedure are as follows and are shown in
The steps of this procedure are as follows and are shown in
The steps of this procedure are as follows and are shown in
The steps of this procedure are as follows and are shown in
The steps of this procedure are as follows and are shown in
During the initial retrograde nephrostomy puncture wire advancement, the puncture wire passed through the flank fascia, traverses the flank fat and emerges at the flank skin. The subcutaneous fat has a variable thickness depending on the patient's body habitus. The retrograde nephrostomy puncture wire can deflect slightly while traversing this subcutaneous fat, and thus may deviate from its precise alignment with the infundibular long axis (see axis L of
Fluoroscopy is a guide to the path of the puncture wire advancing through the subcutaneous fat. Two limitations of the current system of retrograde nephrostomy are: 1) Fluoroscopy is a two-dimensional imaging modality; the wire path is three dimensional, so exact position of the wire in three dimensions is not knowable using biplanar fluoroscopy, unless more advanced fluoroscope rotations are employed. These are difficult to learn and teach and use ionizing radiation; and 2) There is not currently a retrieval system for a wire in the subcutaneous fat; wire emergence at the flank is passive at this time.
That is, in some cases, such as in obese patients with longer paths to the flank skin, the puncture wire advancement does not emerge from the flank skin before it deflects from its original course or stalls in subcutaneous or flank tissues. Despite the wire not emerging at the skin, the complex anatomy of the kidney and flank muscles have been successfully and safely penetrated; in these cases, the only remaining task is to deliver the wire from the subcutaneous tissues, or flank tissues, to complete the puncture portion of the procedure, prior to applying catheter(s) over the emergent wire for wire exchange (or prior to applying endoscopes over the emergent wire as described herein). The present invention provides several strategies to effect retrieval of the puncture wire from the subcutaneous tissues. These may include, but are not limited to: (1) ultrasound localization of the wire, and then incision of the skin and retrieval of the puncture wire tip with a clamping device; (2) fluoroscopy based localization of the wire, and then incision of the skin and retrieval of the puncture wire tip with a clamping device or; (3) preplacement of radiopaque or ultrasound visible markers on the flank skin, to inform the positioning of the ureteroscope tip prior to puncture wire advancement, or to inform a skin incision at the flank to retrieve an already deployed puncture wire. For example, if one or more radiopaque markers are placed on the skin, they can serve as a reference point to the fluoroscopic position of the puncture wire in the subcutaneous tissues to direct a skin incision to find and capture the puncture wire tip that has not emerged from the skin. This is shown for example in
Regardless of which method to complete wire retrieval from the flank is employed, subsequent wire exchange at the flank may proceed with either coaxial catheter, single lumen catheter, or serial dilators to exchange the puncture wire for a larger diameter endourology working wire or sheaths, catheters or scopes can be placed over the emergent puncture wire in accordance with some of the methods described herein.
To the extent that each fluoroscopy image is two dimensional, for any one fluoroscopy image, the wire's position in the third dimension remains unknown. Typically, this unknown dimension is the ‘anterior/posterior’ position, though this can be any third dimension. Thus, in this approach of the present invention, the surgeon may need to attempt wire capture at more than one position in the third, unknown plane, until the wire is captured. Alternatively, the fluoroscope can be rotated to inform the third plane. Once the wire 220 is captured, the clamp 340 is drawn out of the skin thereby completing the retrograde nephrostomy procedure as the captured wire 220 can be advanced out the flank. The puncture wire 220 can then be exchanged with a flexible catheter advanced over the puncture wire 220, where this catheter will enter traverse the flank tissues, kidney, and ureter, to permit “through and through” renal access. This exchange catheter can be a single lumen, dual lumen, or coaxial in configuration as described in detail herein. Alternatively, the puncture wire could be a dual function wire as described above and a sheath, catheter or scope passed over the emergent puncture wire to enable the endourology procedure.
In another approach/method of the present invention for wire alignment, a multi-function port is utilized to provide access for a clamping instrument rather than direct insertion as in the embodiment of
The port 350 includes a light to illuminate the subcutaneous or perinephric space (though the subcutaneous space is considered preferable), compatibility with, or a built in camera which connects to a display monitor for visualization, a channel/lumen 354 for fluid or insufflation and drainage, and a working channel 355 to permit advancement of a grasping (clamping) member to capture the puncture wire 220 seen under direct endoscopic vision. In alternate embodiments, the fluid channel 354 could also be used as the working channel for the grasper so fewer channels could be provided. An integrated grasper function is also contemplated wherein for example the grasper member is part of and not removable form the port. Preferably, the port includes an access port and channel (see e.g., channel 354) capable of transmitting a fluid or gaseous medium to create tissue separation to permit increased visibility of the puncture wire in the subcutaneous or perinephric space though the subcutaneous space. Once the port 350 is in position, the tissue working space is increased with fluid or gas, the light/camera (illumination/imaging) system is employed directed toward the puncture wire 220, and the grasper 340 is used to capture the puncture wire 220 either at its tip or along its length. Note the grasper of the embodiments of
Note
Once the wire 220 is securely grasped by the clamping member 340, two approaches/methods are contemplated, referred to herein as Approach (method) A and Approach (method) B for convenience.
In Approach A, the port 350 and captured wire 220 are removed through the skin S in the same direction as the retrograde puncture advancement, thereby completing the retrograde nephrostomy creation procedure. The clamping member 340 is released from the puncture wire 220 and removed with the port 350 (
In Approach B (
This atraumatic tip for tissue dilation may either be at the distal end of an intubating obturator 380 within a working channel of the port 370 and removable therefrom as shown in
In an alternate embodiment, there are two separate ports; the first port to retrieve the puncture wire and the second port to effect the planned endourology procedure.
It should be appreciated that this concept of retrograde nephrostomy puncture wire directed targeting of renal access could be applied to treatment of renal tumors or other renal parenchymal diagnostics or therapeutics (beyond the collecting system space), wherein the retrograde puncture wire path, once controlled, is leveraged toward a directed and safe advancement of a diagnostic or therapeutic member (e.g., endoscope or port or catheter) over the controlled puncture wire in a direction opposite the retrograde puncture.
In the setting where an exchange catheter is used to change the emergent retrograde nephrostomy puncture wire at the flank, the method steps are as follows. Any of the puncture wires disclosed herein can be utilized with this method.
In this setting, the subsequent endourology procedure may require tract dilation using a sheath and inner tapered dilator, a sheath/nephrostomy dilation balloon, etc., or a diagnostic/therapeutic catheter, e.g., chemotherapy catheter, nephrostomy catheter.
A kit is contemplated herein which would include the nephrostomy puncture wire and sheath, with releasable lock, an exchange catheter (single or coaxial lumen), an endourology working wire, and any of 1) a sheath/releasable inner dilator; 2) sheath/nephrostomy balloon; 3) (1) or (2) above AND either (a) a diagnostic/therapeutic catheter, or (b) an endoscope (e.g., miniperc).
In the scenarios herein where an exchange catheter is discussed, a dual lumen exchange catheter is described. One embodiment of the exchange catheter is shown in
The procedure for use of this exchange catheter is as follows:
The various components of the present invention, e.g., wires, sheaths, catheters, scopes, etc., can be packaged as various kits. Examples of such kits are as follows. Note other combinations of components, i.e., other kits, are also contemplated to facilitate performance of the methods disclosed above and illustrated in the drawings.
A nephrostomy puncture wire and tip protective sheath with releasable clamp as well as a separate dilator/sheath. A separate working endoscope may or may not be included.
A nephrostomy puncture wire and protective sheath with releasable clamp as well as an endoscope with a releasable inner dilator inside the endoscope lumen.
A nephrostomy puncture wire and protective sheath with releasable clamp, and a balloon nephrostomy tract dilation set and sheath. A separate endoscope may or may not be included.
A nephrostomy puncture wire and protective sheath with releasable clamp, along with an endoscope with a tapered tip.
A nephrostomy puncture wire and protective sheath with releasable clamp, along with a diagnostic and/or therapeutic catheter with a tapered tip.
A dual function puncture wire in a protective sheath with releasable clamp. The puncture wire could have multiple properties.
A nephrostomy wire and protective sheath with releasable clamp, and an endourology scope, e.g., for miniperc, microperc, endourologic surgery. This scope would have capabilities including connection to video, and one or more channels for irrigation/instrumentation. This scope may have a narrowed tip to permit atraumatic insertion into the kidney.
A nephrostomy puncture wire and protective sheath with releasable clamp, along with a separate wire clamp, e.g., tonsil clamp or Halstead style clamp, to control the emergent wire at the flank, and possibly to capture the wire while in a subcutaneous position. This clamp could be radio-opaque to aid in wire delivery under fluoroscopic guidance. This clamp could be compatible with the working channel of an endourology scope which may be included in the kit, such that the wire clamp could be inserted through the scope and used to capture the wire using the endoscope video and irrigation function.
A nephrostomy puncture wire and a wire exchange catheter whose tip is radiopaque either with a radiopaque tip alone (e.g., platinum band or similar) or with a radiopacifying agent mixed in the catheter material, in the form of either a single or coaxial system catheter system (to allow upsizing the puncture wire to a standard 0.035″ or 0.038″ endourology working wire).
Same as the kit example 9, with an endourology scope included.
A dual lumen exchange catheter. This kit may or may not include a nephrostomy puncture wire with protective sheath and releasable lock, and may include other items per above kits to effect the endourology procedure.
While the above description contains many specifics, those specifics should not be construed as limitations on the scope of the disclosure, but merely as exemplifications of preferred embodiments thereof. Those skilled in the art will envision many other possible variations that are within the scope and spirit of the disclosure as defined by the claims appended hereto.
Although the apparatus and methods of the subject disclosure have been described with respect to preferred embodiments, those skilled in the art will readily appreciate that changes and modifications may be made thereto without departing from the spirit and scope of the present disclosure as defined by the appended claims.
Additionally, persons skilled in the art will understand that the elements and features shown or described in connection with one embodiment may be combined with those of another embodiment without departing from the scope of the present invention and will appreciate further features and advantages of the presently disclosed subject matter based on the description provided.
Throughout the disclosure invention, terms such as “approximately,” “generally,” “substantially,” and the like should be understood to allow for variations in any numerical range or concept with which they are associated. For example, it is intended that the use of terms such as “approximately” and “generally” and “substantially” should be understood to encompass variations on the order of 25%, or to allow for manufacturing tolerances and/or deviations in design.
Although terms such as “first,” “second,” “third,” etc. may be used herein to describe various operations, elements, components, regions, and/or sections, these operations, elements, components, regions, and/or sections should not be limited by the use of these terms in that these terms are used to distinguish one operation, element, component, region, or section from another. Thus, unless expressly stated otherwise, a first operation, element, component, region, or section could be termed a second operation, element, component, region, or section without departing from the scope of the present disclosure.
Each and every claim is incorporated as further disclosure into the specification and represents embodiments of the present disclosure. Also, the phrases “at least one of A, B, and C” and “A and/or B and/or C” should each be interpreted to include only A, only B, only C, or any combination of A, B, and C.
This application claims priority to three provisional applications 63/351,463, filed on Jun. 13, 2022, 63/391,771, filed on Jul. 24, 2022 and 63/391,785, filed on Jul. 24, 2022 and is a continuation in part of application Ser. No. 17/860,176, filed on Jul. 8, 2022 which claims priority to provisional application 63/315,578 filed on Mar. 2, 2022, 63/254,101, filed on Oct. 9, 2021, 63/254,128, filed on Oct. 10, 2021, and 63/254,503, filed on Oct. 11, 2021. The entire contents of each of these applications are incorporated herein by reference.
Number | Date | Country | |
---|---|---|---|
63391785 | Jul 2022 | US | |
63391771 | Jul 2022 | US | |
63351463 | Jun 2022 | US | |
63315578 | Mar 2022 | US | |
63254101 | Oct 2021 | US | |
63254128 | Oct 2021 | US | |
63254503 | Oct 2021 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 17860176 | Jul 2022 | US |
Child | 18207713 | US |