Source: https://patents.google.com/patent/US10258355B2/en
Timestamp: 2019-10-21 04:17:41
Document Index: 177132758

Matched Legal Cases: ['§ 119', 'Application No. 62', 'Application No. 62', 'Application No. 62', 'arts 73', 'art 73', 'arts 73']

US10258355B2 - Endoscopic stone-extraction device - Google Patents
Endoscopic stone-extraction device Download PDF
US10258355B2
US10258355B2 US15/175,893 US201615175893A US10258355B2 US 10258355 B2 US10258355 B2 US 10258355B2 US 201615175893 A US201615175893 A US 201615175893A US 10258355 B2 US10258355 B2 US 10258355B2
US15/175,893
US20160278798A1 (en
2014-06-12 Priority to US201462011367P priority Critical
2014-08-05 Priority to US14/452,179 priority patent/US9655634B2/en
2016-06-07 Application filed by Innon Holdings LLC filed Critical Innon Holdings LLC
2016-06-07 Priority to US15/175,893 priority patent/US10258355B2/en
2016-06-13 Assigned to INNON HOLDINGS, LLC reassignment INNON HOLDINGS, LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DHINDSA, AVTAR S.
2016-09-29 Publication of US20160278798A1 publication Critical patent/US20160278798A1/en
2019-04-16 Publication of US10258355B2 publication Critical patent/US10258355B2/en
238000000605 extraction Methods 0 abstract claims description title 48
239000004575 stone Substances 0 description 61
An endoscopic stone-extraction device is provided comprising a support filament comprising an end portion, a sheath comprising a lumen, wherein the support filament is disposed in the lumen such that the sheath is slideable with respect to the support filament, and a handle comprising an actuator. Movement of the actuator in a first direction retracts the sheath and causes a shape to expand outside the lumen. Movement of the actuator in a second direction advances the sheath and causes the shape to at least partially collapse inside the lumen. Other embodiments are provided, and any of these embodiments can be used alone or in combination.
This application is a divisional of U.S. patent application Ser. No. 14/452,179, filed on Aug. 5, 2014, entitled “Endoscopic Stone-Extraction Device,” which claims the benefit under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 62/011,367, filed Jun. 12, 2014, and entitled “Endoscopic Stone-Extraction Device.” U.S. patent application Ser. No. 14/452,179 and U.S. Provisional Application No. 62/011,367 are assigned to the assignee of the present application. The subject matter disclosed in U.S. patent application Ser. No. 14/452,179 and U.S. Provisional Application No. 62/011,367 is hereby incorporated by reference into the present disclosure as if fully set forth herein.
Basket-type devices have been used for extracting stones such as ureteral stones, calaceal stones and other calculus and the like from the renal or biliary systems. Various types of stone extraction baskets have been used in the past to extract stones and stone fragments (or other debris) from various biological systems. A typical stone extraction basket includes a wire basket carried by one end of a wire that is received within the lumen of a sheath. The end of the wire opposite the basket is secured to a handle that is used to slide the sheath over the wire, thereby moving the basket into and out of the lumen of the sheath. When the basket is out of the sheath, it expands to receive a stone. The sheath is then moved toward the basket to reduce the size of the basket openings, and the basket and the enclosed stone are removed from the body. Ultrasonic, laser, and electro-hydraulic techniques have been used to fragment stones in situ. Typically, the stone fragments are left in the body to be excreted or can be attempted to be removed with a stone extraction basket or the like.
FIG. 1 illustrates perspective view of an endoscopic stone extraction device of an embodiment;
FIGS. 3, 4 and 5 illustrate detailed views of a thumb wheel included in the embodiment of FIGS. 1 and 2.
FIG. 6 illustrates an exploded perspective view of a portion of the handle and the end portion of the wire of the embodiment of FIGS. 1 and 2.
FIG. 6A illustrates an exploded perspective view of the elements 73, 74 of FIG. 6 from another viewing angle.
FIG. 7 illustrates a cross-sectional view corresponding to that of FIG. 2 of another embodiment.
FIG. 8 illustrates a fragmentary side view of selected elements of the embodiment of FIG. 7.
FIGS. 9-12 illustrate an endoscopic stone-extraction device of an embodiment having a tapered corkscrew shape.
FIGS. 13-16 illustrate an endoscopic stone-extraction device of an embodiment having a non-tapered corkscrew shape.
FIGS. 17-20 illustrate an endoscopic stone-extraction device of an embodiment having an arced corkscrew shape.
FIGS. 21-24 illustrate an endoscopic stone-extraction device of an embodiment having a rake shape.
FIGS. 25-26 illustrate an alternate rake shape of an embodiment.
FIGS. 27A-30 illustrate an endoscopic stone-extraction device of an embodiment having an open basket, circular shape.
FIGS. 31-32 illustrate an endoscopic stone-extraction device of an embodiment having a meshed basket, circular shape.
FIGS. 33-36 illustrate an endoscopic stone-extraction device of an embodiment having an open and closed basket, rectangular shapes.
FIGS. 37-40 illustrate an endoscopic stone-extraction device of an embodiment having an open and closed basket, triangular shapes.
FIGS. 41-44 illustrate an endoscopic stone-extraction device of an embodiment having a two-dimensional meshed shape.
FIG. 45 illustrates a handle of an endoscopic stone-extraction device of an embodiment.
FIG. 46 illustrates a handle of an endoscopic stone-extraction device of an embodiment, wherein the handle has a laser fiber entry port.
FIG. 47A illustrates a cross-section of a sheath of an embodiment where a laser fiber is internal to a stone-extraction filament.
FIG. 47B illustrates a cross-section of a sheath of an embodiment where a laser fiber is external to a stone-extraction filament.
FIG. 48 illustrates a two-port endoscope that can be used with an endoscopic stone-extraction device of an embodiment.
FIG. 49 illustrates a Y-adapter that can be used with the two-port endoscope of FIG. 48.
In a stone-removal procedure, an endoscope (e.g., a ureteroscope) is inserted into the body, with the distal end of the scope near the stone to be extracted. As shown in FIG. 48, an endoscope 200 typically has two ports 210, 220. One of the ports 210 is typically used as an irrigation port (for saline to be introduced into the extraction site), and the second port 220 is used for various instruments. In some situations, the second port 220 is initially used for the sheath that holds a stone extraction basket (however, other situations are possible, as will be discussed below).
The procedure begins with inserting the endoscope into the body (e.g., inserting the ureteroscope into the ureter) and identifying and locating the stone. Once the stone is identified, a decision is made whether the stone can be extracted out intact or whether the stone needs to be fragmented because it is too large to be extracted out. There are several technologies that are available for fragmentation, and a popular and effective technology is a laser. One of the problems faced during fragmentation is retropulsion, whereby the stone migrates up the ureter towards the kidney. Retropulsion makes the procedure more difficult and is associated with more complications.
To prevent migration of the stone, a mechanical device can be used as a backstop to the stone. When a mechanical backstop/trapping device is used, the scope is inserted, the stone is identified, and the mechanical backstop device is inserted through one of the ports of the scope (the other port is used as an irrigation channel). The mechanical backstop device is then placed beyond the stone and deployed. Since a two-port scope does not have any other access point for the laser fiber, the mechanical backstop is left in the body, while the uretroscope is removed from the body and then reinserted. The stone is identified again, and the laser fiber is then inserted into the open port to fragment the stone. The fragmented stone can be left inside the ureter to be passed out or can be dragged into the bladder and then extracted out either by irrigation or by using a stone basket (the mechanical backstop device usually is not very effective in removing stone fragments, which is why the separate stone basket is used).
Instead of using a mechanical backstop device, a gel can be inserted into the body just beyond the stone, and the patient's body temperature heats the gel to form a jelly that acts as a backstop to the stone. After the stone fragments have been removed, the physician introduces cold saline into the patient, which dissolves the jelly so it can drain out of the ureter. As another alternative to using a mechanical backstop device, a standard stone basket can be used to engage the stone. Once the stone is engaged, the basket filament and sheath are cut at the handle and left inside the body. The ureteroscope is then removed, and the procedure is carried out as mentioned above. However, some stone baskets, such as a four-wire basket, may not serve as an effective backstop since stone fragments can escape from the sides of the basket.
There are several difficulties associated with the current procedure. First, it is a multistep process, requirement the scope to be removed and re-inserted into the patient multiple times. Second, when a mechanical backstop device is used, it may not stay in place when the scope is removed and reinserted into the body (e.g., the backstop device can move up or down the ureter and sometimes into the kidney or come out in front of the stone instead of staying behind the stone). Third, stone fragments can escape around the backstop device (or a stone basket when a separate backstop device is not used) because these devices do not completely occlude the lumen.
The following endoscopic stone-extraction devices can function both as a trapping/backstop device and a stone extraction device, which eliminates at least one of the steps in the multi-step process described above. In addition to being more effective and useful, these devices can be easier to manufacture than traditional stone baskets.
Exemplary Endoscopic Stone-Extraction Devices
FIGS. 9-44 illustrate endoscopic stone-extraction devices of several embodiments. Turning first to FIG. 9, the endoscopic stone-extraction device 900 in this embodiment has a support filament 910 comprising an end portion and a sheath 930 comprising a lumen 940, wherein the support filament 910 is disposed in the lumen 940 such that the sheath 930 is slideable with respect to the support filament 910. A handle 1700 (see FIG. 45) comprises an actuator 1710. (Any type of handle with an actuator can be used, and other examples of handles are provided below. Details of any particular handle design (discussed herein or otherwise) should not be read into the claims unless explicitly recited therein). Movement of the actuator 1710 in a first direction retracts the sheath 930 and causes the end portion to expand outside the lumen in a corkscrew shape 950. Movement of the actuator in a second direction advances the sheath 930 and causes the corkscrew shape 950 to at least partially collapse inside the lumen 940. FIGS. 10-12 show how the endoscopic stone-extraction device can be deployed to hold a stone in place before destruction and collect the stone fragments after destruction.
In this embodiment, the corkscrew shape 950 is a conical-corkscrew shape that tapers from a larger portion closer to the lumen 940 to a smaller portion farther away from the lumen 940. However, other configurations are possible. For example, FIGS. 13-16 show a non-tapered corkscrew shape 1000, and FIGS. 17-20 show a corkscrew shape 1010 that is arced in a direction generally perpendicular to an axis of the lumen 940, wherein the corkscrew shape 1010 is connected to the support filament via a plurality of secondary filaments 1020, 1030.
In another embodiment (shown in FIGS. 21-24), movement of the actuator in a first direction retracts the sheath and causes the end portion to expand outside the lumen in a rake shape 1050, wherein the rake shape 1050 is connected to the support filament via a plurality of secondary filaments 1060, 1070. The rake shape can have pointed prongs 1080 (as in FIG. 21) or rounded prongs 1090 (as in FIGS. 25 and 26).
In yet another embodiment (shown in FIGS. 31 and 32), movement of the actuator in a first direction retracts the sheath and causes the end portion to expand outside the lumen in a basket shape 2000 that tapers from a larger portion 2010 closer to the lumen to a smaller portion 2020 farther away from the lumen, wherein the larger portion 2010 is an opening of the basket shape 2000, and the smaller portion 2020 is meshed. The basket shape 2000 is connected to the support filament via a plurality of secondary filaments 2030, 2040, and the larger and smaller portions 2010, 2020 are joined together by an additional plurality of filaments 2050, 2060. The sides of the basket shape can be meshed (as in FIGS. 31 and 32) or open (as in FIGS. 27A-30). Also, the smaller and larger portions can take any suitable shape, such as circular (as in FIGS. 27A-32), rectangular/square (as in FIGS. 33-36), or triangular (as in FIGS. 37-40). Of course, other shapes can be used.
In yet another embodiment, movement of the actuator in a first direction retracts the sheath and causes the end portion to expand outside the lumen in a two-dimensional mesh shape 2500 (see FIGS. 41-44) that is generally perpendicular to an axis of the lumen, wherein the two-dimensional mesh shape 2500 is connected to the support filament via a plurality of secondary filaments 2510, 2520. The two-dimensional mesh shape can take any suitable shape, such as a square (as in FIG. 41) or other shapes.
Regarding construction, the shapes can be formed from a plurality of individual filaments, all of which are joined (e.g., welded, soldered, swaged or otherwise held in place) to the support filament, or the shapes can be formed from a single filament. That single filament can be the support filament or can be a filament that is separate from but joined to the support filament. Further, shapes can be made from a shape memory metal, such as nitinol, although other materials can be used. In one embodiment, the shape can be made from preferably small, flexible, kink-resistant wires that are capable of collapsing together to fit within the lumen. Also, the shapes can be sized in any suitable fashion. For example, in one embodiment, the opening of the shape can be sized to admit a stone that is at least two millimeters in diameter (or less) or as large as 5 mm (or more) in diameter. Of course, other sizes and ranges can be used.
Exemplary Handles
As noted above, any type of handle can be used with the stone-extraction devices of these embodiments. For example, the handle 1700 can simply be a device with an actuator 1710 to deploy the plurality of loops (as in FIG. 45). In another embodiment (see FIG. 46), the handle 1800 not only has an actuator 1810, but also has a port 1820 for a laser fiber 1830. (The omniFORCE™ Laser Stone Cage by Omnitech Systems is an example of such a handle.) As shown in FIGS. 47A and 47B, the laser fiber 1830 can either be internal to (FIG. 47A) or external to (FIG. 47B) the filament 1900, 1910 within the sheath 1840. The advantage of using this type of handle 1800 is that a two-port scope does not need to be removed and reinserted into the body in order to provide a free port for the laser fiber, as the laser fiber is already provided in the sheath 1840. Another way of obtaining this advantage of not removing the scope is by using a Y-adaptor 2100 (see FIG. 49) that would fit on one of the ports 220 of the scope 200, allowing both the stone-extraction sheath and the laser fiber to use the same port 220 on the scope 200. (The Y-adaptor used with the Escape® Basket from Boston Scientific is an exemplary adaptor.) In this alternative, it is preferred that the sheath and the laser fiber be sized so that they can both fit together inside the port 220.
As mentioned above, other handle designs can be used. The following paragraphs and drawings describe yet another handle design. Again, this and the other handle designs described herein are merely examples and should not be read into the claims.
Returning to the drawings, FIG. 1 shows an endoscopic stone extraction device 10 of an embodiment. The device 10 includes a handle 12 that in turn includes a grip 14 and a slide 16. As explained in greater detail below, the slide 16 is mounted to slide longitudinally along the length of the grip 14.
A tubular sheath 18 is secured to the slide 16. The sheath 18 defines a lumen 19, and the sheath 18 can be formed of any suitable flexible material. A strain relief collar 20 is provided at the point where the sheath 18 is secured to the slide 16 to reduce the incidence of kinking.
The device also includes a filament 22 having a first end 24 (FIG. 2) and a second end 26 (FIG. 1). The first end 24 is rotatably secured to the grip 14 (FIG. 2), and the second end 26 supports a stone extraction basket (this basket is of a different shape than the stone-extraction device discussed above, as this handle can be used with a variety of baskets). The filament 22 can be formed of any suitable material, and is typically formed of a flexible metallic wire. Preferably, the first end 24 is thicker and stiffer than the second end 26 to facilitate insertion and manipulation of the basket 28.
The following sections will first describe the handle 12 in greater detail.
As best shown in FIG. 2, the handle 12 includes a tube 30 that defines a longitudinally extending slot 32. The tube 30 forms a bore 34 and terminates at one end in external threads 36. Protruding elements 38 extend away from the perimeter of the tube 30 to facilitate the grasping of the tube 30 by a physician during use. For purposes of discussion, the portion of the tube 30 adjacent the external threads 36 will be referred to as the rear portion 42, and the opposite end of the tube 30 will be referred to as the front portion 40. The tube 30 may for example be formed of any suitable, moldable thermoplastic material, though the widest variety of materials can be adapted for use.
As best shown in FIGS. 1, 2, 6 and 6A, the handle 12 carries a threaded cap 70 that defines a set of internal threads sized to mate with the external threads 36. The cap 70 includes a socket 71 that bears on a chuck 72. When the cap 70 is tightened in place, the chuck 72 is held between the socket 71 and an internal socket 31 formed by the tube 30. The chuck 72 is free to rotate but not to translate with respect to the tube 30.
The chuck 72 includes two parts 73, each having a central groove 77 sized to clamp against the filament 22. The groove 77 may be lined with an elastomeric layer to ensure good frictional contact between the chuck 72 and the filament 22. Each part 73 defines external threads, and the parts 73 are clamped against the filament by a cap nut 74 such that the chuck 72 rotates and translates in unison with the filament 22. The chuck 72 forms a convex surface 75 that engages the socket 31, and a convex surface 76 that engages the socket 71. The surfaces 75, 76 are shaped to allow low-friction rotation of the chuck 72 and the filament 22 relative to the tube 30. Thus, the chuck 72 and associated elements carried by the tube 30 form a rotational joint. Other types of rotational joints may be used, including ball-and-socket joints. For example, a ball-and-socket joint may be included in the filament 22 near the first end 24, and the first end 24 may be fixed to the tube 30. Also, the filament may have an enlarged end that forms part of the rotational joint, and the enlarged end may be sized to fit through the lumen of the sheath 18. Alternatively, the enlarged end may be too large to fit through the lumen of the sheath, and may be removable from the body of the filament 22, e.g. by disassembling the enlarged end from the filament 22.
In use, the device 10 is assembled as shown in FIGS. 1 and 2. Initially, the slide 16 is advanced (i.e. moved to the right in the view of FIG. 2) to move the sheath 18 over the basket 28. This reduces the cross-sectional dimensions of the basket 28 and facilitates insertion of the basket 28 into a region of the body adjacent to the stone to be removed. The slide 16 is then moved to the left in the view of FIG. 2 to expose the basket 28, which resiliently assumes an enlarged operational shape.
It should be apparent from the foregoing detailed description that improved endoscopic stone extraction devices have been described that are well suited to the collection of a wide variety of stones, including stone fragments. The baskets described above are well suited for the removal of many types of debris, including for example, stones, stone fragments, and cholesterol plaque fragments. The devices described above can be used with the widest variety of endoscopes, including ureteroscopes, nephroscopes and other endoscopic devices, and they can be used within the lumens of many body tissues, including for example, ureters, bile ducts, and blood vessels.
The term “surface” is intended broadly to encompass perforated surfaces. The term “filament” is intended broadly to encompass wires and other elongated structures formed of any of a wide range of materials, including metals, plastics, and other polymers.
Also, any of the embodiments in the following documents, which are hereby incorporated by reference, can be used in combination with the embodiments discussed herein: U.S. Pat. Nos. 6,743,237; 7,087,062; 6,419,679; 6,494,885; 6,551,327; and U.S. patent application Ser. No. 13/963,780.
a support filament comprising an end portion;
a sheath comprising a lumen, wherein the support filament is disposed in the lumen such that the sheath is slideable with respect to the support filament; and
wherein movement of the actuator in a first direction retracts the sheath and causes the end portion to expand outside the lumen in a basket shape that tapers from a larger portion closer to the sheath to a smaller portion farther away from the sheath, wherein the larger portion is an opening of the basket shape and the opening is a first two-dimensional shape that is generally perpendicular to an axis of the lumen, wherein the smaller portion is meshed across a perimeter and the perimeter is a second two-dimensional shape that is smaller than the first two-dimensional shape and generally perpendicular to the axis of the lumen, and wherein the basket shape is connected to the support filament via two secondary filaments attached on opposite sides of the opening, and the larger portion and the smaller portion are joined together by at least two additional filaments; and
wherein movement of the actuator in a second direction advances the sheath and causes the larger portion of the basket shape to at least partially collapse inside the lumen.
2. The endoscopic stone-extraction device of claim 1, wherein the first and second two-dimensional shapes are circular shapes.
3. The endoscopic stone-extraction device of claim 1, wherein the first and second two-dimensional shapes are rectangular shapes.
4. The endoscopic stone-extraction device of claim 1, wherein the first and second two-dimensional shapes are triangular shapes.
5. The endoscopic stone-extraction device of claim 1, wherein sides of the basket shape are meshed.
6. The endoscopic stone-extraction device of claim 1, wherein sides of the basket shape are open.
a support filament comprising an end portion and configured to be disposed in a lumen of a sheath that is slideable with respect to the support filament; and
the end portion configured, in response to retraction of the sheath, to expand in a basket shape that tapers from a larger portion to a smaller portion, wherein the larger portion is an opening of the basket shape, the smaller portion is a flat meshed surface coupled to the larger portion by at least two filaments, and the opening of the larger portion is substantially parallel to the flat meshed surface of the smaller portion.
8. The endoscopic stone-extraction device of claim 7, wherein the larger and smaller portions are circular shapes.
9. The endoscopic stone-extraction device of claim 7, wherein the larger and smaller portions are rectangular shapes.
10. The endoscopic stone-extraction device of claim 7, wherein the larger and smaller portions are triangular shapes.
11. The endoscopic stone-extraction device of claim 7, wherein sides of the basket shape are meshed.
12. The endoscopic stone-extraction device of claim 7, wherein sides of the basket shape are open.
US15/175,893 2014-06-12 2016-06-07 Endoscopic stone-extraction device Active 2035-04-22 US10258355B2 (en)
US201462011367P true 2014-06-12 2014-06-12
US14/452,179 US9655634B2 (en) 2014-06-12 2014-08-05 Endoscopic stone-extraction device
US15/175,893 US10258355B2 (en) 2014-06-12 2016-06-07 Endoscopic stone-extraction device
US14/452,179 Division US9655634B2 (en) 2014-06-12 2014-08-05 Endoscopic stone-extraction device
US20160278798A1 US20160278798A1 (en) 2016-09-29
US10258355B2 true US10258355B2 (en) 2019-04-16
ID=54834105
US14/452,179 Active 2035-03-27 US9655634B2 (en) 2014-06-12 2014-08-05 Endoscopic stone-extraction device
US15/175,893 Active 2035-04-22 US10258355B2 (en) 2014-06-12 2016-06-07 Endoscopic stone-extraction device
US (2) US9655634B2 (en)
EP (1) EP3154453B1 (en)
WO (1) WO2015191288A1 (en)
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2014-08-05 US US14/452,179 patent/US9655634B2/en active Active
2015-05-27 EP EP15807083.9A patent/EP3154453B1/en active Active
2015-05-27 WO PCT/US2015/032750 patent/WO2015191288A1/en active Application Filing
2016-06-07 US US15/175,893 patent/US10258355B2/en active Active
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EP3154453A4 (en) 2018-04-18
US20150359548A1 (en) 2015-12-17
WO2015191288A9 (en) 2016-09-09
US9655634B2 (en) 2017-05-23
EP3154453A1 (en) 2017-04-19
EP3154453B1 (en) 2019-07-10
WO2015191288A1 (en) 2015-12-17
US20160278798A1 (en) 2016-09-29
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