IRRIGATION DEVICES, METHODS, AND SYSTEMS
20220023528 · 2022-01-27
Assignee
Inventors
- Jerry Long (Jamaica Plain, MA, US)
- Timothy Harrah (Cambridge, MA)
- Aaron Kirkemo (Gladstone, NJ, US)
- Brandon Craft (Edgewater, MD, US)
- Elizabeth Stokley (Baltimore, MD, US)
- Sebastian Koerner (Berlin, DE)
- CHAD SCHNEIDER (Owings Mills, MD, US)
Cpc classification
A61M2205/3344
HUMAN NECESSITIES
A61B17/22
HUMAN NECESSITIES
A61M3/005
HUMAN NECESSITIES
A61M3/0204
HUMAN NECESSITIES
A61M25/0017
HUMAN NECESSITIES
A61M2025/1052
HUMAN NECESSITIES
A61B6/12
HUMAN NECESSITIES
A61M2039/0276
HUMAN NECESSITIES
A61M2205/3379
HUMAN NECESSITIES
International classification
A61B17/22
HUMAN NECESSITIES
A61B5/20
HUMAN NECESSITIES
Abstract
Irrigation devices, methods, and systems are disclosed. The system comprises a catheter with one or more lumens and an expandable portion. One or more pumps are used to supply a mixture of contrasting and dilating agents in an interior kidney volume and flush a portion of the mixture out of the interior kidney volume. The method comprises placing a catheter into the interior kidney volume through a ureter, occluding a portion of the ureter with a distal end of the catheter, forming an exit port through an exterior kidney surface, flowing the contrasting and dilating agents through the one or more lumens to supply the mixture in the interior kidney volume, and flushing a portion of the mixture out of the exit port.
Claims
1-20. (canceled)
21. An irrigation system, the system comprising: a catheter including one or more lumens and an expandable portion, wherein the expandable portion is positioned at a distal end of the catheter; a pump for flowing a contrasting agent from a reservoir, through one of the one or more lumens, and into an interior kidney volume; and at least one sensor configured to detect a radiopacity measure in the interior kidney volume, wherein the pump is operable to supply the contrasting agent in the interior kidney volume, and wherein the pump is operable to deliver the contrasting agent based on the radiopacity measure in order to obtain a target radiopacity measure.
22. The system of claim 21, wherein the expandable portion of the catheter is a balloon located at the distal end of the catheter.
23. The system of claim 21, further comprising at least one switch for operating the pump, and wherein the reservoir is removably attached to the pump.
24. The system of claim 21, wherein the pump is operable at a steady flow rate or at a variable flow rate.
25. The system of claim 21, further comprising another pump and a pressure sensor configured to detect a pressure measure, wherein the another pump is configured to flow a dilating agent from another reservoir, and wherein the another pump is operable in response to the pressure measure.
26. The system of claim 21, wherein the at least one sensor comprises an image sensor configured to detect the radiopacity measure.
27. The system of claim 26, further comprising another pump configured to flow a dilating agent from another reservoir, wherein the another pump is operable in response to the radiopacity measure.
28. The system of claim 21, further comprising another catheter configured to form an exit port in the interior kidney volume.
29. An irrigation system, the system comprising: a catheter including a first lumen and a second lumen, wherein a distal portion of the catheter is configured to be delivered to a body cavity; a first pump for flowing a dilating agent from a first reservoir and through the first lumen; a second pump for flowing a contrasting agent from a second reservoir and through the second lumen; and at least one sensor configured to detect a radiopacity measure in the body cavity, wherein the first and second pumps are operable to supply a mixture of the contrasting and dilating agents in the body cavity, and wherein at least one of the first and second pumps are operable to deliver the dilating agent and/or the contrasting agent in order to obtain a target measure in the body cavity based on the radiopacity measure.
30. The system of claim 29, wherein the catheter further includes expandable balloon located at a distal end of the catheter.
31. The system of claim 29, further comprising at least one switch for operating the first and second pumps, wherein the first and second reservoirs are removably attached to the first and second pumps.
32. The system of claim 29, wherein the at least one sensor includes an image sensor configured to detect the radiopacity measure, and wherein the second pump is operable in response to the radiopacity measure.
33. The system of claim 32, further comprising a pressure sensor configured to detect a pressure measure, and wherein the first pump is operable in response to the pressure measure.
34. The system of claim 29, further comprising another catheter configured to form an exit port in the interior kidney volume.
35. An irrigation system, the system comprising: a catheter including one or more lumens, wherein a distal portion of the catheter is configured to be delivered to a body cavity; a pump for flowing a contrasting agent from a reservoir, through one of the one or more lumens, and into the body cavity; and at least one sensor configured to detect a radiopacity measure in the body cavity, wherein the pump is operable to supply the contrasting agent in the interior kidney volume, and wherein the pump is operable to deliver the contrasting agent based on the radiopacity measure in order to obtain a target radiopacity measure.
36. The system of claim 35, wherein the at least one sensor comprises an image sensor configured to detect the radiopacity measure.
37. The system of claim 36, further comprising at least one switch for operating the pump, wherein the reservoir is removably attached to the pump, and wherein the pump is operable at a steady flow rate or at a variable flow rate.
38. The system of claim 35, further comprising another pump and a pressure sensor configured to detect a pressure measure, wherein the another pump is configured to flow a dilating agent from another reservoir, and wherein the another pump is operable in response to the pressure measure.
39. The system of claim 35, wherein the catheter further includes an expandable balloon positioned at a distal end of the catheter.
40. The system of claim 35, further comprising another catheter configured to form an exit port in the body cavity.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects that, together with the written descriptions, serve to explain the principles of this disclosure.
[0016]
[0017]
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[0023]
DETAILED DESCRIPTION
[0024] The present disclosure is now described with reference to exemplary aspects of irrigation devices, methods, and systems. Some aspects are depicted and/or described with reference to a PCNL procedure, wherein irrigation techniques are used to flush a kidney with a mixture of different fluids. A plurality of kidney stone fragments may be flushed out of the kidney with the mixture. The plurality of stone fragments may be formed by fragmenting a kidney stone in advance. Any reference to a particular procedure (such as PCNL), targeted area of treatment (such as a kidney), technique (such as irrigation), or different fluids (such as dilating and contrasting agents) is provided for convenience and not intended to limit the present disclosure unless claimed. Accordingly, the concepts and novelty underlying each aspect may be utilized for any analogous device or method, medical or otherwise.
[0025] The directional terms “proximal” and “distal” are used to describe relative components and features of the present disclosure. Proximal refers to a position closer to the exterior of the body or a user, whereas distal refers to a position closer to the interior of the body or further away from the user. The term “elongated” as used herein refers to any object that is substantially longer in relation to its width, such as an object having a length that is at least two times longer than its width. Some elongated objects, for example, are axially extending in a proximal or distal direction along an axis. Unless claimed, these directional terms are provided for convenience and not intended to limit the present disclosure to a particular direction or orientation.
[0026] As used herein, the terms “comprises,” “comprising,” or like variation, are intended to cover a non-exclusive inclusion, such that a device or method that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent thereto. Unless stated otherwise, the term “exemplary” is used in the sense of “example,” rather than “ideal.”
[0027] One aspect of the present disclosure is depicted in
[0028] Distal end 11 of catheter 10 is configured to occlude a portion of ureter 4. In the aspect of
[0029] Catheter 10 may have at least two lumens extending therethrough. The aspect of catheter 10 depicted in
[0030] Proximal end 15 of catheter 10 is attached to a fluid source 30. As shown in
[0031] Each reservoir 30A and 30B is configured to hold a fluid. In
[0032] Plungers 36A and 36B are operable to flush at least portion of the mixture out of exit port 22. As shown in
[0033] Numerous methods for using catheter 10 and fluid source 30 are now described with reference to
[0034] An exemplary method 50 comprises a step 51 of placing the distal end 11 of catheter 10 adjacent interior kidney volume 2 through ureter 4. Step 51 may be performed using a retrograde approach, wherein step 51 further comprises a step for inserting distal end 11 into urethra 6; and a step for guiding distal end 11 through bladder 5 and ureter 4 for placement adjacent interior volume 2. Another step 52 comprises occluding a portion of ureter 4 with distal end 11. As described above, catheter 10 may have an expandable portion 12, such that step 52 further comprises expanding portion 12. If portion 12 is a balloon, then step 52 may further comprise inflating the balloon. In some aspects, step 52 may further comprise seating expandable portion 12 at ureterojunction 3 by, for example, applying a proximally-directed force to elongated catheter body 14.
[0035] In this method 50, another step 53 comprises forming exit port 22 by inserting the distal tip 21 of second catheter 20 through the exterior surface of kidney 1 (
[0036] Method 50 further comprises a step 54 of flowing a different fluid through either or both of at least two lumens 16A, 16B of catheter 10 to supply a mixture in interior kidney volume 2; and a step 55 of flushing at least a portion of the mixture out of exit port 22. Each of steps 54 and 55 may be performed by operating plungers 36A and 36B. For example, each step 54, 55 may further comprise a step for depressing either or both of plungers 36A or 36B by a first amount to flow either or both of the different fluids from reservoirs 30A, 30B, through supply lines 32A, 32B, and into lumens 16A, 16B, to supply the mixture in interior kidney volume 2. Method 50 may comprise another step for depressing plungers 36A, 36B by a second amount to flush a portion of the mixture out of exit port 22. For example, plungers 36A and 36B may be depressed to pressurize the mixture in interior kidney volume 2 until a portion of the mixture flows out of exit port 22.
[0037] Another aspect of the present disclosure is shown in
[0038] In contrast to above, fluid source 130 has a first pump 136A and a second pump 136B. Pumps 136A, 136B may comprise any known pumping technology. As shown in
[0039] Aspects of method 50 may be used with fluid source 130. For example, because pumps 136A and 136B perform the function of plungers 36A and 36B, steps 54 and 55 may further comprise activating either or both of switches 137A and 137B to flow either or both of the first and second fluids to supply a mixture to interior kidney volume 3 and flush a portion of the mixture out of exit port 22. A further step may comprise activating switch 137B, for example, to adjust the radiopacity of the mixture. Another step may comprise activating either or both of switches 137A, 137B to maintain a targeted ratio or amount of the dilating and contrasting agents in interior kidney volume 2. In some aspects, the targeted ratio of dilating to contrasting agents may be maintained at a ratio of approximately 1:1 to facilitate placement of first and/or second catheter 10, 20, as described above, and then gradually changed to a ratio of approximately 1:0 for another step of the procedure. Any relative values may be used, and any such values may be varied, as needed, by activating either or both of switches 137A and 137B.
[0040] Another aspect of the present disclosure is now described with reference to catheter 10 and a fluid source 230, which is another alternate fluid source 30. Catheter 10 is described above. An exemplary aspect of fluid source 230 is depicted in
[0041] Fluid source 230 comprises at least one sensor configured to detect a measure in interior kidney volume 2. A first sensor 240 and a second sensor 242 are depicted in
[0042] First and second pumps 236A and 236B of
[0043] Either or both of first and second pumps 236A and 236B may also be operated to flush kidney 1 with the mixture. Thus, to continue this example, a targeted ratio or amount of fluids in volume 2 may be maintained, even if kidney 1 is continually flushed, by operating either or both of the first and second pumps 236A and 236B in response to the radiopacity measure detected by second sensor 242. For example, at least second pump 236B may be operated in response to sensor 242 to maintain the targeted ratio or amount of contrasting and dilating agents in the mixture, even as a portion of the mixture is continuously flushed out of exit port 22. The targeted ratio may also be varied, such that either or both of pumps 236A and 236B may be operated in response to sensor 242 so as to maintain a first targeted ratio during an initial part of a procedure and a second targeted ratio during a subsequent part of a procedure. For example, a first ratio of approximately 1:1 for the dilating and contrasting agents may be maintained to facilitate placement of first or second catheters 10, 20, whilst a second ratio of 1:0, dilating to contrasting agent, may be maintained thereafter. Any relative values may be used. This transition may be rendered in a gradual or abrupt manner by operation of either or both of pumps 236A and 236B.
[0044] Similar to above, aspects of method 50 may be used with fluid source 230. For example, pumps 236A and 236B may be operated in accordance with steps 54 and 55 by using processor 237 to supply the mixture and flush a portion of the mixture out of an exit port 22 formed in interior kidney volume 2. Step 54 may be implemented with method 60 as provided in
[0045] Each device, method, and system has been described as operable to supply a mixture of different fluids in interior kidney volume 2, and flush a portion of the mixture out of volume 2. This disclosure allows the mixture to be used in an irrigation technique that is both compatible with a retrograde approach and provides a means for enhancing the visibility of interior kidney volume 2. Moreover, by flowing the fluids as described, the contrast of the mixture may be modified to any particular level, and maintained indefinitely at that level, even if kidney 1 is flushed continually. Numerous alternative aspects are now described. Each of these alternative aspects may enhance the performance of the any device, method, or system described herein. Any feature of any alternative aspect described herein may be combined with any other feature described herein, each possible variant being part of the present disclosure.
[0046] Distal end 11 is described as having an expandable portion 12 configured to occlude ureter 4. In some aspects, portion 12 is a balloon. Expandable portion 12 may assume any shape, regular or irregular, symmetrical or asymmetrical. For example, portion 12 may be irregularly shaped to seal a particular ureteropelvic junction 3, or formed of a flexible material that naturally form fits to the contours of ureter 4 or junction 3 when expanded. Catheter 10 may have a plurality of expandable portions 12, each portion being spaced apart on elongated catheter body 14 to seal ureter 4 at a plurality of locations. Although described as being expanded by air, portion 12 may alternatively be filled by a fluid. For example, either of lumens 16A, 16B might have a port that opens into portion 12, allowing it to be expanded by either the first or second fluid.
[0047] Catheter 10 of
[0048] First and second fluids have been described as, respectively, a dilating agent and a contrasting agent. Any fluid types may be used. For example, one of the fluids may include a medicating agent, such as an anti-inflammatory, that is circulated through kidney 1 during a procedure. Other fluid types may be circulated to further dissolve the plurality of kidney stone fragments, promote the formation of a seal between expandable portion 12 and ureter 4, or provide like benefits. These additional fluids may be introduced through manifold 33, passed through second catheter 20 (
[0049] Any type of switching and/or sensing technologies may be incorporated into any aspect of fluid sources 30, 130, or 230 to aid in circulating the mixture, maintaining a characteristic of the mixture, or flushing kidney 1. Processor 237 may be utilized to automate any of these functions of these fluid sources. For example, pumps 236A and 236B may be operated, with processor 237, according to automated control sequence responsive to a signal generated by either or both of sensors 240 and 242. Given the variety of sensing technologies, it should be appreciated that pumps 236A and 236B may be operated by any sensing technology to deliver a corresponding variety of benefits. For example, one or more additional sensors may be configured to detect a measure of blood in the fluid mixture, such that either or both of pumps 236A or 236B may be operated in response to the one or more additional sensors to automatically notify the physician if/when a safeguard is tripped, responsively reduce the pressure or increase the opacity of the mixture in interior kidney volume 2, or introduce a medicating agent into the mixture.
[0050] Any of the method steps described above with reference to exemplary methods 50 and 60 may be modified to accommodate the structure of any of these alternative aspects. For example, method 50 may be modified for use with an type of fluids, through any number of lumens, etc.; and method 60 may be modified for use with any type of sensor, switch, processor, or the like. In either instance, methods 50 and 60 may be further modified supply the mixture in interior kidney volume 2 and flush one or more contaminants out of interior volume 2.
[0051] While principles of the present disclosure are described herein with reference to illustrative aspects for particular applications, the disclosure is not limited thereto. Those having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, aspects, and substitution of equivalents all fall in the scope of the aspects described herein. Accordingly, the present disclosure is not to be considered as limited by the foregoing description.