IRRIGATION DEVICES, METHODS, AND SYSTEMS
20240108797 ยท 2024-04-04
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. A method for irrigating an organ, the method comprising: placing a distal end of a catheter adjacent to an interior organ volume, wherein the catheter includes at least two lumens; forming an exit port; flowing a different fluid through each of the at least two lumens in the catheter to supply a mixture in the interior organ volume; flushing a portion of the mixture out of the interior organ volume through the exit port; detecting, with at least one sensor, an actual volume in the interior organ volume; establishing a target volume in the interior organ volume; and delivering the two or more of the different fluids through each of the at least two lumens in the catheter to obtain the target volume in the interior of the organ volume.
22. The method of claim 21, further comprising an occluding step, wherein the interior organ volume is an interior kidney volume, and wherein the occluding step includes occluding a ureter adjacent to the interior kidney volume, wherein the catheter comprises a balloon, and the occluding step further comprises expanding the balloon.
23. The method of claim 21, further comprising a second catheter including a distal tip and at least one lumen, wherein the exit port is located on the distal tip and in communication with the at least one lumen of the second catheter, wherein the step of forming the exit port comprises inserting the distal tip into the interior organ volume through an exterior organ surface.
24. The method of claim 23, wherein forming the exit port is preceded by inserting a distal end of a sheath through an opening in the exterior surface of the organ, and dilating the sheath.
25. The method of claim 21, further comprising at least one plunger or at least one pump, wherein the at least one plunger or the at least one pump is configured to flow the two or more different fluids through each of the at least two lumens, wherein the flowing step comprises operating the at least one plunger or the at least one pump.
26. The method of claim 25, wherein the delivery of the two or more different fluids includes activating at least one plunger or the at least one pump to deliver each of the two or more different fluids, and further including: operating the at least one plunger or the at least one pump to maintain a ratio of the two or more different fluids in the interior organ volume.
27. The method of claim 26, wherein the at least one plunger or the at least one pump are activated to pressurize the mixture in the interior organ volume until a portion of the mixture flows out of the exit port.
28. The method of claim 26, wherein the at least one plunger or the at least one pump includes at least a first pump and a second pump, wherein the first pump or the second pump is activated to flow the two or more different fluids at a constant flow.
29. The method of claim 28, wherein a pressure measure is detected by the at least one sensor, wherein a processor modifies the flow of the two or more different fluids to obtain the target volume in the interior organ volume.
30. A method for irrigating an interior organ volume, the method comprising: placing a distal end of a catheter adjacent to the interior organ volume, wherein the catheter includes one or more lumens and at least one sensor, wherein the at least one sensor is configured to detect a radiopacity measure in the interior organ volume; flowing a contrasting agent from a reservoir, through one of the one or more lumens, and into an interior organ volume; and operating a first pump to deliver the contrasting agent to obtain a target measure in the organ volume based on the radiopacity measure.
31. The method of claim 30, further comprising operating a second pump to flow a dilating agent from another reservoir, wherein the second pump is operable in response to the radiopacity measure.
32. The method of claim 31, wherein the at least one sensor includes an image sensor configured to detect the radiopacity measure, wherein the first pump or the second pump is operable in response to the radiopacity measure.
33. The method of claim 31, further comprising detecting a pressure measure with a pressure sensor, and wherein the first pump or the second pump is operable in response to the pressure measure.
34. The method of claim 30, including forming an exit port, wherein forming the exit port includes inserting a second catheter into the interior organ volume through an exterior organ surface, wherein the second catheter includes a distal tip and at least one lumen, wherein the exit port is located on the distal tip and is in communication with the at least one lumen of the second catheter.
35. A method for irrigating an interior organ volume, the method comprising: placing a distal end of a catheter adjacent to the interior organ volume, wherein the catheter includes one or more lumens; forming an exit port; flowing a contrasting agent and a dilating agent through the one or more lumens to supply a mixture of the contrasting and dilating agents in the interior organ volume, flushing a portion of the mixture out of the interior organ volume through the exit port; detecting, with at least one sensor, an actual measure in the interior organ volume; establishing a target measure in the interior organ volume; and operating a first or a second pump to obtain the target measure in the interior organ volume.
36. The method of claim 35, wherein flowing the contrasting agent and the dilating agent includes operating the first pump to flow the dilating agent, and operating the second pump to flow the contrasting agent.
37. The method of claim 36, wherein the first pump and the second pump are activated to maintain a ratio of the dilating and contrasting agents in the interior organ volume.
38. The method of claim 37, wherein the first pump is operable at a steady flow rate, and wherein the second pump is operable at a variable flow rate.
39. The method of claim 35, further comprising detecting a pressure measure with a pressure sensor, and wherein the actual and target measures are relative to at least the pressure in the interior organ volume.
40. The method of claim 35, wherein the at least one sensor includes an image sensor configured to detect a radiopacity measure, and wherein the first pump or the second pump is operable in response to the radiopacity measure.
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]
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[0022]
[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 asymetrical. 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.