Safety and Effectiveness of a Longer Focal Beam and Burst Duration in Ultrasonic Propulsion for Repositioning Urinary Stones and Fragments

Karmon M. Janssen, Timothy C. Brand, Bryan W. Cunitz, Yak Nam Wang, Julianna C. Simon, Frank Starr, H. Denny Liggitt, Jeff Thiel, Mathew D. Sorensen, Jonathan D. Harper, Michael R. Bailey, Barbrina Dunmire

Research output: Contribution to journalArticle

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Abstract

Purpose: In the first-in-human trial of ultrasonic propulsion, subjects passed collections of residual stone fragments repositioned with a C5-2 probe. Here, effectiveness and safety in moving multiple fragments are compared between the C5-2 and a custom (SC-50) probe that produces a longer focal beam and burst duration. Materials and Methods: Effectiveness was quantified by the number of stones expelled from a calyx phantom consisting of a 30-mm deep, water-filled well in a block of tissue mimicking material. Each probe was positioned below the phantom to move stones against gravity. Single propulsion bursts of 50 ms or 3 s duration were applied to three separate targets: 10 fragments of 2 different sizes (1-2 and 2-3 mm) and a single 4 × 7 mm human stone. Safety studies consisted of porcine kidneys exposed to an extreme dose of 10-minute burst duration, including a 7-day survival study and acute studies with surgically implanted stones. Results: Although successful in the clinical trial, the shorter focal beam and maximum 50 ms burst duration of the C5-2 probe moved stones, but did not expel any stones from the phantom's 30-mm deep calyx. The results were similar with the SC-50 probe under the same 50 ms burst duration. Longer (3 s) bursts available with the SC-50 probe expelled all stones at both 4.5 and 9.5 cm "skin-to-stone" depths with lower probe heating compared to the C5-2. No abnormal behavior, urine chemistry, serum chemistry, or histological findings were observed within the kidney or surrounding tissues for the 10 min burst duration used in the animal studies. Conclusions: A longer focal beam and burst duration improved expulsion of a stone and multiple stone fragments from a phantom over a broad range of clinically relevant penetration depths and did not cause kidney injury in animal studies.

Original languageEnglish (US)
Pages (from-to)793-799
Number of pages7
JournalJournal of Endourology
Volume31
Issue number8
DOIs
StatePublished - Aug 2017

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Urinary Calculi
Ultrasonics
Kidney
Safety
Gravitation
Heating
Swine
Clinical Trials
Urine
Skin
Survival
Water
Wounds and Injuries
Serum

All Science Journal Classification (ASJC) codes

  • Urology

Cite this

Janssen, Karmon M. ; Brand, Timothy C. ; Cunitz, Bryan W. ; Wang, Yak Nam ; Simon, Julianna C. ; Starr, Frank ; Liggitt, H. Denny ; Thiel, Jeff ; Sorensen, Mathew D. ; Harper, Jonathan D. ; Bailey, Michael R. ; Dunmire, Barbrina. / Safety and Effectiveness of a Longer Focal Beam and Burst Duration in Ultrasonic Propulsion for Repositioning Urinary Stones and Fragments. In: Journal of Endourology. 2017 ; Vol. 31, No. 8. pp. 793-799.
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title = "Safety and Effectiveness of a Longer Focal Beam and Burst Duration in Ultrasonic Propulsion for Repositioning Urinary Stones and Fragments",
abstract = "Purpose: In the first-in-human trial of ultrasonic propulsion, subjects passed collections of residual stone fragments repositioned with a C5-2 probe. Here, effectiveness and safety in moving multiple fragments are compared between the C5-2 and a custom (SC-50) probe that produces a longer focal beam and burst duration. Materials and Methods: Effectiveness was quantified by the number of stones expelled from a calyx phantom consisting of a 30-mm deep, water-filled well in a block of tissue mimicking material. Each probe was positioned below the phantom to move stones against gravity. Single propulsion bursts of 50 ms or 3 s duration were applied to three separate targets: 10 fragments of 2 different sizes (1-2 and 2-3 mm) and a single 4 × 7 mm human stone. Safety studies consisted of porcine kidneys exposed to an extreme dose of 10-minute burst duration, including a 7-day survival study and acute studies with surgically implanted stones. Results: Although successful in the clinical trial, the shorter focal beam and maximum 50 ms burst duration of the C5-2 probe moved stones, but did not expel any stones from the phantom's 30-mm deep calyx. The results were similar with the SC-50 probe under the same 50 ms burst duration. Longer (3 s) bursts available with the SC-50 probe expelled all stones at both 4.5 and 9.5 cm {"}skin-to-stone{"} depths with lower probe heating compared to the C5-2. No abnormal behavior, urine chemistry, serum chemistry, or histological findings were observed within the kidney or surrounding tissues for the 10 min burst duration used in the animal studies. Conclusions: A longer focal beam and burst duration improved expulsion of a stone and multiple stone fragments from a phantom over a broad range of clinically relevant penetration depths and did not cause kidney injury in animal studies.",
author = "Janssen, {Karmon M.} and Brand, {Timothy C.} and Cunitz, {Bryan W.} and Wang, {Yak Nam} and Simon, {Julianna C.} and Frank Starr and Liggitt, {H. Denny} and Jeff Thiel and Sorensen, {Mathew D.} and Harper, {Jonathan D.} and Bailey, {Michael R.} and Barbrina Dunmire",
year = "2017",
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language = "English (US)",
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pages = "793--799",
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Janssen, KM, Brand, TC, Cunitz, BW, Wang, YN, Simon, JC, Starr, F, Liggitt, HD, Thiel, J, Sorensen, MD, Harper, JD, Bailey, MR & Dunmire, B 2017, 'Safety and Effectiveness of a Longer Focal Beam and Burst Duration in Ultrasonic Propulsion for Repositioning Urinary Stones and Fragments', Journal of Endourology, vol. 31, no. 8, pp. 793-799. https://doi.org/10.1089/end.2017.0167

Safety and Effectiveness of a Longer Focal Beam and Burst Duration in Ultrasonic Propulsion for Repositioning Urinary Stones and Fragments. / Janssen, Karmon M.; Brand, Timothy C.; Cunitz, Bryan W.; Wang, Yak Nam; Simon, Julianna C.; Starr, Frank; Liggitt, H. Denny; Thiel, Jeff; Sorensen, Mathew D.; Harper, Jonathan D.; Bailey, Michael R.; Dunmire, Barbrina.

In: Journal of Endourology, Vol. 31, No. 8, 08.2017, p. 793-799.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Safety and Effectiveness of a Longer Focal Beam and Burst Duration in Ultrasonic Propulsion for Repositioning Urinary Stones and Fragments

AU - Janssen, Karmon M.

AU - Brand, Timothy C.

AU - Cunitz, Bryan W.

AU - Wang, Yak Nam

AU - Simon, Julianna C.

AU - Starr, Frank

AU - Liggitt, H. Denny

AU - Thiel, Jeff

AU - Sorensen, Mathew D.

AU - Harper, Jonathan D.

AU - Bailey, Michael R.

AU - Dunmire, Barbrina

PY - 2017/8

Y1 - 2017/8

N2 - Purpose: In the first-in-human trial of ultrasonic propulsion, subjects passed collections of residual stone fragments repositioned with a C5-2 probe. Here, effectiveness and safety in moving multiple fragments are compared between the C5-2 and a custom (SC-50) probe that produces a longer focal beam and burst duration. Materials and Methods: Effectiveness was quantified by the number of stones expelled from a calyx phantom consisting of a 30-mm deep, water-filled well in a block of tissue mimicking material. Each probe was positioned below the phantom to move stones against gravity. Single propulsion bursts of 50 ms or 3 s duration were applied to three separate targets: 10 fragments of 2 different sizes (1-2 and 2-3 mm) and a single 4 × 7 mm human stone. Safety studies consisted of porcine kidneys exposed to an extreme dose of 10-minute burst duration, including a 7-day survival study and acute studies with surgically implanted stones. Results: Although successful in the clinical trial, the shorter focal beam and maximum 50 ms burst duration of the C5-2 probe moved stones, but did not expel any stones from the phantom's 30-mm deep calyx. The results were similar with the SC-50 probe under the same 50 ms burst duration. Longer (3 s) bursts available with the SC-50 probe expelled all stones at both 4.5 and 9.5 cm "skin-to-stone" depths with lower probe heating compared to the C5-2. No abnormal behavior, urine chemistry, serum chemistry, or histological findings were observed within the kidney or surrounding tissues for the 10 min burst duration used in the animal studies. Conclusions: A longer focal beam and burst duration improved expulsion of a stone and multiple stone fragments from a phantom over a broad range of clinically relevant penetration depths and did not cause kidney injury in animal studies.

AB - Purpose: In the first-in-human trial of ultrasonic propulsion, subjects passed collections of residual stone fragments repositioned with a C5-2 probe. Here, effectiveness and safety in moving multiple fragments are compared between the C5-2 and a custom (SC-50) probe that produces a longer focal beam and burst duration. Materials and Methods: Effectiveness was quantified by the number of stones expelled from a calyx phantom consisting of a 30-mm deep, water-filled well in a block of tissue mimicking material. Each probe was positioned below the phantom to move stones against gravity. Single propulsion bursts of 50 ms or 3 s duration were applied to three separate targets: 10 fragments of 2 different sizes (1-2 and 2-3 mm) and a single 4 × 7 mm human stone. Safety studies consisted of porcine kidneys exposed to an extreme dose of 10-minute burst duration, including a 7-day survival study and acute studies with surgically implanted stones. Results: Although successful in the clinical trial, the shorter focal beam and maximum 50 ms burst duration of the C5-2 probe moved stones, but did not expel any stones from the phantom's 30-mm deep calyx. The results were similar with the SC-50 probe under the same 50 ms burst duration. Longer (3 s) bursts available with the SC-50 probe expelled all stones at both 4.5 and 9.5 cm "skin-to-stone" depths with lower probe heating compared to the C5-2. No abnormal behavior, urine chemistry, serum chemistry, or histological findings were observed within the kidney or surrounding tissues for the 10 min burst duration used in the animal studies. Conclusions: A longer focal beam and burst duration improved expulsion of a stone and multiple stone fragments from a phantom over a broad range of clinically relevant penetration depths and did not cause kidney injury in animal studies.

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