Sphincterotome and manometry catheter
First Claim
1. A catheter device for diagnosing a dysfunctional sphincter and ablating the sphincter, comprising:
- an elongate sheath comprising a manometry data collecting portion and a sphincter cutting portion;
wherein the elongate sheath further comprises;
a proximal end, a distal end and a longitudinal axis extending therebetween, the distal end comprising the sphincter cutting portion;
a cutting wire passageway extending along the longitudinal axis from the proximal end to the sphincter cutting portion;
a cutting wire extending longitudinally through the cutting wire passageway from the proximal end to the sphincter cutting portion, the cutting wire having an exposed portion located alongside the sphincter cutting portion;
an anchor connecting the cutting wire to the sphincter cutting portion; and
a handle disposed near the proximal end of the elongate sheath and operatively connected to the cutting wire,wherein the cutting wire is adapted for ablating the sphincter.
2 Assignments
0 Petitions
Accused Products
Abstract
A catheter for diagnosis of sphincter motility by measuring pressure exerted by the sphincter and, when necessary, ablating the sphincter immediately after diagnosis of a dysfunction. The catheter is in the form of an elongate sheath that has a proximal end, a distal end, and a longitudinal portion therebetween, with a manometry data collecting portion and a sphincterotome portion located at the distal end, and a handle assembly located at the proximal end. Embodiments are shown wherein the distal end can be aimed in a direction that facilitates cannulating the sphincter by moving the handle assembly. The catheter is used by maneuvering the distal end of the catheter into a sphincter. The manometry data collecting portion is first aligned with the sphincter and pressure measurements are taken. If it is determined that the sphincter is dysfunctional, the sphincterotome portion is aligned with and used to ablate the dysfunctional sphincter.
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Citations
27 Claims
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1. A catheter device for diagnosing a dysfunctional sphincter and ablating the sphincter, comprising:
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an elongate sheath comprising a manometry data collecting portion and a sphincter cutting portion; wherein the elongate sheath further comprises; a proximal end, a distal end and a longitudinal axis extending therebetween, the distal end comprising the sphincter cutting portion; a cutting wire passageway extending along the longitudinal axis from the proximal end to the sphincter cutting portion; a cutting wire extending longitudinally through the cutting wire passageway from the proximal end to the sphincter cutting portion, the cutting wire having an exposed portion located alongside the sphincter cutting portion; an anchor connecting the cutting wire to the sphincter cutting portion; and a handle disposed near the proximal end of the elongate sheath and operatively connected to the cutting wire, wherein the cutting wire is adapted for ablating the sphincter. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A catheter device for diagnosing a dysfunctional sphincter and ablating the sphincter, comprising:
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an elongate sheath comprising a manometry data collecting portion and a sphincter cutting portion; wherein the elongate sheath further comprises; a proximal end, a distal end and a longitudinal axis extending therebetween, a cutting wire passageway extending along the longitudinal axis from the proximal end to the distal end; a cutting wire extending longitudinally through the cutting wire passageway from the proximal end to the distal end, the cutting wire having an exposed portion extending distally from the distal end of the sheath and along a pathway that is substantially parallel to the longitudinal axis of the sheath; and a handle operatively connected to the cutting wire wherein a dysfunctional sphincter can be ablated remotely. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18)
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19. A catheter device for diagnosing a dysfunctional sphincter and ablating the sphincter, comprising:
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an elongate sheath having a longitudinal axis between a proximal end and a distal end, the distal end having a sphincter cutting portion and a manometry data collecting portion coupled to the sphincter cutting portion; a passageway extending along the longitudinal axis from the proximal end to the manometry data collecting portion, the passageway terminating at the manometry data collecting portion in an exit port; a pressure transducer operatively connected to the passageway; and a manometry assembly removably coupled to the passageway at the proximal end, the manometry assembly comprising an infusion pump operatively connected to the passageway, and a data recording unit operatively connected to the pressure transducer, wherein a tension of the sphincter is determined by measuring the pressure of a column of fluid infused through the passageway; a cutting wire passageway extending longitudinally from the proximal end to the sphincter cutting portion, a cutting wire connected to the sphincter cutting portion, the cutting wire extending longitudinally from the sphincter cutting portion through the cutting wire passageway to the proximal end, the cutting wire further having an exposed portion located alongside the sphincter cutting portion, wherein the cutting wire is adapted for ablating the sphincter; and a proximal assembly operatively connected to the proximal end, the proximal assembly comprising a handle operatively connected to the proximal end, the handle comprising a first portion and a second portion, the second portion being slideable relative to the first portion, the second portion further being connected to the cutting wire, wherein the distal end can be aimed in a direction that facilitates cannulating the sphincter, measuring sphincter tension and ablating the sphincter, and an electrosurgical generator operatively connected to the second portion.
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20. A catheter device for diagnosing a dysfunctional sphincter and ablating the sphincter, comprising:
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an elongate sheath having a longitudinal axis between a proximal end and a distal end, the distal end having a sphincter cutting portion and a manometry data collecting portion coupled to the sphincter cutting portion; a plurality of manometry passageways extending longitudinally from the proximal end to the manometry data collecting portion, each of the passageways having a first port exiting the passageway at the manometry data collecting portion; a pressure transducer operatively connected to the manometry passageways; a manometry assembly removably coupled to the manometry passageways at the proximal end, the manometry assembly comprising an infusion pump operatively connected to the first and second passageways, and a data recording unit operatively connected to the pressure transducer, wherein an accurate reading of sphincter tension can be determined by measuring the pressure of a column of fluid infused through the first and second passageways; a cutting wire passageway extending longitudinally from the proximal end to the sphincter cutting portion, a cutting wire connected to the sphincter cutting portion, the cutting wire extending longitudinally from the sphincter cutting portion through the cutting wire passageway to the proximal end, the cutting wire further having an exposed portion located alongside the sphincter cutting portion, wherein a dysfunctional sphincter can be ablated; a tapered tip located on the distal end of the elongate sheath; a guidewire passageway extending along the longitudinal axis from the proximal end to the tapered tip and having an exit port located at the distal end of the tapered tip; an aspiration passageway extending along the longitudinal axis, the aspiration passageway having an exit port communicating the passageway with an outside environment wherein excess fluids can be aspirated from the outside environment; a proximal assembly operatively connected to the proximal end, the proximal assembly comprising a handle operatively connected to the proximal end, the handle comprising a first portion and a second portion, the first portion having a thumb ring, the second portion having two finger rings, the second portion being slideable in relation to the first portion, the second portion further being connected to the cutting wire, wherein the distal end can be aimed in a direction that facilitates cannulating the sphincter, measuring sphincter tension and ablating the sphincter, and an electrosurgical generator operatively connected to the second portion; and a plurality of radiopaque markings fixed to the sheath, the markings being spaced by predetermined lengths.
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21. A method of treating a dysfunctional sphincter, comprising the steps of:
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providing a catheter device comprising; an elongate sheath having a longitudinal axis between a proximal end and a distal end, the distal end having a sphincter cutting portion and a manometry data collecting portion; and a proximal assembly operatively connected to the proximal end, the proximal assembly comprising a handle operatively connected to the sphincter cuffing portion and the manometry data collecting portion, and an electrosurgical generator operatively connected to the proximal assembly; positioning an endoscope having a catheter passageway adjacent to a sphincter opening, the catheter passageway terminating in a catheter passageway exit port; extending the elongate sheath of the catheter device through the catheter passageway to a position wherein the distal end of the elongate sheath protrudes from the exit port and is adjacent to the sphincter opening; cannulating the sphincter opening with the distal end of the elongate sheath; advancing the elongate sheath into the sphincter opening to a position where the manometry data collecting portion aligns with the sphincter; operating the manometry data collecting portion so as to determine a tension of the sphincter; positioning the sphincter cutting portion adjacent to the sphincter after operating the manometry data collecting portion; and ablating the sphincter by operating the sphincter cutting portion, thereby treating a portion of the sphincter.
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22. A catheter device for diagnosing a dysfunctional sphincter and ablating the sphincter, comprising:
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an elongate sheath comprising a manometry data collecting portion and a sphincter cutting portion; wherein the elongate sheath further comprises; a proximal end, a distal end and a longitudinal axis extending therebetween the distal end comprising the manometry data collecting portion; a manometry passageway extending along the longitudinal axis from the proximal end to the manometry data collecting portion, the manometry passageway terminating at the manometry data collecting portion in an exit port, and a pressure transducer operatively connected to the manometry passageway for measuring a pressure of a column of fluid infused through the manometry passageway, wherein the manometry passageway further comprises a plug distal to the exit port. - View Dependent Claims (23, 24, 25)
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26. A method of treating a dysfunctional sphincter, comprising the steps of:
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providing a catheter device comprising; an elongate sheath having a longitudinal axis between a proximal end and a distal end, the distal end having a sphincter cutting portion and a manometry data collecting portion; and a manometry passageway extending longitudinally from the proximal end to the manometry data collecting portion, the manometry passageway comprising a first port exiting the passageway at the manometry data collecting portion; providing a pressure transducer operatively connected to the manometry passageway; advancing the distal end of the sheath so that the manometry data collecting portion is adjacent to a sphincter opening; measuring a pressure of a column of fluid infused through the manometry passageway and exiting the first port to determine a sphincter tension; positioning the sphincter cutting portion adjacent to the sphincter; and cutting the sphincter by operating the sphincter cutting portion. - View Dependent Claims (27)
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Specification