Sphincterotome and manometry catheter

• US 7,056,319 B2
• Filed: 12/03/2002
• Issued: 06/06/2006
• Est. Priority Date: 12/04/2001
• Status: Expired due to Term

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Wilson-Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Gaskill, Jason M., Aliperti, Giuseppe
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US10/309,681
• Publication Number:
  US 20030130679A1
• Time in Patent Office: 1,281 Days
• Field of Search: 606/47, 606/170, 606/41, 606/45, 600/561, 600/587
• US Class Current: 606/41
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2018/00273 Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00535 Biliary tract
• CPC Class Codes: A61B 2018/00553 Sphincter
• CPC Class Codes: A61B 2018/1407 Loop
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

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.

Claims

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. The catheter device of claim 1, wherein the elongate sheath further comprises:

the distal end further 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;

a pressure transducer operatively connected to the manometry passageway; and

a manometry assembly removably coupled to the manometry passageway at the proximal end, the manometry assembly comprising an infusion pump operatively connected to the manometry 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 manometry passageway.

3. The catheter device of claim 2 further comprising:

a guide wire passageway extending along the longitudinal axis from the proximal end to the distal end and terminating at a guide wire exit port.

4. The catheter device of claim 1 further comprising:

an electrosurgical generator operatively connected to the cutting wire, wherein a dysfunctional sphincter can be ablated by simultaneously contacting the cutting wire and the dysfunctional sphincter and energizing the cutting wire.

5. The catheter device of claim 1, wherein the handles comprises 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 sliding the second portion causes deflection of the distal end.

6. The catheter device of claim 1 further comprising:

an aspiration passageway extending through the elongate sheath and parallel to the longitudinal axis from the proximal end to the distal end and terminating at an aspiration passageway exit port; and

an aspirator operatively connected to the aspiration passageway at the proximal end.

7. The catheter device of claim 1 further comprising:

a plurality of radiopaque markings located on the elongate sheath, the markings being separated by predetermined lengths.

8. The catheter device of claims 1 wherein:

the elongate sheath is made of polytetrafluoroethylene.

9. The catheter device of claim 1 further comprising:

a tapered tip located at a terminal distal end of the elongate sheath.

10. 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,

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.

11. The catheter device of claim 10 further comprising:

an aspiration passageway extending through the elongate sheath and parallel to the longitudinal axis from the proximal end to the distal end and terminating at an aspiration passageway exit port; and

an aspirator operatively connected to the aspiration passageway at the proximal end.

12. The catheter device of claim 10 further comprising:

a plurality of radiopaque markings located on the elongate sheath, the markings being separated by predetermined lengths.

13. The catheter device of claim 10, wherein the elongate sheath is made of polytetrafluoroethylene.

14. The catheter device of claim 10 wherein:

the cutting wire is selected from the group consisting of a needle knife and an electrosurgical cutter.

15. The catheter device of claim 10, wherein the elongate sheath further comprises:

the distal end further 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;

a pressure transducer operatively connected to the manometry passageway; and

a manometry assembly removably coupled to the manometry passageway at the proximal end, the manometry assembly comprising an infusion pump operatively connected to the manometry 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 manometry passageway.

16. The catheter device of claim 10 further comprising:

a guide wire passageway extending along the longitudinal axis from the proximal end to the distal end and terminating at a guide wire exit port.

17. The catheter device of claim 10 further comprising:

an electrosurgical generator operatively connected to the cutting wire, wherein a dysfunctional sphincter can be ablated by simultaneously contacting the cutting wire and the dysfunctional sphincter and energizing the cutting wire.

18. The catheter device of claim 10 wherein the handle comprises:

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 sliding the second portion causes extension or retraction of the cutting wire.

19. A catheter device for diagnosing a dysfunctional sphincter and ablating the sphincter, 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 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.

20. A catheter device for diagnosing a dysfunctional sphincter and ablating the sphincter, 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 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.

21. A method of treating a dysfunctional sphincter, comprising the steps of:

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.

22. 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 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.

23. The catheter device of claim 22 further comprising a plurality of manometry passageways, each of the passageways comprising an exit port exiting the passageway at the manometry data collecting portion.

24. The catheter device of claim 22 further comprising a manometry assembly removably coupled to the manometry passageway at the proximal end, the manometry assembly comprising an infusion pump operatively connected to the manometry passageway.

25. The catheter device of claim 22 wherein the sheath further comprises a radiopaque marking at the exit port.

26. A method of treating a dysfunctional sphincter, comprising the steps of:

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.

27. The method of claim 26 comprising the step of operating the sphincter cutting portion by sliding movement of a handle to change the position of the sphincter cutting portion with respect to a terminal distal tip.