Catheters with suction capability and related methods and systems for obtaining biosamples in vivo

• US 20050054994A1
• Filed: 04/19/2004
• Published: 03/10/2005
• Est. Priority Date: 09/25/2002
• Status: Abandoned Application

• Current Assignee: Wit Ip Corporation
• Original Assignee: Wit Ip Corporation
• Inventors: Cioanta, Iulian, Klein, Richard Barry, Lazarovitz, Jacob
• Application Number:
  US10/827,741
• Publication Number:
  US 20050054994A1
• Time in Patent Office: Days
• US Class Current: 604/317
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

Methods, systems, and computer program products for obtaining a sample in vivo and/or treating a subject include positioning an elongated transurethral catheter in the prostatic urethra of a subject, the catheter having a bladder anchoring balloon, at least one biosample entry port disposed axially away from the bladder anchoring balloon, and an axially extending biosample flow channel in fluid communication with the biosample entry port held internally in the catheter. The anchoring balloon is inflated to position the catheter so that the fluid entry port is proximate the prostatic urethra of the subject and prostatic fluid is suctioned from the prostatic urethra into the biosample entry port and into the biosample flow channel. The catheter can include a thermal treatment balloon and/or dilatation balloon and the suctioned sample can be obtained concurrently with, during, or proximate in time to the applied treatment. The catheter can be configured to allow urine to drain therethrough during the treatment/collection of the sample while keeping the urine isolated from the collected prostatic fluid sample.

Claims

1. A method for obtaining a sample and/or treating a subject, comprising:

positioning an elongated transurethral catheter in the prostatic urethra of a subject, the catheter having a bladder anchoring balloon, at least one biosample entry port disposed axially away from the bladder anchoring balloon, and an axially extending biosample flow channel in fluid communication with the biosample entry port positioned internally in the catheter;

inflating the anchoring balloon to position the catheter so that the biosample entry port is proximate the prostatic or membraneous urethra of the subject; and

suctioning prostatic fluid from the prostatic urethra through the biosample entry port and into the biosample flow channel.

2. A method according to claim 1, further comprising directing the prostatic fluid to exit the body so that the suctioned prostatic fluid is substantially void of urine and then capturing the prostatic fluid after it exits the body.

3. A method according to claim 2, further comprising monitoring the quantity or flow rate of the captured fluid over a predetermined time.

4. A method according to claim 3, further comprising evaluating alterations in the level of at least one selected analyte in the captured prostatic fluid over time.

5. A method according to claim 1, wherein the catheter includes a urine drainage channel separate from the biosample flow channel, the method further comprising allowing urine to drain through the drainage channel during said suctioning step.

6. A method according to claim 1, wherein the catheter further comprises a treatment balloon disposed intermediate the at least one biosample entry port and the anchoring balloon, and wherein the method further comprises:

expanding the treatment balloon after the positioning step so that the expanded treatment balloon contacts prostatic tissue, wherein, in proper position, the expanded treatment balloon is sized and configured to reside in the prostatic urethra above the verumontanum; and

applying heat to the prostatic tissue based on said expanding step.

7. A method according to claim 6, wherein the suctioning step is carried out semi-continuously or continuously during the applying heat step.

8. A method according to claim 6, wherein the suctioning step is carried out at at least one desired time during the applying heating step.

9. A method according to claim 6, wherein the suctioning step is carried out before and after the applying heating step.

10. A method according to claim 6, wherein the suctioning step is carried out at selected intervals during the applying heat step.

11. A method according to claim 6, further comprising altering the pressure in the expanded treatment balloon such that the expanded treatment balloon repetitively laterally expands and contracts a desired distance in the prostatic urethra to internally massage the prostate.

12. A method according to claim 1, wherein the steps of applying heat and massage are carried out concurrently.

13. A method according to claim 12, wherein said internally massaging step is carried out by circulating pulsating heated fluid in an enclosed circulating travel path.

14. A method according to claim 6, wherein the subject is treated for prostatitis.

15. A method according to claim 6, wherein the subject is treated for BPH.

16. A method according to claim 6, wherein said applying heating step comprises heating fluid external of the body of the subject to a temperature of between about 40-67°

C., and wherein said method further comprises directing circulating heated fluid to travel in a travel path in the catheter to and from the treatment balloon for a period of at least about 20 minutes.

17. A method according to claim 16, wherein the heated fluid circulating travel path is defined by a closed loop system which includes the catheter, an inlet conduit and an outlet conduit in fluid communication with the catheter, a heater, a pump, a pressure sensor and temperature sensors operably associated with the catheter, and wherein said massaging step comprises adding fluid to the closed loop system to increase the pressure in the treatment balloon at desired intervals over the duration of the treatment period.

18. A method for treating the prostate of a subject, comprising:

(a) inserting a catheter into the urethra of a subject, the catheter having, in serial order from the most distal portion, a bladder anchoring balloon, at least one expandable treatment balloon, and at least one fluid entry port formed in the wall of the catheter, the catheter also having an axially extending biosample flow path in fluid communication with the fluid entry port disposed internal of the catheter wall;

(b) expanding the bladder-anchoring balloon to contact and reside against the bladder neck of the subject to secure the catheter in position in the subject;

(c) heating fluid to a desired temperature;

(d) directing heated fluid to travel captured in the catheter to the at least one expandable treatment balloon;

(e) inflating the at least one treatment balloon responsive to the directing step, wherein, in position, the inflated treatment balloon takes on a radially expanded configuration and circumferentially contacts targeted tissue in the prostatic urethra;

(f) heating a targeted region in the prostatic urethra to a temperature of between about 40-67°

C. for a desired treatment time of at least about 20 minutes; and

(g) collecting a biosample comprising prostatic fluid into the fluid entry port and into the biosample flow path of the catheter.

19. A method according to claim 18, wherein the biosample is substantially void of urine.

20. A method according to claim 18, wherein the collecting step comprises suctioning the biosample into the catheter.

21. A method according to claim 18, wherein the collecting step is carried out substantially continuously during the heating step.

22. A method according to claim 21, wherein the suctioning step is carried out at least one of before, after, and at least intermittently or at a plurality of discrete intervals for a predetermined period of time during the treatment.

23. A method according to claim 18, wherein the catheter further comprises a urine drainage channel in fluid isolation from the biosample flow path, and wherein urine is allowed to drain therein during the suctioning step.

24. A method according to claim 18, further comprising internally massaging a portion of the prostatic urethra by repetitively altering the fluid pressure in the treatment balloon causing the treatment balloon to repetitively expand and contract a desired distance in response thereto during the heating step.

25. A method according to claim 18, wherein said heating step heats the fluid to between about 40-45°

C. to heat prostatic tissue for about 20-60 minutes.

26. A method according to claim 24, wherein said internally massaging step comprises circulating pulsating heated fluid in an enclosed circulating travel path in the catheter, the circulating fluid travel path being in fluid isolation from the biosample travel path.

27. A method according to claim 24, wherein the treatment balloon is repetitively expanded and contracted at a rate of about 1-5 times per second.

28. A method according to claim 24, wherein the expanded treatment balloon is sized and configured to reside in the prostatic urethra above the verumontanum during said heating and massaging steps.

29. A method according to claim 24, wherein the catheter comprises a blocking balloon disposed below the at least one entry port, the method further comprising:

expanding the blocking balloon so that it contacts tissue in the membraneous or bulbous urethra to define a treatment region extending above the expanded blocking balloon and below the anchoring balloon; and

delivering a medicament through the catheter and out the at least one entry port so that the medicament is injected into the treatment region proximate in time with the heating step.

30. A method according to claim 29, wherein the medicament is expelled from the catheter at elevated pressures.

31. A method of collecting a biosample in a subject, comprising:

inserting a catheter into the male urethra, the catheter having a biofluid travel path defined therein;

collecting a biosample from the prostatic urethra into the catheter in vivo; and

directing the biosample to travel in the biofluid travel path and to exit the body in a manner that maintains the biosample substantially void of urine.

32. A method according to claim 31, further comprising applying heat to the prostatic urethra proximate in time to or during the collecting step.

33. A method according to claim 31, further comprising allowing urine to drain from the bladder of the subject through the catheter during the collecting step without contacting the biosample in the biofluid travel path.

34. A method according to claim 31, further comprising massaging the prostatic urethra proximate in time or during the collecting step.

35. A method according to claim 34, wherein the catheter comprises an outwardly expandable balloon thereon, and wherein the massaging step is carried out internally by repetitively alternating the pressure in the balloon.

36. A method according to claim 31, wherein the collecting step comprises suctioning the biosample into the biofluid flow path of the catheter.

37. A method of collecting a biosample in a subject that is substantially void of urine, comprising:

inserting a catheter into a urethra of a subject, the catheter having a biofluid travel path defined therein;

suctioning a biosample from a targeted location along the urethra into the catheter in vivo; and

directing the suctioned biosample to travel in the biofluid travel path and to exit the body in a manner that maintains the biosample substantially void of urine.

38. A method according to claim 37, wherein the urethra is the female urethra.

39. A method according to claim 37, wherein the urethra is the male urethra.

40. A method according to claim 37, further comprising applying heat to a portion of the urethra proximate in time to or during the suctioning step.

41. A method according to claim 37, further comprising allowing urine to drain from the bladder of the subject during the suctioning step.

42. A method according to claim 37, further comprising massaging a portion of the urethra proximate in time or during the suctioning step.

43. A method according to claim 42, wherein the catheter comprises an outwardly expandable balloon thereon, and wherein the massaging step is carried out internally by repetitively alternating the pressure in the balloon.

44. A method according to claim 39, wherein the treatment is carried out proximate in time to administering radiation to the prostate of the subject.

45. A set of prostatic treatment catheters comprising:

a plurality of flexible elongated catheters sized and configured to be inserted into the male urethra, each catheter having an expandable treatment balloon positioned thereon and comprising a plurality of prostate drainage ports in communication with a prostate drainage lumen held internal of the catheter,

wherein the treatment balloons of the catheters in the set are configured with a length that is sized in the range of between about 1 cm to 6 cm such that, in operation, a selected treatment balloon resides above the verumontanum of the subject in the prostatic urethra.

46. A set of treatment catheters according to claim 45, wherein the catheter comprises a plurality of separate internal lumen fluid channels, including a circulating fluid inlet channel, a circulating fluid outlet channel, a urine drainage channel, and the prostate drainage lumen, and wherein the prostate drainage lumen is in fluid isolation from the other channels.

47. A system for collecting a prostatic fluid specimen in vivo in a subject, comprising:

a transurethral elongated catheter having an outer wall, the catheter having at least one prostate drainage port formed through the outer wall and an axially extending prostatic flow channel therein; and

a suction source in fluid communication with the at least one prostate drainage port, wherein in operation, the suction source provides a suction force sufficient to draw prostatic fluid into the at least one prostate drainage port and into the prostatic flow channel, thereby flowing out of the body of the subject so as to be able to be collected for evaluation.

48. A system for collecting a prostatic fluid specimen in vivo in a subject and/or facilitating the administration of a treatment to a subject, comprising:

an elongated transurethral catheter having an outer wall, the catheter comprising;

a plurality of axially extending internal fluid flow channels disposed in the catheter, an inlet circulating fluid channel, an outlet fluid circulating channel, a urinary drainage channel, and an axially extending prostatic fluid channel, wherein the prostatic fluid channel is in fluid isolation from the urine drainage and inlet and outlet channels;

an outwardly expandable treatment or dilatation balloon;

a bladder-anchoring balloon; and

at least one prostate drainage port formed through the outer wall of the catheter in fluid communication with the prostatic fluid channel;

a quantity of circulating fluid in the inlet and outlet channels;

a heater operably associated with fluid traveling in the inlet and outlet channels;

a pump operably associated with the circulating fluid to cause the fluid to circulate in the catheter;

at least one temperature sensor operably associated with the heater and the circulating fluid in the inlet and outlet channels; and

a suction source in fluid communication with the at least one prostate drainage port, wherein in operation, the suction source provides a suction force sufficient to draw prostatic fluid into the at least one prostate drainage port and into the prostatic flow channel, thereby flowing out of the body of the subject so as to be collected for evaluation.

49. A catheter or stent according to claim 48, wherein the suction source is the circulating fluid pump.

50. A transurethral catheter having an axially extending elongated body with an outer wall, the catheter comprising an anchoring balloon and at least one prostate drainage port formed through the outer wall and at least one axially extending prostate fluid collection channel located in the catheter in fluid communication with the at least one prostate drainage port, wherein, in proper position in the subject, the prostate drainage port is configured to reside proximate the verumontanum.

51. A catheter according to claim 50, wherein the at least one prostate drainage port is a plurality of drainage ports.

52. A catheter according to claim 50, wherein the anchoring balloon is a bladder-anchoring balloon, and wherein the catheter is devoid of a balloon located below the at least one prostate drainage port and above the urinary sphincter in the urethra of the subject.

53. A catheter or stent according to claim 50, wherein the anchoring balloon is a bladder anchoring balloon, and the catheter further comprises an outwardly expandable thermal treatment or dilation balloon located intermediate the anchoring balloon and the at least one prostate drainage port.

54. A computer program product for obtaining a biosample of the prostatic urethra, the computer program product comprising:

a computer readable storage medium having computer readable program code embodied in said medium, said computer-readable program code comprising;

computer readable program code computer readable program code for activating and applying a suction force to a fluid channel extending from a suction source located external of the body of the subject to the prostatic urethra via a catheter that is in fluid communication with the prostate; and

computer readable program code for drawing in and capturing a biosample comprising prostatic fluid in the catheter, the captured biosample being held so that it is substantially void of urine as it is directed to exit the subject in the catheter.

55. A computer program product for administering a thermal therapy to a subject, the thermal treatment being provided by a closed loop system having a heater, a circulating fluid pump, a suction source, and a trans-lumenal catheter configured and sized to be inserted through the urethra and having a biosample collection port and associated flow channel, and an outwardly expandable treatment balloon thereon that is configured, in operation, to expand while the catheter circulates heated fluid to heat a targeted region via the expandable treatment balloon, the computer program product comprising:

a computer readable storage medium having computer readable program code embodied in said medium, said computer-readable program code comprising;

computer readable program code for controlling the temperature of fluid circulating in the catheter so that the temperature of the fluid entering the catheter to travel to the expandable treatment balloon is between about 40-85°

C.;

computer readable program code for timing the duration of the thermal massage treatment so that the treatment has a duration of between about 5 minutes to 1.5 hours; and

computer readable program code for activating the suction source to draw a biosample from the subject into the catheter and collect the sample so that it is delivered out of the subject.

56. A computer program product according to claim 55, wherein the targeted region is the prostatic and/or membraneous urethra, wherein the collected sample delivered out of the subject is in a condition that is representative of the concentration and content that it had when it was collected in the target region in the urethra, and wherein, the program product further comprising computer readable program code for internally massaging the prostatic urethra proximate in time to the capturing of the biosample by repetitively altering the expansion degree of the expandable treatment balloon by altering one of the pumping speed or pressure in the balloon.

57. A method for treating prostatitis, comprising:

(a) inserting a catheter with a prostatic fluid collection port and associated flow channel, a urinary drainage inlet and associated flow channel, and at least one expandable treatment balloon thereon into the urethra of a subject, the treatment balloon positioned to extend outwardly about the perimeter of a portion of the catheter;

(b) inflating the at least one treatment balloon so that, in position, the inflated treatment balloon takes on a radially expanded configuration and circumferentially contacts targeted tissue in the prostatic urethra;

(c) heating a targeted region in the prostatic urethra to a temperature of between about 40-47°

C. for a desired treatment time of at least about 20 minutes thereby administering a thermal therapy to the prostate; and

(d) collecting prostatic fluid by directing the prostatic fluid into the collection port associated channel during or proximate in time to the treatment; and

(e) allowing urine to drain through the catheter drainage channel so that it is in fluid isolation from the collected prostatic fluid in the prostatic fluid collection channel.

58. A method according to claim 57, wherein the heating step is carried out by heating fluid to a desired temperature and directing the heated fluid such that it travels captured through the catheter to the at least one expandable treatment balloon in a circulating fluid travel path.

59. A method according to claim 57, wherein the collecting step comprises suctioning the prostatic fluid out at least once during the heating step.

60. A method according to claim 57, wherein the suctioning step is carried out substantially continuously during the heating step.

61. A method according to claim 57, further comprising internally massaging the prostatic urethra proximate in time or during the collecting step.

62. A method according to claim 61, further comprising and directing medicament to flow up into the catheter and out the prostatic fluid collection port after the massaging and heating steps to deliver the medicament to the targeted treatment region.

63. A method according to claim 57, wherein the catheter comprises a porous sleeve disposed over the treatment balloon, and the method further comprises delivering a medicament to the subject by allowing the medicament to travel through the membrane at a desired time before, during, or after the treatment.

64. A method for treating BPH, comprising:

(a) inserting a catheter with a suction port and associated flow channel and at least one expandable treatment balloon thereon into the urethra of a subject, the treatment balloon positioned to extend outwardly about the perimeter of a portion of the catheter;

(b) inflating the at least one treatment balloon, wherein, in position, the inflated treatment balloon takes on a radially expanded configuration and circumferentially contacts targeted tissue in the prostatic urethra;

(c) heating a targeted region in the prostatic urethra to a temperature of between about 40-67°

C. for a desired treatment time of at least 20 minutes thereby administering a thermal therapy to the prostate; and

(d) collecting prostatic fluid in the catheter proximate in time to the treatment.

65. A method according to claim 64, wherein the heating step is carried out by heating fluid to a desired temperature and directing the heated fluid such that it travels captured through the catheter to the at least one expandable treatment balloon in a circulating fluid travel path, and wherein the method further comprises allowing urine to drain through the catheter so that it is in fluid isolation from the collected prostatic fluid.

66. A method according to claim 64, wherein the collecting step comprises suctioning the prostatic fluid into the catheter out at least once during or proximate in time but after the heating step.

67. A method according to claim 64, wherein the collecting step is carried out substantially continuously during the heating step.

68. A method according to claim 64, wherein said treatment is repeated in about 18 hours to about 1 month from the first treatment.

69. A method according to claim 65, wherein said heating step heats the fluid to about 45-65°

C. to heat prostatic tissue for about 20-90 minutes.

70. A method according to claim 64, wherein the catheter includes a urinary drainage inlet and associated drainage channel, the drainage channel being separate from the prostatic fluid flow channel, and an anchoring balloon thereon.

71. A method according to claim 64, further comprising internally massaging the prostatic urethra proximate in time or during the collecting step.

72. A method according to claim 71, further comprising and directing the medicament to flow up into the catheter and out the prostatic fluid collection port after the massaging and heating steps to deliver the medicament to the targeted treatment region.

73. A method according to claim 64, wherein the catheter comprises a porous sleeve disposed over the treatment balloon, and the method further comprises delivering a medicament to the subject by allowing the medicament to travel through the membrane at a desired time before, during, or after the treatment.

74. A method according to claim 64, further comprising analyzing the collected prostatic fluid for one of quantity and constituent content.