Bowel management system with physiologic sensors

• US 20060100595A1
• Filed: 11/09/2004
• Published: 05/11/2006
• Est. Priority Date: 11/09/2004
• Status: Active Grant

• Current Assignee: Hollister Incorporated
• Original Assignee: Hollister Incorporated
• Inventors: Minasi, John S., von Dyck, Peter M., Schneider, James G., Martino, Nick
• Granted Patent: US 8,075,540 B2
• Time in Patent Office: Days
• US Class Current: 604/348
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/4255 Intestines, colon or appendix
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61F 5/44 Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aidsabsorbent pads, e.g. sanitary towels, A61F13/15; drainage appliances for wounds A61M27/00; emptying devices for urine bags B65B69/0016; Colostomy devices adhesives for colostomy devices A61L24/00; materials for colostomy devices A61L28/00

Abstract

A bowel management system includes a rectal catheter; and at least one physiologic sensor. The rectal catheter has a portion in contact with a patient'"'"'s body internally thereof during use of the system, to thereby determine a preselected physiologic parameter of a patient having the rectal catheter inserted into the patient'"'"'s bowel. The position of the sensor relative to the rectal catheter portion is such that the sensor is disposed in close proximity to the internal tissue of the patient, or within the fecal flow, when the bowel management system is place for use within the patient.

Claims

1. A bowel management system comprising:

a rectal catheter; and

at least one physiologic sensor and a rectal catheter, a portion of which is disposed in contact with a patient'"'"'s body internally thereof during use of the system, to thereby determine a preselected physiologic parameter of a patient having the rectal catheter inserted into the patient'"'"'s bowel, wherein the position of the sensor relative to the rectal catheter portion is such that the sensor is disposed in close proximity to the internal tissue of the patient when the bowel management system is place for use within the patient.

2. The bowel management system of claim 1, and further comprising a wire connected to the at least one physiologic sensor and extending to outside of the patient'"'"'s body in normal use position, to thereby transmit physiologic information from the patient to a caregiver.

3. The bowel management system of claim 1, wherein the at least one physiologic sensor is wireless.

4. The bowel management system of claim 1, wherein the rectal catheter comprises a main catheter having a patient proximal end and a wall defining a major lumen, the patient proximal end being the portion disposed within the patient'"'"'s bowel during use of the system and the major lumen providing communication between the interior of the patient'"'"'s bowel and the exterior of the patient'"'"'s body.

5. The bowel management system of claim 4, wherein one of the at least one physiologic sensors is disposed on the wall of the main catheter, externally to the main catheter lumen.

6. The bowel management system of claim 4, wherein one of the at least one physiologic sensors is disposed internally on the wall of the main catheter, within the lumen thereof.

7. The bowel management system of claim 4, wherein the at least one sensor is embedded within the catheter wall defining the major lumen.

8. The bowel management system of claim 4 and further comprising an inflatable cuff mounted to the patient proximal end of the main catheter to thereby retain the system within the patient'"'"'s bowel when the inflatable cuff is inflated.

9. The bowel management system of claim 8, wherein one of the at least one physiologic sensors is disposed internally of the inflatable cuff.

10. The bowel management system of claim 8, wherein one of the at least one physiologic sensors is disposed externally of the inflatable cuff on an external surface thereof.

11. The bowel management system of claim 8, wherein one of the at least one physiologic sensors is embedded within material of which the inflatable cuff is formed.

12. The bowel management system of claim 4 and further comprising at least one small diameter tube connected to the major catheter and having a wall defining a minor lumen.

13. The bowel management system of claim 12, wherein one of the at least one physiologic sensors is disposed within the minor lumen.

14. The bowel management system of claim 12, wherein the at least one small diameter tube is connected inside the major lumen of the main catheter and one of the at least one physiologic sensors is disposed within the minor lumen of the at least one small diameter tube.

15. The bowel management system of claim 12, wherein one of the at least one physiologic sensors is embedded within the wall of a small diameter tube connected to the main catheter.

16. The bowel management system of claim 4, further comprising a dedicated cuff (30) at the patient proximal end of the main catheter.

17. The bowel management system of claim 16, wherein one of the at least one physiologic sensors is disposed internally of the dedicated cuff (30).

18. The bowel management system of claim 16, wherein one of the at least one physiologic sensors is disposed externally of the dedicated cuff (30).

19. The bowel management system of claim 16, wherein one of the at least one physiologic sensors is embedded within the material of which the dedicated cuff is formed.

20. The bowel management system of claim 4, and further comprising a retention device mounted to the patient proximal end of the main catheter to thereby retain the system within the patient'"'"'s bowel for extended periods of time.

21. The bowel management system of claim 20, wherein one of the at least one physiologic sensors is disposed internally on the wall of the main catheter, within the lumen thereof.

22. The bowel management system of claim 20, wherein one of the at least one physiologic sensors is disposed on the wall of the main catheter, externally to the main catheter lumen.

23. The bowel management system of claim 20, wherein one of the at least one physiologic sensors is disposed internally of the retention device, substantially adjacent to the patient proximal end of the major lumen of the main catheter.

24. The bowel management system of claim 20, wherein one of the at least one physiologic sensors is disposed externally of the retention device on an external surface thereof.

25. The bowel management system of claim 20, wherein one of the at least one physiologic sensors is embedded within material of which the retention device is formed.

26. The bowel management system of claim 20, and further comprising at least one small diameter tube connected to the major catheter and having a wall defining a minor lumen.

27. The bowel management system of claim 26, wherein one of the at least one physiologic sensors is disposed within a minor lumen.

28. The bowel management system of claim 26, wherein the at least one small diameter tube is connected inside the major lumen of the main catheter and one of the at least one physiologic sensors is disposed within the minor lumen of the at least one small diameter tube.

29. The bowel management system of claim 26, wherein one of the at least one physiologic sensors is embedded within the wall of a small diameter tube connected within the main catheter.

30. The bowel management system of claim 26, wherein one of the at least one physiologic sensors is embedded within the catheter wall defining the major lumen.

31. The bowel management system of claim 20, further comprising a dedicated cuff (30) at the patient proximal end of the main catheter.

32. The bowel management system of claim 31, wherein one of the at least one physiologic sensors is disposed internally of the dedicated cuff (30).

33. The bowel management system of claim 31, wherein one of the at least one physiologic sensors is disposed externally of the dedicated cuff (30).

34. The bowel management system of claim 31, wherein one of the at least one physiologic sensors is embedded within the material of which the dedicated cuff (30) is formed.

35. The combination of an ano/rectal probe and an indwelling rectal catheter, the indwelling rectal catheter comprising a drain catheter disposed during normal operative position within a portion of a patient'"'"'s bowel, the drain catheter having a wall defining a major lumen;

the probe comprising a sensor for detecting and transmitting information from the patent'"'"'s bowel when disposed in close proximity to the mucosa of the rectum or anal canal of the patient, and an elongated portion connected to the sensor, the elongated portion being capable of conducting patient information from the sensor to a caregiver, the probe being suitable for at least a single use and being sized and shaped so as to be insertable via a lumen of the catheter in order to gain access to a preselected monitoring site within the patient'"'"'s bowel.

36. The combination of claim 35, wherein the indwelling rectal catheter has at least one small diameter tube having a wall defining a lumen connected to the indwelling catheter and the probe is sized and shaped so as to be insertable into the at least one small diameter tube.

37. The combination of claim 35, wherein the probe is reusable.

38. The combination of claim 35, wherein the probe is disposable.

39. The combination of claim 35, and further comprising structure connected to a patient proximal end of the drain catheter, the sensor of the probe being connected to the structure, which structure is activatable to thereby trigger a patient reading to be taken by the probe and transmitted externally of the patient.

40. The combination of claim 35, wherein the sensor is selectively activatable.

41. The combination of claim 35, wherein the sensor is automatically activatable at predetermined times.

42. The combination of claim 35, wherein the probe is wireless.

43. The combination of claim 35, wherein the probe further comprises a wire by which to thereby transmit physiologic information from the patient.

44. A bowel management system comprising:

a rectal catheter insertable into a patient'"'"'s bowel; and

at least one physiologic sensor within a portion of the rectal catheter, wherein the position of the at least one physiologic sensor is such that the sensor is disposed in the path of fecal flow within the catheter when the bowel management system is place for use within the patient, to thereby monitor characteristics of the fecal content.

45. A method of managing a patient'"'"'s bowel comprising the steps of:

(a) providing a combination of an ano/rectal probe and an indwelling rectal catheter, the indwelling rectal catheter having a drain catheter;

(b) positioning the drain catheter in a patient'"'"'s bowel;

(c) inserting the probe via a lumen of the drain catheter to a preselected monitoring site within the patient'"'"'s bowel with a sensor of the ano/rectal probe disposed in close proximity to the mucosa of the rectum or anal canal of the patient for detecting and transmitting information from the patient'"'"'s bowel; and

(d) actively managing the patient'"'"'s bowel, including selectively draining fecal material from the bowel, containing fecal material within the bowel until the time for selective draining and irrigating the patient'"'"'s bowel.

46. The method of claim 45, and further comprising the step

(e) physiologically monitoring the patient'"'"'s bowel, including the steps of inserting at preselected times the probe through a lumen in the drain catheter of the bowel management system within a patient'"'"'s bowel;

and obtaining data from the patient'"'"'s bowel via the probe and evaluating the data with regard to patient status and therapeutic measures to be taken.

47. The method of claim 45, and further comprising the steps of:

(e) administering agents selected from the group consisting of diagnostic substances and therapeutic substances, and

(f) monitoring the effluent of the patient'"'"'s bowel to thereby determine the efficacy of the administration of agents.