Adhesion Prevention and an Intra-Luminal Cooling System Therefor

Abstract

By present invention it has been found that hypothermia decreases adhesion formation more specifically pneumoperitoneum-enhanced adhesion formation. A cooling system has been designed to reduce the peritoneal cavity temperature during surgery, while maintaining at all times a 100% relative humidity in order to prevent desiccation, and a regulatory unit designed to condition the insufflated gas to achieve this while minimalising the necessary cooling. This is a new method for more effectively preventing adhesion though cooling while preventing desiccation. In mice it was demonstrated that factors such as environmental temperature, anaesthesia, ventilation and pneumoperitoneum can be used to influence body temperature in order to prevent adhesion formation.

Description

DRAWING DESCRIPTION

Brief Description of the Drawings

FIG. 1

Effect of environment temperature upon body temperature (left side) and upon adhesion formation (right side) in mice. Basal and pneumoperitoneum (PP)-enhanced adhesions were induced during laparoscopy at 20 cm H₂O insufflation pressure and mice were kept either at RT or at 37° C.

Symbols: ◯ 10 min PP, RT;  60 min PP, RT; □ 10 min PP, 37° C.; ▪ 60 min PP, 37° C. p<0.05: ^a10 vs. 60 min at RT or at 37° C., ^bRT vs. 37° C. at 10 or at 60 min (Two-way ANOVA for temperature and Mann Whitney test for adhesion formation)

FIG. 2

Effect of body temperature (left side) upon adhesion formation (right side) in mice. Pneumoperitoneum (PP)-enhanced adhesions were induced during laparoscopy at 20 cm H₂O insufflation pressure.

Symbols: □ group I, ▴ group II,  group III. Mean±SE of body temperature during T₂₀-T₈₀ is indicated on the adhesion graph.

p<0.05: ^avs. group I, ^bvs. group II (Two-way ANOVA for temperature and Mann Whitney test for adhesion formation).

FIG. 3

Effect at 37° C. of the duration of pneumoperitoneum and of adding oxygen to the pneumoperitoneum upon adhesion formation in mice. Basal (group VI) and pneumoperitoneum (PP)-enhanced adhesions (group I, IV and V) were induced during laparoscopy at 20 cm H₂O insufflation pressure with CO₂ containing 0% (group I and VI), 3% (group IV) or 12% of oxygen (group V). Mean±SE of body temperature during T₂₀-T₈₀ is indicated. p<0.05 ^avs group I, ^bvs group V (Mann Whitney test).

FIG. 4

Relationship between body temperature and adhesion formation. Individual values of the mean of body temperature between T₂₀ and T₈₀ with their respective proportion of adhesions are depictured for pneumoperitoneum-enhanced adhesion for experiment I and III. p=0.0036 (Pearson correlation).

FIG. 5

Displays a cross-sectional side of a patient subjected to an insufflation for endoscopy. This insufflator can be integrated with an intra-abdominal cooling means designed to obtain an intra-abdominal temperature (K) below 37° C., preferably below 35° C., ideally between 32 to 34° C., a humidification system to prevent completely dessication, and a regulatory unit permitting to obtain simultaneously cooling, and absence of dessication. J=patient, K=intra-abdominal cavity, L=trocar, N=is insufflator means and M is endoscope comprising camera and lighting

FIG. 6 is a cross-sectional side view of an assembly for intra-abdominal cooling, insufflation and humidification, wherein a=a control unit, b=an intra-abdominal cooling means, c=the intra-abdominal cooling conduit, d=an intra-abdominal temperature probe, e=a means for insufflation measurement and conditioning, f=a conditioned insufflation tubing, g=a humidifier, h=an insufflation tubing and i=an insufflator The control and measurement signals are indicated by the following symbols: S0=set point intra-abdominal cooling t₀; S1=the measurement of insufflation temperature t₁, the measurement of insufflation relative humidity h₁, the set point insufflation temperature t'₁, or the set point relative humidity h'₁; S2=the measurement of the intra-abdominal temperature T₂, S3=the demanded relative humidity h₃ and S4 is the insufflation flow rate r.

FIG. 7 is a cross-sectional side view an intra-abdominal cooling means as which can be integrated into the assembly of FIG. 5 but demonstrating that alternatively the intra-abdominal cooling can be directed via the trocar of the endoscope.

b=an intra-abdominal cooling means, c=the site intra-abdominal cooling, d=an intra-abdominal temperature probe, e=a means for insufflation measurement and conditioning, The control and measurement signals are indicated by the following symbols: S0=set point intra-abdominal cooling t₀; S1=the measurement of insufflation temperature t₁, the measurement of insufflation relative humidity h₁, the set point insufflation temperature t'₁ or the set point relative humidity h'₁; S2=the measurement of the intra-abdominal temperature T₂,

FIG. 8 is a feedback based control loop which can be used to regulate towards a desired intra abdominal temperature, the desired relative humidity of the insufflated gas and which can establish the necessary temperature difference between insufflated gas and intra abdominal temperature in order to get condensation of the insufflated gas in the abdominal cavity ensuring full humidification and preventing dessication. Optional input signals are shown as dashed lines, and comprise mainly the setpoint of the relative humidity of the humidifier and flow rate generated by the insufflator. This control mechanism is a concrete implementation of the aforementioned regulatory unit (control unit FIG. 6a), but by no means the one and only workable solution.

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Claims

1-27. (canceled)

28. A cooling and humidification assembly to cool and humidify a patient's abdominal cavity while preventing dessication, comprising an intra-luminal cooling means (b) designed to cool a patient's abdominal cavity or abdominal cavity surface to a condition of hypothermia, wherein said cooling means (b) is mountable to a cooling conduit (c) designed to transport cooling fluid into the patient's abdominal cavity, wherein said cooling means is integrateable with or mountable to an insufflation assembly (N) for administering insufflation fluid and wherein said cooling and humidification assembly further comprises a controlling means (a) to regulate the intra-abdominal cooling and humidification, maintaining continuously a 95 to 100% relative humidity in the abdominal cavity of said patient and maintaining a temperature in the insufflation fluid which is 1° C. to 5° C. higher than the temperature in the abdominal cavity.

29. The cooling and humidification assembly of claim 28, characterised in that the cooling conduit is designed to comprise a liquid fluid.

30. The cooling and humidification assembly of claim 28, characterised in that the cooling conduit is designed to comprise a gas/liquid fluid.

31. The cooling and humidification assembly of claim 28, characterised in that the cooling conduit (c) is designed to sprinkle the cooling fluid into the patient's abdominal cavity or to a region of patient's abdominal cavity.

32. The cooling and humidification assembly of claim 28, characterised in that the controlling means (a) is designed to regulate the intra-abdominal cooling while maintaining continuously a relative humidity of 96 to 100% in patient's abdominal cavity.

33. The cooling and humidification assembly of claim 28, characterised in that the controlling means (a) is designed to regulate the intra-abdominal cooling while maintaining continuously a 100% relative humidity in patient's abdominal cavity.

34. The cooling and humidification assembly of claim 28, wherein the insufflation assembly comprises a means for insufflation measurement and conditioning (e), an insufflation tubing (f), a humidifier (g), and an insufflator (i).

35. The cooling and humidification assembly of claim 28, wherein the insufflation assembly (N) is integrated with said cooling means within said cooling and humidification assembly.

36. The cooling and humidification assembly of claim 28, characterised in that the controlling means comprises at least one sensor to measure the temperature in the patient's abdominal cavity, at least one sensor to measure the flow rate of the insufflation fluid, at least one sensor to measure the temperature of the insufflation fluid, at least one sensor to measure the humidity of the insufflation fluid and at least one actuator to condition the temperature and absolute humidity in the insufflation fluid.

37. The cooling and humidification assembly of claim 36, characterised in that the controlling means further comprises at least one sensor to measure the flow rate in the cooling conduit.

38. The cooling and humidification assembly of claim 28, characterised in that the cooling conduit comprises a fluid guidance including an interior wall and an exterior wall, wherein said interior wall defines one boundary of said interior fluid guidance from a fluid inlet in said exterior wall to a fluid outlet in said exterior wall.

39. The cooling and humidification assembly of claim 28, characterised in that the controlling means is designed to condition the temperature and absolute humidity in the insufflation fluid to achieve an absolute humidity in said insufflation fluid which is 0.1 to 5% higher than the relative humidity at the intra-abdominal temperature.

40. The cooling and humidification assembly of claim 28, characterised in that the controlling means is designed to adapt the cooling rate in the abdominal cavity to maintain a continuously 97-100% relative humidity at the desired intra-abdominal temperature.

41. The cooling and humidification assembly of claim 28, characterised in that its controlling means is designed to maintain a temperature in the insufflation fluid which is 2° C. to 4° C. higher than the temperature in the abdominal cavity.

42. The cooling and humidification assembly of claim 28, characterised in that its controlling means is designed to regulate the temperature, humidity and/or flow rate in the cooling conduit until a predestined temperature of the intra-abdominal surface between 32-23° C. has been reached.

43. The cooling and humidification assembly of claim 28, characterised in that its controlling means is designed to regulate the temperature, humidity and/or flow rate in the cooling conduit until a predestined temperature of the intra-abdominal surface between 23-12° C. has been reached.

44. The cooling and humidification assembly of claim 28, characterised in that it cools the patient's abdominal cavity or abdominal cavity surface to a moderate hypothermia.

45. The cooling and humidification assembly of claim 28, characterised in that it cools the patient's abdominal cavity or abdominal cavity surface to a profound hypothermia

46. The cooling and humidification assembly of claim 28, characterised in that the fluid outlet of the cooling conduit is near the proximal end of the trocar (L) of an endoscopic surgery device.

47. The cooling and humidification assembly of claim 28, characterised in that the cooling channel is extending coaxially within the trocar (L) of an endoscopic surgery device to the distal end thereof.

48. A method to prevent or decrease post-operative adhesion formation between tissue surfaces in an abdominal cavity, which method comprises the step of cooling the tissue surfaces in said abdominal cavity which is, has been or will be subjected to pneumoperitoneum by administration of insufflation fluid, to a condition of hypothermia and an intra-abdominal relative humidity of 95 to 100% at said temperature, whereby the temperature of said insufflation fluid is higher than said temperature of said tissue surfaces of said abdominal cavity and the absolute humidity of said insufflation fluid is higher than said intra-abdominal relative humidity at said body temperature.

49. The method of claim 48, wherein the surfaces in an abdominal cavity or part of the surface is cooled to a moderate hypothermia.

50. The method of claim 48, wherein the surfaces in an abdominal cavity or part of the surface is cooled to a profound hypothermia.

51. The method of claim 48, characterised in that the temperature of the insufflation fluid and absolute humidity of the insufflation fluid is conditioned to obtain an absolute humidity of the insufflation fluid that is 0.1 to 5% higher than the intra-abdominal relative humidity.

52. The method of claim 48, wherein said abdominal cavity is contacted with a cooling and humidification assembly to cool and humidify a patient's abdominal cavity while preventing dessication, comprising an intra-luminal cooling means (b) designed to cool a patient's abdominal cavity or abdominal cavity surface to a condition of hypothermia, wherein said cooling means (b) is mountable to a cooling conduit (c) designed to transport cooling fluid into the patient's abdominal cavity, wherein said cooling means is integrateable with or mountable to an insufflation assembly (N) for administering insufflation fluid and wherein said cooling and humidification assembly further comprises a controlling means (a) to regulate the intra-abdominal cooling and humidification, maintaining continuously a 95 to 100% relative humidity in the abdominal cavity of said patient and maintaining a temperature in the insufflation fluid which is 1° C. to 5° C. higher than the temperature in the abdominal cavity.