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Publication numberWO2008051672 A2
Publication typeApplication
Application numberPCT/US2007/079264
Publication date2 May 2008
Filing date24 Sep 2007
Priority date25 Oct 2006
Also published asWO2008051672A3
Publication numberPCT/2007/79264, PCT/US/2007/079264, PCT/US/2007/79264, PCT/US/7/079264, PCT/US/7/79264, PCT/US2007/079264, PCT/US2007/79264, PCT/US2007079264, PCT/US200779264, PCT/US7/079264, PCT/US7/79264, PCT/US7079264, PCT/US779264, WO 2008/051672 A2, WO 2008051672 A2, WO 2008051672A2, WO-A2-2008051672, WO2008/051672A2, WO2008051672 A2, WO2008051672A2
InventorsChristopher C. Thompson
ApplicantThe Brigham And Women's Hospital, Inc.
Export CitationBiBTeX, EndNote, RefMan
External Links: Patentscope, Espacenet
A system for isolating a surgical site
WO 2008051672 A2
Abstract
A system for isolating a volume of a lumen includes first and second balloons each including a sealable valve, wherein the balloons are configured to inflate on either side of and to seal the lumen, wherein at least one of the balloons includes a pair of opposing sealable ports.
Claims  (OCR text may contain errors)
1. A system for isolating a volume of a lumen, the system comprising: first and second balloons each including a sealable valve, wherein the balloons are configured to inflate on cither side of and to seal the lumen; wherein at least one of the balloons includes a pair of opposing sealable ports.
2. The system of claim 1 , further comprising: a tool configured to pass through the pair of sealable ports to access the lumen.
3. The system of claim 1 , further comprising: an insufflator in fluid communication with a sealable valve.
4. The system of claim 1 , further comprising: a pressure monitor in pneumatic communication with a sealable valve.
5. The system of claim 1 , wherein at least one sealable valve is configured to receive an insufflation needle.
6. The system of claim 2, wherein the tool is configured to introduce a fluid into the lumen.
7. The system of claim 2, wherein the tool comprises an endoscope.
8. The system of claim 2, wherein the tool comprises: a longitudinal portion extending from a nozzle portion, wherein the nozzle portion comprises: an perforated portion configured to irrigate the surgical site; a plurality of bristles extending from the perforated portion; and walls defining a conduit through the longitudinal portion to provide fluid communication into the lumen.
9. The system of claim 1, wherein the balloons are configured to inflate in a colon.
10. The system of claim 1, wherein the balloons comprise self-sealing 5 biocompatible material.
11. The system of claim 1, wherein the balloons are configured for inflation to a maximum pressure between 50 and 100 mmHg. C
12. The system of claim 1, wherein the balloons have an inflated dimension in excess of one inch.
13. A method for isolating a volume of a lumen, the method comprising: occluding the lumen at a first location; 5 occluding the lumen at a second location longitudinally displaced from the first location; and inflating the lumen.
14. The method of claim 13, further comprising: 0 introducing at least one tool into the lumen.
15. The method of claim 13, further comprising: monitoring pressure of the lumen. 5
16. The method of claim 13, further comprising: controlling pressure of the lumen.
17. The method of claim 13, further comprising: irrigating the lumen. 0
18. The method of claim 13, further comprising: scrubbing the lumen.
19. The method of claim 13, further comprising: providing suction in the lumen.
20. The method of claim 13, wherein occluding comprises inflating a balloon.
21. The method of claim 13, further comprising: creating a hole in a wall of the lumen; and passing a surgical instrument through the hole.
22. The method of claim 20, further comprising: monitoring pressure of the balloon.
Description  (OCR text may contain errors)

A SYSTEM FOR ISOLATING A SURGICAL SITE

FIFXD OF DISCLOSURE

This application relates to surgical devices, and in particular, to surgical devices for transcolonic surgery.

BACKGROUND

Problems that can be associated with accessing the peritoneal cavity during transcolonic surgery include poor visualization of the surgical site on the colonic wall due to the pliant nature of colonic tissue and risk of localized and systemic infection due to leakage of contaminates through the surgically opened colonic wall and into the periotoneal cavity.

SUMMARY In one aspect, a system for isolating a volume of a lumen includes first and second balloons each including a sealable valve, wherein the balloons are configured to inflate on either side of and to seal the lumen, wherein at least one of the balloons includes a pair of opposing sealable ports. Implementations include one or more of the following. A tool configured to pass through the pair of sealable ports to access the lumen. An insufflator in fluid communication with a sealable valve. A pressure monitor in pneumatic communication with a sealable valve. At least one sealable valve is configured to receive an insufflation needle. The tool is configured to introduce a fluid into the lumen. The tool includes an endoscope. The tool includes a longitudinal portion extending from a nozzle portion, wherein the nozzle portion includes a perforated portion configured to irrigate the surgical site, a plurality of bristles extending from the perforated portion, and walls defining a conduit through the longitudinal portion to provide fluid communication into the lumen. The balloons arc configured to inflate in a colon. The balloons include self-sealing biocompatible material. The balloons are configured for inflation to a maximum pressure between 50 and 100 mmHg, The balloons have an inflated dimension in excess of one inch.

SUBSTITUTE SHEET (RLlLE 26) In one aspect, a method for isolating a volume of a lumen includes occluding the lumen at a first location, occluding the lumen at a second location longitudinally displaced from the first location, and inflating the lumen. Implementations include one or more of the following. The method further includes introducing at least one tool into the lumen. The method further includes monitoring pressure of the lumen. The method further includes controlling pressure of the lumen. The method further includes irrigating the lumen. The method further includes scrubbing the lumen. The method further includes providing suction in the lumen. Occluding includes inflating a balloon. The method further includes creating a hole in a wall of the lumen, and passing a surgical instrument through the hole. The method further includes monitoring pressure of the balloon.

DESCRIPTION OFTHR DRAWINGS

FIGS. IA to ID and 2 A to 2D show a system for isolating a surgical site. FIGS. 3 A and 3B show an assembly for cleaning the surgical site.

DETAILED DESCRIPTION

FIG. IA shows a system 10 for preparing and/or accessing a transcolonic surgical site 12. Colon 18 forms a lumen in which the system 10 is positioned. The first part of the system 10 includes an expandable device 14 having an interior cavity 16, e.g., a balloon, constructed of a biocompatible material, e.g., silicone rubber. The device 14, in an unexpanded state, is positioned within the colon 18 proximal to the surgical site 12.

As shown in FIG. 2 A, once positioned in a site that is proximal to the surgical site 12, the expandable device 14 is expanded by introducing fluid, e.g., air, into the cavity 16 of the expandable device 14 such that the expandable device 14 becomes lodged, e.g., frictionally fit, between the walls of the colon 18. Fluid communication will thus be prevented between the portion of the colon 18 that lies proximal to the lodged, expandable device 14 and the portion of colon 18 that lies distal to the lodged, expandable device 14.

In the embodiment of FIG. 1C, the expandable device 14 further includes a sealable valve 20 disposed thereon. One end of a tether 22, e.g., a catheter, is secured to the sealable valve 20 and the other end of the tether 22 is secured to an insufflator 24. Fluid, e.g., air, can be passed through the tether 22, the end of which can lie outside the rectum 26, and through the sealable valve 20 and into the cavity 16 at a pressure that expands and lodges the expandable device 14. Pressures suitable for expansion and lodgment of the expandable device 14 include pressures within the range of between 50-100 mmHg. Maintenance of such pressure may be accomplished by coupling a pressure monitor 28 to the tether 22. In some embodiments, the sealable valve 20 is adapted to receive an insufflation needle 30. Withdrawal of the insufflation needle 30 seals the sealable valve 20. As shown in the embodiment of FIG. 1 D, the expandable device 14 is constructed of a puncturable, resealable material. In operation, a means for introducing fluid into the cavity, e.g., a needle 30 having a lumen therethrough, pierces the expandable device 14 to form a puncture hole 32. Fluid is then passed through the lumen and hole 32 to expand and lodge the expandable device 14. Withdrawal of the needle 30 seals the hole 32.

As shown in FIG. 2A, the second part of the system 10 includes an expandable apparatus 34 of like construction to that of the expandable device 14 and which further features a pair of sealable ports (a first sealable port 36 and a second sealable port 38). The expandable apparatus 34, in an unexpanded state, is positioned within the colon 18 distal to the surgical site 12 and the lodged, expandable device 14.

Referring to FIG. 2B, once positioned in a site that is distal to the surgical site 12 and the lodged, expandable device 14, the expandable apparatus 34 may be expanded to lodge, e.g., frictionally fit, the expandable apparatus 34 between the walls of the colon 18 by introducing fluid, e.g., air, into the cavity 40 of the apparatus 34 in like manner to that previously described for the expandable device 14.

As shown in FIG. 2C, in one embodiment, the tether 22 of the lodged, expandable device 14 is threaded through the first and second sealable ports 36, 38 prior to expanding the apparatus 34. Upon expansion, a portion of the lodged, expandable apparatus 34 may, but does not necessarily have to, extend outside of the rectum 26. Subsequent to the expansion and lodgment of the expandable device 14 and expandable apparatus 34, a means for introducing fluid, e.g., an insufflation needle 42, is passed through the first and second scalable ports 36, 38, respectively. Fluid, e.g., air, flows through the means for introducing fluid to create a pressure, e.g., a pressure within the range of between 10-50mmHg, at the surgical site 12. Pressure at the surgical site 12 may be monitored with a pressure monitor 44 and controlled with an insufflator 46. The pressure monitor 44 and insufflator 46 may be the pressure monitor 28 or insufflator 24 that is secured to the tether 22 of the expandable device 14 or, alternatively, may be separate modules. Once pressurized, the surgical site 12 may be viewed and/or the surgical site 12 operated on by inserting at least one tool 48, e.g., an endoscope, a snare, etc., through the first and second sealable valves 36, 38.

In the alternative embodiment shown in FIG. 2D, the apparatus 34 further includes a second pair of sealable ports (third sealable port 50 and fourth sealable port 52). In this embodiment, the first and second sealable ports 36, 38 lie in registration and arc adapted to allow insertion of the means for introducing fluid through the apparatus 34 and the third and fourth scalable ports 50, 52 lie in registration and are adapted to allow insertion of a surgical tool 48 through the apparatus 34.

When both the expandable device 14 and apparatus 34 are lodged, fluid migration into and out of the surgical site 12 will be substantially controlled thereby resulting in an transcolonic operating environment that has a decreased susceptibility to contamination. Also, when lodged, the expandable apparatus 34 may function as an anchoring device that facilitates manipulation of the tools 48 at the surgical site 12. In addition, control of the pressure at the surgical site 12 will result in enhanced visual acuity of the site.

In the embodiment of FIG. 3A, the tool 48 is a medical instrument assembly 54 used to clean the surgical site 12. The assembly 54 features a nozzle portion 56 and a longitudinal portion 60. The nozzle portion 56 includes a perforated chamber 58. Materials suitable for use for the construction of the nozzle and longitudinal portions 56, 60 include any metals or polymers that have been governmentally approved for endoscopic and/or surgical procedures and similar materials thereto. The longitudinal portion 60 includes a channel 62 that communicates with the apertured chamber 58. The channel 60 features first and second side walls 64, 66. Positioned adjacent to the first and second side walls 64, 66 are conduits 68, the ends of which are defined by shoulders that extend laterally from the longitudinal portion. Mesh 70 is applied over the ends of the first and second side walls 64, 66. Disposed on the nozzle portion 56 are bristles 72. Materials suitable for the construction of the bristles can include biocompatible polymers having mechanical properties that allow brushing, but not insulting, of colon wall tissue or similar materials thereto. The medical instrument assembly 54 brushes the surgical site 12 with the bristles 72. Prior to, concurrent with, and/or subsequent to the brushing, cleansing fluid, e.g., betadyne, is flowed through channel 62 and out of the perforated chamber 58 of the nozzle portion 56 to irrigate the surgical site 12. Prior to, concurrent with and/or subsequent to the scrubbing and irrigating, a vacuum force is created within the conduit 68 to aspirate fluid and particulate matter from the surgical site 12, e.g., the cleaning fluid and excrement dislodged from the brushing. When implemented into system 10, the medical instrument assembly 54 can be positioned at the surgical site 12 subsequent to the expansion and lodgmentof the expandable device 14 and prior to expansion and lodgment of the expandable apparatus 34 or, alternatively, can be inserted through the expandable apparatus 34 subsequent to the expansion and lodgment of the expandable apparatus 34 by way of the first and second port 36, 38.

As shown in FIG. 3B, the expandable apparatus 34 further includes a third pair of sealable ports (fifth sealable port 74 and sixth sealable port 76). Subsequent to expansion and lodgment of both the expandable device 14 and expandable apparatus 34, the medical instrument assembly 54 is passed through the fifth and sixth ports 74,- 76 whereupon it can be positioned at the surgical site 12 for use as a cleaning tool as previously described. In this embodiment, an irrigation/aspiration source 78 is secured to the end of the longitudinal portion 60.

Having described the invention, and a preferred embodiment thereof, I claim, as new and secured by letters patent:

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Classifications
International ClassificationA61M29/00
Cooperative ClassificationA61B17/12136, A61B17/12099, A61M2025/1052, A61B17/12045, A61B2017/12127, A61M25/10
European ClassificationA61B17/12P5, A61B17/12P7B, A61B17/12P1T2, A61M25/10
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