Patent EA-004013-B1 (EA)
Title: An arrangement and method for interacting with an internal body organ
Inventor: AGERUP BENGT
IPC: A61B17/34
Filed: 2001-07-04
Abstract: 1. An arrangement to be passed through a body cavity for interacting with an internal body organ, comprising: an elongate sheath having at least one interior passage, said sheath having a proximal end and a distal end, said distal end being open and in communication with said at least one passage; and at least two elongate structural elements, each structural element having a proximal end and a distal end; wherein the structural elements are inserted in said at least one passage so that at least a distal portion of each element extends therethrough in the longitudinal direction of the sheath; wherein the structural elements are arranged to be displaced relative to the sheath from a first position, in which the distal end of each structural element is located inside said at least one passage and in which the arrangement is intended to be passed through a body cavity, to a second position, in which a distal portion of each structural element extends through the open distal end of the sheath and at least partly in the transverse direction away from the sheath for distending and/or expanding interaction between the distal end of each structural element and a body organ approached by the arrangement through a body cavity. 2. The arrangement as claimed in claim 1, wherein the sheath is tubular and has a lumen as said at least one passage. 3. The arrangement as claimed in any one of claims 1-2, wherein each elongate structural element is tubular, preferably in the form of a cannula, especially an injection needle for injecting a substance into said body organ. 4. The arrangement as claimed in any one of claims 1-3, wherein said elongate structural elements are mechanically biased in said first position and strive to deflect past the circumference of the sheath in the transverse direction thereof so that the structural elements reach said second position when being displaced relative the sheath through the open distal end thereof. 5. The arrangement as claimed in any one of claims 1-4, wherein, in said second position, the distal end of each structural element is located beyond the transverse extent of the sheath. 6. The arrangement as claimed in any one of claims 1-5, wherein, in said first position, the sheath is arranged to be proximally retracted relative to the structural elements so that they will have said second position. 7. The arrangement as claimed in any one of claims 1-6, wherein said sheath is provided with at least one lateral aperture through which said elongate structural elements are inserted into said at least one passage, there being preferably one aperture for each structural element. 8. The arrangement as claimed in claim 7, wherein said at least one lateral aperture is shaped as a slot extending generally in the longitudinal direction of the sheath, wherein the transverse dimension of said slot essentially corresponds to the transverse dimension of a structural element inserted therethrough so that the structural element can be displaced along the length of the slot. 9. The arrangement as claimed in claim 8, wherein the structural element abuts against the distal end of the slot when the structural element is in said second position. 10. The arrangement as claimed in any one of claims 7-9, wherein a plurality of lateral apertures are circumferentially spaced round the sheath, and wherein at least two of the elongate structural elements, being received through different apertures, intersect each other crosswise in said at least one passage. 11. The arrangement as claimed in any one of claims 1-10 wherein the proximal end of the sheath is open and said at least one passage extends between the proximal end and the distal end of the sheath, thereby allowing fluid communication between the two ends via said at least one passage. 12. The arrangement as claimed in any one of claims 1-11, wherein the transverse dimension of said at least one passage essentially corresponds to the total transverse dimension of the inserted structural elements. 13. The arrangement as claimed in any one of claims 1-12, further comprising a sheath holder for holding and guiding the sheath in the longitudinal direction of the sheath. 14. The arrangement as claimed in claim 13, wherein said sheath holder has a hole having a transverse dimension which substantially corresponds to the transverse dimension of the sheath, wherein said sheath is allowed to be at least partially passed through said hole. 15. The arrangement as claimed in any one of claims 13-14, wherein a proximal stop is provided on the outside of the sheath, at a proximal portion thereof, for interaction with the sheath holder so as to limit distal advancement of the sheath relative to the sheath holder. 16. The arrangement as claimed in any one of claims 13-15, wherein stopping means is provided on the outside of the sheath, preferably at a distal portion thereof, for interaction with the sheath holder so as to limit proximal retraction of the sheath relative to the sheath holder. 17. The arrangement as claimed in any one of claims 13-16, wherein said sheath holder is further arranged to guide and align said elongate structural elements in a direction towards said at least one passage. 18. The arrangement as claimed in claim 17, wherein said sheath holder has a channel for each structural element, the transverse dimension of each channel essentially corresponding to the transverse dimension of the structural element inserted in said channel, wherein each structural element extends at least from said channel, through said aperture in the sheath, and into said at least one passage. 19. The arrangement as claimed in claim 18, wherein said channels are located radially externally to said hole and extend generally in the longitudinal direction of the sheath, said channels being preferably evenly spaced. 20. The arrangement as claimed in any one of claims 18-19, wherein the channels are straight and have an angle of inclination relative to the longitudinal direction of the sheath, such that the channels converge distally, wherein said angle preferably is chosen in accordance with the particular body organ to be accessed, preferably 8 degree -20 degree . 21. The arrangement as claimed in any one of claims 18-20, wherein the channels have an elongate slit-like cross section perpendicular to the longitudinal direction of the sheath allowing the structural elements to be arranged with different angles of inclination. 22. The arrangement as claimed in any one of claims 17-21, wherein the sheath holder is arranged for keeping the elongate structural elements unmoved relative to the sheath holder, when the sheath is retracted relative to the sheath holder. 23. The arrangement as claimed in any one of claims claims1-22, wherein at least a portion of each elongate structural element is flexible. 24. The arrangement as claimed in any one of claims claims1-23, wherein the elongate structural elements are circumferentially distributed, preferably evenly spaced, in relation to the sheath, the number of the structural elements preferably being 2-12, more preferably 3-8, especially 4. 25. The arrangement as claimed in any one of claims 1-24, wherein at least one of said elongate structural elements includes information transfer means, such as a sensor for chemical probing or a light guide, or sampling means. 26. A method for interacting with an internal body organ through a body cavity, comprising the steps of: providing an elongate tubular sheath having at least one interior passage, said sheath having a proximal end and a distal end, said distal end being open and in communication with said at least one passage; introducing at least two elongate structural elements in said at least one passage so that at least a distal portion of each element extends through said at least one passage in the longitudinal direction of the sheath, each structural element having a distal end and a proximal end, and so that the distal end of each structural element is located inside said at least one passage; inserting the sheath and the structural elements into the body cavity; displacing the structural elements relative to the sheath through said open distal end of the sheath so as to expose the distal ends of each structural element; and bringing the distal end of each structural element in the transverse direction of and away from the sheath so that the distal end of each structural element interacts with the body organ in a distending and/or expanding manner. 27. The method as claimed in claim 26, wherein a tubular sheath is used having a lumen as said at least one passage. 28. The method as claimed in any one of claims 26-27, wherein tubular elongate structural elements are used, preferably in the form of a cannula, especially an injection needle for injecting a substance into said body organ. 29. The method as claimed in any one of claims 26-28, wherein said elongate structural elements are brought to a mechanically biased state when the distal ends are inside said lumen so that they strive to deflect past the circumference of the sheath in the transverse direction thereof, wherein a deflection follows automatically after the exposure of the distal ends of the structural elements as they are displaced through the opening. 30. The method as claimed in any one of claims 26-29, wherein said step of relatively displacing includes proximally retracting the sheath so as to expose the distal ends of the structural elements. 31. The method as claimed in any one of claims 26-30, wherein said step of inserting includes distally advancing the sheath and the structural elements until fluid, entering said at least one passage through the open distal end of the sheath from said body cavity, is detected. 32. The method as claimed in claim 31, wherein the fluid is detected at the proximal end of the sheath, said proximal end being open and in communication with said at leas one passage. 33. The method as claim