Apparatus for forming implants in gastrointestinal tract and kit for use therewith

• US 6,358,197 B1
• Filed: 03/29/2000
• Issued: 03/19/2002
• Est. Priority Date: 08/13/1999
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Enteric Medical Technologies, Inc. (Boston Scientific Corporation)
• Inventors: Stein, Alan, Silverman, David E., Gough, Edward J.
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US09/538,863
• Time in Patent Office: 720 Days
• Field of Search: 600/563, 600/565, 600/567, 600/29, 600/127, 600/129, 600/104, 604/164.06, 604/170.03, 604/173, 604/49, 128/898, 128/897, 606/1
• US Class Current: 600/29
• CPC Class Codes: A61B 1/00089 Hoods
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00269 endoscopic mucosal resection EMR
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 5/0069 in the wall of the stomach

Abstract

An apparatus comprising an elongate probe member having proximal and distal extremities for use with a suction source to treat a portion of a wall forming a cavity in a body having a natural body opening for accessing the cavity. The elongate probe member has a length so that when the distal extremity is in the vicinity of the portion of the wall the proximal extremity is outside of the body. The distal extremity of the elongate probe member has an outer surface and is provided with at least one recess opening onto the outer surface and an internal passageway communicating with the recess. When the suction source is coupled to the apparatus a suction is created in the recess by means of the passageway to draw the portion of the wall into the recess. A hollow needle is slidably disposed in the elongate probe member and has a distal end portion. The needle is actuatable from outside the body for movement from a retracted position in which the distal end portion of the needle is out of the recess and an extended position in which the distal end portion of the needle extends into the recess. The needle can be extended into the portion of the wall drawn into the recess so as to introduce a material into the portion of the wall and form an implant in the portion of the wall.

Claims

1. An apparatus for use with a suction source to treat a portion of a wall forming a cavity in a body having a natural body opening for accessing the cavity comprising an elongate probe member having proximal and distal extremities, the elongate probe member having a length so that when the distal extremity is in the vicinity of the portion of the wall the proximal extremity is outside of the body, the distal extremity of the elongate probe member having an outer surface and being provided with at least one recess opening onto the outer surface and an internal passageway communicating with the recess whereby when the suction source is coupled to the apparatus a suction is created in the recess by means of the passageway to draw the portion of the wall into the recess, a hollow needle slidably disposed in the elongate probe member and having a distal end portion, the needle being actuatable from outside the body for movement from a retracted position in which the distal end portion of the needle is out of the recess to an extended position in which the distal end portion of the needle extends into the recess whereby the needle can be extended into the portion of the wall drawn into the recess so as to introduce a material into the portion of the wall and form an implant in the portion of the wall.

2. The apparatus of claim 1 wherein the elongate probe member has a lumen extending from the proximal extremity to the distal extremity whereby the suction source is coupled to the lumen in the vicinity of the proximal extremity of the elongate probe member.

3. The apparatus of claim 1 wherein the material is a fluid that includes at least one nonaqueous solution capable of forming a nonbiodegradable solid in the body, further comprising a supply of the at least one nonaqueous solution coupled to the needle for introducing the nonaqueous solution through the needle into the portion of the wall whereby the nonbiodegradable solid forms from the nonaqueous solution in the wall to create the implant.

4. The apparatus of claim 1 wherein the elongate probe member has a lumen extending from the proximal extremity to the distal extremity, the hollow needle being slidably disposed in the lumen.

5. The apparatus of claim 1 wherein the elongate probe member includes an elongate first member and a second member removably mounted on the elongate first member, the second member including the distal extremity provided with the at least one recess therein.

6. The apparatus of claim 5 wherein the elongate first member has a lumen extending longitudinally therethrough for slidably carrying the hollow needle and the second member has guide means for directing the distal end portion of the needle into the at least one recess.

7. The apparatus of claim 5 wherein the second member has a longitudinally-extending lumen communicating with the at least one recess, the hollow needle being slidably disposed in the lumen of the second member.

8. The apparatus of claim 5 further comprising sealing means forming a fluid-tight seal between the second member and the elongate first member.

9. The apparatus of claim 8 wherein the second member has an internal chamber for receiving at least a portion of the elongate first member, the internal chamber being in fluid communication with the passageway and the sealing means being disposed between the second member and the elongate first member for permitting a reduced pressure to be created in the chamber.

10. The apparatus of claim 8 wherein the second member is an end piece, the sealing means including a flexible sleeve carried by the end piece and extendable over at least a portion of the elongate first member.

11. The apparatus of claim 5 wherein the elongate first member extends along a longitudinal axis and wherein the elongate first member and the second member are rotatable relative to each other about the longitudinal axis.

12. The apparatus of claim 5 further comprising an optical viewing device carried within the elongate first member, the optical viewing device having a field of view and the second member having a window for permitting the optical viewing device to view forwardly of the second member.

13. The apparatus of claim 5 wherein the second member is an overtube concentrically disposable about at least a portion of the elongate first member, the overtube having an internal chamber for receiving the portion of the elongate first member, the overtube having proximal and distal portions and having a length so that when the distal portion is in the vicinity of the portion of the wall the proximal portion is outside of the body, a seal disposed between the elongate probe member and the overtube for permitting a reduced pressure to be created in the chamber.

14. The apparatus of claim 5 wherein the elongate first member is flexible.

15. The apparatus of claim 1 further comprising a balloon carried by the distal extremity for urging the at least one recess against the portion of the wall.

16. An apparatus for use with a suction source to treat a portion of a wall forming a cavity in a body having a natural body opening for accessing the cavity comprising an elongate probe member having proximal and distal extremities, the elongate probe member having a length so that when the distal extremity is in the vicinity of the portion of the wall the proximal extremity is outside of the body, the distal extremity of the elongate probe member having an outer cylindrical surface and being provided with a recess extending circumferentially around the outer cylindrical surface and an internal passageway communicating with the recess whereby when the suction source is coupled to the apparatus a suction is created in the recess by means of the passageway to draw the portion of the wall into the recess, a hollow needle slidably disposed in the elongate probe member and having a distal end portion, the needle being actuatable from outside the body for movement from a retracted position in which the distal end portion of the needle is out of the recess to an extended position in which the distal end portion of the needle extends into the recess whereby the needle can be extended into the portion of the wall drawn into the recess so as to introduce a material into the portion of the wall and form an implant in the portion of the wall.

17. An apparatus for use with a suction source to treat a portion of a wall forming a cavity in a body having a natural body opening for accessing the cavity comprising an elongate probe member having proximal and distal extremities, the elongate probe member having a length so that when the distal extremity is in the vicinity of the portion of the wall the proximal extremity is outside of the body, the distal extremity of the elongate probe member having an outer cylindrical surface and being provided width lurality of cirwumferentially spaced-apart recesses in the outer cylindrical surface and an internal passageway communicating with the recesses whereby when the suction source is coupled to the apparatus a suction is created in the recesses by means of the passageway to draw the portion of the wall into at least one of the recesses, a hollow needle slidably disposed in the elongate probe member and having a distal end portion, the needle being actuatable from outside the body for movement from a retracted position in which the distal end portion of the needle is out of the at least one of the recesses and an extended position in which the distal end portion of the needle extends into the at least one of the recesses whereby the needle can be extended into the portion of the wall drawn into the at least one of the recesses so as to introduce a material into the portion of the wall and form an implant in the portion of the wall.

18. An apparatus for use with a suction source to treat a portion of a wall forming a cavity in a body having a natural body opening for accessing the cavity comprising an elongate probe member having proximal and distal extremities, the elongate probe member having a length so that when the distal extremity is in the vicinity of the portion of the wall the proximal extremity is outside of the body, the distal extremity of the elongate probe member having an outer surface and being provided with at least one recess opening onto the outer surface and an internal passageway communicating with the recess whereby when the suction source is coupled to the apparatus a suction is created in the recess by means of the passageway to draw the portion of the wall into the recess, a hollow needle slidably disposed in the elongate probe member and having a distal end portion, the needle being actuatable from outside the body for movement from a retracted position in which the distal end portion of the needle is out of the recess to an extended position in which the distal end portion of the needle extends into the recess whereby the needle can be extended into the portion of the wall drawn into the recess so as to introduce a material into the portion of the wall and form an implant in the portion of the wall, the elongate probe member including an elongate first member and a second member removably mounted on the elongate first member, the second member including the distal extremity provided with the recess therein, sealing means forming a fluid-tight seal between the second member and the elongate first member, the second member having an internal chamber for receiving at least a portion of the elongate first member, the internal chamber being in fluid communication with the passageway and the sealing means being disposed between the second member and the elongate first member for permitting a reduced pressure to be created in the chamber, the second member having a recessed wall which serves as a base for the recess, the recessed wall having a plurality of spaced-apart openings fluidly communicating with respective passageways.

19. An apparatus for use with a suction source to treat a portion of a wall forming a cavity in a body having a natural body opening for accessing the cavity comprising an elongate probe member having proximal and distal extremities, the elongate probe member having a length so that when the distal extremity is in the vicinity of the portion of the wall the proximal extremity is outside of the body, the dislextrity of the eloate probe member having an outer surface and being provided with at least one recess opening onto the outer surface and an internal passageway communicating with the recess whereby when the suction source is coupled to the apparatus a suction is created in the recess by means of the passageway to draw the portion of the wall into the recess, a hollow needle slidably disposed in the elongate probe member and having a distal end portion, the needle being actuatable from outside the body for movement from a retracted position in which the distal end portion of the needle is out of the recess to an extended position in which the distal end portion of the needle extends into the recess whereby the needle can be extended into the portion of the wall drawn into the recess so as to introduce a material into the portion of the wall and form an implant in the portion of the wall, the elongate probe member including an elongate first member and an end piece removably mounted on the elongate first member, the end piece including the distal extremity provided with the recess therein, an overtube member rotatably mounted about the end piece and at least a portion of the elongate first member, the overtube member having proximal and distal end portions and having a length so that when the distal end portion is in the vicinity of the portion of the wall the proximal end portion is outside of the body, the distal end portion of the overtube member being provided with a plurality of circumferentially disposed side openings whereby the end piece and the overtube member can be rotated relative to each other to selectively register the recess in the end piece with one of the openings in the overtube member.

20. The apparatus of claim 19 wherein the overtube member has a distal opening for permitting viewing distal of the overtube member.

21. An apparatus for use with a suction source to treat a portion of a wall forming a cavity in a body having a natural body opening for accessing the cavity comprising an elongate probe member having proximal and distal extremities, the elongate probe member having a length so that when the distal extremity is in the vicinity of the portion of the wall the proximal extremity is outside of the body, the distal extremity of the elongate probe member having an outer surface and being provided with at least one recess opening onto the outer surface and an internal passageway communicating with the recess whereby when the suction source is coupled to the apparatus a suction is created in the recess by means of the passageway to draw the portion of the wall into the recess, a hollow needle slidably disposed in the elongate probe member and having a distal end portion, the needle being actuatable from outside the body for movement from a retracted position in which the distal end portion of the needle is out of the recess to an extended position in which the distal end portion of the needle extends into the recess whereby the needle can be extended into the portion of the wall drawn into the recess so as to introduce a material into the portion of the wall and form an implant in the portion of the wall, an additional hollow needle slidably disposed in the elongate probe member and having a distal end portion, the additional needle being actuatable from outside the body for movement from a retracted position in which the distal end portion of the additional needle is out of the recess to an extended position in which the distal end portion of the additional needle extends into the recess.

22. An apparatus for treating a portion of a wall forming a cavity in a body having a natural body opening for accessing the cavity with a suction source and an elongate member extending along a longitudinal axis and having proximal and distal extremities and with a hollow needle slidably disposed in the elongate member and actuatable from the proximal extremity of the elongate member comprising an end piece and means adapted to mount the end piece on the distal extremity of the elongate member, the end piece having an outer surface and being provided with at least one recess opening onto the outer surface and an internal passageway communicating with the recess whereby when the suction source is coupled to the apparatus so as to communicate with the passageway a suction is created in the recess to draw the portion of the wall into the recess, the end piece having guide means for directing the needle into the recess whereby the needle can be extended into the portion of the wall drawn into the recess so as to introduce a fluid into the portion of the wall and form an implant in the portion of the wall from the fluid.

23. The apparatus of claim 22 wherein the end piece has a diameter approximating the diameter of the elongate member and wherein the end piece extends forwardly of the elongate member.

24. The apparatus of claim 23 further comprising a tube extendable alongside the elongate member and secured to the end piece for providing suction to the passageway.

25. The apparatus of claim 24 further comprising a sleeve for removably securing the tube to the elongate member.

26. The apparatus of claim 22 further comprising a balloon carried by the end piece for urging the at least one recess against the portion of the wall.

27. The apparatus of claim 26 further comprising a tube extendable alongside the elongate member and secured to the end piece for providing a fluid to inflate the balloon.

28. The apparatus of claim 22 wherein the elongate member has a lumen extending from proxinal extremity to the distal extremity for providing suction to the passageway.

29. An apparatus for use with a suction source to treat a portion of a wall forming a cavity in a body comprising an elongate probe member having proximal and distal extremities, the elongate probe member having a length so that when the distal extremity is in the vicinity of the portion of the wall the proximal extremity is outside of the body, means carried by the distal extremity of the elongate probe member and coupleable to the suction source for immobilizing the portion of the wall to be treated and meanscoupled to the elongate member for introducing a material into and forming an implant in the portion of the wall while the portion of the wall is immobilized.

30. The apparatus of claim 29, wherein the immobilizing means includes the distal extremity having an outer surface and being provided with at least one recess opening onto the outer surface and a passageway communicating with the recess whereby when the suction source is coupled to the apparatus a suction is created in the recess to draw the portion of the wall into the recess.

31. The apparatus of claim 30 wherein the introducing means includes a hollow needle slidably disposed in the elongate probe member and having a distal end portion, the needle being actuatable from outside the body for movement from a retracted position in which the distal end portion of the needle is out of the recess to an extended position in which the distal end portion of the needle extends into the recess whereby the needle can be extended into the portion of the wall drawn into the recess.