Method for treating gastroesophageal reflux disease and apparatus for use therewith

Claim 2

1 . A method for treating gastroesophageal reflux disease in a body of a mammal having an esophagus extending through a lower esophageal sphincter to a stomach and a wall forming the esophagus and the stomach comprising the steps of introducing at least one nonaqueous solution into the wall in the vicinity of the lower esophageal sphincter and forming from the at least one nonaqueous solution a nonbiodegradable solid in the wall to augment the wall.

Claim 3

2 . The method of claim 1 wherein the at least one solution is a solution of a biocompatible polymer and a biocompatible solvent and wherein the forming step includes the step of precipitating the biocompatible polymer from the solution so that the biocompatible polymer solidifies in the wall so as to augment the wall and the biocompatible solvent disperses in the body.

Claim 4

3 . The method of claim 2 further comprising the step of introducing a physiologic solution into the wall whereby the physiologic solution facilitates the implantation of the biocompatible polymer in the body.

Claim 5

4 . The method of claim 3 wherein the physiologic solution is a saline solution.

Claim 6

5 . The method of claim 3 further comprising the step of creating a space in the wall with the physiologic solution for receiving the solution of the biocompatible polymer and the biocompatible solvent.

Claim 7

6 . The method of claim 5 wherein the step of introducing the solution of the biocompatible polymer and the biocompatible solvent includes the step of introducing an amount of such solution into the space so that the biocompatible polymer occupies less than all of the space.

Claim 8

7 . The method of claim 2 wherein the solution of the biocompatible polymer and the biocompatible solvent has a composition comprising from about 2.5 to about 8.0 weight percent of a biocompatible polymer, from about 10 to about 40 weight percent of a water insoluble biocompatible contrast agent and from about 52 to about 87.5 weight percent of a biocompatible solvent.

Claim 9

8 . The method of claim 2 wherein the introducing step includes the steps of extending a needle into the wall and supplying the biocompatible polymer and the biocompatible solvent through the needle into the wall.

Claim 10

9 . The method of claim 1 wherein the mammal is a human.

Claim 11

10 . The method of claim 1 wherein the wall includes a mucosal layer and wherein the introducing step includes introducing the at least one nonaqueous solution into the wall beneath the mucosal layer.

Claim 12

11 . The method of claim 1 wherein the wall includes a muscle layer and wherein the introducing step includes introducing the at least one nonaqueous solution into the muscle layer.

Claim 13

12 . The method of claim 1 further comprising the steps of sealing the esophagus above and below the lower esophageal sphincter to provide an isolated space.

Claim 14

13 . The method of claim 12 wherein the at least one nonaqueous solution is a solution of a biocompatible polymer and a biocompatible solvent, further comprising the step of supplying an aqueous solution to the isolated space to facilitate implantation of the biocompatible polymer.

Claim 15

14 . The method of claim 12 further comprising the step of supplying air to the isolated space.

Claim 16

15 . The method of claim 12 wherein the sealing step includes the step of inserting a balloon into the esophagus and inflating the balloon below the lower esophageal sphincter.

Claim 17

16 . The method of claim 12 wherein the sealing step includes the step of inserting an additional balloon into the esophagus and inflating the additional balloon above the lower esophageal sphincter.

Claim 18

17 . The method of claim 1 wherein the at least one nonaqueous solution includes a contrast agent for facilitating visualization of the nonbiodegradable solid in the wall.

Claim 19

18 . The method of claim 1 further comprising the step of ultrasonically viewing the nonbiodegradable solid in the wall.

Claim 20

19 . The method of claim 1 further comprising the step of forming a plurality of discrete deposits of the nonbiodegradable solid in the wall.

Claim 21

20 . The method of claim 1 further comprising the step of forming a plurality of discrete deposits of the nonbiodegradable solid in the wall disposed substantially in a plane extending perpendicularly to a longitudinal axis extending along the esophagus and into the stomach.

Claim 22

21 . The method of claim 20 wherein the plane is disposed at the lower esophageal sphincter.

Claim 23

22 . The method of claim 20 wherein the plane is disposed above the lower esophageal sphincter.

Claim 24

23 . The method of claim 20 wherein the plane is disposed below the lower esophageal sphincter.

Claim 25

24 . The method of claim 23 further comprising the step of forming a plurality of discrete deposits of the nonbiodegradable solid in the wall disposed substantially in an additional plane extending perpendicularly to the longitudinal axis disposed above the lower esophageal sphincter.

Claim 26

25 . The method of claim 20 wherein the forming step includes the step of forming a sufficient plurality of discrete deposits of the nonbiodegradable solid to partially coapt the wall in the vicinity of the lower esophageal sphincter.

Claim 27

26 . The method of claim 20 wherein the forming step includes the step of forming a sufficient plurality of discrete deposits of the nonbiodegradable solid to completely coapt the wall in the vicinity of the lower esophageal sphincter.

Claim 28

27 . The method of claim 1 further comprising the step of forming a plurality of discrete deposits of the nonbiodegradable solid in the wall to reduce the distensibility of the wall in the vicinity of the lower esophageal sphincter.

Claim 29

28 . The method of claim 1 wherein the at least one solution is a solution of a biocompatible prepolymer and wherein the forming step includes the step of forming a biocompatible polymer from the solution that solidifies in the wall so as to augment the wall.

Claim 30

29 . A method for treating gastroesophageal reflux disease in a human body having an esophagus extending through a lower esophageal sphincter to a stomach and a wall forming the esophagus and the stomach comprising the steps of introducing a solution of a biocompatible polymer and a biocompatible solvent into the wall in the vicinity of the lower esophageal sphincter and precipitating the biocompatible polymer from the solution so that the biocompatible polymer solidifies in the wall so as to augment the wall and the biocompatible solvent disperses in the body.

Claim 31

29 . A method for treating gastroesophageal reflux disease in a human body having an esophagus extending through a lower esophageal sphincter to a stomach and a wall forming the esophagus and the stomach comprising the steps of introducing a solution of a biocompatible polymer and a biocompatible solvent into the wall in the vicinity of the lower esophageal sphincter and precipitating the biocompatible polymer from the solution so that the biocompatible polymer solidifies in the wall so as to augment the wall and the biocompatible solvent disperses in the body.

Claim 32

30 . A method for augmenting a wall forming a cavity in a human body comprising the steps of introducing a solution of a biocompatible polymer and a biocompatible solvent into the wall, precipitating the biocompatible polymer from said solution so that the biocompatible polymer solidifies in the wall and the biocompatible solvent disperses in the body and supplying an aqueous solution to the wall in the vicinity of the solution of the biocompatible polymer and the biocompatible solvent to facilitate implantation of the biocompatible polymer.

Claim 33

30 . A method for augmenting a wall forming a cavity in a human body comprising the steps of introducing a solution of a biocompatible polymer and a biocompatible solvent into the wall, precipitating the biocompatible polymer from said solution so that the biocompatible polymer solidifies in the wall and the biocompatible solvent disperses in the body and supplying an aqueous solution to the wall in the vicinity of the solution of the biocompatible polymer and the biocompatible solvent to facilitate implantation of the biocompatible polymer.

Claim 34

31 . The method of claim 30 wherein the supplying step includes the step of injecting the aqueous solution into the wall.

Claim 35

32 . The method of claim 30 wherein the supplying step includes the step of injecting the aqueous solution into the wall prior to introducing the solution of the biocompatible polymer and the biocompatible solvent into the wall.

Claim 36

33 . The method of claim 30 wherein the aqueous solution is a saline solution.

Claim 37

34 . The method of claim 30 wherein the solution of the biocompatible polymer and a biocompatible solvent includes a contrast agent for facilitating visualization of said solution in the body.

Claim 38

35 . The method of claim 30 wherein the solution has a composition comprising from about 2.5 to about 8.0 weight percent of a biocompatible polymer, from about 10 to about 40 weight percent of a water insoluble biocompatible contrast agent and from about 52 to about 87.5 weight percent of a biocompatible solvent.

Claim 39

36 . A method for treating tissue in a body of a mammal comprising the steps of introducing a solution into the tissue to condition the tissue for treatment and performing a treatment on the tissue.

Claim 40

36 . A method for treating tissue in a body of a mammal comprising the steps of introducing a solution into the tissue to condition the tissue for treatment and performing a treatment on the tissue.

Claim 41

37 . The method of claim 36 wherein the performing step includes the step of bulking the tissue with a bulking material.

Claim 42

38 . The method of claim 37 wherein the bulking material is a nonbiodegradable material.

Claim 43

39 . The method of claim 38 wherein the nonbiodegradable material is a biocompatible polymer.

Claim 44

40 . The method of claim 37 wherein the introducing step includes the step of introducing a solution into the tissue to enhance acceptance of the bulking material.

Claim 45

41 . An apparatus for augmenting a wall forming a cavity in a body having a natural body opening for accessing the cavity comprising a flexible elongate member having proximal and distal extremities, the flexible elongate member having a passageway extending from the proximal extremity to the distal extremity, a handle coupled to the proximal extremity of the flexible elongate member for introducing the distal extremity of the flexible elongate member into the natural body opening, the flexible elongate member having a length so that when the distal extremity is in the vicinity of the wall the proximal extremity is outside of the body, a needle disposed in the passageway and accessible from the proximal extremity of the flexible elongate member for movement from a retracted position disposed in the passageway to an extended position disposed out of the passageway for penetrating the wall, the needle having a distal end portion provided with at least one opening and a passage extending through the needle to the opening and a supply assembly including at least one reservoir of at least one nonaqueous solution capable of forming a nonbiodegradable solid in the body coupled to the proximal extremity of the flexible elongate member for introducing the nonaqueous solution through the passage and the at least one opening in the needle into the wall whereby the nonbiodegradable solid forms from the nonaqueous solution in the wall to augment the wall.

Claim 46

41 . An apparatus for augmenting a wall forming a cavity in a body having a natural body opening for accessing the cavity comprising a flexible elongate member having proximal and distal extremities, the flexible elongate member having a passageway extending from the proximal extremity to the distal extremity, a handle coupled to the proximal extremity of the flexible elongate member for introducing the distal extremity of the flexible elongate member into the natural body opening, the flexible elongate member having a length so that when the distal extremity is in the vicinity of the wall the proximal extremity is outside of the body, a needle disposed in the passageway and accessible from the proximal extremity of the flexible elongate member for movement from a retracted position disposed in the passageway to an extended position disposed out of the passageway for penetrating the wall, the needle having a distal end portion provided with at least one opening and a passage extending through the needle to the opening and a supply assembly including at least one reservoir of at least one nonaqueous solution capable of forming a nonbiodegradable solid in the body coupled to the proximal extremity of the flexible elongate member for introducing the nonaqueous solution through the passage and the at least one opening in the needle into the wall whereby the nonbiodegradable solid forms from the nonaqueous solution in the wall to augment the wall.

Claim 47

42 . The apparatus of claim 41 wherein the distal end portion of the needle has a cylindrical wall forming the passage, the cylindrical wall being provided with a plurality of circumferentially spaced-apart openings extending through the cylindrical wall into the passage.

Claim 48

43 . The apparatus of claim 41 wherein the at least one solution is a solution of a biocompatible polymer and a biocompatible solvent and wherein the supply assembly includes a reservoir of a solution of a biocompatible polymer and a biocompatible solvent.

Claim 49

44 . The apparatus of claim 43 wherein the supply assembly includes a delivery mechanism for supplying a plurality of discrete preselected amounts of the solution of the biocompatible polymer and the biocompatible solvent from the reservoir thereof to the needle for introduction into the wall.

Claim 50

45 . The apparatus of claim 44 wherein the reservoir is a syringe having a barrel and a plunger for dispelling solution from the barrel and wherein the delivery mechanism includes finger operable means coupled to the plunger for causing incremental relative movement between the barrel and the plunger.

Claim 51

46 . The apparatus of claim 43 wherein the supply assembly further includes a reservoir of an aqueous solution for facilitating the implantation of the biocompatible polymer in the body.

Claim 52

47 . The apparatus of claim 43 wherein the needle is slidably disposed in the passageway of the flexible elongate member and has a proximal end portion accessible from the proximal extremity of the flexible elongate member and wherein the supply assembly is coupled to the proximal end portion of the needle.

Claim 53

48 . The apparatus of claim 41 wherein the at least one solution is a nonaqueous solution and wherein the supply assembly includes an additional reservoir of an aqueous solution, further comprising an additional needle slidably disposed in the flexible elongate member and accessible from the proximal extremity of the flexible elongate member for movement from a retracted position disposed within the flexible elongate member to an extended position disposed out of the flexible elongate member for penetrating the wall.

Claim 54

49 . The apparatus of claim 48 wherein the additional needle is fixed longitudinally relative to the first-named needle and has a distal end portion spaced longitudinally of the distal end portion of the first-named needle.

Claim 55

50 . The apparatus of claim 48 wherein the additional needle is movable longitudinally relative to the first-named needle.

Claim 56

51 . The apparatus of claim 41 wherein the needle is slidably disposed in the passageway of the flexible elongate member and has a proximal end portion accessible from the proximal extremity of the flexible elongate member, a sleeve slidably disposed on the needle and having a proximal end portion accessible from the proximal extremity of the flexible elongate member, a finger operable adjustment mechanism connected to the proximal end portion of the needle and the proximal end portion of the sleeve for causing longitudinal relative movement between the needle and the sleeve so as to select the amount which the distal end portion of the needle extends beyond the sleeve.

Claim 57

52 . The apparatus of claim 41 for use in treating gastroesophageal reflux disease in a human body having an esophagus extending through a lower esophageal sphincter to a stomach and a wall forming the esophagus and the stomach, the apparatus comprising a balloon assembly for introduction into the esophagus, the balloon assembly having a first balloon for disposition below the lower esophageal sphincter to seal the esophagus below the lower esophageal sphincter and a second balloon for disposition above the lower esophageal sphincter to seal the esophagus above the lower esophageal sphincter whereby the first and second balloons create a sealed space about the lower esophageal sphincter and the needle extends from the sealed space into the wall in the vicinity of the lower esophageal sphincter.

Claim 58

53 . The apparatus of claim 52 wherein the first balloon is provided within an opening therethrough for receiving the flexible elongate member.