1. A method for treating one or more symptoms associated with a prion disease in a patient diagnosed with a prion disease comprising administering to the patient a therapeutically effective amount of a pharmaceutical composition comprising one or more digestive enzymes.
2. The method of claim 1 wherein the one or more digestive enzymes comprise one or more enzymes selected from the group consisting of proteases, amylases, celluloses, sucrases, maltases, papaya, papain, and lipases.
3. The method of claim 1 wherein the one or more digestive enzymes comprise one or more pancreatic enzymes.
4. The method of claim 2 wherein the proteases comprise chymotrypin and trypsin.
5. The method of claim 1 wherein the one or more digestive enzymes are, independently, derived from an animal source, a microbial source, or a plant source, or are synthetically prepared.
6. The method of claim 5 wherein the animal source is a pig.
7. The method of claim 1 wherein the pharmaceutical composition comprises at least one amylase, a mixture of proteases comprising chymotrypsin and trypsin, at least one lipase, and papain.
8. The method of claim 7 wherein the pharmaceutical composition further comprises papaya.
9. The method of claim 1 wherein the pharmaceutical composition comprises: amylases from about 10,000 to about 60,000 U.S.P, proteases from about 10,000 to about 70,000 U.S.P, lipases from about 4,000 to about 30,000 U.S.P, chymotrypsin from about 2 to about 5 mg, trypsin from about 60 to about 100 mg, papain from about 3,000 to about 10,000 USP units, and papaya from about 30 to about 60 mg.
10. The method of claim 1 wherein the pharmaceutical composition comprises at least one protease and at least one lipase, and wherein the ratio of total proteases to total lipases (in USP units) ranges from about 1:1 to about 20:1.
11. The method of claim 10 wherein the ratio of proteases to lipases ranges from about 4:1 to about 10:1.
12. The method of claim 1 wherein the one or more symptoms of the prion disease are selected from personality changes, psychiatric problems, lack of coordination, unsteady gait, myoclonus, unusual sensations, insomnia, confusion, memory problems, severe mental impairment, loss of the ability to move or speak, and a combination thereof.
13. The method of claim 1 wherein the pharmaceutical composition is a dosage formulation selected from the group consisting of: pills, tablets, capsules, microcapsules, mini-capsules, time released capsules, mini-tabs, sprinkles, and a combination thereof.
14. A method of diagnosing a patient comprising:
obtaining a fecal sample from the patient;
determining a level of chymotrypsin present in the fecal sample; and
diagnosing the patient as having a prion disease if the determined fecal chymotrypsin level is 8.4 Ugram or less and the patient exhibits at least one symptom associated with.
15. The method of claim 14 wherein the fecal chymotrypsin level is between 8.4 and 4.2 Ugram.
16. The method of claim 14 wherein the fecal chymotrypsin level is less than 4.2 Ugram.
17. The method of claim 14 wherein the level of chymotrypsin present in the fecal sample is determined using an enzymatic photospectrometry method.
18. The method of claim 14 further comprising administering to the patient an effective amount of a pharmaceutical composition comprising one or more digestive enzymes if the patient is diagnosed as having the prion disease.
19. The method of claim 18 further comprising determining if the administration of the pharmaceutical composition reduces one or more symptoms associated with the prion disease.
20. The method of claim 19 further comprising comparing the post-administration measurement of one or more prion disease symptoms to a pre-administration measurement of the one or more prion disease symptoms.
21. A method of identifying a patient likely to benefit from administration of a pharmaceutical composition comprising one or more digestive enzymes comprising:
obtaining a fecal sample from the patient;
determining a level of chymotrypsin present in the fecal sample; and
identifying the patient as likely to benefit from administration of the pharmaceutical composition if the determined fecal chymotrypsin level is 8.4 Ugram or less and the patient is diagnosed with a prion disease.
22. The method of claim 21 further comprising determining if the patient exhibits one or more symptoms of the prion disease.
23. The method of claim 21 wherein the benefit comprises a reduction in one or more symptoms associated with the prion disease.
24. The method of claim 21 wherein the level of chymotrypsin present in the fecal sample is determined using an enzymatic photospectrometry method.
25. The method of claim 21 further comprising administering to the patient an effective amount of a pharmaceutical composition comprising one or more digestive enzymes.
26. A pharmaceutical composition comprising one or more digestive enzymes, wherein the one or more digestive enzymes comprise at least one lipase and at least one protease, and wherein the ratio of total proteases to total lipases (in USP units) ranges from about 1:1 to about 20:1.
27. The pharmaceutical composition of claim 26 wherein the ratio of total proteases to total lipases ranges from about 4:1 to about 10:1.
28. A pharmaceutical composition comprising at least one amylase, a mixture of proteases comprising chymotrypsin and trypsin, at least one lipase, and papain.
29. The pharmaceutical composition of claim 28 wherein the pharmaceutical composition further comprises papaya.
30. The pharmaceutical composition of claim 28 wherein the ratio of total proteases to total lipases ranges from about 1:1 to about 20:1.
31. A pharmaceutical preparation for treating an individual exhibiting one or more symptoms of a prion disease comprising a therapeutically effective amount of a digestive enzyme.
32. The pharmaceutical preparation of claim 31 wherein the digestive enzyme is selected from the group consisting of: amylase, lipase, protease, and a combination thereof.
33. The pharmaceutical preparation of claim 31 wherein the digestive enzyme is further selected from the group consisting of: chymotrypsin, trypsin, papaya, papain, and a combination thereof.
34. The pharmaceutical preparation of claim 31 wherein the enzyme is derived from a source selected from the group consisting of animal enzymes, plant enzymes, synthetic enzymes, and a combination thereof.
35. The pharmaceutical preparation of claim 31 wherein the preparation is manufactured using a technology selected from the group consisting of Prosolv\xae technology, enteric coating, lipid encapsulation, direct compression, dry granulation, wet granulation, and a combination thereof.
36. The pharmaceutical preparation of claim 31 wherein the preparation is administered orally via a dosage formulation selected from the group consisting of: pills, tablets, capsules, microcapsules, mini-capsules, time released capsules, mini-tabs, sprinkles, and a combination thereof.
37. The pharmaceutical preparation of claim 32 wherein the amount of amylase ranges from 10,000 to 60,000 USP unitsmg.
38. The pharmaceutical preparation of claim 32 wherein the amount of protease ranges from 10,000 to 70,000 USP unitsmg.
39. The pharmaceutical preparation of claim 32 wherein the amount of lipase ranges from 4,000 to 30,000 USP unitsmg.
40. The pharmaceutical preparation of claim 33 wherein the amount of pancreatin ranges from 2,000 to 6,000 USP unitsmg.
41. The pharmaceutical preparation of claim 33 wherein the amount of chymotrypsin ranges from 2 to 5 mg.
42. The pharmaceutical preparation of claim 33 wherein the amount of papain ranges from 3,000 to 10,000 USP unitsmg.
43. The pharmaceutical preparation of claim 33 wherein the amount of papaya ranges from 30 to 60 mg.
44. The pharmaceutical preparation of claim 33 wherein the amount of trypsin ranges from 60 to 100 mg.
45. The pharmaceutical preparation of claim 31 wherein a symptom of the prion disease is ameliorated.
46. The pharmaceutical preparation of claim 31 wherein the symptom of the prion disease is selected from the group consisting of: personality changes, psychiatric problems, lack of coordination, unsteady gait, myoclonus, unusual sensations, insomnia, confusion, memory problems, severe mental impairment, loss of the ability to move or speak, and a combination thereof.
47. A method of treating an individual having a prion disease with a therapeutically effective amount of digestive enzymes comprising the steps of:
measuring a level of fecal chymotrypsin in a stool sample of the individual;
comparing the level of fecal chymotrypsin with a normal fecal chymotrypsin level; and
administering the digestive enzymes to the individual if the level of fecal chymotrypsin in the individual is less than the normal fecal chymotrypsin level.
48. The method of claim 47 further comprising the steps of:
administering the digestive enzymes to the individual in order to promote protein digestion; and
administering the digestive enzymes to the individual in order to ameliorate a symptom of the prion disease.
49. The method of claim 47 wherein the stool sample is measured using a technique selected from the group consisting of: enzymatic photospectrometry, colorimetry, treatment with substrates, assays, and a combination thereof.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
1. A tissue manipulation device, comprising:
a first jaw member pivotally coupled to a distal end of an elongate shaft at a proximal end thereof, the first jaw member having an articulating portion located distal to the proximal end of the first jaw member;
a second jaw member pivotally coupled to the first jaw member at a location distal to the articulating portion, the first and second jaw members being configured to open in a first plane;
a fastener delivery member attached to the second jaw member and having an inner lumen extending therethrough;
wherein the articulating portion of the first jaw member is configured to move the first and second jaw members between a straight configuration in which a longitudinal axis of the elongate shaft is contained within the first plane and an articulated configuration in which the longitudinal axis of the elongate shaft is transverse to the first plane.
2. The device of claim 1, wherein the longitudinal axis of the elongate shaft is perpendicular to the first plane in the articulated configuration.
3. The device of claim 1, wherein the articulating portion comprises a hinge.
4. The device of claim 1, wherein the articulating portion comprises a plurality of jointed segments.
5. The device of claim 1, wherein the articulating portion comprises a ball-and-socket joint.
6. The device of claim 1, further comprising an articulation actuating member configured to control the articulating portion.
7. The device of claim 6, wherein the articulation actuating member comprises one or more connecting members extending proximally from a location distal to the articulating portion.
8. The device of claim 7, wherein the one or more connecting members are contained in a lumen of a sheath covering the articulating portion.
9. The tissue manipulation device of claim 1, wherein the second jaw member has a channel formed therein and the fastener delivery member is configured to urge the first and second jaw members between a low-profile delivery configuration in which a distal portion of the fastener delivery member is positioned substantially within the channel and an open configuration in which the distal portion of the fastener delivery member is positioned substantially outside of the channel.
10. The device of claim 1, wherein the distal end of the fastener delivery member is pivotally coupled to the second jaw member.
11. The device of claim 1, wherein the fastener delivery member comprises a distally located flexible portion.
12. The device of claim 11, wherein the fastener delivery member further comprises a rigid portion proximal to the flexible portion.
13. The device of claim 1, further comprising a fastener deployment assembly within the inner lumen of the fastener delivery member.
14. The device of claim 13, wherein the fastener deployment assembly comprises a needle having a tip moveable out of the fastener delivery member and through openings formed in the first and second jaw members.
15. A tissue acquisition and fixation system, comprising:
an elongate shaft having proximal and distal ends;
an end effector having first and second jaws configured to pivot in a first plane, the end effector being coupled to the distal end of the elongate shaft and configured to pivot relative to the elongate shaft in a second plane that is transverse to the first plane;
a flexible fastener delivery member extending from the elongate shaft and coupled to the second jaw; and
a tissue grasper capable of moving independently from the end effector and configured to draw tissue through the first and second jaws.
16. The system of claim 15, wherein the end effector is configured to move between an insertion configuration in which a longitudinal axis of the elongate shaft is contained within the first plane and a grasping configuration in which the longitudinal axis of the elongate shaft is transverse to the first plane.
17. The system of claim 16, wherein the longitudinal axis of the elongate shaft is perpendicular to the first plane in the grasping configuration.
18. A method of acquiring and fixating tissue, comprising:
inserting into a body lumen a tissue grasper, an elongate shaft, and an end effector having first and second jaws that are pivotally coupled to a distal end of the elongate shaft;
pivoting the end effector with respect to the elongate shaft in a first plane;
pivoting the first and second jaws in a second plane that is transverse to the first plane;
positioning the tissue grasper to engage tissue;
drawing tissue through the first and second jaws by moving the tissue grasper transversely with respect to the first and second jaws; and
delivering a fastener through the tissue disposed between the first and second jaws from a fastener delivery member coupled to the second jaw.
19. The method of claim 18, wherein inserting the end effector and elongate shaft into a body lumen comprises positioning the elongate shaft perpendicular to an inner surface of the body lumen, and pivoting the end effector in the first plane comprises positioning the end effector such that a longitudinal axis of the end effector is parallel to the inner surface of the body lumen.
20. The method of claim 18, wherein moving the tissue grasper transversely with respect to the first and second jaws comprises moving the tissue grasper perpendicular to a longitudinal axis of the first and second jaws.