TISSUE TREATMENT DEVICES, SYSTEMS, AND METHODS
Systems, devices and methods for performing medical procedures in the intestine of a patient are provided. A medical device for performing a treatment and/or a diagnostic procedure can include an elongate shaft assembly comprising at least a shaft assembly first section comprising a distal section of the shaft assembly, and a shaft assembly second section proximal to the first section, and a functional assembly positioned on the shaft assembly first section. Additional sections of the shaft assembly can be included, and each section can comprise a different construction, such as to achieve a different stiffness as described herein. Variable stiffness along the length of the shaft assembly can be provided to aid in translation of the device through the patient's GI tract (e.g. through the stomach and into the small intestine), as described herein.
1 . (canceled)
2 . A device for performing a medical procedure in the intestine of a patient comprising:
an elongate shaft assembly comprising at least a shaft assembly first section comprising a distal section of the shaft assembly, and a shaft assembly second section proximal to the first section; and
a functional assembly positioned on the shaft assembly first section,
wherein the shaft assembly first section comprises a first stiffness,
wherein the shaft assembly second section comprises a second stiffness, and
wherein the first stiffness is less stiff than the second stiffness.
3 . The device according to claim 2 , wherein the intestine comprises at least a portion of the small intestine.
4 . The device according to claim 3 , wherein the intestine comprises at least a portion of the duodenum.
5 . The device according to claim 2 , wherein the shaft assembly comprises a multi lumen shaft.
6 . The device according to claim 5 , wherein the elongate shaft assembly further comprises at least one conduit positioned within a lumen of the multi lumen shaft.
7 . The device according to claim 2 , wherein the shaft assembly first section comprises a length of at least 2 inches.
8 . The device according to claim 2 , wherein the shaft assembly second section comprises a length of at least 10 inches.
9 . The device according to claim 2 , wherein the shaft assembly further comprises a shaft assembly third section proximal to the shaft assembly second section.
10 . The device according to claim 9 , wherein the shaft assembly third section comprises a length of at least 32 inches.
11 . The device according to claim 9 , wherein the shaft assembly third section is longer than the shaft assembly second section and the shaft assembly second section is longer than the shaft assembly first section.
12 . The device according to claim 9 , wherein the shaft assembly first section comprises a material with a durometer of approximately 40 D, the shaft assembly second section comprises a material with a durometer of approximately 55 D, and the shaft assembly third section comprises a material with a durometer of approximately 63 D.
13 . The device according to claim 9 , wherein the shaft assembly third section comprises a length of approximately 57 inches, the shaft assembly second section comprises a length of approximately 10 inches, and the shaft assembly first section comprises a length of approximately 5 inches.
14 . The device according to claim 13 , wherein the shaft assembly first section comprises a material with a durometer of approximately 40 D, the shaft assembly second section comprises a material with a durometer of approximately 55 D, and the shaft assembly third section comprises a material with a durometer of approximately 63 D.
15 . The device according to claim 9 , wherein the shaft assembly is constructed and arranged to bend as follows:
a midpoint of a 2 inch span of a section deflects a distance of approximately 0.125 inches when the following force is applied:
at least 10 lbf, at least 13 lbf, or at least 16 lbf applied to the shaft assembly third section;
at least 8 lb, at least 10 lbf, or at least 11 lbf applied to the shaft assembly second section; and/or at most 14 lbf, at most 11 lbf, or at most 8 lbf applied to the shaft assembly first section.
16 . The device according to claim 9 , wherein the shaft assembly is constructed and arranged to bend as follows:
a midpoint of a 2 inch span of the first section deflects a distance of approximately 0.125 inches when a first force is applied; and
a midpoint of a 2 inch span of the second section deflects a distance of approximately 0.125 inches when a second force is applied;
wherein the second force is at least 3 lbf more than the first force.
17 . The device according to claim 9 , wherein the shaft assembly is constructed and arranged to bend as follows:
a midpoint of a 2 inch span of the second section deflects a distance of approximately 0.125 inches when a second force is applied; and
a midpoint of a 2 inch span of the third section deflects a distance of approximately 0.125 inches when a third force is applied;
wherein the third force is at least 4 lbf more than the second force.
18 . The device according to claim 9 , wherein the shaft assembly is constructed and arranged to bend as follows:
a midpoint of a 2 inch span of the first section deflects a distance of approximately 0.125 inches when a first force is applied; and
a midpoint of a 2 inch span of the third section deflects a distance of approximately 0.125 inches when a third force is applied;
wherein the third force is at least 7 lbf more than the first force.
19 . The device according to claim 2 , wherein the shaft assembly further comprises a fourth section comprising a distal tip fixedly attached to a distal end of the shaft assembly first section, wherein the fourth section comprises a stiffness less than the stiffness of the shaft assembly first section.
20 . The device according to claim 19 , wherein the distal tip comprises a tapered distal tip.
21 . The device according to claim 2 , wherein the functional assembly is configured to expand tissue within the intestine of the patient.
22 . The device according to claim 2 , wherein the functional assembly is configured to ablate tissue within the intestine of the patient.
23 . The device according to claim 2 , wherein the functional assembly is configured to remove tissue within the intestine of the patient.
24 . The device according to claim 2 , wherein the functional assembly is configured to expand and ablate tissue within the intestine of the patient.
25 . The device according to claim 2 , wherein the functional assembly comprises a balloon.
26 . The device according to claim 25 , wherein the functional assembly is configured to ablate tissue within the intestine of the patient with a hot fluid.
27 . The device according to claim 2 , further comprising an injection assembly including at least one needle, at least one port, and at least one fluid delivery tube.