US20220023563A1 - Blockage clearing devices, systems, and methods - Google Patents
Blockage clearing devices, systems, and methods Download PDFInfo
- Publication number
- US20220023563A1 US20220023563A1 US17/498,312 US202117498312A US2022023563A1 US 20220023563 A1 US20220023563 A1 US 20220023563A1 US 202117498312 A US202117498312 A US 202117498312A US 2022023563 A1 US2022023563 A1 US 2022023563A1
- Authority
- US
- United States
- Prior art keywords
- catheter
- sheath
- esophagus
- assembly
- balloon
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000000034 method Methods 0.000 title description 78
- 210000003238 esophagus Anatomy 0.000 claims abstract description 117
- 238000005520 cutting process Methods 0.000 claims abstract description 19
- 239000012530 fluid Substances 0.000 claims description 65
- 239000000463 material Substances 0.000 claims description 45
- 230000033228 biological regulation Effects 0.000 claims description 37
- 238000004891 communication Methods 0.000 claims description 30
- 238000001125 extrusion Methods 0.000 claims description 9
- JHWNWJKBPDFINM-UHFFFAOYSA-N Laurolactam Chemical compound O=C1CCCCCCCCCCCN1 JHWNWJKBPDFINM-UHFFFAOYSA-N 0.000 claims description 6
- 229920000299 Nylon 12 Polymers 0.000 claims description 6
- 230000008878 coupling Effects 0.000 claims description 4
- 238000010168 coupling process Methods 0.000 claims description 4
- 238000005859 coupling reaction Methods 0.000 claims description 4
- 230000007704 transition Effects 0.000 claims description 3
- 238000003780 insertion Methods 0.000 description 21
- 230000037431 insertion Effects 0.000 description 21
- 125000006850 spacer group Chemical group 0.000 description 21
- 206010003504 Aspiration Diseases 0.000 description 19
- 230000000712 assembly Effects 0.000 description 16
- 238000000429 assembly Methods 0.000 description 16
- 230000033001 locomotion Effects 0.000 description 15
- 239000004606 Fillers/Extenders Substances 0.000 description 13
- 238000004806 packaging method and process Methods 0.000 description 11
- 210000003484 anatomy Anatomy 0.000 description 9
- 238000005336 cracking Methods 0.000 description 9
- 230000009471 action Effects 0.000 description 8
- 230000006835 compression Effects 0.000 description 8
- 238000007906 compression Methods 0.000 description 8
- 230000006870 function Effects 0.000 description 8
- 230000008569 process Effects 0.000 description 8
- 210000002784 stomach Anatomy 0.000 description 8
- 210000003097 mucus Anatomy 0.000 description 6
- 229910001220 stainless steel Inorganic materials 0.000 description 6
- 239000010935 stainless steel Substances 0.000 description 6
- 229920002614 Polyether block amide Polymers 0.000 description 5
- 208000007536 Thrombosis Diseases 0.000 description 5
- 239000000853 adhesive Substances 0.000 description 5
- 230000001070 adhesive effect Effects 0.000 description 5
- 239000008280 blood Substances 0.000 description 5
- 210000004369 blood Anatomy 0.000 description 5
- 230000006378 damage Effects 0.000 description 5
- 239000000203 mixture Substances 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- 208000037260 Atherosclerotic Plaque Diseases 0.000 description 4
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 4
- 208000005489 Esophageal Perforation Diseases 0.000 description 4
- 206010065567 Oesophageal food impaction Diseases 0.000 description 4
- 206010030181 Oesophageal perforation Diseases 0.000 description 4
- 230000008901 benefit Effects 0.000 description 4
- 238000013461 design Methods 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 210000003811 finger Anatomy 0.000 description 4
- 210000003026 hypopharynx Anatomy 0.000 description 4
- 210000004283 incisor Anatomy 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 4
- 239000002245 particle Substances 0.000 description 4
- 239000004810 polytetrafluoroethylene Substances 0.000 description 4
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 4
- 229920002725 thermoplastic elastomer Polymers 0.000 description 4
- 238000012800 visualization Methods 0.000 description 4
- 208000034693 Laceration Diseases 0.000 description 3
- 206010052211 Oesophageal rupture Diseases 0.000 description 3
- 208000031481 Pathologic Constriction Diseases 0.000 description 3
- 238000001574 biopsy Methods 0.000 description 3
- 230000001419 dependent effect Effects 0.000 description 3
- 238000000605 extraction Methods 0.000 description 3
- 210000004072 lung Anatomy 0.000 description 3
- 230000002093 peripheral effect Effects 0.000 description 3
- 210000003800 pharynx Anatomy 0.000 description 3
- 239000004417 polycarbonate Substances 0.000 description 3
- 229920000515 polycarbonate Polymers 0.000 description 3
- 229920000139 polyethylene terephthalate Polymers 0.000 description 3
- 239000005020 polyethylene terephthalate Substances 0.000 description 3
- 230000001681 protective effect Effects 0.000 description 3
- 210000003813 thumb Anatomy 0.000 description 3
- 230000000007 visual effect Effects 0.000 description 3
- 206010003210 Arteriosclerosis Diseases 0.000 description 2
- 206010064212 Eosinophilic oesophagitis Diseases 0.000 description 2
- RYECOJGRJDOGPP-UHFFFAOYSA-N Ethylurea Chemical compound CCNC(N)=O RYECOJGRJDOGPP-UHFFFAOYSA-N 0.000 description 2
- 208000000913 Kidney Calculi Diseases 0.000 description 2
- 206010029148 Nephrolithiasis Diseases 0.000 description 2
- 239000004677 Nylon Substances 0.000 description 2
- 206010035669 Pneumonia aspiration Diseases 0.000 description 2
- 208000037656 Respiratory Sounds Diseases 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 239000003570 air Substances 0.000 description 2
- 230000004075 alteration Effects 0.000 description 2
- 238000004873 anchoring Methods 0.000 description 2
- 210000001367 artery Anatomy 0.000 description 2
- 201000009807 aspiration pneumonia Diseases 0.000 description 2
- 238000005452 bending Methods 0.000 description 2
- 239000003086 colorant Substances 0.000 description 2
- 230000034994 death Effects 0.000 description 2
- 231100000517 death Toxicity 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 229920001971 elastomer Polymers 0.000 description 2
- 238000001839 endoscopy Methods 0.000 description 2
- 201000000708 eosinophilic esophagitis Diseases 0.000 description 2
- 239000002783 friction material Substances 0.000 description 2
- 230000036541 health Effects 0.000 description 2
- 238000010330 laser marking Methods 0.000 description 2
- 229910052757 nitrogen Inorganic materials 0.000 description 2
- 229920001778 nylon Polymers 0.000 description 2
- -1 polyethylene terephthalate Polymers 0.000 description 2
- 229920000098 polyolefin Polymers 0.000 description 2
- 238000003825 pressing Methods 0.000 description 2
- 230000001105 regulatory effect Effects 0.000 description 2
- 210000002345 respiratory system Anatomy 0.000 description 2
- 210000001584 soft palate Anatomy 0.000 description 2
- 210000003437 trachea Anatomy 0.000 description 2
- 238000012549 training Methods 0.000 description 2
- 210000005166 vasculature Anatomy 0.000 description 2
- 210000003462 vein Anatomy 0.000 description 2
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 description 1
- 239000010963 304 stainless steel Substances 0.000 description 1
- 241000191291 Abies alba Species 0.000 description 1
- 206010052820 Acquired oesophageal web Diseases 0.000 description 1
- 208000000884 Airway Obstruction Diseases 0.000 description 1
- 206010008479 Chest Pain Diseases 0.000 description 1
- 206010008469 Chest discomfort Diseases 0.000 description 1
- 206010008589 Choking Diseases 0.000 description 1
- 241000272194 Ciconiiformes Species 0.000 description 1
- 206010011224 Cough Diseases 0.000 description 1
- 229920004943 Delrin® Polymers 0.000 description 1
- 208000000461 Esophageal Neoplasms Diseases 0.000 description 1
- 208000004262 Food Hypersensitivity Diseases 0.000 description 1
- 206010016946 Food allergy Diseases 0.000 description 1
- 206010028836 Neck pain Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 206010030155 Oesophageal carcinoma Diseases 0.000 description 1
- 206010068319 Oropharyngeal pain Diseases 0.000 description 1
- MUBZPKHOEPUJKR-UHFFFAOYSA-N Oxalic acid Chemical compound OC(=O)C(O)=O MUBZPKHOEPUJKR-UHFFFAOYSA-N 0.000 description 1
- 229920010042 Pebax® 3533 SA 01 MED Polymers 0.000 description 1
- 229920011563 Pebax® 5533 SA 01 MED Polymers 0.000 description 1
- 239000004952 Polyamide Substances 0.000 description 1
- 206010038776 Retching Diseases 0.000 description 1
- 229910000589 SAE 304 stainless steel Inorganic materials 0.000 description 1
- 206010039897 Sedation Diseases 0.000 description 1
- 206010040047 Sepsis Diseases 0.000 description 1
- 206010042241 Stridor Diseases 0.000 description 1
- 239000004433 Thermoplastic polyurethane Substances 0.000 description 1
- LEHOTFFKMJEONL-UHFFFAOYSA-N Uric Acid Chemical compound N1C(=O)NC(=O)C2=C1NC(=O)N2 LEHOTFFKMJEONL-UHFFFAOYSA-N 0.000 description 1
- TVWHNULVHGKJHS-UHFFFAOYSA-N Uric acid Natural products N1C(=O)NC(=O)C2NC(=O)NC21 TVWHNULVHGKJHS-UHFFFAOYSA-N 0.000 description 1
- 206010047700 Vomiting Diseases 0.000 description 1
- 206010047924 Wheezing Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 230000005856 abnormality Effects 0.000 description 1
- DHKHKXVYLBGOIT-UHFFFAOYSA-N acetaldehyde Diethyl Acetal Natural products CCOC(C)OCC DHKHKXVYLBGOIT-UHFFFAOYSA-N 0.000 description 1
- 150000001241 acetals Chemical class 0.000 description 1
- 230000001668 ameliorated effect Effects 0.000 description 1
- CKMXBZGNNVIXHC-UHFFFAOYSA-L ammonium magnesium phosphate hexahydrate Chemical compound [NH4+].O.O.O.O.O.O.[Mg+2].[O-]P([O-])([O-])=O CKMXBZGNNVIXHC-UHFFFAOYSA-L 0.000 description 1
- 210000003445 biliary tract Anatomy 0.000 description 1
- 230000000740 bleeding effect Effects 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 208000030303 breathing problems Diseases 0.000 description 1
- 210000000621 bronchi Anatomy 0.000 description 1
- 230000005465 channeling Effects 0.000 description 1
- HGAZMNJKRQFZKS-UHFFFAOYSA-N chloroethene;ethenyl acetate Chemical compound ClC=C.CC(=O)OC=C HGAZMNJKRQFZKS-UHFFFAOYSA-N 0.000 description 1
- 201000001883 cholelithiasis Diseases 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 210000001953 common bile duct Anatomy 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 210000004351 coronary vessel Anatomy 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 230000000994 depressogenic effect Effects 0.000 description 1
- 238000009795 derivation Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000035475 disorder Diseases 0.000 description 1
- 239000000806 elastomer Substances 0.000 description 1
- 238000011846 endoscopic investigation Methods 0.000 description 1
- 229920003247 engineering thermoplastic Polymers 0.000 description 1
- 201000004101 esophageal cancer Diseases 0.000 description 1
- 238000002594 fluoroscopy Methods 0.000 description 1
- 238000011010 flushing procedure Methods 0.000 description 1
- 235000020932 food allergy Nutrition 0.000 description 1
- 208000001130 gallstones Diseases 0.000 description 1
- 239000007789 gas Substances 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 229920001903 high density polyethylene Polymers 0.000 description 1
- 239000004700 high-density polyethylene Substances 0.000 description 1
- 229920001519 homopolymer Polymers 0.000 description 1
- 229920002674 hyaluronan Polymers 0.000 description 1
- 229960003160 hyaluronic acid Drugs 0.000 description 1
- 208000019016 inability to swallow Diseases 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 230000002262 irrigation Effects 0.000 description 1
- 238000003973 irrigation Methods 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 210000002429 large intestine Anatomy 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 239000002991 molded plastic Substances 0.000 description 1
- 230000004899 motility Effects 0.000 description 1
- 210000004789 organ system Anatomy 0.000 description 1
- 230000037361 pathway Effects 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920002647 polyamide Polymers 0.000 description 1
- 229920005644 polyethylene terephthalate glycol copolymer Polymers 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 230000001012 protector Effects 0.000 description 1
- 230000002685 pulmonary effect Effects 0.000 description 1
- 238000010992 reflux Methods 0.000 description 1
- 239000011347 resin Substances 0.000 description 1
- 229920005989 resin Polymers 0.000 description 1
- 239000005060 rubber Substances 0.000 description 1
- 230000036280 sedation Effects 0.000 description 1
- 230000035807 sensation Effects 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 239000012781 shape memory material Substances 0.000 description 1
- 230000011664 signaling Effects 0.000 description 1
- 210000000813 small intestine Anatomy 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 238000010561 standard procedure Methods 0.000 description 1
- 230000036262 stenosis Effects 0.000 description 1
- 208000037804 stenosis Diseases 0.000 description 1
- 229910052567 struvite Inorganic materials 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
- 229920002803 thermoplastic polyurethane Polymers 0.000 description 1
- 208000023409 throat pain Diseases 0.000 description 1
- 235000013619 trace mineral Nutrition 0.000 description 1
- 239000011573 trace mineral Substances 0.000 description 1
- 238000002627 tracheal intubation Methods 0.000 description 1
- 210000002438 upper gastrointestinal tract Anatomy 0.000 description 1
- 210000000626 ureter Anatomy 0.000 description 1
- 229940116269 uric acid Drugs 0.000 description 1
- 210000003932 urinary bladder Anatomy 0.000 description 1
- 230000002485 urinary effect Effects 0.000 description 1
- 230000008673 vomiting Effects 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
- A61M16/0463—Tracheal tubes combined with suction tubes, catheters or the like; Outside connections
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00064—Constructional details of the endoscope body
- A61B1/00071—Insertion part of the endoscope body
- A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
- A61B1/00082—Balloons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/273—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the upper alimentary canal, e.g. oesophagoscopes, gastroscopes
- A61B1/2733—Oesophagoscopes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/50—Instruments, other than pincettes or toothpicks, for removing foreign bodies from the human body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
- A61M16/0402—Special features for tracheal tubes not otherwise provided for
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/32053—Punch like cutting instruments, e.g. using a cylindrical or oval knife
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
- A61B2017/0034—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means adapted to be inserted through a working channel of an endoscope
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
- A61B2017/00561—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated creating a vacuum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00778—Operations on blood vessels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00818—Treatment of the gastro-intestinal system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00818—Treatment of the gastro-intestinal system
- A61B2017/00827—Treatment of gastro-esophageal reflux
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/0084—Material properties low friction
- A61B2017/00845—Material properties low friction of moving parts with respect to each other
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
- A61B2017/22062—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation to be filled with liquid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
- A61B2017/22065—Functions of balloons
- A61B2017/22069—Immobilising; Stabilising
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22079—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with suction of debris
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/06—Measuring instruments not otherwise provided for
- A61B2090/062—Measuring instruments not otherwise provided for penetration depth
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0807—Indication means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2217/00—General characteristics of surgical instruments
- A61B2217/002—Auxiliary appliance
- A61B2217/005—Auxiliary appliance with suction drainage system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0222—Materials for reducing friction
Definitions
- Certain embodiments described herein relate generally to devices for treating blockages in patients, and further embodiments relate more particularly to devices, systems, and methods for treating esophageal food impactions in patients.
- Blockages within the body can take various forms.
- esophageal food impactions are one of the most common and dangerous emergencies in gastroenterology, with an annual incidence rate of at least 13/100,000 population (Longstreth, GIE; 2001); moreover, the incidence has been increasing in recent years due to a rise in eosinophilic esophagitis (Desai, GIE; 2005).
- Food impactions can occur when a bolus of swallowed food becomes lodged in the esophagus and is unable to pass spontaneously into the stomach.
- FIG. 1 depicts a side elevation view of an illustrative embodiment of a catheter for clearing a blockage from within a body of a patient;
- FIG. 2 depicts a side elevation view of an illustrative embodiment of a system for clearing a bolus of food or other debris or foreign body lodged within an esophagus of a patient, the system including the catheter of FIG. 1 ;
- FIG. 2A is an end-on plan view of a distal tip of an embodiment of an endoscope that is compatible with the system of FIG. 2 ;
- FIG. 3 depicts a portion of the system of FIG. 2 with the bolus of food or other debris being partially cored;
- FIG. 4 depicts an illustrative embodiment of a distal end of the catheter for coring the bolus of food or other debris shown in FIG. 1 ;
- FIG. 5 depicts another illustrative embodiment of a distal end of a catheter for coring the bolus of food or other debris, such as that shown in FIG. 1 ;
- FIG. 6 depicts an illustrative embodiment of a proximal end of a catheter tube of FIG. 1 coupled to an embodiment of a syringe;
- FIG. 7 depicts a side elevation view of an illustrative embodiment of a stylet that is compatible with the system of FIG. 2 ;
- FIG. 8 depicts a side elevation view of the stylet of FIG. 7 positioned within the catheter of FIG. 1 ;
- FIG. 9 depicts a side elevation view of another embodiment of a catheter having a Y-fitting for removing a bolus of food or other debris lodged within an esophagus;
- FIG. 10 is a perspective view of the catheter of FIG. 9 ;
- FIG. 11 is a perspective view of a proximal portion of the catheter of FIG. 9 with a stylet advanced fully therethrough;
- FIG. 12 shows another perspective view of the proximal portion of the catheter of FIG. 9 ;
- FIG. 13 shows another view of the proximal portion of the catheter of FIG. 9 with the stylet partially removed therefrom;
- FIG. 14 shows an enlarged view of the proximal portion of the catheter of FIG. 9 ;
- FIG. 15 shows another view of the proximal portion of the catheter of FIG. 9 with a cap of the suction port removed;
- FIG. 16 shows a distal end of the catheter of FIG. 9 ;
- FIG. 17 shows the distal end of the catheter of FIG. 9 ;
- FIG. 18 shows another example embodiment of a stylet for removing a bolus of food or other debris lodged within an esophagus
- FIG. 19 shows an end portion of the stylet of FIG. 18 ;
- FIG. 20 shows another example embodiment of a system for removing a bolus of food or other debris lodged within an esophagus
- FIG. 21 shows a portion of the device of FIG. 20 ;
- FIG. 22 shows another example embodiment of a system for removing a bolus of food or other debris lodged within an esophagus
- FIG. 23 shows a cross-sectional view of a portion of the device of FIG. 22 ;
- FIG. 24 shows another cross-sectional view of a portion of the device of FIG. 22 ;
- FIG. 25 is an exploded elevation view of another embodiment of a blockage clearing system
- FIG. 26 is a side elevation view of a proximal end of an embodiment of a sheath assembly that may be used with the system of FIG. 25 ;
- FIG. 27 is a cross-sectional view of a sheath portion of the sheath assembly of FIG. 26 taken along the view line 27 - 27 in FIG. 26 ;
- FIG. 28A is an elevation view of a distal end of the sheath assembly that includes a positioning element in an undeployed state
- FIG. 28B is an elevation view of the distal end of the sheath assembly that depicts the positioning element in a deployed state
- FIG. 29 is an elevation view of a proximal end of an embodiment of a catheter assembly that may be used with the system of FIG. 25 ;
- FIG. 30 is a cross-sectional view of a catheter portion of the catheter assembly of FIG. 29 taken along the view line 30 - 30 in FIG. 29 ;
- FIG. 31 is an elevation view of a distal end of the catheter of FIG. 29 ;
- FIG. 32A is an early stage in an illustrative method of using the system of FIG. 25 in which the sheath is inserted into the esophagus of a patient;
- FIG. 32B is a subsequent stage in the illustrative method in which the distal end of the sheath contacts an impacted bolus of food;
- FIG. 32C is a subsequent stage in the illustrative method in which the positioning element is deployed into contact with the esophagus;
- FIG. 32D is a subsequent stage in the illustrative method in which the distal tip of the catheter is advanced through the sheath and brought into contact with a proximal end of the food bolus;
- FIG. 32E is a subsequent stage in the illustrative method in which a morsel of food from the food bolus is cut or, more specifically, cored by the distal tip of the catheter and is drawn into a lumen of the catheter;
- FIG. 32F is a subsequent stage in the illustrative method in which the morsel of food has detached from the food bolus and is suctioned through the lumen of the catheter;
- FIG. 32G is a subsequent stage in the illustrative method in which the catheter is withdrawn into or from the sheath;
- FIG. 32H is a subsequent stage in a further illustrative method in which further coring of the food bolus is desired, wherein in the depicted stage, the positioning element is returned to the undeployed configuration to permit ready movement of the sheath relative to the esophageal wall;
- FIG. 32I is a subsequent stage in the further illustrative method in which the distal end of the sheath has been advanced to a more distal position, wherein the proximal end of the cored food bolus has been reshaped in the absence of the suctioned-off food morsel;
- FIG. 32J is a subsequent stage in the further illustrative method in which the positioning element is deployed again into contact with the esophagus;
- FIG. 32 K is a subsequent stage in the further illustrative method in which the distal tip of the catheter is again brought into contact with the proximal end of the food bolus for further coring of the food bolus;
- FIG. 33A is an elevation view of a distal end of another embodiment of a sheath assembly that includes a differently shaped positioning element in an undeployed state;
- FIG. 33B is another elevation view of the distal end of the sheath assembly of FIG. 33A that depicts the positioning element in a deployed state in which the positioning element is substantially shaped as a frustocone;
- FIG. 34 is an elevation view of a proximal end of another embodiment of a sheath assembly that includes a pressure regulation valve
- FIG. 35A is an elevation view of a distal end of the sheath assembly of FIG. 34 that depicts a positioning element in an undeployed state;
- FIG. 35B is a further elevation view of the distal end of the sheath assembly of FIG. 34 that depicts the positioning element in a deployed state;
- FIG. 35C is a further elevation view of the distal end of the sheath assembly of FIG. 34 that depicts the positioning element in a further state of operation in which the positioning element has been maintained in the deployed state at a substantially constant pressure via the pressure regulation valve of FIG. 34 , despite attempts to further pressurize the positioning element;
- FIG. 36 is an elevation view of a proximal end of another embodiment of a catheter assembly that, in some instances, may be used with a system such as that depicted in FIG. 25 , or in other instances, may be used without a sheath;
- FIG. 37 is a cross-sectional view of a catheter portion of the catheter assembly of FIG. 36 taken along the view line 37 - 37 in FIG. 36 ;
- FIG. 38A is an elevation view of a distal end of the catheter assembly of FIG. 36 in which a positioning element is depicted in an undeployed state;
- FIG. 38B is another elevation view of the distal end of the catheter assembly in which the positioning element is depicted in a deployed state
- FIG. 39A is an elevation view of a distal end of another embodiment of a catheter assembly that includes a differently shaped positioning element that is depicted in an undeployed state;
- FIG. 39B is another elevation view of the distal end of the catheter assembly of FIG. 39A that depicts the positioning element in a deployed state;
- FIG. 40A is an elevation view of a distal end of another embodiment of a catheter assembly that includes a differently shaped and differently oriented positioning element that is depicted in an undeployed state;
- FIG. 40B is another elevation view of the distal end of the catheter assembly of FIG. 40A that depicts the positioning element in a deployed state;
- FIG. 41 is an elevation view of a distal end of another embodiment of a catheter assembly that depicts a distal tip of a catheter that includes an internal bevel;
- FIG. 42 is an elevation view of a distal end of another embodiment of a catheter assembly that depicts a distal tip of a catheter that is substantially flat and that includes a cutting element recessed from the distal tip within a lumen of the catheter;
- FIG. 43 is a cross-sectional view of the catheter assembly of FIG. 42 taken along the view line 43 - 43 in FIG. 42 ;
- FIG. 44 is an elevation view of a distal end of another embodiment of a catheter assembly that depicts a distal tip of a catheter that is substantially rounded and that includes a cutting element recessed from the distal tip within a lumen of the catheter;
- FIG. 45 is an elevation view of another embodiment of a blockage clearing system in an assembled, pre-use, undeployed, packaged, or insertion state;
- FIG. 46 is an elevation view of an embodiment of a sheath assembly of the blockage clearing system of FIG. 45 , the sheath assembly being shown in a deployed state;
- FIG. 47 is a cross-sectional view of a hub of the sheath assembly of FIG. 46 ;
- FIG. 48 is a partial cross-sectional view of a portion of the sheath assembly that includes the hub, when the assembly is in an assembled state;
- FIG. 49 is a cross-sectional view of a sheath of the sheath assembly of FIG. 46 taken along the view line 49 - 49 in FIG. 46 (not necessarily to scale);
- FIG. 50 is an enlarged elevation view of a distal end of the sheath assembly of FIG. 46 , which includes a positioning element that is depicted in a deployed state;
- FIG. 51 is an elevation view of an embodiment of a catheter assembly that is compatible with the blockage clearing system of FIG. 45 and/or, in other or further embodiments, is compatible for use with an endoscope;
- FIG. 52 is a cross-sectional view of a catheter of the catheter assembly of FIG. 51 taken along the view line 52 - 52 in FIG. 51 (not necessarily to scale);
- FIG. 53 is an enlarged elevation view of a distal end of the catheter
- FIG. 54 is a perspective view of an embodiment of a spacer compatible with the system of FIG. 45 ;
- FIG. 55 is an elevation view of an embodiment of a kit that includes the system of FIG. 45 ;
- FIG. 56 is an elevation view of another embodiment of a kit that includes an embodiment of the catheter assembly of FIG. 51 ;
- FIG. 57A is an elevation view of another embodiment of a sheath assembly, which can be used with embodiments of systems previously disclosed, the sheath assembly being shown in an undeployed state;
- FIG. 57B is another elevation view of the sheath assembly of FIG. 57A shown in a deployed state;
- FIG. 58A is an elevation view of another embodiment of a sheath assembly, which can be used with embodiments of systems previously disclosed, the sheath assembly being shown in an undeployed state;
- FIG. 58B is another elevation view of the sheath assembly of FIG. 58A shown in a deployed state
- FIG. 59A is an elevation view of another embodiment of a sheath assembly, which can be used with embodiments of systems previously disclosed, the sheath assembly being shown in an undeployed state;
- FIG. 59B is another elevation view of the sheath assembly of FIG. 59A shown in a deployed state.
- the present disclosure relates generally to devices, systems, and methods for addressing a blockage within a lumen of a patient. While specific examples of such devices, systems, and methods are discussed with respect to esophageal food impactions, the disclosure is not limited to this specific application. For example, other foreign bodies positioned within the esophagus and/or blockages within other body lumens may be cleared in manners such as disclosed herein. As a further example, certain embodiments described herein can be used to clear, remove, break up, or otherwise treat other blockages within the body, such as those in the lungs.
- Some endoscopic techniques employ forceps that include “rat-tooth” type designs, snares, or variable wire basket designs to break up food into smaller 1 s for extraction. Such techniques are laborious, time-consuming, and often fail.
- Certain embodiments disclosed herein can resolve, remedy, ameliorate, and/or avoid one or more of the limitations of known techniques for treating a patient who suffers from an esophageal food impaction, such as those just described, and/or can be advantageous over such techniques for other reasons, as will be apparent from the present disclosure.
- a device is configured to clear a bolus of food impacted within an esophagus.
- the device can include a catheter tube having a hollow interior and a distal end configured to core the bolus of food and can include a proximal end configured to be coupled to a source of suction to clear the core.
- Certain systems described herein assist in resolving the buildup of pieces of food in the esophagus while minimizing the risk of aspiration.
- the systems are further designed in an atraumatic manner, helping to avoid esophageal laceration and perforation.
- an inner region of a food impaction that is spaced from the esophageal wall is cored out.
- the system includes a catheter (e.g., hollow tube) with a distal end that is delivered to the site of the blockage.
- the distal end of the catheter is used to core out portions of the blockage until the blockage is reduced in volume in a piecemeal manner. The smaller volume blockage can then pass through the esophagus spontaneously and/or be more easily removed.
- the catheter can be delivered to the blockage site through an endoscope (e.g., through the instrument channel of the endoscope) or other similar device.
- the catheter can be delivered to the blockage site through a dedicated or specialized sheath, which may include a positioning element to prevent the catheter tip from contacting the esophageal wall.
- the dedicated sheath may permit the catheter to define a larger internal lumen, as compared with catheters that are deployed through the instrument or working channel of a standard endoscope, which can facilitate and/or increase a rate of blockage clearance.
- the dedicated sheath may permit the catheter to be used in a blind procedure, such as in an emergency room setting, without endoscopic or other visualization of the impaction during the procedure.
- the sheath includes a positioning element that spaces the distal tip of the catheter away from the esophageal wall to prevent laceration or perforation of the esophagus.
- the catheter itself may include a positioning element to prevent the catheter tip from contacting the esophageal wall.
- the catheter may be used without an endoscope or other sheathing element.
- suction can be provided to remove the cored portions of the blockage.
- the suction can be provided at the proximal end of the catheter to assist with the coring and/or to cause the cored portions to be suctioned from the site of the blockage and passed through the catheter and discarded, thus minimizing a risk of food aspiration.
- suctioning arrangements can preserve endoscopic visualization.
- a coring aspiration catheter may be deployed through the working channel of an endoscope to remove portions of a food bolus without blocking a viewing lens at a distal end of the endoscope and/or without obscuring, or without significantly or fully obscuring, a field of view of the lens.
- the impacted food bolus and the coring aspiration catheter may be viewed via the viewing lens at the distal end of the endoscope throughout at least a portion of the clearing procedure.
- Certain embodiments can include features that allow cored portions of the food to be cleared, should the portions become caught in the catheter while being suctioned away from the blockage site.
- a source of compressed air such as a syringe
- a stylet can be passed through the interior of the catheter to clear any portions of food caught therein.
- the stylet can also perform other or further functions, such as providing stiffness for the catheter during delivery of the catheter to the blockage site.
- the stylet can be configured to assist in the manipulation of the blockage, such as by advancing the stylet into the blockage one or multiple times to create a nidus for coring and suctioning.
- the catheter 100 includes a hollow catheter tube 102 that generally can be used to core out a portion of a blockage.
- the catheter tube 102 includes a distal end 104 that is configured to contact and core the blockage one or more times. As the blockage is cored by the distal end 104 of the catheter tube 102 , the volume of the blockage is reduced until the blockage is able to be passed through the esophagus spontaneously and/or removed.
- the catheter assembly 100 includes a proximal end 106 configured to be coupled to various devices.
- the proximal end 106 of the catheter assembly 100 is configured to be coupled to a source of suction to allow the cored food portions to be suctioned and/or removed through the catheter tube 102 .
- the proximal end 106 of the catheter tube 102 is configured to be coupled to a source of pressurized air, such as a syringe, to allow any cored food stuck within the catheter tube 102 to be cleared.
- a source of pressurized air such as a syringe
- the proximal end 106 is formed as a tapered connector that can be directly connected to a standard vacuum tubing arrangement, such as in a hospital setting, as discussed further below with respect to FIG. 2 .
- the catheter or catheter assembly 100 can include a strain relief sleeve 53 of any suitable variety.
- the strain relief sleeve 53 can inhibit kinking or other undesirable deformation of the catheter tube 102 during use of the catheter tube 102 .
- the catheter 100 includes a shoulder 55 at a proximal end of the strain relief sleeve 53 .
- the shoulder can define a larger diameter than the strain relief sleeve 53 .
- the catheter 100 can further include a handle 57 via which a user may manipulate the proximal end of the catheter 100 .
- the catheter 100 is shown within an example system 200 configured to remove a blockage 202 positioned within an esophagus 204 of a patient.
- the blockage 202 generally food or other debris, but could also be other blockages like blood or blood clots, mucus, etc.
- the blockage 202 has become caught within the esophagus 204 .
- the catheter 100 is delivered to the blockage 202 using an endoscope 210 .
- the endoscope 210 can be of any suitable variety, including those presently in use and/or those yet to be devised.
- the endoscope can be any of a variety of standard endoscopes typically used for upper GI tract endoscopy.
- the endoscope 210 contains a working channel 260 that is generally hollow and allows the catheter 100 to be delivered through the endoscope 210 to the blockage 202 .
- the endoscope 210 may generally be referred to as a tubular member that defines a channel—specifically, the working channel 260 .
- the endoscope 210 can include one or more additional ports having a variety of additional functions.
- the endoscope 210 includes a viewing port 262 , which may include a lens, via which a region beyond the distal tip of the endoscope 210 can be viewed.
- the endoscope 210 can further include a light guide that terminates at a light port 264 for illuminating the region beyond the distal tip of the endoscope 210 .
- the endoscope 210 can include a water jet 266 and/or can include an air and/or water nozzle 268 .
- Various embodiments of endoscopes can include more or fewer features.
- the endoscope 210 can be withdrawn or can remain in place as the blockage 202 is manipulated.
- the endoscope 210 remains in close proximity to the blockage 202 during coring via the catheter tube 102 to permit visualization of the coring.
- the endoscope 210 can be positioned such that the region that is illuminated by the light port 264 and that is within the field of view of the lens of the viewing port 262 includes both the proximal end of the blockage 202 and the distal end of the catheter tube 102 as the catheter tube 102 is used to core pieces out of the blockage 202 .
- the catheter tube 102 of the catheter 100 is configured to be advanced so that the distal end 104 impacts the blockage 202 so as to reduce the volume of the blockage 202 , such as by repetitively coring the food. As the volume is reduced (such as is shown in FIG. 3 ), the blockage 202 can be naturally passed through the esophagus 204 and into a stomach 206 of the person.
- the catheter tube 102 is at least semi-rigid but flexible, which allows the catheter tube to flex and/or bend during delivery through the endoscope, as the endoscope flexes and bends. This allows the catheter tube 102 to be directed more precisely as it is inserted to a desired location.
- the endoscope is introduced into the patient through the nose of the patient—or stated otherwise, is introduced into the patient via transnasal endoscopy—such that the endoscope defines a curved route through the upper respiratory tract of the patient.
- the endoscope is introduced into the patient through the mouth, such that the endoscope defines a curved route from the mouth to the esophagus, in manners such as described elsewhere herein.
- the catheter tube 102 may be sufficiently flexible to pass through the curved portion of the endoscope, or more specifically, pass through the curved portion of the working channel 260 .
- the distal end 104 of the catheter tube 102 is configured to assist in the coring of the blockage 202 .
- the distal end 104 of the catheter tube 102 is tapered.
- the distal end 104 includes an inner diameter 402 that is smaller than an inner diameter 404 of a more proximal portion 406 of the catheter tube 102 .
- the difference in diameters can be less than one-hundredth of a millimeter. Other sizes are possible.
- the walls of the catheter tube 102 can be thinned as the walls extend to the distal end 104 , as depicted.
- This tapering of the distal end 104 can allow a core 410 of the blockage 202 that is formed by the distal end 104 to be more easily suctioned through the catheter tube 102 . Since the cores formed by the distal end 104 will typically have a diameter smaller than that of the portion 406 , the cores can be more easily suctioned through the catheter tube 102 for evacuation, as is illustrated by Poiseuille's law.
- the catheter tube 102 is formed of a first portion 502 at the distal end 104 having a smaller diameter, and a second portion 504 extending along a remainder of the catheter tube 102 having a larger diameter. This again allows the cores of the blockage 202 that are created by the first portion 502 to be smaller in diameter so that the cores can more easily pass through the remainder of the catheter tube 102 (i.e., the second portion 504 ).
- a tip 508 of the distal end 104 of the catheter tube 102 can be beveled and/or serrated.
- the tip 508 can take multiple forms, including a serrated edge, to cut (e.g., saw) or shave bits of the blockage 202 off of the bolus to better aid suctioning.
- the tip 508 can help core the blockage.
- the catheter tube 102 may be rotated relative to the working channel of the endoscope, whether in a single direction or back and forth, as the tip 508 contact the blockage 202 . In some instances, this rotation, coupled with a serrated or otherwise configured tip can assist in coring the blockage 202 .
- This technique may be used with other embodiments as well, including those in which a catheter is inserted through a sheath assembly, rather than an endoscope.
- a source of suction can be applied to the proximal end 106 of the catheter 100 to allow the cores of the blockage 202 to be removed through the catheter tube 102 .
- a vacuum line 220 can be coupled to the proximal end 106 of the catheter tube 102 .
- the vacuum line 220 can include a suction line fitting 221 that is connected to the proximal end 106 of the catheter 100 .
- the vacuum line 220 can be coupled to a collection canister 222 of any suitable variety, including those presently known or those yet to be devised, and the collection canister 222 is coupled to a suction line 224 .
- the suction line 224 is coupled to a source of suction, such as a hospital vacuum source.
- a source of suction such as a hospital vacuum source.
- pieces of the blockage 202 that are cored or otherwise dislodged by the catheter tube 102 can thereupon be sucked up the catheter tube 102 , through the vacuum line 220 , and collected in the collection canister 222 .
- an example syringe 602 is coupled to the proximal end 106 of the catheter 100 using, for example, a suction line fitting or Luer-lock style connection.
- the syringe 602 can be a typical 60 cc syringe that is used to deliver air into the catheter tube 102 during coring of the blockage 202 to dislodge and/or remove portions of the blockage 202 that are in the catheter tube 102 .
- a plunger of the syringe 602 is actuated to displace air within the syringe 602 into and through the catheter tube 102 .
- This air can be used to dislodge obstructions within the tube.
- Other configurations are possible.
- other types of fluids such as a jet spray of water, could be used to help clear the tube or break up food.
- a stylet 700 is shown that is sized to fit through the hollow interior of the catheter tube 102 .
- the stylet 700 can be used to perform various functions.
- the stylet 700 can be used to stiffen the catheter 100 during delivery to the blockage 202 . Further, the stylet 700 can be introduced through the catheter tube 102 to clear the catheter tube 102 when one or more cores get stuck, performing a function of a pusher rod. In other or further instances, the stylet 700 can be used to pierce the blockage 202 to start a nidus for coring and suctioning. In various examples, the stylet 700 can be solid or hollow.
- the stylet 700 further includes a stylet knob 702 that is configured to be engaged with the proximal end 106 of the catheter 100 .
- the proximal end 106 can be configured to include a Luer taper that allows the proximal end 106 to engage the stylet knob 702 of the stylet 700 .
- Other coupling arrangements such as a threaded engagement, for example, can be used.
- the stylet knob 702 is coupled to the proximal end 106 of the catheter tube 102 .
- the catheter 100 can be delivered to the desired location within the esophagus 204 .
- the stylet knob 702 can be disengaged from the proximal end 106 to free the stylet 700 for movement. This movement can include the caregiver pushing the stylet 700 into and out of the catheter tube 102 to generally disrupt the blockage 202 and/or removal of the stylet 700 completely from the catheter tube 102 .
- the vacuum line 220 can be connected to the proximal end 106 of the catheter tube 102 for suctioning, as described previously.
- the catheter tube 102 is approximately 80.5 inches in length and the stylet 700 is approximately 84 inches in length, although many different lengths can be provided such as, for example, shorter lengths for children and longer lengths for adults or to accommodate different length endoscopes, bronchoscopes or colonoscopes.
- the example catheter tube 102 has an outer diameter of 0.135 inches and an inner diameter of 0.115 inches.
- the stylet 700 has an outer diameter of 0.105 inches. Other sizes can be used.
- the catheter tube 102 can be variable in length and diameter, or stated otherwise, a variety of lengths and diameters are contemplated.
- another embodiment of the catheter tube 102 measures 0.093 inches in outer diameter and 0.082 for the inner diameter, allowing for easy introduction and sliding within the working channel of any of a variety of endoscopes.
- the catheter tube 102 is long enough to extend through an endoscope. In some embodiments, the catheter tube 102 is at least 120 cm in length, but it can be longer in other embodiments.
- the stylet 700 can vary in diameter, but in the preferred embodiment measures 0.070 inches in outer diameter to allow easy introduction and sliding within the catheter tube 102 , and is slightly longer than the catheter tube 102 to allow the stylet 700 to extend beyond the distal end 104 of the catheter tube 102 to clear the catheter tube 102 and extend further into the blockage 202 , if desired.
- the catheter tube 102 can be made from a thin-walled extruded tube sized to fit the working channel (e.g., biopsy channel) of any commercially available endoscope.
- a thin-walled extruded tube sized to fit the working channel (e.g., biopsy channel) of any commercially available endoscope.
- PEBAX® 7233 SA available from Arkema, or any other suitable thermoplastic elastomer.
- PETG glycol-modified polyethylene terephthalate
- suitable materials include polyamide or extrusion grade Nylon or DELRIN® (acetal homopolymer resin, an engineering thermoplastic, available from DuPont), such as Nylon 10 or Nylon 12.
- the stylet 700 could be made of the same or similar material.
- the catheter tube 102 and the stylet 700 can be made of the same material to allow the stylet 700 to fit within the catheter tube 102 while minimizing friction.
- other materials and different materials for each can be used.
- the device 900 includes the catheter tube 102 with a suction port 902 at the proximal end 106 and with the distal end 104 that is designed (e.g., beveled) to be advanced through the biopsy channel of any commercial endoscope and that can accommodate the stylet 700 to clear any food that may stick in the catheter tube 102 after removal from the esophagus.
- the catheter tube 102 is designed to fit through the biopsy channel of an endoscope positioned within the esophagus to reach a food blockage, but can also be advanced adjacent to an endoscope and can also be advanced orally without the aid of an endoscope.
- the catheter tube 102 is also bendable and maneuverable as the endoscope bends and maneuvers, yet is rigid enough to withstand kinking.
- the catheter tube 102 is also sufficiently rigid to withstand suction forces that are sufficient to remove cored portions of a food or other blockage through the lumen of the catheter tube 102 .
- FIGS. 9 and 15 there is a Y-fitting 904 wherein one arm 906 of the Y is attached to and forms the suction port 902 , and another arm 908 of the Y accommodates the stylet 700 .
- a compression seal 910 or rubber stopper, at the proximal end of the arm 908 that accommodates the stylet 700 , so that any air escaping the proximal end—or entering through the proximal end—is minimized when the stylet 700 is in the catheter tube 102 , so that suction and stylet clearance of the vacuum tube can occur simultaneously.
- the compression seal 910 is loosened, the stylet 700 can be easily advanced into and out of the catheter tube 102 using a handle 912 of the stylet 700 .
- the compression seal 910 can also secure the stylet 700 in any location along the shaft of the catheter tube 102 .
- a cap 914 is threaded onto the proximal end 916 of the arm 908 to retain the compression seal 910 in place.
- the compression seal 910 is configured, in some embodiments, to close the proximal end 916 so that suction can be performed through the catheter tube 102 and the suction port 902 .
- the catheter tube 102 can work with the stylet 700 completely removed; the stylet 700 can also be introduced as needed, and advanced any distance in the catheter tube 102 .
- the distal end 104 of the catheter tube 102 can disrupt food, core food, shave food and suction food.
- the catheter tube 102 wall could be thin and rigid to better accommodate a larger lumen of the tube.
- the stylet 700 can help support the catheter tube 102 to help prevent kinking, in some embodiments.
- the stylet 700 can both help clear the suction tube and act as a stylet to stiffen the catheter tube 102 .
- a stylet 1800 could have a spline shape 1802 with splines 1804 formed along the stylet to better accommodate suction when the stylet in is the catheter tube.
- spaces 1806 are formed between the splines 1804 to allow suction to be provided through the catheter tube 102 even with the stylet 1800 in place within the catheter tube 102 .
- Other configurations are possible.
- the stylet 2000 is a wire 2002 with a piston 2004 positioned at an end 2006 thereof.
- the piston 2004 can be automatically (and/or manually) actuated intermittently or at regularly intervals (such as by a motor) to drive the stylet 2000 through the catheter tube 102 to engage the blockage in the esophagus.
- Other configurations are possible.
- FIGS. 22-24 another example device 2200 is shown.
- the device 2200 is similar to the embodiment of FIGS. 20-21 , except that the device 2200 does not necessarily need suction. Instead, the device 2200 includes a handle 2202 and a tube 2204 .
- the handle 2202 includes an actuator member 2206 that can be moved (e.g., by the caregiver's finger or thumb) in a direction 2208 in or out.
- the actuator member 2206 is coupled to a wire 2210 that runs through the tube 2204 to an ejector piston 2402 .
- the ejector piston 2402 is positioned within a cavity 2404 formed in a distal end 2406 of the tube 2204 .
- the distal end 2406 of the tube 2204 forms an opening 2408 sized to core or otherwise carve the obstruction as the caregiver moves the handle 2202 and the tube 2204 attached thereto. This is accomplished, for example, by the pieces of the obstruction being carved by the distal end 2406 of the tube 2204 and received in the cavity 2404 .
- the caregiver can move the actuator member 2206 to cause the ejector piston 2402 to be moved by the wire 2210 through the cavity 2404 towards the distal end 2406 of the tube 2204 to eject food out of the opening 2408 .
- This process can be done multiple times until the obstruction is cleared.
- the actuator member 2206 can be biased to return to the retracted position and/or simply be moved in the opposite direction 2208 by the caregiver's finger to return the ejector piston 2402 to the retracted position.
- the distal end 2406 of the tube 2204 can be configured to more easily core the obstruction.
- the distal end can be thinned or serrated so as to be sharper.
- additional features such as a stainless steel tip, can be added to the distal end 2406 of this (or any other embodiment disclosed herein) to enhance the coring impact of the device 2200 .
- the inner surface of the tubes can be configured to more easily allow cores of the obstruction to pass therethrough.
- the inner surface of a tube can be coated with a low friction or lubricious material to encourage passage and discourage clumping of the cores.
- low friction materials include, without limitation, polyvinyl pyrrolidone and hyaluronic acid. Such materials can be typically bonded using heat or ultraviolet light.
- the external surface of the catheter 102 can optionally also be coated with low friction materials to enable passage through the endoscope. Other mechanisms, such as differing tapers and/or channeling of the inner surface, can also be used.
- FIG. 25 depicts an exploded view of an embodiment of a blockage clearing system 3000 that includes a sheath assembly 3002 and a catheter assembly 3004 .
- the sheath assembly 3002 is configured to be coupled with the catheter assembly 3004 during use, as further discussed below.
- the catheter assembly 3004 is configured to be coupled with a suction system 3006 during use.
- the sheath assembly 3002 extends between a proximal end 3010 that is configured to remain outside of the patient during use and a distal end 3012 that is configured for insertion into the esophagus of a patient.
- the illustrated sheath assembly 3002 includes a hub 3014 , a sheath 3016 , and a positioning element 3018 .
- the hub 3014 of the sheath assembly 3002 can be configured to direct a catheter 3026 of the catheter assembly 3004 into a lumen of the sheath 3016 .
- the catheter 3026 may also be referred to as a catheter tube, or more generally, as a tube, cannula, cutting member, cutting-and-suction member, or coring member. In further instances, the catheter 3026 may be referred to as an aspiration catheter, aspiration cannula, or aspiration tube.
- At least a proximal portion of the sheath 3016 may define a preformed curve region 3017 .
- the curved region 3017 is sized and oriented to facilitate introduction of the sheath 3016 into the esophagus of a patient.
- the curved region 3017 may additionally or alternatively enhance the patient's comfort during use of the sheath 3016 , such as when the curved portion 3017 extends through the mouth, against or adjacent to the soft palate, and through the hypopharynx.
- the curved portion 3017 may be pre-formed to correspond to a natural curvature of a patient's anatomy.
- different sized sheath assemblies 3002 may be used for different sized patients to adjust to their differently sized anatomies, which may enhance comfort of the patients.
- the curved region 3017 may be sufficiently flexible to adjust to different patient anatomies.
- the sheath 3016 may be devoid of a curved region 3017 .
- the sheath 3016 may be substantially linear prior to insertion into the patient, and can be sufficiently flexible to follow, deflect, adjust, and/or conform to a curvature of the patient's anatomy as the sheath 3016 is advanced through the mouth, against or adjacent to the soft palate, and through the hypopharynx of the patient.
- the sheath 3016 may be advanced through the nose and through at least a portion of the upper respiratory tract and into the esophagus of the patient.
- the positioning element 3018 can assist in centering or otherwise positioning a distal tip 3023 of the catheter 3026 relative to the esophagus to prevent the distal tip 3023 from contacting or damaging the esophagus.
- the positioning element 3018 is formed as an inflatable balloon 3019 .
- Other or further varieties of positioning elements 3018 are also contemplated, illustrative examples of which are discussed further below.
- the positioning element 3018 may also or instead be referred to as a centering element, anchoring element, contact element, expansion element, spacing element, and/or as a centering, anchoring, contact, expansion, and/or spacing member.
- the catheter assembly 3004 extends between a proximal end 3020 that is configured to remain outside of the patient during use and a distal end 3022 that is configured for insertion into the esophagus of a patient.
- the distal end 3022 of the catheter 3026 can include a distal tip 3023 that is capable of coring an impacted food bolus.
- the distal tip 3023 may be sharp, and may be referred to as one or more of a cutting tip or a coring tip.
- the distal tip 3023 can cut into the food bolus on its own and/or in combination with suction provided by the suction system 3006 .
- the distal tip 3023 can cooperate with the suction provided by the suction system 3006 to core the food bolus, e.g., as the suction tears from the food bolus a morsel that has been cut by the distal tip 3023 .
- the illustrated catheter assembly 3004 includes a hub 3024 attached to a proximal end of the catheter 3026 .
- the catheter hub 3024 can be configured to selectively couple with the suction system 3006 .
- the catheter hub 3024 includes a connector 3028 for establishing a fluid connection to the suction system 3006 .
- the connector 3028 is formed as a Christmas tree fitting or connector 3029 . Any other suitable connection interface is contemplated.
- the connector 3028 may instead define a substantially smooth outer surface, such as a smooth conical surface similar to that of the connector at the proximal end 106 of the catheter assembly 100 depicted in FIG. 1 , rather than a ribbed outer surface of multiple stacked conical surfaces, such as depicted in FIGS. 25 and 29 .
- the catheter hub 3024 includes a handle 3040 and a suction port 3042 positioned thereon.
- the handle 3040 can be of any suitable configuration.
- the handle 3040 is sized and shaped to rest or be gripped comfortably within a single hand of a practitioner.
- the handle 3040 can be gripped with four fingers of a hand of a practitioner, and the port 3042 can be operated with the thumb of the same hand of the practitioner.
- the port 3042 can be left open to prevent suction from being applied, or to significantly reduce an amount of suction being applied, through the catheter 3026 .
- the port 3042 can be closed, such as by placing a thumb or other finger thereon, to permit or increase an amount of suction to be applied through the catheter 3026 .
- the handle 3040 can be devoid of a suction port 3042 .
- suction through the catheter assembly 3004 can be continuous when the connector 3028 is coupled with the suction system 3006 .
- the suction system 3006 includes a suction tube 3044 , a container or suction trap 3046 , and a suction, aspiration, or vacuum source 3048 .
- the suction tube 3044 may be of any suitable variety, and may be configured to couple with the connector 3028 of the catheter assembly 3004 .
- the suction tube 3044 may include a suction fitting 3045 , such as the suction fitting 221 discussed above.
- the suction trap 3046 can be configured to permit air to pass through, but may be configured to retain therein pieces of a food bolus that are removed from a patient via the system 3000 .
- the suction trap 3046 may include any suitable filters or other arrangements, including those known in the art or those yet to be devised.
- the suction trap 3046 can comprise a collection cannister, such as the collection cannister 222 disclosed above.
- the vacuum source 3048 may be of any suitable variety.
- the vacuum source 3048 can be a dedicated vacuum line or vacuum system of a hospital.
- the proximal end 3010 of the sheath assembly 3002 is shown in greater detail and from a viewpoint that is rotated 90 degrees about a vertical axis relative to the view of FIG. 25 .
- the sheath hub 3014 includes a housing element 3050 that defines an entry passage or guide 3052 .
- the guide 3052 is substantially funnel shaped, which can facilitate insertion of the distal end 3022 of the catheter 3026 into a lumen 3054 of the sheath 3016 .
- the sheath hub 3014 further includes an actuator 3060 via which the positioning element 3018 can be deployed.
- the actuator 3060 is configured as an inflation port 3060 via which the balloon 3019 can be selectively inflated or deflated. Stated otherwise the actuator 3060 is communicatively coupled with the balloon 3019 , and, in this instances, the communication comprises fluid communication.
- the illustrated inflation port 3060 includes a connector 3062 , such as a Luer fitting 3063 , via which any suitable inflation device can be connected thereto.
- the inflation device can be an air-, gas- liquid-, or other fluid-filled syringe or other medical fluid delivery device.
- saline, air, nitrogen, or any other suitable fluid may be used to inflate the balloon 3019 .
- the inflation device may have its own pressure controls, such as to ensure that the fluid is delivered to the balloon 3019 within an acceptable range, or stated otherwise, does not exceed a predetermined limit. Any suitable inflation device, including any known in the art or any yet to be devised, is contemplated.
- the sheath hub 3014 can further include a stopcock 3064 that can be selectively opened and closed via a handle or lever 3065 .
- the stopcock 3064 can be opened to permit inflation or deployment of the balloon 3019 , and can be closed maintain the balloon 3019 in an inflated or deployed state.
- the stopcock 3064 can be in an open configuration to permit passage of inflation fluid therethrough for inflation of the balloon 3019 , and once the balloon 3019 has been filled to a desired amount and/or the fluid pressurized to a desired or predetermined level, the stopcock 3064 can be closed to prevent passage of the fluid back through the stopcock and thus maintain the balloon 3019 in a filled, inflated, and/or pressurized state.
- the inflation port 3060 can be in fluid communication with an inflation lumen 3066 , which may also be referred to as an inflation passageway, channel, etc. Stated otherwise, and is apparent from at least the foregoing, the connector 3062 is in fluid communication with the stopcock 3064 , and the stopcock 3064 is in fluid communication with the inflation lumen 3066 . When the stopcock 3064 is in the open state, the connector 3062 is in fluid communication with the inflation lumen 3066 , and when the stopcock 3064 is in the closed state, the connector 3062 no longer fluidly communicates with the inflation lumen 3066 .
- the stopcock 3064 may be said to be in line with, between, or fluidly coupled with the connector 3062 and the inflation lumen 3066 .
- the housing 3050 defines a proximal end of the inflation lumen 3066 , and the inflation lumen 3066 extends through a sidewall of the sheath 3016 .
- an extender 3067 of any suitable variety may extend between the housing 3050 and the stopcock 3064 to establish fluid communication between the inflation port 3060 and the inflation lumen 3066 .
- the extender 3067 can comprise tubing (e.g., flexible tubing) of any suitable variety.
- the extender 3067 may alternatively be referred to as an extension line. Further, the extender 3067 and the inflation port or actuator 3060 may be referred to, collectively, as an actuation branch 3068 of the sheath assembly 3002 .
- the inflation lumen 3066 and the instrument delivery lumen 3054 of the sheath 3016 are shown in greater detail. Any suitable arrangement of the lumens 3054 , 3066 is contemplated. In various embodiments, more than one inflation lumen 3066 may be present. For example, in some embodiments, one or more additional inflation lumens may be present in the sheath 3016 for redundancy in the event that one of the lumens is inadvertently blocked, such as due to kinking of the sheath 3016 .
- the sheath 3016 may generally be referred to as a tubular member that defines a channel through which the catheter 3026 can be advanced. In particular, the sheath 3016 defines the working channel or lumen 3054 .
- the sheath 3016 may be formed of a material and/or a thickness of the sidewall may be sufficient to provide the sheath 3016 with desirable amounts of columnar or other strength.
- the sheath 3016 can resist compression, crushing, kinking, and/or other deformation that could undesirably alter the shape of the lumen 3054 in a manner that could interfere with insertion therein and/or removal therefrom of the catheter 3026 .
- the material may also be flexible so as to permit the sheath 3016 to conform to the anatomy of a patient.
- the material may be sufficiently flexible to permit the sheath 3016 to be bent from a substantially linear arrangement to a curved arrangement as the sheath 3016 is inserted through the mouth of the patient into the esophagus, all while maintaining the lumen 3054 sufficiently patent to permit ready passage therethrough of the catheter 3026 .
- suitable materials for a catheter are disclosed above, and in many instances, these and/or other suitable materials for the sheath are contemplated.
- the sheath 3016 comprises any suitable thermoplastic elastomer, such as any suitable variety of PEBAX®, available from Arkema.
- a lubricious layer or coating may be provided at the inner surface of the sheath 3016 , which could facilitate insertion of the catheter 3026 into the lumen 3054 and/or removal of the catheter 3026 from the lumen 3054 .
- the sheath 3016 for insertion into the esophagus is contemplated.
- the sheath 3016 i.e., the outer diameter thereof
- the sheath 3016 can be no larger than 7, 10, 15, 20, 25, or 30 French.
- the sheath 3016 is between 7 and 30 French, between 7 and 25 French, between 7 and 20 French, or between 7 and 15 French.
- the lumen 3054 is sized to receive a catheter 3026 that is only slightly smaller, which can allow a lumen of the catheter 3026 to be relatively large and permit ready passage therethrough of cored pieces of blockage material (e.g., food).
- the sheath 3016 is 12 French, which can be fairly easy for many patients to swallow, and the catheter 3026 can be as large as 10 or 11 French.
- the catheter 3026 can be no less than 4, 6, 8, 10, or 12 French, or may be between 4 and 12 French.
- FIG. 28A depicts the distal end 3012 of the sheath assembly 3002 when the positioning element 3018 is in the undeployed state.
- the balloon 3019 can define an outer diameter that may be only slightly greater than an outer diameter of more proximal portions of the sheath 3016 when in the undeployed state. In other embodiments, the outer diameter of the undeployed balloon 3019 may be the same as or slightly smaller than that of an adjacent portion of the sheath 3016 .
- the instrument delivery lumen 3054 extends through an axial center of the balloon 3019 . Stated otherwise, the balloon 3019 encompasses a longitudinal axis of the sheath 3016 .
- FIG. 28B depicts the distal end 3012 of the sheath assembly 3002 when the positioning element 3018 has been transitioned to the deployed state, such as by introduction of an inflation fluid into the balloon 3019 via the inflation channel or inflation lumen 3066 (see FIG. 27 ).
- the inflation fluid can be introduced into the balloon 3019 by coupling a fluid-filled syringe or other medical fluid delivery device with the connector 3062 , ensuring that the stopcock 3064 is in the opened state, and delivering fluid from the medical fluid delivery device through the connector 3062 , through the stopcock 3064 , through the inflation lumen 3066 , and into the balloon 3019 .
- the balloon 3019 can be maintained in the deployed state by closing the stopcock 3064 .
- the balloon 3019 can define an outer diameter that is significantly greater than an outer diameter of more proximal portions of the sheath 3016 when in the deployed state.
- the balloon 3019 can be rotationally symmetrical when inflated. In further instances, the balloon 3019 can be configured to be rotationally symmetrical throughout inflation. Certain of such arrangements can substantially center the lumen 3054 relative to the esophagus.
- the inflated balloon 3019 also can anchor the lumen 3054 relative to the esophagus, or stated otherwise, the inflated balloon 3019 can stabilize the lumen 3054 relative to the esophagus to ensure the catheter tip 3023 does not come into contact with the esophageal wall.
- such an arrangement can ensure that the distal tip 3023 of the catheter 3026 does not come into contact with, or otherwise remains distanced from, the esophageal wall when the distal tip 3023 is advanced past the distal tip of the sheath 3016 .
- the lumen 3054 may not be centered relative to the esophagus.
- the positioning element 3018 may anchor the sheath 3016 such that a longitudinal axis thereof runs parallel to a central longitudinal axis of the esophagus.
- the balloon 3019 is semi-compliant or non-compliant.
- the balloon 3019 may expand to a predetermined size via application of a first amount of pressure therein, and thereafter may either expand only minimally or not at all upon further addition of pressure therein.
- a portion of the balloon 3019 may be semi-compliant or non-compliant and another portion thereof can be compliant.
- a central portion of the balloon 3019 can be semi-compliant or non-compliant and one or more of a proximal or distal end of the balloon may be compliant.
- the semi- or non-compliant portion defines a predetermined diameter, and if further pressure is applied, the proximal and/or distal ends may expand (e.g., longitudinally) to preserve the predetermined diameter of the balloon.
- Any suitable configuration of the balloon 3019 is contemplated. In some instances, it can be desirable for the balloon 3019 to not expand to a circumference or diameter that would damage the esophagus of the patient. On the other hand, it can be desirable for the balloon to expand by a sufficient amount to securely position the cutting distal tip 3023 of the catheter 3026 away from the esophageal wall. In some instances, the balloon can press against the esophageal wall around a full periphery of the balloon and/or around a full periphery of the inner surface of the esophageal wall.
- FIG. 29 depicts the proximal end 3020 of the catheter assembly 3004 in greater detail than is shown in FIG. 25 .
- the catheter hub 3024 includes a handle 3040 and a suction port 3042 .
- the suction connector 3028 is positioned at a proximal end of the handle 3040 . Other positions for the suction connector 3028 are contemplated.
- FIG. 30 is a cross-sectional view of the catheter 3026 .
- the catheter 3026 includes a body 3070 and a lubricious layer 3072 at an internal surface thereof.
- the lubricious layer 3072 can define a lumen 3074 through which morsels of food that are removed from an impacted food bolus can pass.
- the body 3070 can be formed of a material and/or can have a sidewall thickness that is sufficient to provide the catheter 3026 with desirable amounts of columnar or other strength.
- the catheter 3026 can resist compression, crushing, kinking, and/or other deformation that could undesirably alter the shape of the lumen 3074 in a manner that could interfere with passage therethrough of food morsels.
- Various suitable materials for the catheter 3026 are disclosed above. These and or other suitable materials are contemplated.
- the material comprises a relatively hard durometer.
- the material may comprise a braided configuration.
- the catheter 3026 may be more compliant than the sheath 3016 .
- the sheath 3016 can protect the catheter 3026 from kinking or other undesired deformation.
- the body 3070 can maintain its shape when significant suction forces are present within the lumen 3074 .
- the lubricious layer 3072 can be formed of any suitable material, and may have a low coefficient of friction or exhibit other physical properties that permit food morsels to pass readily by without sticking, adhering, or otherwise being stopped.
- the lubricious layer 3072 can include one or more of PTFE or HDPE.
- the lubricious layer 3072 may be omitted.
- the lumen 3074 is sufficiently large to reduce the chances of food morsels being stuck thereto during use. Stated otherwise, the lumen 3074 is sufficiently large to inhibit the food morsels from being stuck thereto during use.
- an outer diameter of the body 3070 is sufficiently smaller than an inner diameter of the sheath 3016 to permit the body 3070 to readily pass through the sheath 3016 .
- the outer and inner diameters are sufficiently similar, however, such that the sheath 3016 can significantly limit lateral movement of the catheter 3026 .
- FIG. 31 depicts the distal end 3022 of the catheter assembly 3020 in greater detail than is shown in FIG. 25 .
- an inner diameter of the lumen 3074 is substantially constant along a full length of the catheter 3026 .
- a diameter of the catheter 3026 may be narrower near the distal tip 3023 than it is along a proximal length thereof.
- An enlarged diameter along the proximal length may facilitate suctioning of food morsels through the catheter 3026 after those morsels are cored from the food bolus via the tip 3023 .
- the distal tip 3023 defines a sharp edge.
- the edge is formed in part by a back bevel 3076 at an outer surface of the catheter 3026 .
- Other cutting arrangements are contemplated, including those discussed further below.
- FIG. 32A is an early stage in an illustrative method of using the system 3000 .
- the distal end 3012 of the sheath assembly 3002 is inserted into the esophagus 3090 of a patient.
- the distal end 3012 of the sheath assembly 3002 can be inserted through the mouth of the patient and into the esophagus, as disclosed elsewhere herein.
- the distal tip of the sheath 3016 is advanced toward a foreign body 3092 that is lodged in the esophagus 3090 .
- the foreign body 3092 is an impacted bolus of food, and will be referred to as such hereafter.
- FIG. 32B is a subsequent stage in the illustrative method.
- the sheath 3016 has been advanced distally a sufficient distance to bring the distal tip of the sheath assembly 3002 into contact with a proximal end 3098 of the food bolus 3092 .
- the procedure is performed blind.
- performing a procedure “blind” means that the procedure is not visualized, such as via a camera of an endoscope, under fluoroscopy, etc.
- the practitioner may be able to discern this contact with the food bolus 3092 via tactile feedback. For example, the practitioner can sense that the food bolus 3092 has been reached by a sudden increase in resistance to distal advancement of the sheath 3016 .
- FIG. 32C is a subsequent stage in the illustrative method.
- the positioning element 3018 is deployed into contact with the esophagus 3090 .
- an inflation device e.g., a syringe
- an inflation fluid e.g., air
- the stopcock 3064 can be closed to maintain the balloon 3019 in the deployed state.
- the positioning element 3018 , or balloon 3019 substantially centers the lumen 3054 relative to the esophagus 3090 .
- FIG. 32D is a subsequent stage in the illustrative method in which the distal tip 3023 of the catheter 3026 is advanced through the sheath 3016 and brought into contact with the proximal end 3098 of the food bolus 3092 .
- suction may be applied via the catheter 3026 throughout advancement of the catheter 3026 toward the food bolus 3092 .
- the practitioner may utilize tactile feedback to determine that contact has been made with the food bolus 3092 , and may then instigate suction. The suction can draw a portion of the food bolus 3092 into the lumen 3074
- FIG. 32E is a subsequent stage in the illustrative method in which a morsel of food 3094 from the food bolus 3092 is cut, or cored, by the distal tip 3023 of the catheter 3026 and is drawn into the lumen 3074 of the catheter 3026 .
- the catheter 3026 defines a length that is only slightly longer than a length of the sheath 3016 . This maximum advanced length of the catheter 3026 may be delimited to reduce the chances of the distal tip 3023 coming into contact with the esophageal wall.
- the distal tip 3023 is limited from moving past the distal tip of the sheath 3016 by a distance of no greater than 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, or 2.0 inches. Stated otherwise, movement of the catheter 3026 relative to the sheath 3016 is delimited to inhibit the distal tip of the catheter 3026 from coming into contact with the esophageal wall when the distal end of the catheter 3026 is extended to its distalmost orientation relative to the sheath 3016 .
- delimitation of the maximum advanced length can be due to interaction of the proximal end 3020 of the catheter assembly 3004 and the proximal end 3010 of the sheath assembly 3002 .
- the distal end of the catheter 3026 is attached to the catheter hub 3024 , which defines an enlarged diameter, as compared with a diameter of the catheter 3026 , at the distal end of the catheter hub 3024 .
- the catheter hub 3024 can interact with the sheath hub 3014 to delimit the maximum advanced length to which the catheter 3026 can extend past the distal end of the sheath 3016 .
- the catheter 3026 of the catheter assembly 3004 can be advanced distally through the guide 3052 of the sheath hub 3014 of the sheath assembly 3002 , whereas the distal face of the catheter hub 3024 can interfere with a proximal face of the sheath hub 3014 or with the tapered surface of the guide 3052 to delimit the distal movement of the catheter 3026 .
- the catheter assembly 3004 can define a stopping region 3047 (see FIG. 29 ) having an enlarged diameter, relative to a diameter of a working length of the catheter 3026 .
- This stopping region 3047 can, for example, be defined at least in part by the catheter hub 3024 .
- the stopping region 3047 is defined entirely by a distal end of the catheter hub 3024 .
- the stopping region 3047 can interfere with a portion of the sheath hub 3014 to delimit distal movement of the catheter 3026 .
- the portion of the sheath hub 3014 with which the stopping region 3047 (e.g., the distal end of the catheter hub 3014 ) can interfere is the proximal face of the sheath hub 3014 or a proximal end of the guide 3052 .
- FIG. 32F is a subsequent stage in the illustrative method in which the morsel of food 3094 has detached from the food bolus 3092 and is suctioned through the lumen 3074 of the catheter 3026 .
- FIG. 32G is a subsequent stage in the illustrative method in which the catheter 3026 is withdrawn from the sheath 3016 .
- the catheter 3026 is only partially withdrawn into the lumen 3054 so as not to inadvertently contact the esophagus. In other instances, the catheter 3026 may be fully withdrawn.
- a sufficient amount of material from the food bolus may have been withdrawn at this point for at least a portion of the food bolus to collapse by an amount sufficient to allow the food bolus to pass naturally into the stomach of the patient. Such passage may result in sudden relief to the patient, which can indicate that no further coring or clearing is needed.
- the sheath 3016 and the catheter 3026 may be withdrawn together, or one after the other.
- the procedure may continue, such as by positioning the system 3000 more distally within the esophagus 3090 .
- system 3000 can clear the food bolus 3092 without passing any portion of the system 3000 beyond a distal end of the food bolus 3092 . In other or further instances, the system 3000 can clear the food bolus 3092 without passing any portion of the system 3000 completely through the food bolus 3092 .
- FIG. 32H is a subsequent stage in one such further illustrative method in which further coring of the food bolus is desired.
- the positioning element 3018 is returned to the undeployed configuration to permit ready movement of the sheath 3016 relative to the esophageal wall.
- FIG. 32I is a subsequent stage in the further illustrative method in which the distal end of the sheath 3016 has been advanced to a more distal position within the esophagus 3090 .
- the proximal end 3098 of the cored food bolus has been reshaped in the absence of the suctioned-off food morsel 3094 .
- FIG. 32J is a subsequent stage in the further illustrative method in which the positioning element 3018 is deployed again into contact with the esophagus 3090 .
- Such repositioning can, in certain instances, permit further coring of the food bolus 3092 with little or no risk of the distal end of catheter coming into contact with the esophagus.
- FIG. 32K is a subsequent stage in the further illustrative method in which the distal tip 3023 of the catheter 3026 is again brought into contact with the proximal end 3098 of the food bolus 3092 for further coring thereof.
- the catheter 3026 When coring is completed, the catheter 3026 can be drawn into the sheath 3016 to shield the sharpened distal end of the catheter 3026 , or may be fully withdrawn from the sheath assembly 3002 .
- the balloon 3019 can be deflated out of contact with the esophagus and fully or partially returned to the undeployed state.
- the stopcock 3064 can be opened to release inflation fluid (e.g., air) from the balloon 3019 .
- the sheath 3016 may then be withdrawn from the patient.
- FIG. 33A is an elevation view of a distal end of another embodiment of a sheath assembly 3102 that includes a differently shaped positioning element 3118 in an undeployed state.
- the positioning element 3118 comprises a balloon that is compressed, folded, or otherwise formed into a low-profile arrangement such as that depicted in FIG. 33A so as to have a substantially cylindrically shaped outer surface that may be only slightly larger than a cylindrical outer surface of the sheath to which it is attached.
- FIG. 33B is another elevation view of the distal end of the sheath assembly 3102 that depicts the positioning element 3118 in a deployed state in which the positioning element 3118 is substantially shaped as a frustocone.
- Other configurations of the deployed positioning element 3118 are contemplated.
- the positioning element 3118 can be radially symmetrical.
- FIGS. 34, 35A, and 35B depict various views of another embodiment of a sheath assembly 3202 that includes a pressure regulation valve 3211 .
- the pressure regulation valve 3211 can regulate a pressure within a positioning member 3218 , such as an inflation balloon 3219 .
- the pressure regulation valve 3211 can ensure that a pressure within the inflation balloon 3219 does not exceed a preset maximum value.
- Such an arrangement may be configured to ensure that excess pressure that might injure or otherwise negatively impact the esophagus is not applied to the esophagus.
- the sheath assembly 3202 can be a component in another embodiment of a blockage clearing system 3200 , such as the blockage clearing system 3000 described above.
- the pressure regulation valve 3211 is depicted in fluid communication with a pressurization port 3260 , which may also be referred to as an inflation port 3260 .
- the pressure regulation valve 3211 is also depicted in fluid communication with an inflation lumen 3266 .
- the pressure regulation valve 3211 is operationally positioned between the inflation port 3260 and the portion of the inflation lumen 3266 that is defined by a sheath 3216 . Stated otherwise, the pressure regulation valve 3211 is in line with inflation port 3260 and is in line with the portion of the inflation lumen 3266 defined by the sheath 3216 .
- the pressure regulation valve 3211 is in line with each of the inflation port 3260 and the inflation lumen 3266 , and further, is positioned between the inflation port 3260 and the inflation lumen 3266 .
- the pressure regulation valve 3211 is coupled with a hub 3214 .
- the pressure regulation valve 3211 is coupled to the hub 3214 via an extender 3267 .
- FIG. 35A depicts the positioning element 3218 in an undeployed state.
- FIG. 35B depicts the positioning element 3218 in a deployed state.
- FIG. 35C depicts the positioning element 3218 in a further state of operation in which the positioning element has been maintained in the deployed state at a substantially constant pressure via the pressure regulation valve 3211 , despite attempts to further pressurize the positioning element via the pressurization port 3260 .
- FIG. 36 is an elevation view of a proximal end of another embodiment of a catheter assembly 3304 that, in some instances, may be used with a system such as the system 3000 discussed above; in other or further instances, may be used with an endoscope; or in still other instances, may be used without a sheath or endoscope.
- the catheter assembly 3304 can include a hub 3324 similar to the hub 3024 discussed above.
- the catheter assembly 3304 includes a handle 3340 having a different gripping arrangement (more akin to a gun or drill) and a similar suction port 3342 .
- the hub 3324 can further include an actuator or inflation port 3360 , such as the inflation port 3060 discussed above with respect to the sheath assembly 3002 .
- FIG. 37 is a cross-sectional view of a catheter 3326 of the catheter assembly 3304 .
- the catheter 3326 can resemble the catheter 3026 described above in many respects, but may further include an inflation channel or inflation lumen 3366 , such as the like-numbered lumen 3066 discussed above with respect to the sheath 3016 .
- FIG. 38A is an elevation view of a distal end of the catheter assembly 3304 in which a positioning element 3318 is depicted in an undeployed state.
- the positioning element 3318 can function in the same manner as other positioning elements described above, and may be in fluid communication with the inflation lumen 3366 .
- the positioning element 3318 can distance a distal tip 3323 of the catheter 3326 from the esophagus wall when deployed.
- the positioning element 3318 may be symmetrical and/or may center the distal tip 3323 from the esophagus.
- the distal tip 3323 is positioned at a distance distally from the distal end of the positioning element 3318 .
- FIG. 38B is another elevation view of the distal end of the catheter assembly 3304 in which the positioning element 3318 is depicted in a deployed state, such as described with respect to various other embodiments above.
- FIG. 39A is an elevation view of a distal end of another embodiment of a catheter assembly 3404 that includes a differently shaped positioning element 3418 that is depicted in an undeployed state.
- FIG. 39B is another elevation view of the distal end of the catheter assembly 3404 that depicts the positioning element 3418 in a deployed state.
- the catheter assembly 3404 is used to clear an impacted food bolus in manners such as described above, but without a sheath.
- the catheter assembly 3404 is used with a sheath, such as the sheath 3016 , in manners such as described above.
- both the sheath 3016 and the catheter assembly 3404 can include inflatable positioning members that inhibit contact between the esophagus and the catheter.
- the catheter assembly 3404 can instead be inserted into the esophagus of a patient through the working channel of an endoscope.
- the positioning element 3418 can be advanced past a distal end of the endoscope and deployed into contact with the esophagus to prevent inadvertent contact of the distal tip of the catheter to the esophageal wall.
- FIG. 40A is an elevation view of a distal end of another embodiment of a catheter assembly 3504 that includes a differently shaped and differently oriented positioning element 3518 that is depicted in an undeployed state.
- FIG. 40B is another elevation view of the distal end of the catheter assembly 3504 that depicts the positioning element in a deployed state. When deployed, the positioning element 3518 is substantially donut-shaped. The positioning element 3518 is also closer to the distal end of the catheter assembly 3504 .
- the catheter assembly 3504 can be particularly well-suited for use with a sheath and/or an endoscope, such as, for example, those previously described. The positioning element 3518 may be advanced just beyond a distal tip of the sheath or endoscope before being deployed, in some instances.
- FIG. 41 is an elevation view of a distal end of another embodiment of a catheter assembly 3604 that depicts a distal tip 3623 of a catheter 3626 that includes an internal bevel 3676 .
- the internal bevel 3676 may be formed as a conical chamfer.
- FIGS. 42 and 43 depict a distal end of another embodiment of a catheter assembly 3704 that includes a catheter 3726 that has a distal tip 3723 that is substantially flat.
- the catheter assembly 3704 includes a cutting element 3775 , such as a blade, that is recessed from the distal tip 3723 within a lumen of the catheter 3726 .
- the cutting element 3775 includes a cutting edge 3777 , which is substantially circular in the illustrated embodiment.
- the cutting element 3775 is attached to the catheter 3726 via a plurality of brackets or supports 3779 .
- a cutting area of the cutting edge 3777 can be smaller than an inner diameter of a lumen of the catheter 3726 .
- FIG. 44 is an elevation view of a distal end of another embodiment of a catheter assembly 3804 that depicts a distal tip 3823 of a catheter 3826 that is substantially rounded and that includes a cutting element 3875 that is recessed from the distal tip 3823 within a lumen of the catheter.
- the catheter assembly 3804 further includes a positioning element or centering balloon 3819 , which can function similarly to other embodiments described herein.
- the rounded tip 3823 may be substantially atraumatic to the esophagus.
- the recessed cutting element 3875 may further aid in preventing inadvertent damage to the esophagus.
- the centering balloon 3819 may likewise prevent inadvertent damage to the esophagus when deployed.
- the catheter assembly 3804 may be used with or without a sheath or endoscope, in various embodiments.
- Catheter assemblies such as the assembly 3804 may also be referred to as catheter systems.
- FIG. 45 is an elevation view of another embodiment of a blockage clearing system 4000 that can resemble blockage clearing systems described above (e.g., the systems 3000 , 3200 ) in certain respects. Accordingly, like features are designated with like reference numerals, with the leading digits incremented to “40.” Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the system 4000 may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and/or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the system 4000 and components thereof.
- any suitable combination of the features and variations of the same described with respect to the systems 3000 , 3200 can be employed with the system 4000 , and vice versa. More generally, any suitable combination of like-numbered components herein is contemplated.
- any of the positioning element arrangements 3018 , 3118 , 3218 , 3318 , 3418 , 3518 , 3819 disclosed above, and the positioning element arrangements described hereafter may be used in place of any of the other positioning elements, mutatis mutandis.
- This pattern of disclosure applies equally to further embodiments depicted in subsequent figures and described hereafter, wherein the leading digits may be further incremented.
- the system 4000 is shown in a pre-use, undeployed, packaged, or insertion state.
- the system 4000 is shown in a state in which it may be packaged, or stated otherwise, in a state in which it exists when removed from packaging by a user (e.g., medical practitioner) for insertion into a patient.
- the system 4000 can include a sheath assembly 4002 and a catheter assembly 4004 , such as like-numbered features previously disclosed.
- the sheath assembly 4002 is discussed further below with respect to at least FIGS. 46-50
- the catheter assembly 4004 is discussed further below with respect to at least FIGS. 51-53 .
- the system 4000 further includes a retainer or spacer 4080 that can maintain a fixed relative orientation of the sheath assembly 4002 and the catheter assembly 4004 .
- the spacer 4080 can maintain a fixed longitudinal relationship, such as a fixed longitudinal separation, between hubs of the sheath assembly 4002 and the catheter assembly 4004 . Maintenance of such a fixed relationship between the hubs can likewise maintain a fixed longitudinal relationship between the distal tips of the sheath assembly 4002 and the catheter assembly 4004 .
- the spacer 4080 can ensure that a distal tip of the catheter assembly 4004 , which may comprise a sharpened cutting tip, is positioned at an interior of the sheath assembly 4004 (e.g., is proximally recessed relative to a distal tip of the sheath assembly 4004 ) when the spacer 4080 is in place.
- a distal tip of the catheter assembly 4004 which may comprise a sharpened cutting tip
- the spacer 4080 may be provided in the assembled state shown with the spacer 4080 in place.
- the system 4000 may be packaged with the spacer 4080 positioned in engagement with the sheath assembly 4002 and the catheter assembly 4004 .
- the spacer 4080 is formed as a clip 4082 that is selectively attachable to and detachable from specific regions of the sheath assembly 4002 and the catheter assembly 4004 .
- the clip 4082 may only be selectively detachable from the sheath assembly 4002 and the catheter assembly 4004 .
- portions of the clip 4082 may be permanently attached to the sheath assembly 4002 and the catheter assembly 4004 , respectively, and a further portion of the clip 4082 may permanently detach from the portions that are attached to the sheath assembly 4002 and the catheter assembly 4004 to permit relative movement of the sheath assembly 4002 and the catheter assembly 4004 .
- the clip 4082 may be provided with the system 4000 in an initial or pre-deployment state (e.g., a packaged state), and may be used during an initial insertion of the system 4000 into the patient and into contact with a blockage, such as a food impaction.
- the detachable portion of the clip 4082 e.g., the clip 4082 in its entirety or a detachable portion thereof
- FIG. 46 is an elevation view of the sheath assembly 4002 in a deployed state.
- the sheath assembly 4002 can include an inflation port 4060 , which can include a connector 4062 , such as a luer fitting 4063 .
- the inflation port 4060 can further include a stopcock 4064 , which can be transitioned between open and closed states via a knob or lever 4065 .
- the inflation port 4060 can be formed of any suitable materials.
- the inflation port 4060 comprises polycarbonate.
- the inflation port 4060 can be coupled with a sheath hub 4014 in any suitable manner.
- the inflation port 4060 is coupled to an extender 4067 , such as tubing of any suitable construct, and the extender 4067 is coupled to the hub 4014 .
- the extender tubing can comprise any suitable material.
- the tubing comprises TYGON®, available from Saint-Gobain Performance Plastics.
- the extender 4067 can be attached to a connector portion of the stopcock 4064 in any suitable manner.
- the hub 4014 can include a housing 4050 , which is discussed further below with respect to FIGS. 47 and 48 .
- a pressure regulation valve 4011 is coupled with the housing 4050 .
- the pressure regulation valve 4011 is directly connected to the housing 4050 .
- the hub 4014 can further be coupled with a sheath 4016 and a strain relief sleeve 4015 .
- the pressure regulation valve 4011 may also be referred to as a pressure regulator.
- the sheath 4016 can be coupled with a positioning element 4018 , such as an inflatable balloon 4019 .
- the sheath 4016 can include a soft or atraumatic distal tip 4013 .
- the inflation port 4060 may also be referred to as an actuator. As further discussed below, the inflation port 4060 is configured to be actuated to achieve deployment of the positioning element 4018 , and can be further actuated to achieve retraction of the positioning element 4018 .
- the sheath 4016 can include one or more depth indicia or indicators 4084 .
- the indicators 4084 can comprise any suitable marking or other signaling element to provide a visual cue to a user to indicate a depth to which the distal tip of the sheath assembly 4002 has been inserted into a patient.
- the one or more indicators 4084 can be printed or may be formed as laser markings.
- one of the indicators for example, the distalmost indicator 4084 —may indicate a minimum depth to which the distal tip of the sheath assembly 4002 should desirably be inserted prior to deployment of the positioning element 4018 .
- the minimum depth indicator 4084 is positioned, e.g., 25 centimeters from the distal tip of the sheath 4016 .
- a practitioner may use the minimum depth indicator 4084 to ensure that the distal tip of the sheath 4016 has been inserted to a sufficient depth past the incisors of the patient, which can ensure that the positioning element 4018 is not deployed within the pharynx of the patient.
- the minimum depth indicator 4084 may be closer to or further from the distal tip of the sheath 4016 than 25 centimeters. In some instances, the minimum depth indicator 4084 is selected to ensure that the pharynx of any patient, regardless of patient size or anatomy variation, will be avoided when the positioning element 4018 is deployed.
- the hub 4014 can include a housing 4050 , which can be formed in any suitable manner.
- the housing 4050 may be an injection-molded plastic component.
- the housing 4050 comprises polycarbonate.
- the housing 4050 can define a connector 4055 at a proximal end thereof.
- the connector 4055 comprises a luer fitting 4056 .
- the connector 4055 can permit selective coupling with any suitable medical device to provide the medical device with access to an instrument delivery lumen 4054 defined by the sheath 4016 (see FIG. 49 ). For example, if a practitioner desires to flush the instrument delivery lumen 4054 of the sheath 4016 , a flushing syringe could be coupled with the connector 4055 and fluid dispensed through the instrument delivery lumen 4054 .
- the connector 4055 portion of the housing 4050 can define an entry passage or guide 4052 .
- the guide 4052 is substantially funnel shaped, which can facilitate insertion of a distal end of a catheter portion of the catheter assembly 4004 into the instrument delivery lumen 4054 of the sheath 4016 .
- the guide 4052 defines a luer taper that decreases in diameter in the distal direction.
- the housing 4050 can further define a connector 4057 , such as a flanged or ribbed post, or the like, to which the extender 4067 can be attached in any suitable manner.
- the housing 4050 can define a connector 4058 , such a flanged or ribbed post, or the like, to which the strain relief sleeve 4015 can be attached in any suitable manner.
- the extender 4067 is fitted over the connector 4057 and the strain relief sleeve 4015 is fitted over the connector 4058 to achieve said attachments.
- the housing 4050 can define a sheath receptacle 4059 into which a proximal end of the sheath 4016 can be received.
- the sheath 4016 can be inserted into the sheath receptacle 4059 until the proximal end contacts a ledge at the proximal end of the receptacle.
- the proximal end of the sheath 4016 thus may be at or slightly below a distal end of the guide 4052 when the sheath 4016 has been secured to the housing 4050 .
- the housing 4050 can further define an inflation channel or lumen 4066 a that extends through the connector 4057 and that terminates at and is in fluid communication with the sheath receptacle 4059 .
- the housing 4050 can further define an inflation channel or lumen 4066 b that extends from a valve receptacle 4069 to the lumen 4066 a .
- the lumen 4066 b intersects the lumen 4066 at a junction 4061 . Stated otherwise, fluid communication between the lumens 4066 a , 4066 b is established at the junction 4061 .
- the lumens 4066 a , 4066 b are in fluid communication with each other and define separate branches of a unitary fluid passageway defined by the housing 4050 .
- the channels 4066 a , 4066 b may be considered to be, and may also be referred to as, separate branches of a unitary inflation passageway or inflation lumen 4066 , of which a proximal end is defined by the housing 4050 and a distal end is defined by the sheath 4016 . That is, as with other embodiments herein, and as previously noted, the sheath assembly 4002 can include multiple lumens for expanding the balloon 4019 , including one or more lumens that extend through the sheath 4016 . All of the lumens may be interconnected or in fluid communication with each other, and may collectively define the fluid passageway or inflation lumen 4066 .
- the sheath 4016 defines two separate inflation lumens 4066 c , 4066 d that are each in fluid communication with the inflation lumen 4066 a defined by the housing 4050 at or near their proximal ends, and further, are in fluid communication with an interior of the balloon 4019 at or near their distal ends.
- the inflation lumens 4066 c , 4066 d define the distal end of the inflation passageway or inflation lumen 4066 of the sheath assembly 4002 .
- the sheath 4016 can define two or more inflation lumens, such as, for example, for purposes of redundancy in the event that one of the lumens 4066 c , 4066 d is inadvertently blocked (e.g., due to kinking of the sheath 4016 ).
- the other can permit inflation or deflation of the balloon 4019 .
- the inflation lumen 4066 can be a unitary lumen or fluid pathway or passageway that includes a plurality of interconnected lumens or branches 4066 a , 4066 b , 4066 c , 4066 d .
- the inflation lumens 4066 a , 4066 b are connected and in fluid communication with each other at the junction 4061 .
- the inflation lumens 4066 c , 4066 d are in fluid communication with the distal end of the inflation lumen 4066 a at their proximal ends, and are in fluid communication with an interior of the balloon 4019 at their distal ends.
- a pressure within the balloon 4019 and within any of the inflation lumens 4066 a , 4066 b , 4066 c , 4066 d can be substantially the same at any given time. Stated otherwise, the inflation lumens 4066 a , 4066 b , 4066 c , 4066 d and the balloon 4019 can be pressurized substantially in unison, or may increase in pressure substantially concurrently and/or substantially at the same rate during deployment of the balloon 4019 .
- an air-filled syringe can be coupled with the connector 4062 .
- the stopcock 4064 can be oriented in an open state (e.g., the lever 4065 can be rotated to the open state).
- a plunger of the syringe can be depressed. This can cause air to flow from the syringe, through the stopcock 4064 , through the extender 4067 , into the inflation lumen 4066 a , and from the inflation lumen 4066 a into the inflation lumen 4066 b , and further, into the inflation lumens 4066 c , 4066 d of the sheath 4016 and from thence into the balloon 4019 .
- pressurization in each of the branches of the inflation lumen 4066 and within the balloon 4019 can proceed substantially in unison as more air is urged from the syringe and, after full deployment of the balloon 4019 (which, in some embodiments, may be non-compliant or semi-compliant) is compressed within a fixed-volume inflation fluid receptacle defined by the inflation lumen 4066 and the expanded balloon 4019 .
- the pressure regulation valve 4011 is attached to the housing 4050 within the valve receptacle 4069 .
- the pressure regulation valve 4011 may be secured in place via an adhesive.
- the pressure regulation valve 4011 can be of any suitable variety.
- the pressure regulation valve 4011 can comprise a check valve that is configured to permit passage therethrough of a fluid (e.g., air) at or above a cracking pressure.
- a fluid e.g., air
- Any suitable commercially available or other variety of check valve is contemplated.
- a commercially available cartridge check valve or pressure relief valve is used.
- the check valve 4011 is positioned such that an entry port thereof 4017 a is in fluid communication with the inflation channel 4066 b , and hence with the inflation channel 4066 a . More generally, the entry port 4017 a of the check valve 4011 is in fluid communication with the inflation passageway or inflation lumen 4066 of the sheath assembly 4002 . Further, in the illustrated embodiment, the pressure regulation valve 4011 is oriented such that an exit port 4017 b thereof is in fluid communication with an environment external to the housing 4014 . The pressure regulation valve 4011 thus can leak inflation fluid (e.g., air) to the environment when a threshold pressure—i.e., the cracking pressure—is reached or exceeded within the inflation lumen 4066 and within the balloon 4019 .
- inflation fluid e.g., air
- the pressure regulation valve can regulate a pressure within the balloon 4019 .
- the pressure regulation valve 4011 can ensure that a pressure within the inflation balloon 4019 does not exceed a preset maximum value, which corresponds with the cracking pressure of the valve.
- Such an arrangement may be configured to ensure that excess pressure that might injure or otherwise negatively impact the esophagus is not applied to the esophagus.
- the pressure regulation valve 4011 is depicted as being in fluid communication with the pressurization or inflation port 4060 .
- the pressure regulation valve 4011 is in fluid communication with the inflation lumen 4066 ( FIG. 48 )
- the inflation lumen 4066 is in fluid communication with the tubing 4067 ( FIG. 48 )
- the tubing 4067 is in fluid communication with the inflation port 4060 ( FIG. 46 ).
- the pressure regulation valve 4011 is operationally positioned between the inflation port 4060 and the portion of the inflation lumen 4066 defined by the sheath 4016 (e.g., the inflation lumens 4066 c , 4066 d , as shown in FIG. 49 ).
- the pressure regulation valve 4011 is in line with the inflation port 4060 and is in line with the portion of the inflation lumen 4066 defined by the sheath 4016 (e.g., the inflation lumens 4066 c , 4066 d ).
- the pressure regulation valve 4011 is fluidly coupled to the inflation lumen 4066 at a position that is in line with or is between the inflation port 4060 and the portion of the lumen 4066 that is defined by the sheath 4016 (e.g., the inflation lumens 4066 c , 4066 d ).
- the pressure regulation valve 4011 is coupled with the hub 4014 .
- the pressure regulation valve 4011 is directly attached to the hub 4014 .
- any suitable cracking pressure of the pressure regulation valve 4011 is contemplated.
- the cracking pressure may be relatively low to ensure that the balloon 4019 does not deform the esophagus, does not significantly deform the esophagus, or does not deform the esophagus beyond an acceptable amount (e.g., an amount less than that at which injury might occur).
- the cracking pressure which may also be referred to as the threshold pressure, is no greater than 3 psi, 4 psi, or 5 psi.
- the cracking pressure is about 4.5 psi (e.g., may be set at 4.56 psi). In other embodiments, higher cracking pressures may be used, such as cracking pressures no greater than 6, 7, or 8 psi.
- connections previously described with respect to the sheath assembly 4002 may be further secured with adhesive.
- adhesive any suitable light curing adhesive is contemplated, including, without limitation, MD 204-CTH-F flexible catheter-bonding adhesive, available from Dymax.
- adhesive may be used to bond the connections between the extender 4067 and each of the stopcock 4060 and the housing 4050 , between the sheath 4016 and the housing 4050 , between the valve 4011 and the housing 4050 , etc.
- the strain relief sleeve 4015 can be positioned over a proximal portion of the sheath 4016 and over the connector 4058 at the distal end of the housing 4050 .
- the strain relief sleeve 4015 may be heat shrunk in place. Any suitable material for the strain relief sleeve 4015 is contemplated.
- the strain relief sleeve 4015 can comprise a polyolefin.
- the strain relief sleeve 4015 can reinforce a proximal end of the sheath 4016 .
- the strain relief sleeve 4015 can contribute to a columnar strength of the sheath 4016 and can stiffen the sheath 4016 . In some embodiments, this stiffening can facilitate insertion of the sheath 4016 into the esophagus of the patient, such as in instances where the sheath 4016 is relatively compliant.
- the strain relief sleeve 4015 can inhibit or prevent kinking of the sheath 4016 , such as kinking that might otherwise close one or more of the inflation lumens 4066 a , 4066 b .
- the sheath 4016 is sufficiently long to cover and reinforce regions of the sheath 4016 that may be most prone to bending or kinking, such as a region at or near the connector 4058 and/or a region (which may be the same or a different region) at or near a portion of the sheath 4016 that undergoes maximum bending during insertion of the sheath 4016 into the esophagus, such as to conform to the anatomy between the mouth and the esophagus.
- the sheath 4016 can be formed in any suitable manner.
- the sheath 4016 comprises a tri-lumen extrusion.
- the sheath 4016 can comprise any suitable material, as previously discussed.
- the sheath 4016 comprises a thermoplastic elastomer, such as PEBAX®.
- the sheath 4016 comprises PEBAX® 5533 SA 01 MED.
- the sheath 4016 can comprise nylon 12 or PEBAX® 7233.
- the atraumatic tip 4013 can be formed in any suitable manner.
- the tip 4013 can be formed of a material that is softer than the remainder of the sheath 4016 .
- the sheath 4016 comprises a thermoplastic elastomer, such as PEBAX®, which could be a softer version than is used for the remainder of the shaft, such as, for example, PEBAX® 3533 SA 01 MED.
- PEBAX® thermoplastic elastomer
- Any suitable manufacturing techniques for forming the tip 4013 are contemplated, such as, for example, reflowing and tipping.
- the proximal end of the sheath 4016 can be positioned within the receptacle 4059 such that both lumens 4066 c , 4066 d are oriented toward the inflation lumen 4066 a defined by the housing 4050 .
- One or more openings 4090 can be formed through the sidewall of the sheath 4016 into the lumens 4066 c , 4066 d in a region that aligns with the inflation lumen 4066 a of the housing to fluidly couple the lumen 4066 a with the lumens 4066 c , 4066 d .
- the one or more openings 4090 can be formed in any suitable manner.
- a fixture that includes one or more blades can retain the unfinished sheath 4016 therein and slice through a portion of the sidewall of the sheath 4016 to provide access to each lumen 4066 c , 4066 d individually (e.g., by forming two longitudinal slices) or to provide access to both of the lumens 4066 c , 4066 d collectively, such as via a single cut through the sidewall that provides fluid communication into each of the lumens 4066 c , 4066 d.
- the sheath 4016 is formed as a thin-walled triple-lumen extrusion having a cross-section such as that depicted in FIG. 49 .
- the lumens 4066 c , 4066 d are closed at their proximal and distal ends in any suitable manner, thus permitting the lumens 4066 c , 4066 d to hold a fluid (e.g., air) therein and withstand pressure increases, such as previously discussed.
- the proximal and distal ends of the lumens 4066 c , 4066 d can be closed or sealed, e.g., so as to be fluid-tight and pressure-resistant, in any suitable manner.
- the sidewall of the extrusion in the region of the proximal and distal ends of the lumens 4066 c , 4066 d is heated or reflowed and reshaped to close off the proximal and distal ends of the lumens 4066 c , 4066 d.
- one or more openings can be formed through the sidewall of the sheath 4016 into the lumens 4066 c , 4066 d in a region that is internal to an inflatable portion of the balloon 4019 .
- the one or more openings can be formed in manners such as discussed above with respect to the one or more openings 4090 ( FIG. 48 ).
- the interior of the balloon 4019 can be in fluid communication with the lumens 4066 c , 4066 d of the sheath 4016 , with the lumens 4066 a , 4066 b of the housing, with the pressure regulation valve 4011 , and with the inflation port 4060 .
- the stopcock 4064 of the inflation port can selectively be opened and closed to selectively establish and terminate, respectively, fluid communication between the connector 4063 and the balloon 4019 .
- a fluid delivery device e.g., an air-filled syringe coupled with the connector 4063 can urge fluid into the balloon 4019 to deploy the balloon 4019 .
- the fluid can fully deploy the balloon 4019 .
- a pressure within the balloon 4019 can reach the threshold value.
- the pressure regulation valve 4011 will permit fluid to escape to the environment to maintain the balloon 4019 at the threshold value of pressure.
- valve 4011 can maintain the balloon 4019 in the deployed state at a substantially constant pressure, despite attempts to further pressurize the balloon 4019 via the inflation or pressurization port 4060 .
- the stopcock 4064 can be closed to maintain the fluid within the sheath assembly 4002 and maintain the balloon 4019 in the deployed state.
- fluid can refer herein to one or more gases, one or more liquids, or a combination thereof.
- an inflation fluid used with the balloon 4019 can comprise one or more of air, nitrogen, water, saline solution, etc.
- the fluid is air.
- the balloon 4019 includes a proximal sleeve or extension 4019 p and a distal sleeve or extension 4019 d .
- the extensions 4019 p , 4019 d can be attached to the sheath 4016 in any suitable manner.
- the extensions 4019 p , 4019 d are bonded or otherwise secured to the sheath 4016 to form fluid tight seals at the proximal and distal ends of the balloon 4019 .
- the balloon 4019 is semi-compliant or non-compliant.
- the balloon 4019 may expand to a predetermined size via application of a first amount of pressure therein, and thereafter may either expand only minimally or not expand at all upon further addition of pressure therein.
- the balloon 4019 may define a preformed shape, such as the shape depicted in FIG. 50 , to which it is inflated when deployed.
- the balloon 4019 may be deflated (e.g., via application of a vacuum at the inflation port 4060 ) or otherwise transitioned to a compressed, deflated, retracted, undeployed, wrapped, folded, or packaged state, as shown.
- a protective sleeve 4098 or other suitable cover may be placed over the balloon 4019 for packaging.
- the sheath assembly 4002 is ready for use, the protective sleeve 4098 can be removed and the balloon 4019 can be advanced to the desired position within the esophagus.
- the balloon 4019 may maintain its low-profile configuration throughout insertion, such as may result from having been contained within the protective sleeve 4098 for an extended period.
- the balloon 4019 can then be inflated into contact with the esophagus, in manners such as previously discussed. Throughout the inflation, the balloon 4019 may undergo little or no stretching. Rather, the balloon 4019 may be flexible so as to be compacted or compressed into its pre-use state, and then can be inflated to its preformed shape without, or substantially without, stretching the material of which the balloon 4019 is formed. Any suitable material is contemplated for the balloon 4019 .
- the balloon 4019 comprises a thermoplastic polyurethane elastomer, such as PELLETHANE®, which is available from Lubrizol.
- the balloon 4019 comprises PELLETHANE® having a Shore A hardness 90 .
- Other materials are also contemplated.
- the balloon 4019 may be more compliant and may be configured to stretch into a desired shape when a predetermined pressure is applied therein.
- the balloon 4019 can define any suitable shape and configuration. As with other embodiments disclosed herein, the illustrated balloon 4019 is substantially cylindrical with curved edges.
- the balloon 4019 defines a length L B and a width W B , which may also be referred to as the diameter of the balloon 4019 .
- the length L B is greater than the width W B .
- the length L B is within a range of from about 1 to about 5 centimeters, from about 2 to about 4 centimeters, or from about 2.5 to about 3.5 centimeters; is no less than about 2, 2.5, 3, 3.5, 4, 4.5 or 5 centimeters; is no greater than about 2, 2.5, 3, 3.5, 4, 4.5, or 5 centimeters; or is about 2, 2.5, 3, 3.5, 4, 4.5, or 5 centimeters.
- the width W B is within a range of from about 1.5 to about 3.5 centimeters or from about 2 to about 3 centimeters; is no less than about 1.5, 2, 2.5, 3, or 3.5 centimeters; is no greater than 1.5, 2, 2.5, 3, or 3.5 centimeters; or is about 1.5, 2, 2.5, 3, or 3.5 centimeters.
- the length L B is 3 centimeters and the width W B is 2.5 centimeters.
- the sheath assembly 4002 can define a total length L T between its proximal and distal tips, and can further define a working length L W , which may represent a portion of the sheath assembly 4002 that can generally be manipulated for insertion into a patient.
- the working length L W may, in some embodiments, desirably be sufficiently long to permit the distal, atraumatic tip 4013 to be inserted sufficiently deep into the esophagus of any of a variety of patients, including those having the largest anatomies, to be able to access a food impaction situated at or near the bottom of the esophagus.
- the working length L W is no less than about 50, 55, 60, 65, or 70 centimeters; is no greater than about 50, 55, 60, 65, or 70 centimeters; or is about 50, 55, 60, 65, or 70 centimeters.
- the total length L T is 64.5 centimeters and the working length L W is 60 centimeters.
- the sheath 4016 is 12 French.
- the instrument delivery lumen 4054 of the sheath 4016 is 0.133 inches.
- FIG. 51 depicts a catheter assembly 4004 that can be well suited for use with the sheath assembly 4002 .
- the catheter assembly 4004 includes a catheter hub 4024 that is fixedly secured to a proximal end of a catheter 4026 , and is further connected to a proximal end of a strain relief sleeve 4025 .
- the catheter hub 4024 includes a suction connector 4028 at a proximal end thereof.
- the suction connector 4028 can be a tapered suction fitting 4029 of any suitable variety, including those presently in use and suitable for connection to a variety of different sizes and constructions of vacuum line tubing.
- the connector 4028 can be configured for slip fit connection to the vacuum system of a hospital via any suitable tubing.
- the hub 4024 can further include a handle 4040 , which may include grips 4041 for increased traction.
- the hub 4024 may define a distally projecting connector 4043 , similar to the connector 4058 of the sheath hub 4014 (see FIG. 47 ), through which the catheter 4026 is inserted for connection to an interior of the hub 4014 and over which the strain relief sleeve 4025 is secured.
- the various components of the catheter assembly 4004 can be formed of any suitable materials.
- the hub 4024 comprises polycarbonate and the strain relief sleeve 4025 comprises a heat shrink polyolefin.
- the catheter 4026 can include a lubricious inner layer 4072 of any suitable variety.
- the layer 4072 comprises a PTFE liner.
- the catheter 4026 can further include a body 4070 that includes a braided material and a polymeric material.
- the body 4070 includes a braided layer 4073 and an outer layer 4075 of polymeric material, which can extend into the braided layer 4073 .
- the braided layer 4073 comprises a layer of braided 304 stainless steel, and the outer layer 4075 comprises nylon 12.
- the illustrated embodiment also includes a distal tip 4023 , which may include one or more different and/or additional materials from other portions of the catheter.
- the tip may be formed of or include polyethylene terephthalate (PET). Any other suitable composition of the catheter 4026 is contemplated.
- the catheter 4026 may be formed via a “stick build” in which the PTFE liner 4072 is placed over a mandrel, the stainless steel is braided over the PTFE liner 4072 to form the braided layer 4073 , a single-lumen extrusion of nylon 12 is slid over the braid, and then the materials are heated and reflowed.
- a “stick build” in which the PTFE liner 4072 is placed over a mandrel, the stainless steel is braided over the PTFE liner 4072 to form the braided layer 4073 , a single-lumen extrusion of nylon 12 is slid over the braid, and then the materials are heated and reflowed.
- the catheter 4026 can include a depth indicator 4027 , which can provide information regarding a position of the distal tip 4023 of the catheter 4026 within the sheath assembly 4002 .
- the depth indicator 4027 comprises a transition line 4026 t between a proximal portion 4026 p and a distal portion 4026 d of the catheter 4026 .
- the proximal and distal portions 4026 p , 4026 d of the catheter are different colors to provide a readily observable visual cue.
- the proximal portion 4026 p is white and the distal portion 4026 d is gray. Any other suitable indicium for the depth indicator 4027 is contemplated.
- the critical depth can be identified with a printed or laser marking.
- the catheter 4026 can be formed in manners such as previously disclosed, but utilizing two different single-lumen extrusions of nylon 12 each having different colorants. The extrusions can be situated end-to-end over the braided layer 4073 prior to reflowing.
- the distal portion 4026 d of the catheter 4026 may define a retraction length L R that is slightly shorter than the total length L T of the sheath assembly 4002 (see FIG. 46 ). In this manner, a practitioner may have a visual cue that the distal tip 4023 of the catheter 4026 is safely withdrawn within an interior of the sheath 4016 when, for example, a proximal end of the gray distal portion 4026 d of the catheter 4026 is visible outside of the proximal end of the sheath assembly 4002 .
- the retraction length L R is shorter than the total length L T of the sheath assembly 4002 by no less than about 0.4, 0.5, 0.6, 0.7, 0.8 centimeters.
- the retraction length L R is shorter than the total length L T of the sheath assembly 4002 by about 0.6 centimeters.
- such an arrangement can ensure that the distal tip 4023 of the catheter 4026 is safely stowed in the sheath 4016 (e.g., is proximally recessed relative to the distal tip of the sheath 4016 ), while permitting the catheter 4026 to support (e.g., inhibit the kinking or other undesired deformation of) nearly an entire length of the sheath 4016 .
- the proximal portion 4026 p of the catheter 4026 and the strain relief sleeve 4025 can define an exposed length L E of which an entirety should be visible beyond the proximal end of the sheath assembly 4002 to ensure that the distal tip 4023 of the catheter 4026 is safely retracted within the sheath 4016 .
- the exposed length L E at the proximal end of the catheter 4026 can be slightly longer than an exposable length of the distal end of the catheter 4026 that is permitted to extend past the distal tip 4013 of the sheath 4016 during coring and suctioning.
- the exposed length L E at the proximal end of the catheter 4026 is longer than the exposable length at the distal end of the catheter 4026 by the same distance to which the distal tip 4023 of the catheter 4026 is retracted from the distal tip 4013 of the sheath 4016 when the interface of the proximal and distal portions 4026 p , 4026 d of the catheter 4026 is flush with the proximal tip of the sheath assembly 4002 .
- the exposable length at the distal end of the catheter 4026 can be relatively short to ensure that the distal tip 4013 of the catheter does not inadvertently come into contact with the esophagus.
- the exposable length may be no greater than 0.75, 1.0, 1.25, 1.5, or 2.0 inches.
- the exposed length L E can include at least a portion of a length of the strain relief sleeve 4025 .
- a proximal end of the exposed length L E terminates substantially at a proximal end of a portion of the catheter 4026 that is not covered by the strain relief sleeve 4025 .
- the catheter assembly 4004 can include a stopping region 4047 , which can interact with the sheath hub 4014 to delimit an amount of distal movement of the catheter 4026 beyond the distal tip 4013 of the sheath 4016 .
- the stopping region 4047 is the diametrically or laterally expanded region defined by the connector 4043 portion of the catheter hub 4024 and the expanded portion of the strain relief sleeve 4025 that is connected thereto.
- the stopping region 4047 can interfere with a proximal end of the connector 4055 or may enter into and interfere with a proximal portion of the guide 4052 within the connector 4055 , each of which is defined by the housing 4050 (see FIG. 47 ), as the catheter assembly 4004 is advanced distally through the sheath assembly 4002 .
- the catheter assembly can define a total length L T and a working length L W .
- the total length L T is 77.5 ⁇ 1 centimeters and the working length L W is 72.8 ⁇ 1 centimeters.
- the exposed length L E is 8.9 ⁇ 0.05 centimeters. Other dimensions are possible and are contemplated by the present disclosure.
- an outer diameter OD of the illustrated catheter 4026 is 0.124 ⁇ 0.005 inches and an inner diameter ID of the catheter 4026 is 0.105 ⁇ 0.005 inches.
- the outer diameter OD may also be referred to as a maximum diameter of the catheter 4026 .
- a height H BEV of the bevel at the distal tip 4023 is 0.025 ⁇ 0.005 inches.
- An angle ⁇ defined by the bevel, relative to an axial or longitudinal dimension of the catheter 4026 is 20.0 ⁇ 0.05 degrees. Other dimensions are possible and are contemplated by the present disclosure.
- the angle ⁇ can be greater than or less than that of the illustrated embodiment. In various embodiments, the angle ⁇ is no greater than 15, 20, 25, 30, or 35 degrees. The other dimensions may similarly be altered in other embodiments.
- FIG. 54 depicts the spacer 4080 in greater detail.
- the spacer 4080 is configured to maintain a predetermined relative position of the sheath assembly 4002 and the catheter assembly 4004 during insertion and/or manipulation of the system 4000 in the patient, such as during introduction of the system 4000 into the esophagus and into contact with an impacted food bolus.
- the spacer 4080 can be configured to maintain a relative orientation in which the distal tip 4023 of the catheter 4013 is retracted within the instrument delivery lumen 4054 of the sheath 4016 , or stated otherwise, is retracted relative to the distal tip 4013 of the sheath 4016 .
- the illustrated spacer 4080 is an elongated clip 4082 that includes a proximal fastener 4086 and a distal fastener 4088 .
- the proximal fastener 4086 is configured to selectively attach to and detach from the connector 4043 portion of the catheter hub 4024 (see FIGS. 45 and 51 ).
- the distal fastener 4088 is configured to selectively attach to and detach from the connector 4055 portion of the sheath hub 4014 (see FIGS. 45 and 47 ).
- the fasteners 4086 , 4088 can be of any suitable variety. In the illustrated embodiment, the fasteners 4086 , 4088 are spring clips with resiliently flexible arms.
- the spacer 4080 is attached to the system 4000 during manufacture and packaging of the system 4000 . Accordingly, when a user removes the system 4000 from the packaging, the spacer 4080 may already be in place. In other embodiments, the spacer 4080 may come separately within the packaging, and instructions for use can indicate that the user can attach the spacer 4080 to the assemblies 4002 , 4004 prior to insertion of the system 4000 into the esophagus of the patient.
- the spacer 4080 can be configured to be selectively detached from the assemblies 4002 , 4004 and selectively reattached to the assemblies 4002 , 4004 .
- a user may deploy the positioning element 4018 into contact with the esophageal wall and core through a portion of the blockage using the catheter assembly 4004 , such as by moving the catheter assembly 4004 longitudinally back and forth relative to the sheath assembly 4002 , which sheath assembly 4002 remains in a substantially fixed orientation relative to the esophagus and the blockage (e.g., food impaction) during the initial phase of coring.
- a user may deploy the positioning element 4018 into contact with the esophageal wall and core through a portion of the blockage using the catheter assembly 4004 , such as by moving the catheter assembly 4004 longitudinally back and forth relative to the sheath assembly 4002 , which sheath assembly 4002 remains in a substantially fixed orientation relative to the esophagus and the blockage (e.g., food impaction
- the user may wish to advance the sheath assembly 4002 to a more distal position within the esophagus, such as to be able to core deeper into the blockage. Accordingly, a user may wish to contract the positioning element 4018 (e.g., deflate the balloon 4019 ) or otherwise transition the positioning element 4018 to a lower profile and then move the system within the esophagus.
- the positioning element 4018 e.g., deflate the balloon 4019
- instructions for use may recommend or require that a user reattach the spacer 4080 prior to any movement within the esophagus when the positioning element 4018 is in the contracted state.
- the spacer 4080 can be reattached prior to removal of the system 4000 from the esophagus.
- a user may not use the spacer 4080 during retraction.
- the user may fully retract the catheter assembly 4004 from the sheath assembly 4002 (e.g., pull proximally out of the sheath assembly 4002 ), may then subsequently contract the positioning element 4018 to a low profile, and then may remove the sheath assembly 4002 from the esophagus.
- the system 4000 may be used in any of the manners disclosed herein, as suitable. For example, the various methods and/or portions (e.g., a subset of steps) thereof discussed with respect to, e.g., the systems 200 , 3000 , 3200 can be performed with the system 4000 .
- any of the systems or components thereof described herein may be provided in a kit 5000 .
- the kit 5000 is particularly well suited for use in an emergency room setting.
- the kit 5000 may be used in blind procedures, such as those in which no direct or indirect visualization of the blockage is performed during the procedure. Accordingly, in some instances, the kit 5000 may be used by practitioners who are not specialized endoscopists, etc.
- the kit 5000 includes an embodiment of the system 4000 .
- the kit 5000 can further include instructions 5002 for using the embodiment of the system 4000 .
- the instructions for use 5002 may provide directions with respect to any of the methods or processes disclosed herein.
- the instructions for use 5002 may recite any method and/or other portion of the present disclosure.
- the kit 5000 can further include packaging 5004 .
- the system 4000 can be contained within the packaging 5004 , and the instructions 5002 can be contained within, printed on, or otherwise made accessible via the packaging 5004 .
- the kit 5000 can be approved of or authorized by a regulating body of a particular jurisdiction.
- the kit 5000 , and the instructions 5002 for use thereof may be approved of or authorized by the Food and Drug Administration of the United States of America and/or may comply with the regulations of other jurisdictions, such as by qualifying for CE marking in the European Union.
- the instructions 5002 can provide directions with respect to any of the methods or processes disclosed herein. That is, the instructions 5002 can provide directions for using the system 4000 , or components thereof, in accordance with any of the methods or processes disclosed herein.
- One illustrative example of a set of instructions 5002 for use with one embodiment of the system 4000 is provided below.
- Other instructions may include more, fewer, and/or different directions than those provided in the illustrative example, and other embodiments of the system 4000 may include more, fewer, and/or different features than those discussed in the instructions.
- An embodiment of the system 4000 is designed to core and aspirate food impactions. It is comprised of the sheath assembly 4002 and the catheter assembly 4004 .
- the sheath assembly 4002 is a 12 Fr OD with a 0.133′′ ID, 62 cm in usable length, has a soft, atraumatic tip. It is designed to connect to a standard 10 cc-20 cc syringe for inflation of the balloon 4019 .
- the sheath assembly 4002 uses the low-pressure balloon 4019 to stabilize and center the aspiration catheter 4026 in the esophagus.
- the catheter assembly 4004 is used through the working channel 4054 ( FIG. 49 ) of the sheath assembly 4002 .
- the catheter assembly 4004 has a molded tapered handle that is a slip fit connection to the vacuum system in the emergency room of a hospital. It has a beveled distal tip to aid in coring through food impactions.
- the catheter assembly 4004 extends approximately 2.00′′ outside the tip of the sheath assembly 4002 during full insertion.
- the proximal portion 4026 p of the catheter 4026 is colored white, and the distal portion 4026 d is colored gray (see FIG. 51 ).
- the system 4000 can be packaged with instructions for use 5002 , which instructions may recite some or all of the following directions.
- the instructions detail illustrative examples of using the system 4000 .
- the system 4000 is indicated for removal of food blockage and impaction in the esophagus.
- the system 4000 may desirably be used by a health care professional with adequate training in the use of the device.
- the catheter assembly 4004 moves freely through the sheath assembly 4002 . Do not remove system 4000 assembly clip 4082 until the sheath assembly 4002 is in final position within the esophagus, which may also be referred to as an anchored position in which the balloon 4019 is fully deployed. Do not use if the system 4000 cannot be advanced to at least 25 cm past the incisors as indicated by the relevant markings.
- the aspiration catheter attached to suction, will then be employed to core pieces of the food impaction and suction the pieces as cored.
- the aspiration catheter will be advanced into the food to core pieces of food and then be withdrawn to allow suction. This process will be repetitively performed (coring and suctioning) as needed to clear the impaction. Repeat this action until food impaction is clear.
- the food impaction may naturally pass into the stomach once a sufficient portion thereof has been cored away.
- the sheath balloon can be deflated by opening the stopcock and pulling a vacuum on the inflation syringe and re-inflated in order to advance, withdraw or reposition the sheath to optimize clearance of the impaction.
- the aspiration catheter should be safely withdrawn into the sheath, and the balloon can be partially or completely deflated to allow free motion of the sheath, to allow advancement of the sheath into any remaining impaction to push any remaining food distally into the stomach. Advancement of the sheath should not be attempted until the aspiration catheter is contained within the confines of the sheath (e.g., the gray distal portion 4026 d of the aspiration catheter 4026 is visible outside of sheath assembly 4002 ).
- the catheter assembly 4004 is particularly well suited for use with any of a variety of standard or otherwise commercially available endoscopes.
- the catheter assembly 4004 may be better suited for use with such endoscopes than with certain embodiments of dedicated sheaths.
- the catheter assemblies can be deployed through a standard working channel of an endoscope.
- the food bolus and progress of the procedure can be visually monitored via the endoscope by a professional during certain uses of the catheter assemblies.
- the catheter assembly 4004 for use with an endoscope may vary from certain embodiments configured for use with a sheath assembly 4002 .
- the catheter assembly 4004 may be devoid of a depth indicator 4027 .
- the shaft of the catheter 4026 may be a uniform color along a full length thereof.
- various dimensions of the catheter assembly 4004 can be optimized for use with endoscopes.
- the total length L T of the catheter assembly 4004 may be relatively longer, whereas the outer diameter OD and the inner diameter ID are smaller.
- the total length L T is 128.7 ⁇ 1 centimeters
- the outer diameter OD is 0.107 ⁇ 0.005 inches
- the inner diameter ID is 0.096 ⁇ 0.005 inches.
- the remaining dimensions e.g., the bevel angle and bevel height
- Other values of the various dimensions are possible and are contemplated by the present disclosure.
- any of the catheter assemblies disclosed herein may be provided in a kit 6000 .
- the kit 6000 is particularly well suited for use with a standard or otherwise commercially available endoscope.
- the kit 6000 may be used by an endoscopist or other similarly trained practitioner.
- the kit 6000 includes an embodiment of the catheter assembly 4004 .
- the kit 6000 can further include instructions 6002 for using the embodiment of the catheter assembly 4004 .
- the instructions 6002 can provide directions to carry out any procedure, procedural step, or other action disclosed herein.
- the instructions for use 6002 may recite any method and/or other portion of the present disclosure
- the kit 6000 can further include packaging 6004 .
- the catheter assembly 4004 can be contained within the packaging 6004 , and the instructions 6002 can be contained within, printed on, or otherwise made accessible via the packaging 6004 .
- the kit 6000 can be approved of or authorized by a regulating body of a particular jurisdiction.
- the kit 6000 , and the instructions for use 6002 thereof may be approved of or authorized by the Food and Drug Administration of the United States of America and/or may comply with the regulations of other jurisdictions, such as by qualifying for CE marking in the European Union.
- the instructions 6002 can provide directions with respect to any of the methods or processes disclosed herein. That is, the instructions 6002 can provide directions for using the catheter assembly 4004 in accordance with any of the methods or processes disclosed above.
- One illustrative example of a set of instructions 6002 for use with one embodiment of the catheter assembly 4004 is provided below.
- Other instructions may include more, fewer, and/or different directions than those provided in the illustrative example, and other embodiments of the catheter assembly 4004 may include more, fewer, and/or different features than those discussed in the instructions.
- the catheter assembly 4004 is designed to be used in the esophagus to remove food blockages. It is an 8 Fr OD with a 0.090 inch max ID, 124 cm useable length, single-lumen, braided biocompatible catheter with a sharp distal tip for cutting through the food impaction.
- the catheter assembly 4004 has a molded, tapered handle that is a slip fit connection to the vacuum system in the hospital.
- the catheter assembly 4004 is designed to be used through the working channel (>2.7 mm ID) of a standard endoscope. It is designed to connect to extend outside the distal end of an endoscope by approximately 1 inch when fully inserted.
- the catheter assembly 4004 can be packaged with instructions for use 6002 , which instructions may recite some or all of the following directions.
- the instructions detail illustrative examples of using the catheter assembly 4004 .
- the catheter assembly 4004 is indicated for removal of food blockage/impaction in the esophagus.
- the catheter assembly 4004 should be used by a health care professional with adequate training in the use of the device.
- the aspiration catheter attached to suction, will then be employed to core pieces of the food impaction and suction the pieces as cored.
- the aspiration catheter will be advanced into the food to core pieces of food and then be withdrawn to allow suction. This process will be repetitively performed (coring and suctioning) as needed to clear the impaction. Repeat this step until food impaction is clear (e.g., until food impaction is naturally passed out of the esophagus and into the stomach by the patient).
- FIGS. 57A and 57B depict another embodiment of a sheath assembly 7002 in an undeployed state and in a deployed state, respectively.
- the sheath assembly 7002 can be used with embodiments of catheter assemblies disclosed herein in manners such as are also disclosed herein.
- the sheath assembly 7002 can function similarly to other sheath assemblies disclosed herein.
- the sheath assembly 7002 includes a positioning element 7018 and an actuator 7060 via which the positioning element 7018 can be deployed and retracted.
- the sheath assembly 7002 includes hub 7014 that is coupled with a sheath 7016 in any suitable manner.
- the sheath 7016 defines an instrument deployment lumen 7054 within which a catheter can be positioned, and through which the catheter can be advanced and/or retracted.
- the sheath 7016 can further define an actuation channel or lumen 7066 , which can resemble the inflation channels or lumens 3066 , 3266 , 4066 described above. All such lumens can allow movement therethrough of an actuation element (such as fluid or, as discussed further hereafter for the present case, an actuation wire or rod) to effect actuation or retraction of a positioning element.
- an actuation element such as fluid or, as discussed further hereafter for the present case, an actuation wire or rod
- the positioning element 7018 comprises an expandable member 7019 of any suitable variety.
- the expandable member 7019 can, for example, comprise a braided or other configuration of wires or other materials that can be selectively expanded to a larger profile configuration or retracted to a lower profile configuration.
- the expandable member 7019 can resemble or be formed as a selectively expandable and retractable stent, such as, for example, a braided stent.
- an expandable member, or positioning element can define a series of longitudinally extending wires or other elongated elements that are predisposed to flare outwardly when compressed and can assume a low-profile configuration when placed under tension.
- an expandable member, or positioning element can define a plurality of resilient arms (e.g., FIGS. 59A and 59B ) configured to press outwardly into contact with the esophagus. Any other suitable system for expanding into contact with the esophagus and retracting away from contact with the esophagus is contemplated.
- the expandable member 7019 is resiliently flexible and/or comprises a shape-memory material.
- the expandable member 7019 may be biased toward a retracted orientation ( FIG. 57A ), such that the bias must be overcome to deploy the expandable member 7019 .
- the expandable member 7019 may readily return to the retracted orientation under influence of the bias, when so permitted.
- the expandable member 7019 may be biased toward the deployed orientation ( FIG. 57B ), such that actuation of the expandable member 7019 includes permitting the bias to naturally deploy the expandable member 7019 .
- the expandable member 7019 may be returned to the retracted orientation by overcoming the bias.
- the expandable member 7019 is not subject to internal or other biases when positioned in either of the retracted or deployed orientations.
- a distal end of the expandable member 7019 can be fixed relative to the sheath 7016 .
- a proximal end of the expandable member 7019 can be movable relative to the sheath 7016 .
- the proximal end of the expandable member 7019 can be permitted to translate longitudinally relative to the sheath 7016 .
- the proximal end of the expandable member 7019 can be coupled with a mechanical linkage 7091 of any suitable variety, such as a wire or rod 7093 .
- the mechanical linkage 7091 can further be coupled with an actuation interface 7095 of any suitable variety, such as a button, lever, switch, slider, etc.
- the actuation interface 7095 can move the mechanical linkage 7091 so as to effect actuation and retraction of the expandable member 7019 .
- the actuator 7060 can be communicatively coupled with the positioning element 7018 .
- the actuation interface 7095 is configured to directly, mechanically communicate with the expandable member 7019 via the mechanical linkage 7091 .
- the actuation interface 7095 comprises a switch that is translatable relative to the housing 7014 .
- the mechanical linkage 7091 is likewise urged distally, which likewise urges the proximal end of the expandable member 7019 distally. Due to the fixed relationship of the distal end of the expandable member 7019 relative to the sheath 7016 , the expandable member 7019 can deploy outwardly to the configuration depicted in FIG. 57B .
- urging the switch proximally from the distal position shown in FIG. 57A to the proximal position shown in FIG. 57B can return the expandable member to the retracted orientation shown in FIG. 57A .
- FIGS. 58A and 58B depict another embodiment of a sheath assembly 8002 in an undeployed state and in a deployed state, respectively.
- the sheath assembly 8002 can closely resemble the sheath assembly 7002 just described, but may include a different expandable member 8019 that includes a plurality of longitudinally extending wires or elongated elements 8095 .
- the expandable member 8019 can perform substantially as previously described with respect to the expandable member 7019 .
- FIGS. 59A and 59B depict another embodiment of a sheath assembly 9002 in an undeployed state and in a deployed state, respectively.
- the sheath assembly 9002 can closely resemble the sheath assemblies 7002 , 8002 just described, but may include a different expandable member 9019 that includes a plurality of resiliently expandable arms 9097 .
- the arms 9097 are configured to rotate outward into contact with the esophageal wall when deployed.
- the arms 9097 are deployed when proximal portions thereof are advanced distally so as to no longer be restrained in a low-profile orientation by a retainer element 9099 .
- embodiments are only examples and should not be construed as limiting.
- the examples described above generally refer to food impactions in the esophagus.
- many other similar impactions can be addressed using the systems and methods described herein.
- embodiments of the systems may be used with any suitable anatomical tube (e.g., the esophagus, a bronchus, a vessel).
- a person can choke while eating, and food can get aspirated and lodge in the trachea, or can also lodge in the lung, specifically any portion of the bronchial tree. Mucus can also become trapped anywhere in the bronchial tree, causing mucus plugging.
- one or more of the embodiments described herein can be used to core and suction said food or mucus, such as by placing the device, for example, through the working channel of a flexible or rigid bronchoscope as opposed to an endoscope.
- One or more of the embodiments described herein can also be used to core, suction and remove trapped blood or blood clots anywhere in the GI tract, specifically the esophagus, stomach, small intestine or large intestine.
- One or more of the embodiments described herein can also be used to core, suction and remove trapped food, blood or blood clots, or mucus or mucus plugs, anywhere in the pulmonary organ system, i.e., the trachea or lung i.e. anywhere in the bronchial tree.
- One or more of the embodiments described herein can be used to core and remove blood or blood clots, or atheroma or atheromatous plaque anywhere in the vasculature system, i.e. great arteries or veins, or peripheral vasculature i.e. the peripheral arteries or veins.
- a stainless steel tip can be attached to the end of the suction catheter.
- One or more of the embodiments described herein can also be used to core and remove blood or blood clots, or atheroma or atheromatous plaque anywhere in the heart or coronary arteries.
- a stainless steel tip can be attached to the end of the suction catheter.
- one or more of the embodiments described herein can be used to core and suction kidney stones from the urinary system, specifically the ureters, bladder and kidneys.
- a stainless steel tip can be attached to the end of the suction catheter.
- one or more of the embodiments described herein can be used to core and remove gallstones or tumors lodged in the biliary tree (common bile duct or peripheral ducts). Harder materials can be cored by attaching a stainless steel tip to the end of the suction catheter.
- Any methods disclosed herein comprise one or more steps or actions for performing the described method.
- the method steps and/or actions may be interchanged with one another.
- the order and/or use of specific steps and/or actions may be modified.
- the term “substantially” refers to the complete or nearly-complete extent or degree of an action, characteristic, property, state, structure, item, or result.
- an object that is “substantially” enclosed would mean that the object is either completely enclosed or nearly completely enclosed.
- the exact allowable degree of deviation from absolute completeness may in some cases depend on the specific context. However, generally speaking the nearness of completion will be so as to have the same overall result as if absolute and total completion were obtained.
- the use of “substantially” is equally applicable when used in a negative connotation to refer to the complete or near complete lack of an action, characteristic, property, state, structure, item, or result.
- compositions that is “substantially free of” particles would either completely lack particles, or so nearly completely lack particles that the effect would be the same as if it completely lacked particles.
- a composition that is “substantially free of” an ingredient or element may still actually contain such item as long as there is no measurable effect thereof.
- the term “about” is used to provide flexibility to a numerical range endpoint by providing that a given value may be “a little above” or “a little below” the endpoint.
- references to approximations such as by use of the terms “about” or “approximately,” or other terms, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation.
- qualifiers such as “about,” “substantially,” and “generally” are used, these terms include within their scope the qualified words in the absence of their qualifiers.
- the term “substantially perpendicular” is recited with respect to a feature, it is understood that in further embodiments, the feature can have a precisely perpendicular orientation.
- claim 3 can depend from either of claims 1 and 2 , with these separate dependencies yielding two distinct embodiments; claim 4 can depend from any one of claim 1 , 2 , or 3 , with these separate dependencies yielding three distinct embodiments; claim 5 can depend from any one of claim 1 , 2 , 3 , or 4 , with these separate dependencies yielding four distinct embodiments; and so on.
Abstract
A system can include a tubular member to be inserted into an esophagus of a patient and a catheter assembly that includes a catheter tube that defines a length greater than a length of the tubular member and is configured to pass through a channel of the tubular member such that a distal tip of the catheter tube extends distally past the distal tip of the tubular member while the tubular member is positioned in the esophagus of the patient. The distal tip of the catheter tube defines a cutting element to core a blockage positioned in the esophagus of the patient. Advancement of the distal tip of the catheter tube into contact with the blockage can core a piece from the blockage that is passed through the catheter tube.
Description
- This application is a continuation of prior U.S. patent application Ser. No. 15/995,112, filed on May 31, 2018, titled BLOCKAGE CLEARING DEVICES, SYSTEMS, AND METHODS, which claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 62/513,419, filed on May 31, 2017, titled BLOCKAGE CLEARING DEVICES, SYSTEMS, AND METHODS, and U.S. Provisional Patent Application No. 62/636,526, filed on Feb. 28, 2018, titled BLOCKAGE CLEARING DEVICES, SYSTEMS, AND METHODS; further, prior U.S. patent application Ser. No. 15/995,112 is a continuation-in-part of U.S. patent application Ser. No. 15/356,975, filed on Nov. 21, 2016, titled BLOCKAGE REMOVAL, which claims the benefit of U.S. Provisional Patent Application No. 62/260,873, filed on Nov. 30, 2015, titled TREATING ESOPHAGEAL FOOD IMPACTIONS; the entire contents of each of the foregoing applications are hereby incorporated by reference herein.
- Certain embodiments described herein relate generally to devices for treating blockages in patients, and further embodiments relate more particularly to devices, systems, and methods for treating esophageal food impactions in patients.
- Blockages within the body can take various forms. For example, esophageal food impactions are one of the most common and dangerous emergencies in gastroenterology, with an annual incidence rate of at least 13/100,000 population (Longstreth, GIE; 2001); moreover, the incidence has been increasing in recent years due to a rise in eosinophilic esophagitis (Desai, GIE; 2005). Food impactions can occur when a bolus of swallowed food becomes lodged in the esophagus and is unable to pass spontaneously into the stomach. This occurs either when the swallowed bolus is too large or when there are diseases of the esophagus that narrow the esophageal lumen, such as GE reflux with a stricture or ring, an esophageal food allergy such as eosinophilic esophagitis with stricture or stenosis of the esophagus, a Schatzki's ring, esophageal webs, or esophageal cancer. Motility disorders of the esophagus typically do not cause impactions.
- Food impactions present acutely and dramatically, with patients noting chest pain or pressure, inability to swallow, painful swallowing, a sensation of choking, and neck or throat pain. Retching and vomiting are also common, and patients can also experience breathing problems due to tracheal or airway compression, with stridor, coughing or wheezing being noted. Known devices, systems, and methods for treating food impactions suffer from one or more drawbacks that can be resolved, remedied, ameliorated, or avoided by certain embodiments described herein.
- The written disclosure herein describes illustrative embodiments that are non-limiting and non-exhaustive. Reference is made to certain of such illustrative embodiments that are depicted in the figures, in which:
-
FIG. 1 depicts a side elevation view of an illustrative embodiment of a catheter for clearing a blockage from within a body of a patient; -
FIG. 2 depicts a side elevation view of an illustrative embodiment of a system for clearing a bolus of food or other debris or foreign body lodged within an esophagus of a patient, the system including the catheter ofFIG. 1 ; -
FIG. 2A is an end-on plan view of a distal tip of an embodiment of an endoscope that is compatible with the system ofFIG. 2 ; -
FIG. 3 depicts a portion of the system ofFIG. 2 with the bolus of food or other debris being partially cored; -
FIG. 4 depicts an illustrative embodiment of a distal end of the catheter for coring the bolus of food or other debris shown inFIG. 1 ; -
FIG. 5 depicts another illustrative embodiment of a distal end of a catheter for coring the bolus of food or other debris, such as that shown inFIG. 1 ; -
FIG. 6 depicts an illustrative embodiment of a proximal end of a catheter tube ofFIG. 1 coupled to an embodiment of a syringe; -
FIG. 7 depicts a side elevation view of an illustrative embodiment of a stylet that is compatible with the system ofFIG. 2 ; -
FIG. 8 depicts a side elevation view of the stylet ofFIG. 7 positioned within the catheter ofFIG. 1 ; -
FIG. 9 depicts a side elevation view of another embodiment of a catheter having a Y-fitting for removing a bolus of food or other debris lodged within an esophagus; -
FIG. 10 is a perspective view of the catheter ofFIG. 9 ; -
FIG. 11 is a perspective view of a proximal portion of the catheter ofFIG. 9 with a stylet advanced fully therethrough; -
FIG. 12 shows another perspective view of the proximal portion of the catheter ofFIG. 9 ; -
FIG. 13 shows another view of the proximal portion of the catheter ofFIG. 9 with the stylet partially removed therefrom; -
FIG. 14 shows an enlarged view of the proximal portion of the catheter ofFIG. 9 ; -
FIG. 15 shows another view of the proximal portion of the catheter ofFIG. 9 with a cap of the suction port removed; -
FIG. 16 shows a distal end of the catheter ofFIG. 9 ; -
FIG. 17 shows the distal end of the catheter ofFIG. 9 ; -
FIG. 18 shows another example embodiment of a stylet for removing a bolus of food or other debris lodged within an esophagus; -
FIG. 19 shows an end portion of the stylet ofFIG. 18 ; -
FIG. 20 shows another example embodiment of a system for removing a bolus of food or other debris lodged within an esophagus; -
FIG. 21 shows a portion of the device ofFIG. 20 ; -
FIG. 22 shows another example embodiment of a system for removing a bolus of food or other debris lodged within an esophagus; -
FIG. 23 shows a cross-sectional view of a portion of the device ofFIG. 22 ; -
FIG. 24 shows another cross-sectional view of a portion of the device ofFIG. 22 ; -
FIG. 25 is an exploded elevation view of another embodiment of a blockage clearing system; -
FIG. 26 is a side elevation view of a proximal end of an embodiment of a sheath assembly that may be used with the system ofFIG. 25 ; -
FIG. 27 is a cross-sectional view of a sheath portion of the sheath assembly ofFIG. 26 taken along the view line 27-27 inFIG. 26 ; -
FIG. 28A is an elevation view of a distal end of the sheath assembly that includes a positioning element in an undeployed state; -
FIG. 28B is an elevation view of the distal end of the sheath assembly that depicts the positioning element in a deployed state; -
FIG. 29 is an elevation view of a proximal end of an embodiment of a catheter assembly that may be used with the system ofFIG. 25 ; -
FIG. 30 is a cross-sectional view of a catheter portion of the catheter assembly ofFIG. 29 taken along the view line 30-30 inFIG. 29 ; -
FIG. 31 is an elevation view of a distal end of the catheter ofFIG. 29 ; -
FIG. 32A is an early stage in an illustrative method of using the system ofFIG. 25 in which the sheath is inserted into the esophagus of a patient; -
FIG. 32B is a subsequent stage in the illustrative method in which the distal end of the sheath contacts an impacted bolus of food; -
FIG. 32C is a subsequent stage in the illustrative method in which the positioning element is deployed into contact with the esophagus; -
FIG. 32D is a subsequent stage in the illustrative method in which the distal tip of the catheter is advanced through the sheath and brought into contact with a proximal end of the food bolus; -
FIG. 32E is a subsequent stage in the illustrative method in which a morsel of food from the food bolus is cut or, more specifically, cored by the distal tip of the catheter and is drawn into a lumen of the catheter; -
FIG. 32F is a subsequent stage in the illustrative method in which the morsel of food has detached from the food bolus and is suctioned through the lumen of the catheter; -
FIG. 32G is a subsequent stage in the illustrative method in which the catheter is withdrawn into or from the sheath; -
FIG. 32H is a subsequent stage in a further illustrative method in which further coring of the food bolus is desired, wherein in the depicted stage, the positioning element is returned to the undeployed configuration to permit ready movement of the sheath relative to the esophageal wall; -
FIG. 32I is a subsequent stage in the further illustrative method in which the distal end of the sheath has been advanced to a more distal position, wherein the proximal end of the cored food bolus has been reshaped in the absence of the suctioned-off food morsel; -
FIG. 32J is a subsequent stage in the further illustrative method in which the positioning element is deployed again into contact with the esophagus; -
FIG. 32 K is a subsequent stage in the further illustrative method in which the distal tip of the catheter is again brought into contact with the proximal end of the food bolus for further coring of the food bolus; -
FIG. 33A is an elevation view of a distal end of another embodiment of a sheath assembly that includes a differently shaped positioning element in an undeployed state; -
FIG. 33B is another elevation view of the distal end of the sheath assembly ofFIG. 33A that depicts the positioning element in a deployed state in which the positioning element is substantially shaped as a frustocone; -
FIG. 34 is an elevation view of a proximal end of another embodiment of a sheath assembly that includes a pressure regulation valve; -
FIG. 35A is an elevation view of a distal end of the sheath assembly ofFIG. 34 that depicts a positioning element in an undeployed state; -
FIG. 35B is a further elevation view of the distal end of the sheath assembly ofFIG. 34 that depicts the positioning element in a deployed state; -
FIG. 35C is a further elevation view of the distal end of the sheath assembly ofFIG. 34 that depicts the positioning element in a further state of operation in which the positioning element has been maintained in the deployed state at a substantially constant pressure via the pressure regulation valve ofFIG. 34 , despite attempts to further pressurize the positioning element; -
FIG. 36 is an elevation view of a proximal end of another embodiment of a catheter assembly that, in some instances, may be used with a system such as that depicted inFIG. 25 , or in other instances, may be used without a sheath; -
FIG. 37 is a cross-sectional view of a catheter portion of the catheter assembly ofFIG. 36 taken along the view line 37-37 inFIG. 36 ; -
FIG. 38A is an elevation view of a distal end of the catheter assembly ofFIG. 36 in which a positioning element is depicted in an undeployed state; -
FIG. 38B is another elevation view of the distal end of the catheter assembly in which the positioning element is depicted in a deployed state; -
FIG. 39A is an elevation view of a distal end of another embodiment of a catheter assembly that includes a differently shaped positioning element that is depicted in an undeployed state; -
FIG. 39B is another elevation view of the distal end of the catheter assembly ofFIG. 39A that depicts the positioning element in a deployed state; -
FIG. 40A is an elevation view of a distal end of another embodiment of a catheter assembly that includes a differently shaped and differently oriented positioning element that is depicted in an undeployed state; -
FIG. 40B is another elevation view of the distal end of the catheter assembly ofFIG. 40A that depicts the positioning element in a deployed state; -
FIG. 41 is an elevation view of a distal end of another embodiment of a catheter assembly that depicts a distal tip of a catheter that includes an internal bevel; -
FIG. 42 is an elevation view of a distal end of another embodiment of a catheter assembly that depicts a distal tip of a catheter that is substantially flat and that includes a cutting element recessed from the distal tip within a lumen of the catheter; -
FIG. 43 is a cross-sectional view of the catheter assembly ofFIG. 42 taken along the view line 43-43 inFIG. 42 ; -
FIG. 44 is an elevation view of a distal end of another embodiment of a catheter assembly that depicts a distal tip of a catheter that is substantially rounded and that includes a cutting element recessed from the distal tip within a lumen of the catheter; -
FIG. 45 is an elevation view of another embodiment of a blockage clearing system in an assembled, pre-use, undeployed, packaged, or insertion state; -
FIG. 46 is an elevation view of an embodiment of a sheath assembly of the blockage clearing system ofFIG. 45 , the sheath assembly being shown in a deployed state; -
FIG. 47 is a cross-sectional view of a hub of the sheath assembly ofFIG. 46 ; -
FIG. 48 is a partial cross-sectional view of a portion of the sheath assembly that includes the hub, when the assembly is in an assembled state; -
FIG. 49 is a cross-sectional view of a sheath of the sheath assembly ofFIG. 46 taken along the view line 49-49 inFIG. 46 (not necessarily to scale); -
FIG. 50 is an enlarged elevation view of a distal end of the sheath assembly ofFIG. 46 , which includes a positioning element that is depicted in a deployed state; -
FIG. 51 is an elevation view of an embodiment of a catheter assembly that is compatible with the blockage clearing system ofFIG. 45 and/or, in other or further embodiments, is compatible for use with an endoscope; -
FIG. 52 is a cross-sectional view of a catheter of the catheter assembly ofFIG. 51 taken along the view line 52-52 inFIG. 51 (not necessarily to scale); -
FIG. 53 is an enlarged elevation view of a distal end of the catheter; -
FIG. 54 is a perspective view of an embodiment of a spacer compatible with the system ofFIG. 45 ; -
FIG. 55 is an elevation view of an embodiment of a kit that includes the system ofFIG. 45 ; -
FIG. 56 is an elevation view of another embodiment of a kit that includes an embodiment of the catheter assembly ofFIG. 51 ; -
FIG. 57A is an elevation view of another embodiment of a sheath assembly, which can be used with embodiments of systems previously disclosed, the sheath assembly being shown in an undeployed state; -
FIG. 57B is another elevation view of the sheath assembly ofFIG. 57A shown in a deployed state; -
FIG. 58A is an elevation view of another embodiment of a sheath assembly, which can be used with embodiments of systems previously disclosed, the sheath assembly being shown in an undeployed state; -
FIG. 58B is another elevation view of the sheath assembly ofFIG. 58A shown in a deployed state; -
FIG. 59A is an elevation view of another embodiment of a sheath assembly, which can be used with embodiments of systems previously disclosed, the sheath assembly being shown in an undeployed state; and -
FIG. 59B is another elevation view of the sheath assembly ofFIG. 59A shown in a deployed state. - The present disclosure relates generally to devices, systems, and methods for addressing a blockage within a lumen of a patient. While specific examples of such devices, systems, and methods are discussed with respect to esophageal food impactions, the disclosure is not limited to this specific application. For example, other foreign bodies positioned within the esophagus and/or blockages within other body lumens may be cleared in manners such as disclosed herein. As a further example, certain embodiments described herein can be used to clear, remove, break up, or otherwise treat other blockages within the body, such as those in the lungs.
- Most food impactions clear spontaneously, but a significant fraction (20%) will not and have traditionally required emergent endoscopic intervention to clear the blocked food. This can be dangerous, since typical emergency endoscopy with removal of food can result in serious complications including aspiration pneumonia, laceration of the esophagus with bleeding, or esophageal perforation, which can result in sepsis and death. The complication rate of endoscopic clearance of a food impaction is approximately 3-5% and the mortality rate is unknown but several deaths have been reported (Simic, Am J Forensic Med Path; 1988).
- Various endoscopic tools may be used to clear impactions, but all have flaws and there is no prior technique that is demonstrably better than any other. Food can sometimes be pushed blindly through the esophagus and into the stomach using the tip of the endoscope, but this technique is performed without vision of the more distal esophagus, so the endoscopist cannot observe, via the endoscope, what the esophagus looks like distal to the obstruction or what abnormalities exist. This technique can work well in some patients (Vicari, GIE; 2001), but because the technique is blind, can often result in esophageal laceration or perforation. Indeed, there is a significant risk the distal tip of the endoscope and/or a sharp surface within the bolus will be deflected toward the esophagus wall during blind pushing of this sort, resulting in laceration or perforation. Many endoscopists avoid blind pushing for this reason.
- Some endoscopic techniques employ forceps that include “rat-tooth” type designs, snares, or variable wire basket designs to break up food into smaller 1 s for extraction. Such techniques are laborious, time-consuming, and often fail.
- Other extraction techniques can also be tried, particularly when the food bolus is not tightly wedged and is firm, or if the food contains bone or sharp surfaces. In this regard, baskets, snares, graspers, “pelican” forceps with longer arms, nets, etc., can be used to remove food in whole or in pieces, but these techniques also frequently fail, and the patient is at risk for aspiration pneumonia if the pieces fall into the hypopharynx or mouth during the extraction attempts. If the food bolus is lodged proximally, then most of the above techniques will fail or are too dangerous to try. Endoscopic suction cannot be used for impactions, since a food bolus cannot be effectively suctioned through an endoscope. Moreover, if suction is used in an attempt to hold the food bolus against a distal tip of the endoscope, and the suction fails at some point to hold a bolus against the tip of the scope, the patient is at high risk for aspiration as the scope is withdrawn through the hypopharynx or mouth. Overtubes for endoscopes can be used if repeated endoscopic intubation is needed, but overtubes are uncomfortable, require deeper sedation, and can be dangerous in and of themselves with risk of esophageal laceration and perforation.
- Certain embodiments disclosed herein can resolve, remedy, ameliorate, and/or avoid one or more of the limitations of known techniques for treating a patient who suffers from an esophageal food impaction, such as those just described, and/or can be advantageous over such techniques for other reasons, as will be apparent from the present disclosure.
- In certain embodiments, a device is configured to clear a bolus of food impacted within an esophagus. The device can include a catheter tube having a hollow interior and a distal end configured to core the bolus of food and can include a proximal end configured to be coupled to a source of suction to clear the core. Certain systems described herein assist in resolving the buildup of pieces of food in the esophagus while minimizing the risk of aspiration. The systems are further designed in an atraumatic manner, helping to avoid esophageal laceration and perforation. In some embodiments, an inner region of a food impaction that is spaced from the esophageal wall (e.g., the mid-region or center of the food impaction) is cored out.
- For example, in one embodiment, the system includes a catheter (e.g., hollow tube) with a distal end that is delivered to the site of the blockage. The distal end of the catheter is used to core out portions of the blockage until the blockage is reduced in volume in a piecemeal manner. The smaller volume blockage can then pass through the esophagus spontaneously and/or be more easily removed. In some embodiments, the catheter can be delivered to the blockage site through an endoscope (e.g., through the instrument channel of the endoscope) or other similar device.
- In other or further embodiments, the catheter can be delivered to the blockage site through a dedicated or specialized sheath, which may include a positioning element to prevent the catheter tip from contacting the esophageal wall. In some instances, the dedicated sheath may permit the catheter to define a larger internal lumen, as compared with catheters that are deployed through the instrument or working channel of a standard endoscope, which can facilitate and/or increase a rate of blockage clearance. The dedicated sheath may permit the catheter to be used in a blind procedure, such as in an emergency room setting, without endoscopic or other visualization of the impaction during the procedure. In some embodiments, the sheath includes a positioning element that spaces the distal tip of the catheter away from the esophageal wall to prevent laceration or perforation of the esophagus.
- In still other or further embodiments, the catheter itself may include a positioning element to prevent the catheter tip from contacting the esophageal wall. In some instances, the catheter may be used without an endoscope or other sheathing element.
- In certain examples, suction can be provided to remove the cored portions of the blockage. The suction can be provided at the proximal end of the catheter to assist with the coring and/or to cause the cored portions to be suctioned from the site of the blockage and passed through the catheter and discarded, thus minimizing a risk of food aspiration. In some instances, suctioning arrangements can preserve endoscopic visualization. Stated otherwise, a coring aspiration catheter may be deployed through the working channel of an endoscope to remove portions of a food bolus without blocking a viewing lens at a distal end of the endoscope and/or without obscuring, or without significantly or fully obscuring, a field of view of the lens. For example, the impacted food bolus and the coring aspiration catheter may be viewed via the viewing lens at the distal end of the endoscope throughout at least a portion of the clearing procedure.
- Certain embodiments can include features that allow cored portions of the food to be cleared, should the portions become caught in the catheter while being suctioned away from the blockage site. In one example, a source of compressed air, such as a syringe, can be placed at the proximal end of the catheter, and air can be passed through the catheter to clear any portions caught in the catheter, via the distal end. In other or further embodiments, a stylet can be passed through the interior of the catheter to clear any portions of food caught therein. The stylet can also perform other or further functions, such as providing stiffness for the catheter during delivery of the catheter to the blockage site. Further, the stylet can be configured to assist in the manipulation of the blockage, such as by advancing the stylet into the blockage one or multiple times to create a nidus for coring and suctioning.
- One or more of the foregoing advantages and/or one or more other or further advantages will be apparent from the discussion that follows.
- Referring now to
FIG. 1 , anexample catheter 100, which may also be referred to as acatheter assembly 100, is shown. Thecatheter 100 includes ahollow catheter tube 102 that generally can be used to core out a portion of a blockage. Specifically, thecatheter tube 102 includes adistal end 104 that is configured to contact and core the blockage one or more times. As the blockage is cored by thedistal end 104 of thecatheter tube 102, the volume of the blockage is reduced until the blockage is able to be passed through the esophagus spontaneously and/or removed. - The
catheter assembly 100 includes aproximal end 106 configured to be coupled to various devices. For example, as described further below, theproximal end 106 of thecatheter assembly 100 is configured to be coupled to a source of suction to allow the cored food portions to be suctioned and/or removed through thecatheter tube 102. In another example, theproximal end 106 of thecatheter tube 102 is configured to be coupled to a source of pressurized air, such as a syringe, to allow any cored food stuck within thecatheter tube 102 to be cleared. Other configurations are possible. In the illustrated embodiment, theproximal end 106 is formed as a tapered connector that can be directly connected to a standard vacuum tubing arrangement, such as in a hospital setting, as discussed further below with respect toFIG. 2 . - The catheter or
catheter assembly 100 can include astrain relief sleeve 53 of any suitable variety. Thestrain relief sleeve 53 can inhibit kinking or other undesirable deformation of thecatheter tube 102 during use of thecatheter tube 102. In some embodiments, thecatheter 100 includes ashoulder 55 at a proximal end of thestrain relief sleeve 53. The shoulder can define a larger diameter than thestrain relief sleeve 53. Thecatheter 100 can further include ahandle 57 via which a user may manipulate the proximal end of thecatheter 100. - Referring now to
FIGS. 2 and 3 , thecatheter 100 is shown within anexample system 200 configured to remove ablockage 202 positioned within anesophagus 204 of a patient. In this example, the blockage 202 (generally food or other debris, but could also be other blockages like blood or blood clots, mucus, etc.) has become caught within theesophagus 204. - In the embodiment shown, the
catheter 100 is delivered to theblockage 202 using anendoscope 210. Theendoscope 210 can be of any suitable variety, including those presently in use and/or those yet to be devised. For example, the endoscope can be any of a variety of standard endoscopes typically used for upper GI tract endoscopy. As shown inFIG. 2A , theendoscope 210 contains a workingchannel 260 that is generally hollow and allows thecatheter 100 to be delivered through theendoscope 210 to theblockage 202. Theendoscope 210 may generally be referred to as a tubular member that defines a channel—specifically, the workingchannel 260. - In various embodiments, the
endoscope 210 can include one or more additional ports having a variety of additional functions. For example, in the illustrated embodiment, theendoscope 210 includes aviewing port 262, which may include a lens, via which a region beyond the distal tip of theendoscope 210 can be viewed. Theendoscope 210 can further include a light guide that terminates at alight port 264 for illuminating the region beyond the distal tip of theendoscope 210. Theendoscope 210 can include awater jet 266 and/or can include an air and/orwater nozzle 268. Various embodiments of endoscopes can include more or fewer features. - With continued reference to
FIGS. 2 and 3 , once thedistal end 104 of thecatheter tube 102 is in position, theendoscope 210 can be withdrawn or can remain in place as theblockage 202 is manipulated. In many methods, theendoscope 210 remains in close proximity to theblockage 202 during coring via thecatheter tube 102 to permit visualization of the coring. In particular, theendoscope 210 can be positioned such that the region that is illuminated by thelight port 264 and that is within the field of view of the lens of theviewing port 262 includes both the proximal end of theblockage 202 and the distal end of thecatheter tube 102 as thecatheter tube 102 is used to core pieces out of theblockage 202. - The
catheter tube 102 of thecatheter 100 is configured to be advanced so that thedistal end 104 impacts theblockage 202 so as to reduce the volume of theblockage 202, such as by repetitively coring the food. As the volume is reduced (such as is shown inFIG. 3 ), theblockage 202 can be naturally passed through theesophagus 204 and into astomach 206 of the person. - In example embodiments, the
catheter tube 102 is at least semi-rigid but flexible, which allows the catheter tube to flex and/or bend during delivery through the endoscope, as the endoscope flexes and bends. This allows thecatheter tube 102 to be directed more precisely as it is inserted to a desired location. For example, in some instances, the endoscope is introduced into the patient through the nose of the patient—or stated otherwise, is introduced into the patient via transnasal endoscopy—such that the endoscope defines a curved route through the upper respiratory tract of the patient. In other instances, the endoscope is introduced into the patient through the mouth, such that the endoscope defines a curved route from the mouth to the esophagus, in manners such as described elsewhere herein. Thecatheter tube 102 may be sufficiently flexible to pass through the curved portion of the endoscope, or more specifically, pass through the curved portion of the workingchannel 260. - In some examples, the
distal end 104 of thecatheter tube 102 is configured to assist in the coring of theblockage 202. For example, as shown inFIG. 4 , thedistal end 104 of thecatheter tube 102 is tapered. Specifically, thedistal end 104 includes aninner diameter 402 that is smaller than aninner diameter 404 of a moreproximal portion 406 of thecatheter tube 102. In one example, the difference in diameters can be less than one-hundredth of a millimeter. Other sizes are possible. In addition, the walls of thecatheter tube 102 can be thinned as the walls extend to thedistal end 104, as depicted. - This tapering of the
distal end 104 can allow acore 410 of theblockage 202 that is formed by thedistal end 104 to be more easily suctioned through thecatheter tube 102. Since the cores formed by thedistal end 104 will typically have a diameter smaller than that of theportion 406, the cores can be more easily suctioned through thecatheter tube 102 for evacuation, as is illustrated by Poiseuille's law. - In another depiction shown in
FIG. 5 , thecatheter tube 102 is formed of afirst portion 502 at thedistal end 104 having a smaller diameter, and asecond portion 504 extending along a remainder of thecatheter tube 102 having a larger diameter. This again allows the cores of theblockage 202 that are created by thefirst portion 502 to be smaller in diameter so that the cores can more easily pass through the remainder of the catheter tube 102 (i.e., the second portion 504). - In some examples, a
tip 508 of thedistal end 104 of thecatheter tube 102 can be beveled and/or serrated. Thetip 508 can take multiple forms, including a serrated edge, to cut (e.g., saw) or shave bits of theblockage 202 off of the bolus to better aid suctioning. Thetip 508 can help core the blockage. For example, in some instances, thecatheter tube 102 may be rotated relative to the working channel of the endoscope, whether in a single direction or back and forth, as thetip 508 contact theblockage 202. In some instances, this rotation, coupled with a serrated or otherwise configured tip can assist in coring theblockage 202. This technique may be used with other embodiments as well, including those in which a catheter is inserted through a sheath assembly, rather than an endoscope. - For example, referring again to the
system 200 depicted inFIG. 2 , a source of suction can be applied to theproximal end 106 of thecatheter 100 to allow the cores of theblockage 202 to be removed through thecatheter tube 102. Specifically, in the example provided, avacuum line 220 can be coupled to theproximal end 106 of thecatheter tube 102. In particular, thevacuum line 220 can include a suction line fitting 221 that is connected to theproximal end 106 of thecatheter 100. Thevacuum line 220 can be coupled to acollection canister 222 of any suitable variety, including those presently known or those yet to be devised, and thecollection canister 222 is coupled to asuction line 224. Thesuction line 224 is coupled to a source of suction, such as a hospital vacuum source. In this configuration, pieces of theblockage 202 that are cored or otherwise dislodged by thecatheter tube 102 can thereupon be sucked up thecatheter tube 102, through thevacuum line 220, and collected in thecollection canister 222. - As described previously, it is possible for one or more cores of the
blockage 202 to become stuck within thecatheter tube 102. In such a scenario, various devices can be used to clear the stuck cores. - For example, referring now to
FIG. 6 , anexample syringe 602 is coupled to theproximal end 106 of thecatheter 100 using, for example, a suction line fitting or Luer-lock style connection. In this embodiment, thesyringe 602 can be a typical 60 cc syringe that is used to deliver air into thecatheter tube 102 during coring of theblockage 202 to dislodge and/or remove portions of theblockage 202 that are in thecatheter tube 102. - In this instance, a plunger of the
syringe 602 is actuated to displace air within thesyringe 602 into and through thecatheter tube 102. This air can be used to dislodge obstructions within the tube. Other configurations are possible. For example, other types of fluids, such as a jet spray of water, could be used to help clear the tube or break up food. - In other instances, different devices can be used to clear the
catheter 100. For example, referring now toFIG. 7-8 , astylet 700 is shown that is sized to fit through the hollow interior of thecatheter tube 102. Generally, thestylet 700 can be used to perform various functions. - For example, the
stylet 700 can be used to stiffen thecatheter 100 during delivery to theblockage 202. Further, thestylet 700 can be introduced through thecatheter tube 102 to clear thecatheter tube 102 when one or more cores get stuck, performing a function of a pusher rod. In other or further instances, thestylet 700 can be used to pierce theblockage 202 to start a nidus for coring and suctioning. In various examples, thestylet 700 can be solid or hollow. - In the illustrated example, the
stylet 700 further includes astylet knob 702 that is configured to be engaged with theproximal end 106 of thecatheter 100. Theproximal end 106 can be configured to include a Luer taper that allows theproximal end 106 to engage thestylet knob 702 of thestylet 700. Other coupling arrangements, such as a threaded engagement, for example, can be used. - As shown in
FIG. 8 , thestylet knob 702 is coupled to theproximal end 106 of thecatheter tube 102. In this configuration, thecatheter 100 can be delivered to the desired location within theesophagus 204. At that time, thestylet knob 702 can be disengaged from theproximal end 106 to free thestylet 700 for movement. This movement can include the caregiver pushing thestylet 700 into and out of thecatheter tube 102 to generally disrupt theblockage 202 and/or removal of thestylet 700 completely from thecatheter tube 102. - When the
stylet 700 is removed from thecatheter tube 102, thevacuum line 220 can be connected to theproximal end 106 of thecatheter tube 102 for suctioning, as described previously. - In this example shown in
FIG. 8 , thecatheter tube 102 is approximately 80.5 inches in length and thestylet 700 is approximately 84 inches in length, although many different lengths can be provided such as, for example, shorter lengths for children and longer lengths for adults or to accommodate different length endoscopes, bronchoscopes or colonoscopes. Theexample catheter tube 102 has an outer diameter of 0.135 inches and an inner diameter of 0.115 inches. Thestylet 700 has an outer diameter of 0.105 inches. Other sizes can be used. - In other embodiments, the
catheter tube 102 can be variable in length and diameter, or stated otherwise, a variety of lengths and diameters are contemplated. For example, another embodiment of thecatheter tube 102 measures 0.093 inches in outer diameter and 0.082 for the inner diameter, allowing for easy introduction and sliding within the working channel of any of a variety of endoscopes. Thecatheter tube 102 is long enough to extend through an endoscope. In some embodiments, thecatheter tube 102 is at least 120 cm in length, but it can be longer in other embodiments. - The
stylet 700 can vary in diameter, but in the preferred embodiment measures 0.070 inches in outer diameter to allow easy introduction and sliding within thecatheter tube 102, and is slightly longer than thecatheter tube 102 to allow thestylet 700 to extend beyond thedistal end 104 of thecatheter tube 102 to clear thecatheter tube 102 and extend further into theblockage 202, if desired. - The
catheter tube 102 can be made from a thin-walled extruded tube sized to fit the working channel (e.g., biopsy channel) of any commercially available endoscope. One example material is PEBAX® 7233 SA, available from Arkema, or any other suitable thermoplastic elastomer. Another possible material is an extrusion grade of PETG (glycol-modified polyethylene terephthalate). Other suitable materials include polyamide or extrusion grade Nylon or DELRIN® (acetal homopolymer resin, an engineering thermoplastic, available from DuPont), such as Nylon 10 or Nylon 12. - The
stylet 700 could be made of the same or similar material. For example, thecatheter tube 102 and thestylet 700 can be made of the same material to allow thestylet 700 to fit within thecatheter tube 102 while minimizing friction. However, other materials and different materials for each can be used. - The above materials would clear food, but would not seriously damage the walls of the esophagus should they inadvertently contact the walls of the esophagus.
- Referring now to
FIGS. 9-17 , anotherexample device 900 is shown. Thedevice 900 includes thecatheter tube 102 with asuction port 902 at theproximal end 106 and with thedistal end 104 that is designed (e.g., beveled) to be advanced through the biopsy channel of any commercial endoscope and that can accommodate thestylet 700 to clear any food that may stick in thecatheter tube 102 after removal from the esophagus. - As shown in
FIG. 9 , thecatheter tube 102 is designed to fit through the biopsy channel of an endoscope positioned within the esophagus to reach a food blockage, but can also be advanced adjacent to an endoscope and can also be advanced orally without the aid of an endoscope. Thecatheter tube 102 is also bendable and maneuverable as the endoscope bends and maneuvers, yet is rigid enough to withstand kinking. Thecatheter tube 102 is also sufficiently rigid to withstand suction forces that are sufficient to remove cored portions of a food or other blockage through the lumen of thecatheter tube 102. - In this example (see
FIGS. 9 and 15 ), there is a Y-fitting 904 wherein onearm 906 of the Y is attached to and forms thesuction port 902, and anotherarm 908 of the Y accommodates thestylet 700. - There is also a
compression seal 910, or rubber stopper, at the proximal end of thearm 908 that accommodates thestylet 700, so that any air escaping the proximal end—or entering through the proximal end—is minimized when thestylet 700 is in thecatheter tube 102, so that suction and stylet clearance of the vacuum tube can occur simultaneously. When thecompression seal 910 is loosened, thestylet 700 can be easily advanced into and out of thecatheter tube 102 using ahandle 912 of thestylet 700. Thecompression seal 910 can also secure thestylet 700 in any location along the shaft of thecatheter tube 102. - In this example, a
cap 914 is threaded onto theproximal end 916 of thearm 908 to retain thecompression seal 910 in place. Upon removal of thestylet 700 from thecatheter tube 102, thecompression seal 910 is configured, in some embodiments, to close theproximal end 916 so that suction can be performed through thecatheter tube 102 and thesuction port 902. - In the example shown, the
catheter tube 102 can work with thestylet 700 completely removed; thestylet 700 can also be introduced as needed, and advanced any distance in thecatheter tube 102. - As with previous embodiments, the
distal end 104 of thecatheter tube 102 can disrupt food, core food, shave food and suction food. Thecatheter tube 102 wall could be thin and rigid to better accommodate a larger lumen of the tube. Thestylet 700 can help support thecatheter tube 102 to help prevent kinking, in some embodiments. Thus, in some instances, thestylet 700 can both help clear the suction tube and act as a stylet to stiffen thecatheter tube 102. - Many alternative designs are possible. For example, in another design shown in
FIGS. 18-19 , astylet 1800 could have aspline shape 1802 withsplines 1804 formed along the stylet to better accommodate suction when the stylet in is the catheter tube. In other words,spaces 1806 are formed between thesplines 1804 to allow suction to be provided through thecatheter tube 102 even with thestylet 1800 in place within thecatheter tube 102. Other configurations are possible. - Referring now to
FIGS. 20-21 , another example of astylet 2000 is shown. In this example, thestylet 2000 is awire 2002 with apiston 2004 positioned at anend 2006 thereof. Thepiston 2004 can be automatically (and/or manually) actuated intermittently or at regularly intervals (such as by a motor) to drive thestylet 2000 through thecatheter tube 102 to engage the blockage in the esophagus. Other configurations are possible. - Referring now to
FIGS. 22-24 , anotherexample device 2200 is shown. Thedevice 2200 is similar to the embodiment ofFIGS. 20-21 , except that thedevice 2200 does not necessarily need suction. Instead, thedevice 2200 includes ahandle 2202 and atube 2204. Thehandle 2202 includes anactuator member 2206 that can be moved (e.g., by the caregiver's finger or thumb) in adirection 2208 in or out. - The
actuator member 2206 is coupled to awire 2210 that runs through thetube 2204 to anejector piston 2402. Theejector piston 2402 is positioned within acavity 2404 formed in adistal end 2406 of thetube 2204. Thedistal end 2406 of thetube 2204 forms anopening 2408 sized to core or otherwise carve the obstruction as the caregiver moves thehandle 2202 and thetube 2204 attached thereto. This is accomplished, for example, by the pieces of the obstruction being carved by thedistal end 2406 of thetube 2204 and received in thecavity 2404. - As the
cavity 2404 is filled, the caregiver can move theactuator member 2206 to cause theejector piston 2402 to be moved by thewire 2210 through thecavity 2404 towards thedistal end 2406 of thetube 2204 to eject food out of theopening 2408. This process can be done multiple times until the obstruction is cleared. Theactuator member 2206 can be biased to return to the retracted position and/or simply be moved in theopposite direction 2208 by the caregiver's finger to return theejector piston 2402 to the retracted position. - In some examples, the
distal end 2406 of thetube 2204 can be configured to more easily core the obstruction. For example, the distal end can be thinned or serrated so as to be sharper. In other examples, additional features, such as a stainless steel tip, can be added to thedistal end 2406 of this (or any other embodiment disclosed herein) to enhance the coring impact of thedevice 2200. - In some examples, the inner surface of the tubes can be configured to more easily allow cores of the obstruction to pass therethrough. For example, the inner surface of a tube can be coated with a low friction or lubricious material to encourage passage and discourage clumping of the cores. Examples of such low friction materials include, without limitation, polyvinyl pyrrolidone and hyaluronic acid. Such materials can be typically bonded using heat or ultraviolet light. The external surface of the
catheter 102 can optionally also be coated with low friction materials to enable passage through the endoscope. Other mechanisms, such as differing tapers and/or channeling of the inner surface, can also be used. - Further embodiments of blockage clearing systems are disclosed hereafter. The systems can resemble systems described above in certain respects. Specific features of these further systems may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments herein (whether discussed above or below) and/or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the following systems. Any suitable combination of the features and variations of the same described with respect to any of the systems and their components can be employed with any of the remaining systems and their components, and vice versa. Moreover, with respect to certain embodiments described hereafter, similar components among various embodiments may be identified with similar numbering, wherein the initial numerals may be incremented in subsequently disclosed embodiments.
-
FIG. 25 depicts an exploded view of an embodiment of ablockage clearing system 3000 that includes asheath assembly 3002 and acatheter assembly 3004. Thesheath assembly 3002 is configured to be coupled with thecatheter assembly 3004 during use, as further discussed below. Moreover, thecatheter assembly 3004 is configured to be coupled with asuction system 3006 during use. - The
sheath assembly 3002 extends between aproximal end 3010 that is configured to remain outside of the patient during use and adistal end 3012 that is configured for insertion into the esophagus of a patient. The illustratedsheath assembly 3002 includes ahub 3014, asheath 3016, and apositioning element 3018. As further discussed below, thehub 3014 of thesheath assembly 3002 can be configured to direct acatheter 3026 of thecatheter assembly 3004 into a lumen of thesheath 3016. Thecatheter 3026 may also be referred to as a catheter tube, or more generally, as a tube, cannula, cutting member, cutting-and-suction member, or coring member. In further instances, thecatheter 3026 may be referred to as an aspiration catheter, aspiration cannula, or aspiration tube. - At least a proximal portion of the
sheath 3016 may define a preformedcurve region 3017. In some embodiments, thecurved region 3017 is sized and oriented to facilitate introduction of thesheath 3016 into the esophagus of a patient. Thecurved region 3017 may additionally or alternatively enhance the patient's comfort during use of thesheath 3016, such as when thecurved portion 3017 extends through the mouth, against or adjacent to the soft palate, and through the hypopharynx. Thecurved portion 3017 may be pre-formed to correspond to a natural curvature of a patient's anatomy. In some embodiments, differentsized sheath assemblies 3002 may be used for different sized patients to adjust to their differently sized anatomies, which may enhance comfort of the patients. In other embodiments, thecurved region 3017 may be sufficiently flexible to adjust to different patient anatomies. A variety of configurations and alterations are contemplated. For example, in other embodiments, thesheath 3016 may be devoid of acurved region 3017. As can be appreciated from the foregoing, in such embodiments that lack a pre-formedcurved region 3016, thesheath 3016 may be substantially linear prior to insertion into the patient, and can be sufficiently flexible to follow, deflect, adjust, and/or conform to a curvature of the patient's anatomy as thesheath 3016 is advanced through the mouth, against or adjacent to the soft palate, and through the hypopharynx of the patient. In other or further embodiments, thesheath 3016 may be advanced through the nose and through at least a portion of the upper respiratory tract and into the esophagus of the patient. - As further discussed below, the
positioning element 3018 can assist in centering or otherwise positioning adistal tip 3023 of thecatheter 3026 relative to the esophagus to prevent thedistal tip 3023 from contacting or damaging the esophagus. In the illustrated embodiment, thepositioning element 3018 is formed as aninflatable balloon 3019. Other or further varieties ofpositioning elements 3018 are also contemplated, illustrative examples of which are discussed further below. In various embodiments, thepositioning element 3018 may also or instead be referred to as a centering element, anchoring element, contact element, expansion element, spacing element, and/or as a centering, anchoring, contact, expansion, and/or spacing member. - With continued reference to
FIG. 25 , thecatheter assembly 3004 extends between aproximal end 3020 that is configured to remain outside of the patient during use and adistal end 3022 that is configured for insertion into the esophagus of a patient. As further discussed below, thedistal end 3022 of thecatheter 3026 can include adistal tip 3023 that is capable of coring an impacted food bolus. Thedistal tip 3023 may be sharp, and may be referred to as one or more of a cutting tip or a coring tip. In some embodiments, thedistal tip 3023 can cut into the food bolus on its own and/or in combination with suction provided by thesuction system 3006. In further embodiments, thedistal tip 3023 can cooperate with the suction provided by thesuction system 3006 to core the food bolus, e.g., as the suction tears from the food bolus a morsel that has been cut by thedistal tip 3023. - The illustrated
catheter assembly 3004 includes ahub 3024 attached to a proximal end of thecatheter 3026. As further discussed below, thecatheter hub 3024 can be configured to selectively couple with thesuction system 3006. In the illustrated embodiment, thecatheter hub 3024 includes aconnector 3028 for establishing a fluid connection to thesuction system 3006. In the illustrated embodiment, theconnector 3028 is formed as a Christmas tree fitting orconnector 3029. Any other suitable connection interface is contemplated. For example, theconnector 3028 may instead define a substantially smooth outer surface, such as a smooth conical surface similar to that of the connector at theproximal end 106 of thecatheter assembly 100 depicted inFIG. 1 , rather than a ribbed outer surface of multiple stacked conical surfaces, such as depicted inFIGS. 25 and 29 . - In the illustrated embodiment, the
catheter hub 3024 includes ahandle 3040 and asuction port 3042 positioned thereon. Thehandle 3040 can be of any suitable configuration. In many embodiments, thehandle 3040 is sized and shaped to rest or be gripped comfortably within a single hand of a practitioner. For example, in some embodiments, thehandle 3040 can be gripped with four fingers of a hand of a practitioner, and theport 3042 can be operated with the thumb of the same hand of the practitioner. In some embodiments, theport 3042 can be left open to prevent suction from being applied, or to significantly reduce an amount of suction being applied, through thecatheter 3026. Conversely, theport 3042 can be closed, such as by placing a thumb or other finger thereon, to permit or increase an amount of suction to be applied through thecatheter 3026. In other embodiments, such as in thecatheter assembly 100 discussed above, thehandle 3040 can be devoid of asuction port 3042. In such embodiments, suction through thecatheter assembly 3004 can be continuous when theconnector 3028 is coupled with thesuction system 3006. - In the illustrated embodiment, the
suction system 3006 includes asuction tube 3044, a container orsuction trap 3046, and a suction, aspiration, orvacuum source 3048. Thesuction tube 3044 may be of any suitable variety, and may be configured to couple with theconnector 3028 of thecatheter assembly 3004. For example, in some embodiments, thesuction tube 3044 may include asuction fitting 3045, such as the suction fitting 221 discussed above. Thesuction trap 3046 can be configured to permit air to pass through, but may be configured to retain therein pieces of a food bolus that are removed from a patient via thesystem 3000. Thesuction trap 3046 may include any suitable filters or other arrangements, including those known in the art or those yet to be devised. For example, thesuction trap 3046 can comprise a collection cannister, such as thecollection cannister 222 disclosed above. Thevacuum source 3048 may be of any suitable variety. For example, in some embodiments, thevacuum source 3048 can be a dedicated vacuum line or vacuum system of a hospital. - With reference to
FIG. 26 , theproximal end 3010 of thesheath assembly 3002 is shown in greater detail and from a viewpoint that is rotated 90 degrees about a vertical axis relative to the view ofFIG. 25 . In the illustrated embodiment, thesheath hub 3014 includes ahousing element 3050 that defines an entry passage orguide 3052. In the illustrated embodiment, theguide 3052 is substantially funnel shaped, which can facilitate insertion of thedistal end 3022 of thecatheter 3026 into alumen 3054 of thesheath 3016. - The
sheath hub 3014 further includes anactuator 3060 via which thepositioning element 3018 can be deployed. In particular, in the illustrated embodiment, theactuator 3060 is configured as aninflation port 3060 via which theballoon 3019 can be selectively inflated or deflated. Stated otherwise theactuator 3060 is communicatively coupled with theballoon 3019, and, in this instances, the communication comprises fluid communication. The illustratedinflation port 3060 includes aconnector 3062, such as a Luer fitting 3063, via which any suitable inflation device can be connected thereto. In various embodiments, the inflation device can be an air-, gas- liquid-, or other fluid-filled syringe or other medical fluid delivery device. In various embodiments, saline, air, nitrogen, or any other suitable fluid may be used to inflate theballoon 3019. In some embodiments, the inflation device may have its own pressure controls, such as to ensure that the fluid is delivered to theballoon 3019 within an acceptable range, or stated otherwise, does not exceed a predetermined limit. Any suitable inflation device, including any known in the art or any yet to be devised, is contemplated. - The
sheath hub 3014 can further include astopcock 3064 that can be selectively opened and closed via a handle orlever 3065. Thestopcock 3064 can be opened to permit inflation or deployment of theballoon 3019, and can be closed maintain theballoon 3019 in an inflated or deployed state. In particular, thestopcock 3064 can be in an open configuration to permit passage of inflation fluid therethrough for inflation of theballoon 3019, and once theballoon 3019 has been filled to a desired amount and/or the fluid pressurized to a desired or predetermined level, thestopcock 3064 can be closed to prevent passage of the fluid back through the stopcock and thus maintain theballoon 3019 in a filled, inflated, and/or pressurized state. - The
inflation port 3060 can be in fluid communication with aninflation lumen 3066, which may also be referred to as an inflation passageway, channel, etc. Stated otherwise, and is apparent from at least the foregoing, theconnector 3062 is in fluid communication with thestopcock 3064, and thestopcock 3064 is in fluid communication with theinflation lumen 3066. When thestopcock 3064 is in the open state, theconnector 3062 is in fluid communication with theinflation lumen 3066, and when thestopcock 3064 is in the closed state, theconnector 3062 no longer fluidly communicates with theinflation lumen 3066. Thestopcock 3064 may be said to be in line with, between, or fluidly coupled with theconnector 3062 and theinflation lumen 3066. In the illustrated embodiment, thehousing 3050 defines a proximal end of theinflation lumen 3066, and theinflation lumen 3066 extends through a sidewall of thesheath 3016. As shown inFIG. 26 , anextender 3067 of any suitable variety may extend between thehousing 3050 and thestopcock 3064 to establish fluid communication between theinflation port 3060 and theinflation lumen 3066. For example, theextender 3067 can comprise tubing (e.g., flexible tubing) of any suitable variety. - The
extender 3067 may alternatively be referred to as an extension line. Further, theextender 3067 and the inflation port oractuator 3060 may be referred to, collectively, as an actuation branch 3068 of thesheath assembly 3002. - With reference to
FIG. 27 , theinflation lumen 3066 and theinstrument delivery lumen 3054 of thesheath 3016 are shown in greater detail. Any suitable arrangement of thelumens inflation lumen 3066 may be present. For example, in some embodiments, one or more additional inflation lumens may be present in thesheath 3016 for redundancy in the event that one of the lumens is inadvertently blocked, such as due to kinking of thesheath 3016. Thesheath 3016 may generally be referred to as a tubular member that defines a channel through which thecatheter 3026 can be advanced. In particular, thesheath 3016 defines the working channel orlumen 3054. - In various embodiments, the
sheath 3016 may be formed of a material and/or a thickness of the sidewall may be sufficient to provide thesheath 3016 with desirable amounts of columnar or other strength. For example, in various embodiments, thesheath 3016 can resist compression, crushing, kinking, and/or other deformation that could undesirably alter the shape of thelumen 3054 in a manner that could interfere with insertion therein and/or removal therefrom of thecatheter 3026. As previously noted, the material may also be flexible so as to permit thesheath 3016 to conform to the anatomy of a patient. For example, the material may be sufficiently flexible to permit thesheath 3016 to be bent from a substantially linear arrangement to a curved arrangement as thesheath 3016 is inserted through the mouth of the patient into the esophagus, all while maintaining thelumen 3054 sufficiently patent to permit ready passage therethrough of thecatheter 3026. Various suitable materials for a catheter are disclosed above, and in many instances, these and/or other suitable materials for the sheath are contemplated. For example, in various embodiments, thesheath 3016 comprises any suitable thermoplastic elastomer, such as any suitable variety of PEBAX®, available from Arkema. Moreover, in some embodiments, a lubricious layer or coating may be provided at the inner surface of thesheath 3016, which could facilitate insertion of thecatheter 3026 into thelumen 3054 and/or removal of thecatheter 3026 from thelumen 3054. - Any suitable size of the
sheath 3016 for insertion into the esophagus is contemplated. For example, in various embodiments, the sheath 3016 (i.e., the outer diameter thereof) can be no larger than 7, 10, 15, 20, 25, or 30 French. In some embodiments, thesheath 3016 is between 7 and 30 French, between 7 and 25 French, between 7 and 20 French, or between 7 and 15 French. In some embodiments, thelumen 3054 is sized to receive acatheter 3026 that is only slightly smaller, which can allow a lumen of thecatheter 3026 to be relatively large and permit ready passage therethrough of cored pieces of blockage material (e.g., food). For example, in some embodiments, thesheath 3016 is 12 French, which can be fairly easy for many patients to swallow, and thecatheter 3026 can be as large as 10 or 11 French. In various embodiments, thecatheter 3026 can be no less than 4, 6, 8, 10, or 12 French, or may be between 4 and 12 French. -
FIG. 28A depicts thedistal end 3012 of thesheath assembly 3002 when thepositioning element 3018 is in the undeployed state. As can be seen, theballoon 3019 can define an outer diameter that may be only slightly greater than an outer diameter of more proximal portions of thesheath 3016 when in the undeployed state. In other embodiments, the outer diameter of theundeployed balloon 3019 may be the same as or slightly smaller than that of an adjacent portion of thesheath 3016. In the illustrated embodiment, theinstrument delivery lumen 3054 extends through an axial center of theballoon 3019. Stated otherwise, theballoon 3019 encompasses a longitudinal axis of thesheath 3016. -
FIG. 28B depicts thedistal end 3012 of thesheath assembly 3002 when thepositioning element 3018 has been transitioned to the deployed state, such as by introduction of an inflation fluid into theballoon 3019 via the inflation channel or inflation lumen 3066 (seeFIG. 27 ). For example, as is clear from the foregoing disclosure, the inflation fluid can be introduced into theballoon 3019 by coupling a fluid-filled syringe or other medical fluid delivery device with theconnector 3062, ensuring that thestopcock 3064 is in the opened state, and delivering fluid from the medical fluid delivery device through theconnector 3062, through thestopcock 3064, through theinflation lumen 3066, and into theballoon 3019. Moreover, theballoon 3019 can be maintained in the deployed state by closing thestopcock 3064. As can be seen inFIG. 28B , theballoon 3019 can define an outer diameter that is significantly greater than an outer diameter of more proximal portions of thesheath 3016 when in the deployed state. - In certain embodiments, the
balloon 3019 can be rotationally symmetrical when inflated. In further instances, theballoon 3019 can be configured to be rotationally symmetrical throughout inflation. Certain of such arrangements can substantially center thelumen 3054 relative to the esophagus. Theinflated balloon 3019 also can anchor thelumen 3054 relative to the esophagus, or stated otherwise, theinflated balloon 3019 can stabilize thelumen 3054 relative to the esophagus to ensure thecatheter tip 3023 does not come into contact with the esophageal wall. In certain embodiments, such an arrangement can ensure that thedistal tip 3023 of thecatheter 3026 does not come into contact with, or otherwise remains distanced from, the esophageal wall when thedistal tip 3023 is advanced past the distal tip of thesheath 3016. Other arrangements are also contemplated. For example, in some embodiments, thelumen 3054 may not be centered relative to the esophagus. For example, in some embodiments, thepositioning element 3018 may anchor thesheath 3016 such that a longitudinal axis thereof runs parallel to a central longitudinal axis of the esophagus. However, it may be desirable for thelumen 3054 to be centered relative to the esophagus to minimize the chances of contacting the esophagus wall with thedistal tip 3023 of thecatheter 3026 in any or all radial directions. - In some embodiments, the
balloon 3019 is semi-compliant or non-compliant. For example, theballoon 3019 may expand to a predetermined size via application of a first amount of pressure therein, and thereafter may either expand only minimally or not at all upon further addition of pressure therein. In other or further embodiments, a portion of theballoon 3019 may be semi-compliant or non-compliant and another portion thereof can be compliant. For example, in some embodiments, a central portion of theballoon 3019 can be semi-compliant or non-compliant and one or more of a proximal or distal end of the balloon may be compliant. When theballoon 3019 is inflated to a predetermined pressure, the semi- or non-compliant portion defines a predetermined diameter, and if further pressure is applied, the proximal and/or distal ends may expand (e.g., longitudinally) to preserve the predetermined diameter of the balloon. Any suitable configuration of theballoon 3019 is contemplated. In some instances, it can be desirable for theballoon 3019 to not expand to a circumference or diameter that would damage the esophagus of the patient. On the other hand, it can be desirable for the balloon to expand by a sufficient amount to securely position the cuttingdistal tip 3023 of thecatheter 3026 away from the esophageal wall. In some instances, the balloon can press against the esophageal wall around a full periphery of the balloon and/or around a full periphery of the inner surface of the esophageal wall. -
FIG. 29 depicts theproximal end 3020 of thecatheter assembly 3004 in greater detail than is shown inFIG. 25 . As previously discussed, thecatheter hub 3024 includes ahandle 3040 and asuction port 3042. In the illustrated embodiment, thesuction connector 3028 is positioned at a proximal end of thehandle 3040. Other positions for thesuction connector 3028 are contemplated. -
FIG. 30 is a cross-sectional view of thecatheter 3026. In the illustrated embodiment, thecatheter 3026 includes abody 3070 and alubricious layer 3072 at an internal surface thereof. Thelubricious layer 3072 can define alumen 3074 through which morsels of food that are removed from an impacted food bolus can pass. - The
body 3070 can be formed of a material and/or can have a sidewall thickness that is sufficient to provide thecatheter 3026 with desirable amounts of columnar or other strength. For example, in various embodiments, thecatheter 3026 can resist compression, crushing, kinking, and/or other deformation that could undesirably alter the shape of thelumen 3074 in a manner that could interfere with passage therethrough of food morsels. Various suitable materials for thecatheter 3026 are disclosed above. These and or other suitable materials are contemplated. For example, in some embodiments, the material comprises a relatively hard durometer. In other or further embodiments, the material may comprise a braided configuration. In some embodiments, thecatheter 3026 may be more compliant than thesheath 3016. For example, in some embodiments, thesheath 3016 can protect thecatheter 3026 from kinking or other undesired deformation. In some embodiments, thebody 3070 can maintain its shape when significant suction forces are present within thelumen 3074. - The
lubricious layer 3072 can be formed of any suitable material, and may have a low coefficient of friction or exhibit other physical properties that permit food morsels to pass readily by without sticking, adhering, or otherwise being stopped. In various embodiments, thelubricious layer 3072 can include one or more of PTFE or HDPE. In other embodiments, thelubricious layer 3072 may be omitted. For example, in some embodiments, thelumen 3074 is sufficiently large to reduce the chances of food morsels being stuck thereto during use. Stated otherwise, thelumen 3074 is sufficiently large to inhibit the food morsels from being stuck thereto during use. - In certain embodiments, an outer diameter of the
body 3070 is sufficiently smaller than an inner diameter of thesheath 3016 to permit thebody 3070 to readily pass through thesheath 3016. In some embodiments, the outer and inner diameters are sufficiently similar, however, such that thesheath 3016 can significantly limit lateral movement of thecatheter 3026. -
FIG. 31 depicts thedistal end 3022 of thecatheter assembly 3020 in greater detail than is shown inFIG. 25 . In the illustrated embodiment, an inner diameter of thelumen 3074 is substantially constant along a full length of thecatheter 3026. In other embodiments, such as those described in detail above, a diameter of thecatheter 3026 may be narrower near thedistal tip 3023 than it is along a proximal length thereof. An enlarged diameter along the proximal length may facilitate suctioning of food morsels through thecatheter 3026 after those morsels are cored from the food bolus via thetip 3023. - In the illustrated embodiment, the
distal tip 3023 defines a sharp edge. The edge is formed in part by aback bevel 3076 at an outer surface of thecatheter 3026. Other cutting arrangements are contemplated, including those discussed further below. -
FIG. 32A is an early stage in an illustrative method of using thesystem 3000. In the illustrated stage, thedistal end 3012 of thesheath assembly 3002 is inserted into theesophagus 3090 of a patient. For example, thedistal end 3012 of thesheath assembly 3002 can be inserted through the mouth of the patient and into the esophagus, as disclosed elsewhere herein. The distal tip of thesheath 3016 is advanced toward aforeign body 3092 that is lodged in theesophagus 3090. In the illustrated method, theforeign body 3092 is an impacted bolus of food, and will be referred to as such hereafter. -
FIG. 32B is a subsequent stage in the illustrative method. In the illustrated stage, thesheath 3016 has been advanced distally a sufficient distance to bring the distal tip of thesheath assembly 3002 into contact with aproximal end 3098 of thefood bolus 3092. In some instances, the procedure is performed blind. As apparent from the present disclosure, performing a procedure “blind” means that the procedure is not visualized, such as via a camera of an endoscope, under fluoroscopy, etc. The practitioner may be able to discern this contact with thefood bolus 3092 via tactile feedback. For example, the practitioner can sense that thefood bolus 3092 has been reached by a sudden increase in resistance to distal advancement of thesheath 3016. -
FIG. 32C is a subsequent stage in the illustrative method. In the illustrated stage, thepositioning element 3018 is deployed into contact with theesophagus 3090. For example, as apparent from other disclosures herein, an inflation device (e.g., a syringe) can be coupled with theinflation port 3060 and, with thestopcock 3064 in the open state, an inflation fluid (e.g., air) can be delivered from the inflation device into theballoon 3019 to deploy theballoon 3019. Once theballoon 3019 has been deployed, thestopcock 3064 can be closed to maintain theballoon 3019 in the deployed state. In the illustrated embodiment, thepositioning element 3018, orballoon 3019, substantially centers thelumen 3054 relative to theesophagus 3090. -
FIG. 32D is a subsequent stage in the illustrative method in which thedistal tip 3023 of thecatheter 3026 is advanced through thesheath 3016 and brought into contact with theproximal end 3098 of thefood bolus 3092. In some instances, suction may be applied via thecatheter 3026 throughout advancement of thecatheter 3026 toward thefood bolus 3092. In other instances, the practitioner may utilize tactile feedback to determine that contact has been made with thefood bolus 3092, and may then instigate suction. The suction can draw a portion of thefood bolus 3092 into thelumen 3074 -
FIG. 32E is a subsequent stage in the illustrative method in which a morsel offood 3094 from thefood bolus 3092 is cut, or cored, by thedistal tip 3023 of thecatheter 3026 and is drawn into thelumen 3074 of thecatheter 3026. In some embodiments, thecatheter 3026 defines a length that is only slightly longer than a length of thesheath 3016. This maximum advanced length of thecatheter 3026 may be delimited to reduce the chances of thedistal tip 3023 coming into contact with the esophageal wall. In various embodiments, thedistal tip 3023 is limited from moving past the distal tip of thesheath 3016 by a distance of no greater than 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, or 2.0 inches. Stated otherwise, movement of thecatheter 3026 relative to thesheath 3016 is delimited to inhibit the distal tip of thecatheter 3026 from coming into contact with the esophageal wall when the distal end of thecatheter 3026 is extended to its distalmost orientation relative to thesheath 3016. - In view of at least the foregoing disclosure and the drawings, it is apparent that delimitation of the maximum advanced length can be due to interaction of the
proximal end 3020 of thecatheter assembly 3004 and theproximal end 3010 of thesheath assembly 3002. For example, in the illustrated embodiment, the distal end of thecatheter 3026 is attached to thecatheter hub 3024, which defines an enlarged diameter, as compared with a diameter of thecatheter 3026, at the distal end of thecatheter hub 3024. Thecatheter hub 3024 can interact with thesheath hub 3014 to delimit the maximum advanced length to which thecatheter 3026 can extend past the distal end of thesheath 3016. In particular, thecatheter 3026 of thecatheter assembly 3004 can be advanced distally through theguide 3052 of thesheath hub 3014 of thesheath assembly 3002, whereas the distal face of thecatheter hub 3024 can interfere with a proximal face of thesheath hub 3014 or with the tapered surface of theguide 3052 to delimit the distal movement of thecatheter 3026. - More generally, the
catheter assembly 3004 can define a stopping region 3047 (seeFIG. 29 ) having an enlarged diameter, relative to a diameter of a working length of thecatheter 3026. This stoppingregion 3047 can, for example, be defined at least in part by thecatheter hub 3024. In the illustrated embodiment, the stoppingregion 3047 is defined entirely by a distal end of thecatheter hub 3024. The stoppingregion 3047 can interfere with a portion of thesheath hub 3014 to delimit distal movement of thecatheter 3026. In the illustrated embodiment, the portion of thesheath hub 3014 with which the stopping region 3047 (e.g., the distal end of the catheter hub 3014) can interfere is the proximal face of thesheath hub 3014 or a proximal end of theguide 3052. -
FIG. 32F is a subsequent stage in the illustrative method in which the morsel offood 3094 has detached from thefood bolus 3092 and is suctioned through thelumen 3074 of thecatheter 3026. -
FIG. 32G is a subsequent stage in the illustrative method in which thecatheter 3026 is withdrawn from thesheath 3016. In some instances, thecatheter 3026 is only partially withdrawn into thelumen 3054 so as not to inadvertently contact the esophagus. In other instances, thecatheter 3026 may be fully withdrawn. - In some instances, a sufficient amount of material from the food bolus may have been withdrawn at this point for at least a portion of the food bolus to collapse by an amount sufficient to allow the food bolus to pass naturally into the stomach of the patient. Such passage may result in sudden relief to the patient, which can indicate that no further coring or clearing is needed. In some instances, the
sheath 3016 and thecatheter 3026 may be withdrawn together, or one after the other. - In other instances, it may be desirable to continue coring the
food bolus 3092. Accordingly, in some instances, the procedure may continue, such as by positioning thesystem 3000 more distally within theesophagus 3090. - In some instances, the
system 3000 can clear thefood bolus 3092 without passing any portion of thesystem 3000 beyond a distal end of thefood bolus 3092. In other or further instances, thesystem 3000 can clear thefood bolus 3092 without passing any portion of thesystem 3000 completely through thefood bolus 3092. -
FIG. 32H is a subsequent stage in one such further illustrative method in which further coring of the food bolus is desired. In the depicted stage, thepositioning element 3018 is returned to the undeployed configuration to permit ready movement of thesheath 3016 relative to the esophageal wall. -
FIG. 32I is a subsequent stage in the further illustrative method in which the distal end of thesheath 3016 has been advanced to a more distal position within theesophagus 3090. Theproximal end 3098 of the cored food bolus has been reshaped in the absence of the suctioned-offfood morsel 3094. -
FIG. 32J is a subsequent stage in the further illustrative method in which thepositioning element 3018 is deployed again into contact with theesophagus 3090. Such repositioning can, in certain instances, permit further coring of thefood bolus 3092 with little or no risk of the distal end of catheter coming into contact with the esophagus. -
FIG. 32K is a subsequent stage in the further illustrative method in which thedistal tip 3023 of thecatheter 3026 is again brought into contact with theproximal end 3098 of thefood bolus 3092 for further coring thereof. - When coring is completed, the
catheter 3026 can be drawn into thesheath 3016 to shield the sharpened distal end of thecatheter 3026, or may be fully withdrawn from thesheath assembly 3002. Theballoon 3019 can be deflated out of contact with the esophagus and fully or partially returned to the undeployed state. For example, thestopcock 3064 can be opened to release inflation fluid (e.g., air) from theballoon 3019. Thesheath 3016 may then be withdrawn from the patient. -
FIG. 33A is an elevation view of a distal end of another embodiment of asheath assembly 3102 that includes a differently shapedpositioning element 3118 in an undeployed state. In some embodiments, thepositioning element 3118 comprises a balloon that is compressed, folded, or otherwise formed into a low-profile arrangement such as that depicted inFIG. 33A so as to have a substantially cylindrically shaped outer surface that may be only slightly larger than a cylindrical outer surface of the sheath to which it is attached. -
FIG. 33B is another elevation view of the distal end of thesheath assembly 3102 that depicts thepositioning element 3118 in a deployed state in which thepositioning element 3118 is substantially shaped as a frustocone. Other configurations of the deployedpositioning element 3118 are contemplated. As with thepositioning element 3018 described above, in certain embodiments, thepositioning element 3118 can be radially symmetrical. -
FIGS. 34, 35A, and 35B depict various views of another embodiment of asheath assembly 3202 that includes apressure regulation valve 3211. Thepressure regulation valve 3211 can regulate a pressure within apositioning member 3218, such as aninflation balloon 3219. For example, thepressure regulation valve 3211 can ensure that a pressure within theinflation balloon 3219 does not exceed a preset maximum value. Such an arrangement may be configured to ensure that excess pressure that might injure or otherwise negatively impact the esophagus is not applied to the esophagus. As indicated inFIG. 34 , thesheath assembly 3202 can be a component in another embodiment of ablockage clearing system 3200, such as theblockage clearing system 3000 described above. - The
pressure regulation valve 3211 is depicted in fluid communication with apressurization port 3260, which may also be referred to as aninflation port 3260. Thepressure regulation valve 3211 is also depicted in fluid communication with aninflation lumen 3266. Thepressure regulation valve 3211 is operationally positioned between theinflation port 3260 and the portion of theinflation lumen 3266 that is defined by asheath 3216. Stated otherwise, thepressure regulation valve 3211 is in line withinflation port 3260 and is in line with the portion of theinflation lumen 3266 defined by thesheath 3216. In particular, in the illustrated embodiment, thepressure regulation valve 3211 is in line with each of theinflation port 3260 and theinflation lumen 3266, and further, is positioned between theinflation port 3260 and theinflation lumen 3266. Thepressure regulation valve 3211 is coupled with ahub 3214. In particular, thepressure regulation valve 3211 is coupled to thehub 3214 via anextender 3267. -
FIG. 35A depicts thepositioning element 3218 in an undeployed state.FIG. 35B depicts thepositioning element 3218 in a deployed state.FIG. 35C depicts thepositioning element 3218 in a further state of operation in which the positioning element has been maintained in the deployed state at a substantially constant pressure via thepressure regulation valve 3211, despite attempts to further pressurize the positioning element via thepressurization port 3260. -
FIG. 36 is an elevation view of a proximal end of another embodiment of acatheter assembly 3304 that, in some instances, may be used with a system such as thesystem 3000 discussed above; in other or further instances, may be used with an endoscope; or in still other instances, may be used without a sheath or endoscope. Thecatheter assembly 3304 can include ahub 3324 similar to thehub 3024 discussed above. For example, thecatheter assembly 3304 includes ahandle 3340 having a different gripping arrangement (more akin to a gun or drill) and asimilar suction port 3342. Thehub 3324 can further include an actuator orinflation port 3360, such as theinflation port 3060 discussed above with respect to thesheath assembly 3002. -
FIG. 37 is a cross-sectional view of acatheter 3326 of thecatheter assembly 3304. Thecatheter 3326 can resemble thecatheter 3026 described above in many respects, but may further include an inflation channel orinflation lumen 3366, such as the like-numberedlumen 3066 discussed above with respect to thesheath 3016. -
FIG. 38A is an elevation view of a distal end of thecatheter assembly 3304 in which apositioning element 3318 is depicted in an undeployed state. Thepositioning element 3318 can function in the same manner as other positioning elements described above, and may be in fluid communication with theinflation lumen 3366. Thepositioning element 3318 can distance adistal tip 3323 of thecatheter 3326 from the esophagus wall when deployed. For example, thepositioning element 3318 may be symmetrical and/or may center thedistal tip 3323 from the esophagus. In the illustrated embodiment, thedistal tip 3323 is positioned at a distance distally from the distal end of thepositioning element 3318. -
FIG. 38B is another elevation view of the distal end of thecatheter assembly 3304 in which thepositioning element 3318 is depicted in a deployed state, such as described with respect to various other embodiments above. -
FIG. 39A is an elevation view of a distal end of another embodiment of acatheter assembly 3404 that includes a differently shapedpositioning element 3418 that is depicted in an undeployed state.FIG. 39B is another elevation view of the distal end of thecatheter assembly 3404 that depicts thepositioning element 3418 in a deployed state. In some embodiments, thecatheter assembly 3404 is used to clear an impacted food bolus in manners such as described above, but without a sheath. In other embodiments, thecatheter assembly 3404 is used with a sheath, such as thesheath 3016, in manners such as described above. For example, both thesheath 3016 and thecatheter assembly 3404 can include inflatable positioning members that inhibit contact between the esophagus and the catheter. In still other or further embodiments, thecatheter assembly 3404 can instead be inserted into the esophagus of a patient through the working channel of an endoscope. Thepositioning element 3418 can be advanced past a distal end of the endoscope and deployed into contact with the esophagus to prevent inadvertent contact of the distal tip of the catheter to the esophageal wall. -
FIG. 40A is an elevation view of a distal end of another embodiment of acatheter assembly 3504 that includes a differently shaped and differently orientedpositioning element 3518 that is depicted in an undeployed state.FIG. 40B is another elevation view of the distal end of thecatheter assembly 3504 that depicts the positioning element in a deployed state. When deployed, thepositioning element 3518 is substantially donut-shaped. Thepositioning element 3518 is also closer to the distal end of thecatheter assembly 3504. In some embodiments, thecatheter assembly 3504 can be particularly well-suited for use with a sheath and/or an endoscope, such as, for example, those previously described. Thepositioning element 3518 may be advanced just beyond a distal tip of the sheath or endoscope before being deployed, in some instances. -
FIG. 41 is an elevation view of a distal end of another embodiment of acatheter assembly 3604 that depicts adistal tip 3623 of acatheter 3626 that includes aninternal bevel 3676. For example, theinternal bevel 3676 may be formed as a conical chamfer. -
FIGS. 42 and 43 depict a distal end of another embodiment of acatheter assembly 3704 that includes acatheter 3726 that has adistal tip 3723 that is substantially flat. Thecatheter assembly 3704 includes acutting element 3775, such as a blade, that is recessed from thedistal tip 3723 within a lumen of thecatheter 3726. Thecutting element 3775 includes acutting edge 3777, which is substantially circular in the illustrated embodiment. Thecutting element 3775 is attached to thecatheter 3726 via a plurality of brackets or supports 3779. A cutting area of thecutting edge 3777 can be smaller than an inner diameter of a lumen of thecatheter 3726. -
FIG. 44 is an elevation view of a distal end of another embodiment of acatheter assembly 3804 that depicts adistal tip 3823 of acatheter 3826 that is substantially rounded and that includes acutting element 3875 that is recessed from thedistal tip 3823 within a lumen of the catheter. Thecatheter assembly 3804 further includes a positioning element or centeringballoon 3819, which can function similarly to other embodiments described herein. The roundedtip 3823 may be substantially atraumatic to the esophagus. The recessedcutting element 3875 may further aid in preventing inadvertent damage to the esophagus. The centeringballoon 3819 may likewise prevent inadvertent damage to the esophagus when deployed. As with other embodiments described herein, thecatheter assembly 3804 may be used with or without a sheath or endoscope, in various embodiments. Catheter assemblies such as theassembly 3804 may also be referred to as catheter systems. -
FIG. 45 is an elevation view of another embodiment of ablockage clearing system 4000 that can resemble blockage clearing systems described above (e.g., thesystems 3000, 3200) in certain respects. Accordingly, like features are designated with like reference numerals, with the leading digits incremented to “40.” Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of thesystem 4000 may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and/or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of thesystem 4000 and components thereof. Any suitable combination of the features and variations of the same described with respect to thesystems system 4000, and vice versa. More generally, any suitable combination of like-numbered components herein is contemplated. Thus, for example, any of thepositioning element arrangements - The
system 4000 is shown in a pre-use, undeployed, packaged, or insertion state. In particular, thesystem 4000 is shown in a state in which it may be packaged, or stated otherwise, in a state in which it exists when removed from packaging by a user (e.g., medical practitioner) for insertion into a patient. Thesystem 4000 can include asheath assembly 4002 and acatheter assembly 4004, such as like-numbered features previously disclosed. Thesheath assembly 4002 is discussed further below with respect to at leastFIGS. 46-50 , and thecatheter assembly 4004 is discussed further below with respect to at leastFIGS. 51-53 . - The
system 4000 further includes a retainer orspacer 4080 that can maintain a fixed relative orientation of thesheath assembly 4002 and thecatheter assembly 4004. Stated otherwise, thespacer 4080 can maintain a fixed longitudinal relationship, such as a fixed longitudinal separation, between hubs of thesheath assembly 4002 and thecatheter assembly 4004. Maintenance of such a fixed relationship between the hubs can likewise maintain a fixed longitudinal relationship between the distal tips of thesheath assembly 4002 and thecatheter assembly 4004. For example, as further discussed below, thespacer 4080 can ensure that a distal tip of thecatheter assembly 4004, which may comprise a sharpened cutting tip, is positioned at an interior of the sheath assembly 4004 (e.g., is proximally recessed relative to a distal tip of the sheath assembly 4004) when thespacer 4080 is in place. Such an arrangement may be useful to ensure that the cutting surface of the catheter does not inadvertently come into contact with the anatomy of a patient as thesystem 4000 is being introduced into the patient (e.g., into the esophagus of the patient). Accordingly, in some instances, thesystem 4000 may be provided in the assembled state shown with thespacer 4080 in place. For example, thesystem 4000 may be packaged with thespacer 4080 positioned in engagement with thesheath assembly 4002 and thecatheter assembly 4004. - In the illustrated embodiment, the
spacer 4080 is formed as aclip 4082 that is selectively attachable to and detachable from specific regions of thesheath assembly 4002 and thecatheter assembly 4004. In other embodiments, theclip 4082 may only be selectively detachable from thesheath assembly 4002 and thecatheter assembly 4004. For example, in some embodiments, portions of theclip 4082 may be permanently attached to thesheath assembly 4002 and thecatheter assembly 4004, respectively, and a further portion of theclip 4082 may permanently detach from the portions that are attached to thesheath assembly 4002 and thecatheter assembly 4004 to permit relative movement of thesheath assembly 4002 and thecatheter assembly 4004. In some instances, theclip 4082 may be provided with thesystem 4000 in an initial or pre-deployment state (e.g., a packaged state), and may be used during an initial insertion of thesystem 4000 into the patient and into contact with a blockage, such as a food impaction. The detachable portion of the clip 4082 (e.g., theclip 4082 in its entirety or a detachable portion thereof) may then be removed to permit relative longitudinal movement of thesheath assembly 4002 and thecatheter assembly 4004, as discussed further below. -
FIG. 46 is an elevation view of thesheath assembly 4002 in a deployed state. As with other sheath assemblies previously discussed (e.g., thesheath assemblies 3002, 3202), thesheath assembly 4002 can include aninflation port 4060, which can include aconnector 4062, such as aluer fitting 4063. Theinflation port 4060 can further include astopcock 4064, which can be transitioned between open and closed states via a knob orlever 4065. Theinflation port 4060 can be formed of any suitable materials. For example, in some embodiments, theinflation port 4060 comprises polycarbonate. - As with other embodiments described herein, the
inflation port 4060 can be coupled with asheath hub 4014 in any suitable manner. In the illustrated embodiment, theinflation port 4060 is coupled to anextender 4067, such as tubing of any suitable construct, and theextender 4067 is coupled to thehub 4014. The extender tubing can comprise any suitable material. For example, in some embodiments, the tubing comprises TYGON®, available from Saint-Gobain Performance Plastics. Theextender 4067 can be attached to a connector portion of thestopcock 4064 in any suitable manner. - The
hub 4014 can include ahousing 4050, which is discussed further below with respect toFIGS. 47 and 48 . In some embodiments, apressure regulation valve 4011 is coupled with thehousing 4050. In particular, in the illustrated embodiment, thepressure regulation valve 4011 is directly connected to thehousing 4050. Thehub 4014 can further be coupled with asheath 4016 and astrain relief sleeve 4015. Thepressure regulation valve 4011 may also be referred to as a pressure regulator. - As with other embodiments disclosed herein, the
sheath 4016 can be coupled with apositioning element 4018, such as aninflatable balloon 4019. In some embodiments, thesheath 4016 can include a soft or atraumaticdistal tip 4013. - As with the
inflation port 3060 discussed above, theinflation port 4060 may also be referred to as an actuator. As further discussed below, theinflation port 4060 is configured to be actuated to achieve deployment of thepositioning element 4018, and can be further actuated to achieve retraction of thepositioning element 4018. - With reference again to
FIG. 45 , in some embodiments, thesheath 4016 can include one or more depth indicia orindicators 4084. Theindicators 4084 can comprise any suitable marking or other signaling element to provide a visual cue to a user to indicate a depth to which the distal tip of thesheath assembly 4002 has been inserted into a patient. For example, the one ormore indicators 4084 can be printed or may be formed as laser markings. In some embodiments, one of the indicators—for example, thedistalmost indicator 4084—may indicate a minimum depth to which the distal tip of thesheath assembly 4002 should desirably be inserted prior to deployment of thepositioning element 4018. For example, in some embodiments, theminimum depth indicator 4084 is positioned, e.g., 25 centimeters from the distal tip of thesheath 4016. A practitioner may use theminimum depth indicator 4084 to ensure that the distal tip of thesheath 4016 has been inserted to a sufficient depth past the incisors of the patient, which can ensure that thepositioning element 4018 is not deployed within the pharynx of the patient. In various embodiments, theminimum depth indicator 4084 may be closer to or further from the distal tip of thesheath 4016 than 25 centimeters. In some instances, theminimum depth indicator 4084 is selected to ensure that the pharynx of any patient, regardless of patient size or anatomy variation, will be avoided when thepositioning element 4018 is deployed. - With reference to
FIGS. 47 and 48 , thehub 4014 can include ahousing 4050, which can be formed in any suitable manner. For example, thehousing 4050 may be an injection-molded plastic component. In some embodiments, thehousing 4050 comprises polycarbonate. - The
housing 4050 can define aconnector 4055 at a proximal end thereof. For example, in some embodiments, theconnector 4055 comprises aluer fitting 4056. Theconnector 4055 can permit selective coupling with any suitable medical device to provide the medical device with access to aninstrument delivery lumen 4054 defined by the sheath 4016 (seeFIG. 49 ). For example, if a practitioner desires to flush theinstrument delivery lumen 4054 of thesheath 4016, a flushing syringe could be coupled with theconnector 4055 and fluid dispensed through theinstrument delivery lumen 4054. - The
connector 4055 portion of thehousing 4050 can define an entry passage orguide 4052. In the illustrated embodiment, theguide 4052 is substantially funnel shaped, which can facilitate insertion of a distal end of a catheter portion of thecatheter assembly 4004 into theinstrument delivery lumen 4054 of thesheath 4016. In particular, in the illustrated embodiment, theguide 4052 defines a luer taper that decreases in diameter in the distal direction. - The
housing 4050 can further define aconnector 4057, such as a flanged or ribbed post, or the like, to which theextender 4067 can be attached in any suitable manner. Similarly, thehousing 4050 can define aconnector 4058, such a flanged or ribbed post, or the like, to which thestrain relief sleeve 4015 can be attached in any suitable manner. For example, as shown inFIG. 48 , in the illustrated embodiment, theextender 4067 is fitted over theconnector 4057 and thestrain relief sleeve 4015 is fitted over theconnector 4058 to achieve said attachments. - The
housing 4050 can define asheath receptacle 4059 into which a proximal end of thesheath 4016 can be received. Thesheath 4016 can be inserted into thesheath receptacle 4059 until the proximal end contacts a ledge at the proximal end of the receptacle. The proximal end of thesheath 4016 thus may be at or slightly below a distal end of theguide 4052 when thesheath 4016 has been secured to thehousing 4050. - The
housing 4050 can further define an inflation channel orlumen 4066 a that extends through theconnector 4057 and that terminates at and is in fluid communication with thesheath receptacle 4059. Thehousing 4050 can further define an inflation channel orlumen 4066 b that extends from avalve receptacle 4069 to thelumen 4066 a. In particular, thelumen 4066 b intersects thelumen 4066 at ajunction 4061. Stated otherwise, fluid communication between thelumens junction 4061. Thelumens housing 4050. Stated otherwise, thechannels inflation lumen 4066, of which a proximal end is defined by thehousing 4050 and a distal end is defined by thesheath 4016. That is, as with other embodiments herein, and as previously noted, thesheath assembly 4002 can include multiple lumens for expanding theballoon 4019, including one or more lumens that extend through thesheath 4016. All of the lumens may be interconnected or in fluid communication with each other, and may collectively define the fluid passageway orinflation lumen 4066. - With reference to
FIG. 49 , in the illustrated embodiment, thesheath 4016 defines twoseparate inflation lumens inflation lumen 4066 a defined by thehousing 4050 at or near their proximal ends, and further, are in fluid communication with an interior of theballoon 4019 at or near their distal ends. Theinflation lumens inflation lumen 4066 of thesheath assembly 4002. As previously noted, in some embodiments, it can be advantageous for thesheath 4016 to define two or more inflation lumens, such as, for example, for purposes of redundancy in the event that one of thelumens lumen balloon 4019. - Again, as previously mentioned, the
inflation lumen 4066 can be a unitary lumen or fluid pathway or passageway that includes a plurality of interconnected lumens orbranches inflation lumens junction 4061. Further, theinflation lumens inflation lumen 4066 a at their proximal ends, and are in fluid communication with an interior of theballoon 4019 at their distal ends. In this manner, a pressure within theballoon 4019 and within any of theinflation lumens inflation lumens balloon 4019 can be pressurized substantially in unison, or may increase in pressure substantially concurrently and/or substantially at the same rate during deployment of theballoon 4019. - For example, in some instances, an air-filled syringe can be coupled with the
connector 4062. Thestopcock 4064 can be oriented in an open state (e.g., thelever 4065 can be rotated to the open state). To deploy theballoon 4019, a plunger of the syringe can be depressed. This can cause air to flow from the syringe, through thestopcock 4064, through theextender 4067, into theinflation lumen 4066 a, and from theinflation lumen 4066 a into theinflation lumen 4066 b, and further, into theinflation lumens sheath 4016 and from thence into theballoon 4019. Once air has passed into all of these cavities, pressurization in each of the branches of theinflation lumen 4066 and within theballoon 4019 can proceed substantially in unison as more air is urged from the syringe and, after full deployment of the balloon 4019 (which, in some embodiments, may be non-compliant or semi-compliant) is compressed within a fixed-volume inflation fluid receptacle defined by theinflation lumen 4066 and the expandedballoon 4019. - With reference again to
FIGS. 47 and 48 , thepressure regulation valve 4011 is attached to thehousing 4050 within thevalve receptacle 4069. In some instances, thepressure regulation valve 4011 may be secured in place via an adhesive. Thepressure regulation valve 4011 can be of any suitable variety. For example, thepressure regulation valve 4011 can comprise a check valve that is configured to permit passage therethrough of a fluid (e.g., air) at or above a cracking pressure. Any suitable commercially available or other variety of check valve is contemplated. For example, in some embodiments, a commercially available cartridge check valve or pressure relief valve is used. Thecheck valve 4011 is positioned such that anentry port thereof 4017 a is in fluid communication with theinflation channel 4066 b, and hence with theinflation channel 4066 a. More generally, theentry port 4017 a of thecheck valve 4011 is in fluid communication with the inflation passageway orinflation lumen 4066 of thesheath assembly 4002. Further, in the illustrated embodiment, thepressure regulation valve 4011 is oriented such that anexit port 4017 b thereof is in fluid communication with an environment external to thehousing 4014. Thepressure regulation valve 4011 thus can leak inflation fluid (e.g., air) to the environment when a threshold pressure—i.e., the cracking pressure—is reached or exceeded within theinflation lumen 4066 and within theballoon 4019. - Accordingly, the pressure regulation valve can regulate a pressure within the
balloon 4019. For example, thepressure regulation valve 4011 can ensure that a pressure within theinflation balloon 4019 does not exceed a preset maximum value, which corresponds with the cracking pressure of the valve. Such an arrangement may be configured to ensure that excess pressure that might injure or otherwise negatively impact the esophagus is not applied to the esophagus. - The
pressure regulation valve 4011 is depicted as being in fluid communication with the pressurization orinflation port 4060. In particular, with reference toFIGS. 46 and 48 , thepressure regulation valve 4011 is in fluid communication with the inflation lumen 4066 (FIG. 48 ), theinflation lumen 4066 is in fluid communication with the tubing 4067 (FIG. 48 ), and thetubing 4067 is in fluid communication with the inflation port 4060 (FIG. 46 ). Thepressure regulation valve 4011 is operationally positioned between theinflation port 4060 and the portion of theinflation lumen 4066 defined by the sheath 4016 (e.g., theinflation lumens FIG. 49 ). Stated otherwise, thepressure regulation valve 4011 is in line with theinflation port 4060 and is in line with the portion of theinflation lumen 4066 defined by the sheath 4016 (e.g., theinflation lumens pressure regulation valve 4011 is fluidly coupled to theinflation lumen 4066 at a position that is in line with or is between theinflation port 4060 and the portion of thelumen 4066 that is defined by the sheath 4016 (e.g., theinflation lumens - The
pressure regulation valve 4011 is coupled with thehub 4014. In particular, in the illustrated embodiment, thepressure regulation valve 4011 is directly attached to thehub 4014. - Any suitable cracking pressure of the
pressure regulation valve 4011 is contemplated. The cracking pressure may be relatively low to ensure that theballoon 4019 does not deform the esophagus, does not significantly deform the esophagus, or does not deform the esophagus beyond an acceptable amount (e.g., an amount less than that at which injury might occur). In various embodiments, the cracking pressure, which may also be referred to as the threshold pressure, is no greater than 3 psi, 4 psi, or 5 psi. In one embodiment, the cracking pressure is about 4.5 psi (e.g., may be set at 4.56 psi). In other embodiments, higher cracking pressures may be used, such as cracking pressures no greater than 6, 7, or 8 psi. - One or more of the connections previously described with respect to the
sheath assembly 4002 may be further secured with adhesive. For example, any suitable light curing adhesive is contemplated, including, without limitation, MD 204-CTH-F flexible catheter-bonding adhesive, available from Dymax. For example, adhesive may be used to bond the connections between theextender 4067 and each of thestopcock 4060 and thehousing 4050, between thesheath 4016 and thehousing 4050, between thevalve 4011 and thehousing 4050, etc. - With reference to
FIGS. 46 and 48 , thestrain relief sleeve 4015 can be positioned over a proximal portion of thesheath 4016 and over theconnector 4058 at the distal end of thehousing 4050. In some embodiments, thestrain relief sleeve 4015 may be heat shrunk in place. Any suitable material for thestrain relief sleeve 4015 is contemplated. For example, in some embodiments, thestrain relief sleeve 4015 can comprise a polyolefin. - The
strain relief sleeve 4015 can reinforce a proximal end of thesheath 4016. For example, in some instances, thestrain relief sleeve 4015 can contribute to a columnar strength of thesheath 4016 and can stiffen thesheath 4016. In some embodiments, this stiffening can facilitate insertion of thesheath 4016 into the esophagus of the patient, such as in instances where thesheath 4016 is relatively compliant. In other or further instances, thestrain relief sleeve 4015 can inhibit or prevent kinking of thesheath 4016, such as kinking that might otherwise close one or more of theinflation lumens sheath 4016 is sufficiently long to cover and reinforce regions of thesheath 4016 that may be most prone to bending or kinking, such as a region at or near theconnector 4058 and/or a region (which may be the same or a different region) at or near a portion of thesheath 4016 that undergoes maximum bending during insertion of thesheath 4016 into the esophagus, such as to conform to the anatomy between the mouth and the esophagus. - With reference to
FIG. 49 , thesheath 4016 can be formed in any suitable manner. For example, in some embodiments, thesheath 4016 comprises a tri-lumen extrusion. Thesheath 4016 can comprise any suitable material, as previously discussed. In the illustrated embodiment, thesheath 4016 comprises a thermoplastic elastomer, such as PEBAX®. For example, in some embodiments, thesheath 4016 comprises PEBAX® 5533 SA 01 MED. In other or further embodiments, thesheath 4016 can comprise nylon 12 or PEBAX® 7233. - With reference to
FIG. 50 , theatraumatic tip 4013 can be formed in any suitable manner. Thetip 4013 can be formed of a material that is softer than the remainder of thesheath 4016. For example, in some embodiments, thesheath 4016 comprises a thermoplastic elastomer, such as PEBAX®, which could be a softer version than is used for the remainder of the shaft, such as, for example, PEBAX® 3533 SA 01 MED. Any suitable manufacturing techniques for forming thetip 4013 are contemplated, such as, for example, reflowing and tipping. - With reference again to
FIGS. 47 and 48 , the proximal end of thesheath 4016 can be positioned within thereceptacle 4059 such that bothlumens inflation lumen 4066 a defined by thehousing 4050. One ormore openings 4090 can be formed through the sidewall of thesheath 4016 into thelumens inflation lumen 4066 a of the housing to fluidly couple thelumen 4066 a with thelumens more openings 4090 can be formed in any suitable manner. For example, in some instances, a fixture that includes one or more blades can retain theunfinished sheath 4016 therein and slice through a portion of the sidewall of thesheath 4016 to provide access to eachlumen lumens lumens - As previously discussed, in some embodiments, the
sheath 4016 is formed as a thin-walled triple-lumen extrusion having a cross-section such as that depicted inFIG. 49 . In some embodiments, thelumens lumens lumens lumens lumens - With reference to
FIG. 50 , one or more openings (not shown) can be formed through the sidewall of thesheath 4016 into thelumens balloon 4019. The one or more openings can be formed in manners such as discussed above with respect to the one or more openings 4090 (FIG. 48 ). Accordingly, the interior of theballoon 4019 can be in fluid communication with thelumens sheath 4016, with thelumens pressure regulation valve 4011, and with theinflation port 4060. Thestopcock 4064 of the inflation port can selectively be opened and closed to selectively establish and terminate, respectively, fluid communication between theconnector 4063 and theballoon 4019. - Accordingly, when the
stopcock 4064 is open, a fluid delivery device (e.g., an air-filled syringe) coupled with theconnector 4063 can urge fluid into theballoon 4019 to deploy theballoon 4019. The fluid can fully deploy theballoon 4019. Whether concurrently upon reaching the fully deployed state of theballoon 4019, or whether at some point thereafter due to continued addition of fluid into theballoon 4019, a pressure within theballoon 4019 can reach the threshold value. At this point, if attempts to pressurize theballoon 4019 above the threshold value, thepressure regulation valve 4011 will permit fluid to escape to the environment to maintain theballoon 4019 at the threshold value of pressure. Accordingly, thevalve 4011 can maintain theballoon 4019 in the deployed state at a substantially constant pressure, despite attempts to further pressurize theballoon 4019 via the inflation orpressurization port 4060. Thestopcock 4064 can be closed to maintain the fluid within thesheath assembly 4002 and maintain theballoon 4019 in the deployed state. - The term “fluid” can refer herein to one or more gases, one or more liquids, or a combination thereof. For example, an inflation fluid used with the
balloon 4019 can comprise one or more of air, nitrogen, water, saline solution, etc. In some embodiments, the fluid is air. - In the illustrated embodiment, the
balloon 4019 includes a proximal sleeve orextension 4019 p and a distal sleeve orextension 4019 d. Theextensions sheath 4016 in any suitable manner. For example, in some embodiments, theextensions sheath 4016 to form fluid tight seals at the proximal and distal ends of theballoon 4019. - As previously discussed, in various embodiments, the
balloon 4019 is semi-compliant or non-compliant. For example, theballoon 4019 may expand to a predetermined size via application of a first amount of pressure therein, and thereafter may either expand only minimally or not expand at all upon further addition of pressure therein. Stated otherwise, theballoon 4019 may define a preformed shape, such as the shape depicted inFIG. 50 , to which it is inflated when deployed. - For example, with reference to
FIG. 45 , during manufacture, after theballoon 4019 has been secured to thesheath 4016, theballoon 4019 may be deflated (e.g., via application of a vacuum at the inflation port 4060) or otherwise transitioned to a compressed, deflated, retracted, undeployed, wrapped, folded, or packaged state, as shown. Aprotective sleeve 4098 or other suitable cover may be placed over theballoon 4019 for packaging. When thesheath assembly 4002 is ready for use, theprotective sleeve 4098 can be removed and theballoon 4019 can be advanced to the desired position within the esophagus. Theballoon 4019 may maintain its low-profile configuration throughout insertion, such as may result from having been contained within theprotective sleeve 4098 for an extended period. - The
balloon 4019 can then be inflated into contact with the esophagus, in manners such as previously discussed. Throughout the inflation, theballoon 4019 may undergo little or no stretching. Rather, theballoon 4019 may be flexible so as to be compacted or compressed into its pre-use state, and then can be inflated to its preformed shape without, or substantially without, stretching the material of which theballoon 4019 is formed. Any suitable material is contemplated for theballoon 4019. For example, in some embodiments, theballoon 4019 comprises a thermoplastic polyurethane elastomer, such as PELLETHANE®, which is available from Lubrizol. In particular, in some embodiments, theballoon 4019 comprises PELLETHANE® having a Shore A hardness 90. Other materials are also contemplated. In some embodiments, theballoon 4019 may be more compliant and may be configured to stretch into a desired shape when a predetermined pressure is applied therein. - With reference again to
FIG. 46 , theballoon 4019 can define any suitable shape and configuration. As with other embodiments disclosed herein, the illustratedballoon 4019 is substantially cylindrical with curved edges. Theballoon 4019 defines a length LB and a width WB, which may also be referred to as the diameter of theballoon 4019. In the illustrated embodiment, the length LB is greater than the width WB. In various embodiments, the length LB is within a range of from about 1 to about 5 centimeters, from about 2 to about 4 centimeters, or from about 2.5 to about 3.5 centimeters; is no less than about 2, 2.5, 3, 3.5, 4, 4.5 or 5 centimeters; is no greater than about 2, 2.5, 3, 3.5, 4, 4.5, or 5 centimeters; or is about 2, 2.5, 3, 3.5, 4, 4.5, or 5 centimeters. In other or further embodiments, the width WB is within a range of from about 1.5 to about 3.5 centimeters or from about 2 to about 3 centimeters; is no less than about 1.5, 2, 2.5, 3, or 3.5 centimeters; is no greater than 1.5, 2, 2.5, 3, or 3.5 centimeters; or is about 1.5, 2, 2.5, 3, or 3.5 centimeters. For example, in the illustrated embodiment, the length LB is 3 centimeters and the width WB is 2.5 centimeters. - The
sheath assembly 4002 can define a total length LT between its proximal and distal tips, and can further define a working length LW, which may represent a portion of thesheath assembly 4002 that can generally be manipulated for insertion into a patient. The working length LW may, in some embodiments, desirably be sufficiently long to permit the distal,atraumatic tip 4013 to be inserted sufficiently deep into the esophagus of any of a variety of patients, including those having the largest anatomies, to be able to access a food impaction situated at or near the bottom of the esophagus. In various embodiments, the working length LW is no less than about 50, 55, 60, 65, or 70 centimeters; is no greater than about 50, 55, 60, 65, or 70 centimeters; or is about 50, 55, 60, 65, or 70 centimeters. In the illustrated embodiment, the total length LT is 64.5 centimeters and the working length LW is 60 centimeters. - As previously discussed, a variety of sizes are contemplated for the
sheath 4016. In the illustrated embodiment, thesheath 4016 is 12 French. Similarly, a variety of sizes are contemplated for theinstrument delivery lumen 4054 of thesheath 4016. In the illustrated embodiment, the minimum inner diameter of the delivery lumen 4054 (e.g., along the horizontal dimension inFIG. 49 ) is 0.133 inches. -
FIG. 51 depicts acatheter assembly 4004 that can be well suited for use with thesheath assembly 4002. Other embodiments of catheter assemblies disclosed herein are also possible. In the illustrated embodiment, thecatheter assembly 4004 includes acatheter hub 4024 that is fixedly secured to a proximal end of acatheter 4026, and is further connected to a proximal end of astrain relief sleeve 4025. - The
catheter hub 4024 includes asuction connector 4028 at a proximal end thereof. Thesuction connector 4028 can be a tapered suction fitting 4029 of any suitable variety, including those presently in use and suitable for connection to a variety of different sizes and constructions of vacuum line tubing. For example, theconnector 4028 can be configured for slip fit connection to the vacuum system of a hospital via any suitable tubing. Thehub 4024 can further include ahandle 4040, which may includegrips 4041 for increased traction. Thehub 4024 may define adistally projecting connector 4043, similar to theconnector 4058 of the sheath hub 4014 (seeFIG. 47 ), through which thecatheter 4026 is inserted for connection to an interior of thehub 4014 and over which thestrain relief sleeve 4025 is secured. - The various components of the
catheter assembly 4004 can be formed of any suitable materials. In the illustrated embodiment, thehub 4024 comprises polycarbonate and thestrain relief sleeve 4025 comprises a heat shrink polyolefin. - With reference to
FIG. 52 , thecatheter 4026 can include a lubricious inner layer 4072 of any suitable variety. In the illustrated embodiment, the layer 4072 comprises a PTFE liner. Thecatheter 4026 can further include abody 4070 that includes a braided material and a polymeric material. In particular, thebody 4070 includes abraided layer 4073 and anouter layer 4075 of polymeric material, which can extend into thebraided layer 4073. In the illustrated embodiment, thebraided layer 4073 comprises a layer of braided 304 stainless steel, and theouter layer 4075 comprises nylon 12. The illustrated embodiment also includes adistal tip 4023, which may include one or more different and/or additional materials from other portions of the catheter. For example, in the illustrated embodiment, the tip may be formed of or include polyethylene terephthalate (PET). Any other suitable composition of thecatheter 4026 is contemplated. - Standard methods may be used to manufacture the
catheter 4026. For example, thecatheter 4026 may be formed via a “stick build” in which the PTFE liner 4072 is placed over a mandrel, the stainless steel is braided over the PTFE liner 4072 to form thebraided layer 4073, a single-lumen extrusion of nylon 12 is slid over the braid, and then the materials are heated and reflowed. - With reference again to
FIG. 51 , thecatheter 4026 can include adepth indicator 4027, which can provide information regarding a position of thedistal tip 4023 of thecatheter 4026 within thesheath assembly 4002. In the illustrated embodiment, thedepth indicator 4027 comprises a transition line 4026 t between aproximal portion 4026 p and adistal portion 4026 d of thecatheter 4026. In some embodiments, the proximal anddistal portions proximal portion 4026 p is white and thedistal portion 4026 d is gray. Any other suitable indicium for thedepth indicator 4027 is contemplated. For example, in other or further embodiments, the critical depth can be identified with a printed or laser marking. In the illustrated embodiment, thecatheter 4026 can be formed in manners such as previously disclosed, but utilizing two different single-lumen extrusions of nylon 12 each having different colorants. The extrusions can be situated end-to-end over thebraided layer 4073 prior to reflowing. - The
distal portion 4026 d of thecatheter 4026 may define a retraction length LR that is slightly shorter than the total length LT of the sheath assembly 4002 (see FIG. 46). In this manner, a practitioner may have a visual cue that thedistal tip 4023 of thecatheter 4026 is safely withdrawn within an interior of thesheath 4016 when, for example, a proximal end of the graydistal portion 4026 d of thecatheter 4026 is visible outside of the proximal end of thesheath assembly 4002. It can be desirable for thedistal tip 4023 to be within thesheath 4016 prior to insertion or repositioning of thesystem 4000 into or within the patient to ensure that theatraumatic tip 4013 of thesheath 4016 is the leading tip of thesystem 4000, rather than thesharper coring tip 4023 of thecatheter 4026. In various embodiments, the retraction length LR is shorter than the total length LT of thesheath assembly 4002 by no less than about 0.4, 0.5, 0.6, 0.7, 0.8 centimeters. For example, in the illustrated embodiment, the retraction length LR is shorter than the total length LT of thesheath assembly 4002 by about 0.6 centimeters. In some instances, such an arrangement can ensure that thedistal tip 4023 of thecatheter 4026 is safely stowed in the sheath 4016 (e.g., is proximally recessed relative to the distal tip of the sheath 4016), while permitting thecatheter 4026 to support (e.g., inhibit the kinking or other undesired deformation of) nearly an entire length of thesheath 4016. - Similarly, the
proximal portion 4026 p of thecatheter 4026 and thestrain relief sleeve 4025 can define an exposed length LE of which an entirety should be visible beyond the proximal end of thesheath assembly 4002 to ensure that thedistal tip 4023 of thecatheter 4026 is safely retracted within thesheath 4016. The exposed length LE at the proximal end of thecatheter 4026 can be slightly longer than an exposable length of the distal end of thecatheter 4026 that is permitted to extend past thedistal tip 4013 of thesheath 4016 during coring and suctioning. In particular, in some embodiments, the exposed length LE at the proximal end of thecatheter 4026 is longer than the exposable length at the distal end of thecatheter 4026 by the same distance to which thedistal tip 4023 of thecatheter 4026 is retracted from thedistal tip 4013 of thesheath 4016 when the interface of the proximal anddistal portions catheter 4026 is flush with the proximal tip of thesheath assembly 4002. - As discussed elsewhere herein, in some instances, it can be desirable for the exposable length at the distal end of the
catheter 4026 to be relatively short to ensure that thedistal tip 4013 of the catheter does not inadvertently come into contact with the esophagus. For example, in various embodiments, the exposable length may be no greater than 0.75, 1.0, 1.25, 1.5, or 2.0 inches. In some embodiments, such as illustrated, the exposed length LE can include at least a portion of a length of thestrain relief sleeve 4025. In other embodiments, a proximal end of the exposed length LE terminates substantially at a proximal end of a portion of thecatheter 4026 that is not covered by thestrain relief sleeve 4025. - As with other embodiments disclosed herein, the
catheter assembly 4004 can include a stoppingregion 4047, which can interact with thesheath hub 4014 to delimit an amount of distal movement of thecatheter 4026 beyond thedistal tip 4013 of thesheath 4016. In the illustrated embodiment, the stoppingregion 4047 is the diametrically or laterally expanded region defined by theconnector 4043 portion of thecatheter hub 4024 and the expanded portion of thestrain relief sleeve 4025 that is connected thereto. The stoppingregion 4047 can interfere with a proximal end of theconnector 4055 or may enter into and interfere with a proximal portion of theguide 4052 within theconnector 4055, each of which is defined by the housing 4050 (seeFIG. 47 ), as thecatheter assembly 4004 is advanced distally through thesheath assembly 4002. - The catheter assembly can define a total length LT and a working length LW. In the illustrated embodiment, which is merely one illustrative example, the total length LT is 77.5±1 centimeters and the working length LW is 72.8±1 centimeters. The exposed length LE is 8.9±0.05 centimeters. Other dimensions are possible and are contemplated by the present disclosure.
- With reference to
FIG. 53 , an outer diameter OD of the illustratedcatheter 4026 is 0.124±0.005 inches and an inner diameter ID of thecatheter 4026 is 0.105±0.005 inches. The outer diameter OD may also be referred to as a maximum diameter of thecatheter 4026. A height HBEV of the bevel at thedistal tip 4023 is 0.025±0.005 inches. An angle α defined by the bevel, relative to an axial or longitudinal dimension of thecatheter 4026, is 20.0±0.05 degrees. Other dimensions are possible and are contemplated by the present disclosure. For example, the angle α can be greater than or less than that of the illustrated embodiment. In various embodiments, the angle α is no greater than 15, 20, 25, 30, or 35 degrees. The other dimensions may similarly be altered in other embodiments. -
FIG. 54 depicts thespacer 4080 in greater detail. As previously discussed, thespacer 4080 is configured to maintain a predetermined relative position of thesheath assembly 4002 and thecatheter assembly 4004 during insertion and/or manipulation of thesystem 4000 in the patient, such as during introduction of thesystem 4000 into the esophagus and into contact with an impacted food bolus. In particular, thespacer 4080 can be configured to maintain a relative orientation in which thedistal tip 4023 of thecatheter 4013 is retracted within theinstrument delivery lumen 4054 of thesheath 4016, or stated otherwise, is retracted relative to thedistal tip 4013 of thesheath 4016. - The illustrated spacer 4080 is an
elongated clip 4082 that includes aproximal fastener 4086 and adistal fastener 4088. Theproximal fastener 4086 is configured to selectively attach to and detach from theconnector 4043 portion of the catheter hub 4024 (seeFIGS. 45 and 51 ). Thedistal fastener 4088 is configured to selectively attach to and detach from theconnector 4055 portion of the sheath hub 4014 (seeFIGS. 45 and 47 ). Thefasteners fasteners - In some embodiments, the
spacer 4080 is attached to thesystem 4000 during manufacture and packaging of thesystem 4000. Accordingly, when a user removes thesystem 4000 from the packaging, thespacer 4080 may already be in place. In other embodiments, thespacer 4080 may come separately within the packaging, and instructions for use can indicate that the user can attach thespacer 4080 to theassemblies system 4000 into the esophagus of the patient. - In some embodiments, such as the illustrated embodiment, the
spacer 4080 can be configured to be selectively detached from theassemblies assemblies positioning element 4018 into contact with the esophageal wall and core through a portion of the blockage using thecatheter assembly 4004, such as by moving thecatheter assembly 4004 longitudinally back and forth relative to thesheath assembly 4002, whichsheath assembly 4002 remains in a substantially fixed orientation relative to the esophagus and the blockage (e.g., food impaction) during the initial phase of coring. - In some instances, after the initial coring, the user may wish to advance the
sheath assembly 4002 to a more distal position within the esophagus, such as to be able to core deeper into the blockage. Accordingly, a user may wish to contract the positioning element 4018 (e.g., deflate the balloon 4019) or otherwise transition thepositioning element 4018 to a lower profile and then move the system within the esophagus. In some instances, in order to protect the esophagus from inadvertent contact with the esophageal wall, it may be desirable for a user to reattach thespacer 4080 to the specified attachment regions of theassemblies catheter 4026 is retracted within the lumen of thesheath 4016. Thus, in some instances, instructions for use may recommend or require that a user reattach thespacer 4080 prior to any movement within the esophagus when thepositioning element 4018 is in the contracted state. - As a further example, the
spacer 4080 can be reattached prior to removal of thesystem 4000 from the esophagus. In other instances, a user may not use thespacer 4080 during retraction. In certain of such instances, the user may fully retract thecatheter assembly 4004 from the sheath assembly 4002 (e.g., pull proximally out of the sheath assembly 4002), may then subsequently contract thepositioning element 4018 to a low profile, and then may remove thesheath assembly 4002 from the esophagus. - The
system 4000 may be used in any of the manners disclosed herein, as suitable. For example, the various methods and/or portions (e.g., a subset of steps) thereof discussed with respect to, e.g., thesystems system 4000. - With reference to
FIG. 55 , any of the systems or components thereof described herein may be provided in akit 5000. In some embodiments, thekit 5000 is particularly well suited for use in an emergency room setting. Thekit 5000 may be used in blind procedures, such as those in which no direct or indirect visualization of the blockage is performed during the procedure. Accordingly, in some instances, thekit 5000 may be used by practitioners who are not specialized endoscopists, etc. - In the illustrated embodiment, the
kit 5000 includes an embodiment of thesystem 4000. Thekit 5000 can further includeinstructions 5002 for using the embodiment of thesystem 4000. For example, the instructions foruse 5002 may provide directions with respect to any of the methods or processes disclosed herein. By way of further example, the instructions foruse 5002 may recite any method and/or other portion of the present disclosure. - The
kit 5000 can further includepackaging 5004. Thesystem 4000 can be contained within thepackaging 5004, and theinstructions 5002 can be contained within, printed on, or otherwise made accessible via thepackaging 5004. - In various embodiments, the
kit 5000—and, in particular, thesystem 4000 and the instructions foruse 5002 thereof—can be approved of or authorized by a regulating body of a particular jurisdiction. For example, thekit 5000, and theinstructions 5002 for use thereof, may be approved of or authorized by the Food and Drug Administration of the United States of America and/or may comply with the regulations of other jurisdictions, such as by qualifying for CE marking in the European Union. - The
instructions 5002 can provide directions with respect to any of the methods or processes disclosed herein. That is, theinstructions 5002 can provide directions for using thesystem 4000, or components thereof, in accordance with any of the methods or processes disclosed herein. One illustrative example of a set ofinstructions 5002 for use with one embodiment of thesystem 4000 is provided below. Other instructions may include more, fewer, and/or different directions than those provided in the illustrative example, and other embodiments of thesystem 4000 may include more, fewer, and/or different features than those discussed in the instructions. - An embodiment of the
system 4000 is designed to core and aspirate food impactions. It is comprised of thesheath assembly 4002 and thecatheter assembly 4004. Thesheath assembly 4002 is a 12 Fr OD with a 0.133″ ID, 62 cm in usable length, has a soft, atraumatic tip. It is designed to connect to a standard 10 cc-20 cc syringe for inflation of theballoon 4019. Thesheath assembly 4002 uses the low-pressure balloon 4019 to stabilize and center theaspiration catheter 4026 in the esophagus. - The
catheter assembly 4004 is used through the working channel 4054 (FIG. 49 ) of thesheath assembly 4002. Thecatheter assembly 4004 has a molded tapered handle that is a slip fit connection to the vacuum system in the emergency room of a hospital. It has a beveled distal tip to aid in coring through food impactions. Thecatheter assembly 4004 extends approximately 2.00″ outside the tip of thesheath assembly 4002 during full insertion. In this example, theproximal portion 4026 p of thecatheter 4026 is colored white, and thedistal portion 4026 d is colored gray (seeFIG. 51 ). - The
system 4000 can be packaged with instructions foruse 5002, which instructions may recite some or all of the following directions. The instructions detail illustrative examples of using thesystem 4000. - The
system 4000 is indicated for removal of food blockage and impaction in the esophagus. Thesystem 4000 may desirably be used by a health care professional with adequate training in the use of the device. Thecatheter assembly 4004 moves freely through thesheath assembly 4002. Do not removesystem 4000assembly clip 4082 until thesheath assembly 4002 is in final position within the esophagus, which may also be referred to as an anchored position in which theballoon 4019 is fully deployed. Do not use if thesystem 4000 cannot be advanced to at least 25 cm past the incisors as indicated by the relevant markings. - When repositioning or withdrawing the
system 4000, always withdraw thecatheter assembly 4004 until the whiteproximal portion 4026 p of thecatheter 4026 is visible outside the sheath. This will ensure the atraumatic tip of thesheath assembly 4002 is always the leading edge during positioning. - Open the package and carefully remove
balloon protector sleeve 4098 from thesheath assembly 4002. Verify that the distal tip of the aspiration catheter is contained within the sheath and does not extend beyond the tip of the sheath. - Introduce the
system 4000, into the mouth and then advance beyond the cricopharyngeus into the esophagus. - Advance the
system 4000 at least 25 cm from the incisors. Verify the depth by the marking on the external surface of the sheath. Insertion of thesystem 4000 to a depth of less than 25 cm from the incisors could lead to inadvertent balloon inflation within the pharynx. - Advance the
system 4000 to the level of the food impaction as indicated by resistance to further passage of thesystem 4000. - Withdraw the
system 4000 approximately 1-2 cm (e.g., a short distance) from the point of contact of the food impaction. This will allow proper positioning, (i.e., centering) and inflation of the balloon. - Inflate the balloon to its full diameter by attaching a standard 10 cc or 20 cc syringe to the luer lock inflation port and injecting 20 cc's of air into the balloon. Once balloon has been inflated close the
stopcock 4064 to seal air within the system. Gently pull on the balloon sheath to confirm the balloon is fully inflated and secured within the esophagus. - Remove the
assembly clip 4082 from thesystem 4000. This will allow free movement of thecatheter assembly 4004 relative to the anchoredsheath assembly 4002. - Attach standard suction tubing of a suction system to the
catheter assembly 4004 handle by pressing tubing firmly onto the handle. Attach the suction system to the wall suction of the hospital in any suitable manner. For example, press fit tubing of the suction system over a wall-mounted nozzle in a hospital room that is connected to the hospital suction source. - Turn on the wall suction. Adjust wall suction to its highest power setting.
- The aspiration catheter, attached to suction, will then be employed to core pieces of the food impaction and suction the pieces as cored. The aspiration catheter will be advanced into the food to core pieces of food and then be withdrawn to allow suction. This process will be repetitively performed (coring and suctioning) as needed to clear the impaction. Repeat this action until food impaction is clear. The food impaction may naturally pass into the stomach once a sufficient portion thereof has been cored away.
- If necessary or desired, the sheath balloon can be deflated by opening the stopcock and pulling a vacuum on the inflation syringe and re-inflated in order to advance, withdraw or reposition the sheath to optimize clearance of the impaction.
- The aspiration catheter should be safely withdrawn into the sheath, and the balloon can be partially or completely deflated to allow free motion of the sheath, to allow advancement of the sheath into any remaining impaction to push any remaining food distally into the stomach. Advancement of the sheath should not be attempted until the aspiration catheter is contained within the confines of the sheath (e.g., the gray
distal portion 4026 d of theaspiration catheter 4026 is visible outside of sheath assembly 4002). - After the food impaction is cleared, withdraw the
catheter assembly 4004 until the graydistal portion 4026 d is visible outside thesheath assembly 4002, open the stopcock and completely deflate the balloon by pulling a vacuum on the inflation syringe. - Withdraw the
system 4000 from the esophagus. - With reference again to
FIGS. 51 and 53 , in some embodiments, thecatheter assembly 4004 is particularly well suited for use with any of a variety of standard or otherwise commercially available endoscopes. In some embodiments, thecatheter assembly 4004 may be better suited for use with such endoscopes than with certain embodiments of dedicated sheaths. For example, the catheter assemblies can be deployed through a standard working channel of an endoscope. In certain of such instances, the food bolus and progress of the procedure can be visually monitored via the endoscope by a professional during certain uses of the catheter assemblies. - In some instances, the
catheter assembly 4004 for use with an endoscope may vary from certain embodiments configured for use with asheath assembly 4002. For example, in some instances, thecatheter assembly 4004 may be devoid of adepth indicator 4027. By way of further example, rather than having differently colored proximal anddistal portions catheter 4026 may be a uniform color along a full length thereof. - In some embodiments, various dimensions of the
catheter assembly 4004 can be optimized for use with endoscopes. In some illustrative examples, the total length LT of thecatheter assembly 4004 may be relatively longer, whereas the outer diameter OD and the inner diameter ID are smaller. For example, in one illustrative example, the total length LT is 128.7±1 centimeters, the outer diameter OD is 0.107±0.005 inches and the inner diameter ID is 0.096±0.005 inches. The remaining dimensions (e.g., the bevel angle and bevel height) may be as previously identified. Other values of the various dimensions are possible and are contemplated by the present disclosure. - With reference to
FIG. 56 , any of the catheter assemblies disclosed herein may be provided in akit 6000. In certain embodiments, thekit 6000 is particularly well suited for use with a standard or otherwise commercially available endoscope. For example, thekit 6000 may be used by an endoscopist or other similarly trained practitioner. In the illustrated embodiment, thekit 6000 includes an embodiment of thecatheter assembly 4004. Thekit 6000 can further includeinstructions 6002 for using the embodiment of thecatheter assembly 4004. In particular, theinstructions 6002 can provide directions to carry out any procedure, procedural step, or other action disclosed herein. By way of further example, the instructions foruse 6002 may recite any method and/or other portion of the present disclosure - The
kit 6000 can further includepackaging 6004. Thecatheter assembly 4004 can be contained within thepackaging 6004, and theinstructions 6002 can be contained within, printed on, or otherwise made accessible via thepackaging 6004. - In various embodiments, the
kit 6000—and, in particular, thecatheter assembly 4004 and the instructions foruse 6002 thereof—can be approved of or authorized by a regulating body of a particular jurisdiction. For example, thekit 6000, and the instructions foruse 6002 thereof, may be approved of or authorized by the Food and Drug Administration of the United States of America and/or may comply with the regulations of other jurisdictions, such as by qualifying for CE marking in the European Union. - The
instructions 6002 can provide directions with respect to any of the methods or processes disclosed herein. That is, theinstructions 6002 can provide directions for using thecatheter assembly 4004 in accordance with any of the methods or processes disclosed above. One illustrative example of a set ofinstructions 6002 for use with one embodiment of thecatheter assembly 4004 is provided below. Other instructions may include more, fewer, and/or different directions than those provided in the illustrative example, and other embodiments of thecatheter assembly 4004 may include more, fewer, and/or different features than those discussed in the instructions. - The
catheter assembly 4004 is designed to be used in the esophagus to remove food blockages. It is an 8 Fr OD with a 0.090 inch max ID, 124 cm useable length, single-lumen, braided biocompatible catheter with a sharp distal tip for cutting through the food impaction. Thecatheter assembly 4004 has a molded, tapered handle that is a slip fit connection to the vacuum system in the hospital. - The
catheter assembly 4004 is designed to be used through the working channel (>2.7 mm ID) of a standard endoscope. It is designed to connect to extend outside the distal end of an endoscope by approximately 1 inch when fully inserted. - The
catheter assembly 4004 can be packaged with instructions foruse 6002, which instructions may recite some or all of the following directions. The instructions detail illustrative examples of using thecatheter assembly 4004. - The
catheter assembly 4004 is indicated for removal of food blockage/impaction in the esophagus. - The
catheter assembly 4004 should be used by a health care professional with adequate training in the use of the device. - Do not use if the device is kinked or damaged in any way.
- Do not use if the
catheter assembly 4004 does not move freely through the working channel of a standard endoscope with a working channel ID of 2.7 mm or greater. - Following standard practices, introduce a standard endoscope (e.g., through the mount of the patient) to the level of the food impaction.
- Insert the
catheter assembly 4004 through the working channel of the endoscope until the aspiration catheter is visible through the distal end of the endoscope. - Once positioned in the endoscope, attach standard suction tubing to the catheter handle by pressing tubing firmly onto the handle. Attach the suction system to the wall suction of the hospital in any suitable manner. For example, press fit tubing of the suction system over a wall-mounted nozzle in a hospital room that is connected to the hospital suction source.
- Deliver a plurality of (e.g., 4 to 5) drops of water through the irrigation lumen of the endoscope. This will help saturate the food impaction making it easier to aspirate.
- The aspiration catheter, attached to suction, will then be employed to core pieces of the food impaction and suction the pieces as cored. The aspiration catheter will be advanced into the food to core pieces of food and then be withdrawn to allow suction. This process will be repetitively performed (coring and suctioning) as needed to clear the impaction. Repeat this step until food impaction is clear (e.g., until food impaction is naturally passed out of the esophagus and into the stomach by the patient).
- When the impaction has been cleared, detach the vacuum from catheter handle and remove the
catheter assembly 4004 from the endoscope. -
FIGS. 57A and 57B depict another embodiment of asheath assembly 7002 in an undeployed state and in a deployed state, respectively. Thesheath assembly 7002 can be used with embodiments of catheter assemblies disclosed herein in manners such as are also disclosed herein. - The
sheath assembly 7002 can function similarly to other sheath assemblies disclosed herein. In general, thesheath assembly 7002 includes apositioning element 7018 and anactuator 7060 via which thepositioning element 7018 can be deployed and retracted. - As with other embodiments disclosed herein, the
sheath assembly 7002 includeshub 7014 that is coupled with asheath 7016 in any suitable manner. Thesheath 7016 defines aninstrument deployment lumen 7054 within which a catheter can be positioned, and through which the catheter can be advanced and/or retracted. Thesheath 7016 can further define an actuation channel orlumen 7066, which can resemble the inflation channels orlumens - In the illustrated embodiment, the
positioning element 7018 comprises anexpandable member 7019 of any suitable variety. Theexpandable member 7019 can, for example, comprise a braided or other configuration of wires or other materials that can be selectively expanded to a larger profile configuration or retracted to a lower profile configuration. For example, theexpandable member 7019 can resemble or be formed as a selectively expandable and retractable stent, such as, for example, a braided stent. - With reference to
FIGS. 58A and 58B , in other instances, rather than defining a braided sleeve, an expandable member, or positioning element, can define a series of longitudinally extending wires or other elongated elements that are predisposed to flare outwardly when compressed and can assume a low-profile configuration when placed under tension. In still other embodiments, an expandable member, or positioning element, can define a plurality of resilient arms (e.g.,FIGS. 59A and 59B ) configured to press outwardly into contact with the esophagus. Any other suitable system for expanding into contact with the esophagus and retracting away from contact with the esophagus is contemplated. - In various embodiments, the
expandable member 7019 is resiliently flexible and/or comprises a shape-memory material. In various embodiments, theexpandable member 7019 may be biased toward a retracted orientation (FIG. 57A ), such that the bias must be overcome to deploy theexpandable member 7019. Theexpandable member 7019 may readily return to the retracted orientation under influence of the bias, when so permitted. In other embodiments, theexpandable member 7019 may be biased toward the deployed orientation (FIG. 57B ), such that actuation of theexpandable member 7019 includes permitting the bias to naturally deploy theexpandable member 7019. Theexpandable member 7019 may be returned to the retracted orientation by overcoming the bias. In other embodiments, theexpandable member 7019 is not subject to internal or other biases when positioned in either of the retracted or deployed orientations. - A distal end of the
expandable member 7019 can be fixed relative to thesheath 7016. A proximal end of theexpandable member 7019 can be movable relative to thesheath 7016. For example, the proximal end of theexpandable member 7019 can be permitted to translate longitudinally relative to thesheath 7016. - The proximal end of the
expandable member 7019 can be coupled with amechanical linkage 7091 of any suitable variety, such as a wire orrod 7093. Themechanical linkage 7091 can further be coupled with anactuation interface 7095 of any suitable variety, such as a button, lever, switch, slider, etc. Theactuation interface 7095 can move themechanical linkage 7091 so as to effect actuation and retraction of theexpandable member 7019. Accordingly, theactuator 7060 can be communicatively coupled with thepositioning element 7018. In particular, theactuation interface 7095 is configured to directly, mechanically communicate with theexpandable member 7019 via themechanical linkage 7091. - For example, in the illustrated embodiment, the
actuation interface 7095 comprises a switch that is translatable relative to thehousing 7014. By urging the switch distally from the proximal position shown inFIG. 57A to the distal position shown inFIG. 57B , themechanical linkage 7091 is likewise urged distally, which likewise urges the proximal end of theexpandable member 7019 distally. Due to the fixed relationship of the distal end of theexpandable member 7019 relative to thesheath 7016, theexpandable member 7019 can deploy outwardly to the configuration depicted inFIG. 57B . Similarly, urging the switch proximally from the distal position shown inFIG. 57A to the proximal position shown inFIG. 57B can return the expandable member to the retracted orientation shown inFIG. 57A . -
FIGS. 58A and 58B depict another embodiment of asheath assembly 8002 in an undeployed state and in a deployed state, respectively. Thesheath assembly 8002 can closely resemble thesheath assembly 7002 just described, but may include a differentexpandable member 8019 that includes a plurality of longitudinally extending wires or elongated elements 8095. Theexpandable member 8019 can perform substantially as previously described with respect to theexpandable member 7019. -
FIGS. 59A and 59B depict another embodiment of asheath assembly 9002 in an undeployed state and in a deployed state, respectively. Thesheath assembly 9002 can closely resemble thesheath assemblies expandable member 9019 that includes a plurality of resiliently expandable arms 9097. In the illustrated embodiment, the arms 9097 are configured to rotate outward into contact with the esophageal wall when deployed. In particular, in the illustrated embodiment, the arms 9097 are deployed when proximal portions thereof are advanced distally so as to no longer be restrained in a low-profile orientation by aretainer element 9099. - Although various embodiments are described herein, the embodiments are only examples and should not be construed as limiting. The examples described above generally refer to food impactions in the esophagus. However, many other similar impactions can be addressed using the systems and methods described herein. For example, embodiments of the systems may be used with any suitable anatomical tube (e.g., the esophagus, a bronchus, a vessel).
- For example, a person can choke while eating, and food can get aspirated and lodge in the trachea, or can also lodge in the lung, specifically any portion of the bronchial tree. Mucus can also become trapped anywhere in the bronchial tree, causing mucus plugging. When this occurs, one or more of the embodiments described herein can be used to core and suction said food or mucus, such as by placing the device, for example, through the working channel of a flexible or rigid bronchoscope as opposed to an endoscope.
- One or more of the embodiments described herein can also be used to core, suction and remove trapped blood or blood clots anywhere in the GI tract, specifically the esophagus, stomach, small intestine or large intestine.
- One or more of the embodiments described herein can also be used to core, suction and remove trapped food, blood or blood clots, or mucus or mucus plugs, anywhere in the pulmonary organ system, i.e., the trachea or lung i.e. anywhere in the bronchial tree.
- One or more of the embodiments described herein can be used to core and remove blood or blood clots, or atheroma or atheromatous plaque anywhere in the vasculature system, i.e. great arteries or veins, or peripheral vasculature i.e. the peripheral arteries or veins. To core harder materials such as calcified plaque, a stainless steel tip can be attached to the end of the suction catheter.
- One or more of the embodiments described herein can also be used to core and remove blood or blood clots, or atheroma or atheromatous plaque anywhere in the heart or coronary arteries. To core harder materials such as calcified plaque, a stainless steel tip can be attached to the end of the suction catheter.
- In another example, one or more of the embodiments described herein can be used to core and suction kidney stones from the urinary system, specifically the ureters, bladder and kidneys. To core harder materials such as calcified, struvite, oxalate or uric acid kidney stones a stainless steel tip can be attached to the end of the suction catheter.
- In yet another example, one or more of the embodiments described herein can be used to core and remove gallstones or tumors lodged in the biliary tree (common bile duct or peripheral ducts). Harder materials can be cored by attaching a stainless steel tip to the end of the suction catheter.
- Although the foregoing detailed description contains many specifics for the purpose of illustration, a person of ordinary skill in the art will appreciate that many variations and alterations to the following details can be made and are considered to be included herein. Accordingly, the foregoing embodiments are set forth without any loss of generality to, and without imposing limitations upon, any claims set forth. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs.
- Any methods disclosed herein comprise one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified.
- As used in this specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a layer” includes a plurality of such layers.
- In this disclosure, “comprises,” “comprising,” “containing” and “having” and the like can have the meaning ascribed to them in U.S. patent law and can mean “includes,” “including,” and the like, and are generally interpreted to be open ended terms. The terms “consisting of” or “consists of” are closed terms, and include only the component structures, steps, or the like specifically listed in conjunction with such terms, as well as that which is in accordance with U.S. patent law. “Consisting essentially of” or “consists essentially of” have the meaning generally ascribed to them by U.S. patent law. In particular, such terms are generally closed terms, with the exception of allowing inclusion of additional items, materials, components, steps, or elements, that do not materially affect the basic and novel characteristics or function of the item(s) used in connection therewith. For example, trace elements present in a composition, but not affecting the compositions nature or characteristics would be permissible if present under the “consisting essentially of” language, even though not expressly recited in a list of items following such terminology. When using an open ended term in the specification, like “comprising” or “including,” it is understood that direct support should be afforded also to “consisting essentially of” language as well as “consisting of” language as if stated explicitly and vice versa.
- The terms “first,” “second,” “third,” “fourth,” and the like in the description and in the claims, if any, are used for distinguishing between similar elements and not necessarily for describing a particular sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances such that the embodiments described herein are, for example, capable of operation in sequences other than those illustrated or otherwise described herein. Similarly, if a method is described herein as comprising a series of steps, the order of such steps as presented herein is not necessarily the only order in which such steps may be performed, and certain of the stated steps may possibly be omitted and/or certain other steps not described herein may possibly be added to the method.
- The terms “left,” “right,” “front,” “back,” “top,” “bottom,” “over,” “under,” and the like in the description and in the claims, if any, are used for descriptive purposes and not necessarily for describing permanent relative positions. It is to be understood that the terms so used are interchangeable under appropriate circumstances such that the embodiments described herein are, for example, capable of operation in other orientations than those illustrated or otherwise described herein. The term “coupled,” as used herein, is defined as directly or indirectly connected in any suitable manner. Objects described herein as being “adjacent to” each other may be in physical contact with each other, in close proximity to each other, or in the same general region or area as each other, as appropriate for the context in which the phrase is used. Occurrences of the phrase “in one embodiment,” or “in one aspect,” herein do not necessarily all refer to the same embodiment or aspect.
- As used herein, the term “substantially” refers to the complete or nearly-complete extent or degree of an action, characteristic, property, state, structure, item, or result. For example, an object that is “substantially” enclosed would mean that the object is either completely enclosed or nearly completely enclosed. The exact allowable degree of deviation from absolute completeness may in some cases depend on the specific context. However, generally speaking the nearness of completion will be so as to have the same overall result as if absolute and total completion were obtained. The use of “substantially” is equally applicable when used in a negative connotation to refer to the complete or near complete lack of an action, characteristic, property, state, structure, item, or result. For example, a composition that is “substantially free of” particles would either completely lack particles, or so nearly completely lack particles that the effect would be the same as if it completely lacked particles. In other words, a composition that is “substantially free of” an ingredient or element may still actually contain such item as long as there is no measurable effect thereof.
- As used herein, the term “about” is used to provide flexibility to a numerical range endpoint by providing that a given value may be “a little above” or “a little below” the endpoint. Moreover, for references to approximations (which are made throughout this specification), such as by use of the terms “about” or “approximately,” or other terms, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as “about,” “substantially,” and “generally” are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term “substantially perpendicular” is recited with respect to a feature, it is understood that in further embodiments, the feature can have a precisely perpendicular orientation.
- As used herein, a plurality of items, structural elements, compositional elements, and/or materials may be presented in a common list for convenience. However, these lists should be construed as though each member of the list is individually identified as a separate and unique member. Thus, no individual member of such list should be construed as a de facto equivalent of any other member of the same list solely based on their presentation in a common group without indications to the contrary.
- Concentrations, amounts, and other numerical data may be expressed or presented herein in a range format. It is to be understood that such a range format is used merely for convenience and brevity and thus should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. As an illustration, a numerical range of “about 1 to about 5” should be interpreted to include not only the explicitly recited values of about 1 to about 5, but also include individual values and sub-ranges within the indicated range. Thus, included in this numerical range are individual values such as 2, 3, and 4 and sub-ranges such as from 1-3, from 2-4, and from 3-5, etc., as well as 1, 2, 3, 4, and 5, individually.
- This same principle applies to ranges reciting only one numerical value as a minimum or a maximum. Furthermore, such an interpretation should apply regardless of the breadth of the range or the characteristics being described.
- References throughout this specification to “an example,” if any, mean that a particular feature, structure, or characteristic described in connection with the example is included in at least one embodiment. Thus, appearances of the phrases “in an example” in various places throughout this specification are not necessarily all referring to the same embodiment.
- Reference throughout this specification to “an embodiment” or “the embodiment” means that a particular feature, structure or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the quoted phrases, or variations thereof, as recited throughout this specification are not necessarily all referring to the same embodiment.
- Similarly, it should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment.
- The claims following this written disclosure are hereby expressly incorporated into the present written disclosure, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims. Moreover, additional embodiments capable of derivation from the independent and dependent claims that follow are also expressly incorporated into the present written description. These additional embodiments are determined by replacing the dependency of a given dependent claim with the phrase “any of claims [x] through the claim that immediately precedes this one” where the bracketed term “[x]” is replaced with the number of the most recently recited independent claim. For example, for the first claim set that begins with independent claim 1, claim 3 can depend from either of claims 1 and 2, with these separate dependencies yielding two distinct embodiments; claim 4 can depend from any one of claim 1, 2, or 3, with these separate dependencies yielding three distinct embodiments;
claim 5 can depend from any one of claim 1, 2, 3, or 4, with these separate dependencies yielding four distinct embodiments; and so on. - Recitation in the claims of the term “first” with respect to a feature or element does not necessarily imply the existence of a second or additional such feature or element. Elements specifically recited in means-plus-function format, if any, are intended to be construed in accordance with 35 U.S.C. § 112(f). Elements not presented in requisite means-plus-function format are not intended to be construed in accordance with 35 U.S.C. § 112(f). Embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows.
Claims (10)
1. A system comprising:
a tubular member that defines a channel and comprises a distal tip, the tubular member configured to be inserted into an esophagus of the patient; and
a catheter assembly comprising:
a catheter tube that defines a length greater than a length of the tubular member and is configured to pass through the channel of the tubular member such that a distal tip of the catheter tube extends distally past the distal tip of the tubular member while the tubular member is positioned in the esophagus of the patient, the distal tip of the catheter tube defining a cutting element configured to core a blockage positioned in the esophagus of the patient; and
a catheter hub fixedly secured to a proximal end of the catheter tube, the catheter hub comprising a connector configured to couple with a vacuum line such that, when suction is provided via the vacuum line, advancement of the distal tip of the catheter tube into contact with the blockage cores a piece from the blockage that is passed through the catheter tube.
2. The system of claim 1 , wherein the catheter tube comprises an inner surface that is coated with a lubricious material to encourage passage of the piece from the blockage through the catheter tube.
3. The system of claim 1 , wherein the catheter tube comprises a thin-walled extrusion.
4. The system of claim 3 , wherein the catheter tube comprises extruded nylon 12.
5. The system of claim 3 , wherein the proximal end of the catheter assembly comprises a tapered portion for coupling with the vacuum line.
6. The system of claim 1 , wherein the tubular member comprises an endoscope and the channel comprises a working channel of the endoscope.
7. The system of claim 1 , wherein a sheath assembly comprises the tubular member.
8. The system of claim 7 , wherein the sheath assembly further comprises a positioning element coupled with the tubular member, the positioning element being configured to transition from an undeployed state to permit the tubular member to be inserted into the esophagus of the patient and a deployed state in which the positioning element contacts the esophagus to substantially center the channel of the tubular member relative to the esophagus.
9. The system of claim 8 , wherein the positioning element comprises a balloon.
10. The system of claim 9 , wherein the sheath assembly further comprises a pressure regulation valve in fluid communication with the balloon to ensure that a pressure within the balloon does not exceed a predetermined limit.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US17/498,312 US20220023563A1 (en) | 2015-11-30 | 2021-10-11 | Blockage clearing devices, systems, and methods |
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201562260873P | 2015-11-30 | 2015-11-30 | |
US15/356,975 US10722267B2 (en) | 2015-11-30 | 2016-11-21 | Blockage removal |
US201762513419P | 2017-05-31 | 2017-05-31 | |
US201862636526P | 2018-02-28 | 2018-02-28 | |
US15/995,112 US11141177B2 (en) | 2015-11-30 | 2018-05-31 | Blockage clearing devices, systems, and methods |
US17/498,312 US20220023563A1 (en) | 2015-11-30 | 2021-10-11 | Blockage clearing devices, systems, and methods |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US15/995,112 Continuation US11141177B2 (en) | 2015-11-30 | 2018-05-31 | Blockage clearing devices, systems, and methods |
Publications (1)
Publication Number | Publication Date |
---|---|
US20220023563A1 true US20220023563A1 (en) | 2022-01-27 |
Family
ID=63671557
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US15/995,112 Active 2036-12-20 US11141177B2 (en) | 2015-11-30 | 2018-05-31 | Blockage clearing devices, systems, and methods |
US17/498,312 Pending US20220023563A1 (en) | 2015-11-30 | 2021-10-11 | Blockage clearing devices, systems, and methods |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US15/995,112 Active 2036-12-20 US11141177B2 (en) | 2015-11-30 | 2018-05-31 | Blockage clearing devices, systems, and methods |
Country Status (1)
Country | Link |
---|---|
US (2) | US11141177B2 (en) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP6941620B2 (en) | 2015-11-30 | 2021-09-29 | ピラーナ メディカル エルエルシーPiranha Medical, LLC | Blockage removal |
WO2021062067A1 (en) * | 2019-09-24 | 2021-04-01 | Ganz Robert A | Material removal from within a patient |
Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4898575A (en) * | 1987-08-31 | 1990-02-06 | Medinnovations, Inc. | Guide wire following tunneling catheter system and method for transluminal arterial atherectomy |
US6042593A (en) * | 1995-11-20 | 2000-03-28 | Storz Endoskop Gmbh | Shaving or cutting instrument |
US20060074478A1 (en) * | 2004-09-28 | 2006-04-06 | Feller Frederick Iii | Thin film medical device and delivery system |
US20090187098A1 (en) * | 2004-04-21 | 2009-07-23 | Acclarent, Inc. | Devices, Systems and Methods for Diagnosing and Treating Sinusitis and Other Disorders of the Ears, Nose, and/or Throat |
US20110275990A1 (en) * | 2008-07-02 | 2011-11-10 | Doron Besser | Balloon catheter system and methods of use thereof |
US20120004596A1 (en) * | 2010-07-02 | 2012-01-05 | Neurodynamics, LLC | Catheter for Use in Revascularization Procedures and Method of Using Same |
US20120071856A1 (en) * | 2010-09-22 | 2012-03-22 | Goldfarb Eric A | Medical Device and Method for Treatment of a Sinus Opening |
Family Cites Families (63)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4754755A (en) | 1984-05-14 | 1988-07-05 | Husted Royce Hill | Catheter with a rotary blade |
US4715848A (en) | 1985-04-15 | 1987-12-29 | Beroza Gregory A | Gastro-intestinal lavage system and method |
EP0310685A1 (en) | 1985-11-22 | 1989-04-12 | Kontron-Holding Ag | Angioplasty catheter |
US5904679A (en) | 1989-01-18 | 1999-05-18 | Applied Medical Resources Corporation | Catheter with electrosurgical cutter |
US5033466A (en) | 1989-02-28 | 1991-07-23 | Weymuller Jr Ernest | Doble-cuffed endotracheal tube |
US5114399A (en) | 1990-10-01 | 1992-05-19 | Intramed Laboratories | Surgical device |
US5222971A (en) | 1990-10-09 | 1993-06-29 | Scimed Life Systems, Inc. | Temporary stent and methods for use and manufacture |
US5197949A (en) | 1991-01-22 | 1993-03-30 | Kraivit Angsupanich | Suction irrigation device with a scraper |
JP2802244B2 (en) | 1994-08-29 | 1998-09-24 | オリンパス光学工業株式会社 | Endoscope sheath |
US5571168A (en) | 1995-04-05 | 1996-11-05 | Scimed Lifesystems Inc | Pull back stent delivery system |
US5931831A (en) | 1996-07-09 | 1999-08-03 | Linder; Gerald S. | Dual-lumen suction catheter with smaller diameter vent lumen having multiple apertures therein |
US5921971A (en) | 1996-09-13 | 1999-07-13 | Boston Scientific Corporation | Single operator exchange biliary catheter |
US5741269A (en) | 1996-11-18 | 1998-04-21 | Mccredy; Doug | Medical vacuum device |
US5782837A (en) | 1997-04-23 | 1998-07-21 | York; Richard | Esophagus clearing device |
ATE404123T1 (en) | 1997-11-12 | 2008-08-15 | Genesis Technologies Llc | DEVICE FOR REMOVAL OF OCCLUSIONS IN BIOLOGICAL PASSAGES |
US6689062B1 (en) | 1999-11-23 | 2004-02-10 | Microaccess Medical Systems, Inc. | Method and apparatus for transesophageal cardiovascular procedures |
US6361540B1 (en) | 2000-04-06 | 2002-03-26 | Michael W. L. Gauderer | Apparatus for removal of esophageal coins and similarly shaped objects |
US6986773B1 (en) | 2000-10-11 | 2006-01-17 | Edward Manougian | Human airway clearing tool |
US6719772B2 (en) | 2001-09-13 | 2004-04-13 | Terumo Medical Corporation | Retaining device for axially restraining movement between tubular elements of a medical device |
US6840909B2 (en) | 2002-03-25 | 2005-01-11 | Acueity, Inc. | Apparatus and method for intraductal cytology |
EP1542577B1 (en) | 2002-09-06 | 2016-05-25 | C.R. Bard, Inc. | Endoscopic accessory mounting adaptor |
US6962585B2 (en) * | 2002-11-22 | 2005-11-08 | Poleo Jr Louis A | Catherization system and method |
EP3222218A1 (en) | 2003-03-17 | 2017-09-27 | Covidien LP | Endoscopic tissue removal apparatus and method |
JP2005296412A (en) | 2004-04-13 | 2005-10-27 | Olympus Corp | Endoscopic treatment apparatus |
US7654997B2 (en) | 2004-04-21 | 2010-02-02 | Acclarent, Inc. | Devices, systems and methods for diagnosing and treating sinusitus and other disorders of the ears, nose and/or throat |
US20070208252A1 (en) | 2004-04-21 | 2007-09-06 | Acclarent, Inc. | Systems and methods for performing image guided procedures within the ear, nose, throat and paranasal sinuses |
US20060063973A1 (en) | 2004-04-21 | 2006-03-23 | Acclarent, Inc. | Methods and apparatus for treating disorders of the ear, nose and throat |
US8057484B2 (en) | 2004-05-25 | 2011-11-15 | U.S. Endoscopy Group, Inc. | Retrieval device |
US20060293612A1 (en) * | 2004-06-24 | 2006-12-28 | Boston Scientific Scimed, Inc. | Apparatus and method for treating occluded vasculature |
JP4302602B2 (en) | 2004-09-24 | 2009-07-29 | オリンパス株式会社 | Endoscopic treatment tool, endoscopic treatment system, and support adapter |
US8016785B2 (en) | 2004-12-02 | 2011-09-13 | Chek-Med Systems, Inc. | Gastrojejunal feeding tube |
US7220253B2 (en) | 2004-12-02 | 2007-05-22 | Chek-Med Systems, Inc. | Gastrojejunal feeding tube |
EP1835847B1 (en) | 2005-01-06 | 2011-05-11 | G.I. View Ltd. | Gastrointestinal tool over guiding element |
US20070250149A1 (en) | 2006-04-21 | 2007-10-25 | Abbott Laboratories | Stiffening Support Catheters and Methods for Using the Same |
US20090018566A1 (en) | 2006-06-30 | 2009-01-15 | Artheromed, Inc. | Atherectomy devices, systems, and methods |
AU2007303132B2 (en) | 2006-10-04 | 2013-03-28 | Boston Scientific Limited | Interventional catheters |
CA2667560C (en) | 2006-10-26 | 2013-02-05 | Wilson-Cook Medical Inc. | Biopsy collection device |
US20080103508A1 (en) | 2006-11-01 | 2008-05-01 | Ali Serdar Karakurum | Apparatus and method for removal of foreign matter from a patient |
US9421071B2 (en) | 2006-12-01 | 2016-08-23 | Boston Scientific Scimed, Inc. | Direct drive methods |
KR100834042B1 (en) | 2007-02-23 | 2008-05-30 | 양건태 | Device for thorn/mucous discharge removal |
US8573218B2 (en) | 2007-03-07 | 2013-11-05 | Michael John RUTTER | Tracheostomy tube |
US20080243137A1 (en) | 2007-03-30 | 2008-10-02 | D Angelo David W | System and methods for clearance of obstructions |
WO2008154406A1 (en) | 2007-06-08 | 2008-12-18 | U.S.Endoscopy Group, Inc. | Retrieval device |
US8591521B2 (en) | 2007-06-08 | 2013-11-26 | United States Endoscopy Group, Inc. | Retrieval device |
US8262645B2 (en) | 2007-11-21 | 2012-09-11 | Actuated Medical, Inc. | Devices for clearing blockages in in-situ artificial lumens |
US8876838B2 (en) | 2008-03-07 | 2014-11-04 | Kevin Winiarski | Anti-choking device |
US20100016885A1 (en) | 2008-07-21 | 2010-01-21 | Eidenschink Tracee E J | Device to close openings in body tissue |
CN201642262U (en) | 2010-02-11 | 2010-11-24 | 吴彩霞 | Mouth cavity and esophagus cleaning device |
CA2799188A1 (en) | 2010-05-11 | 2011-11-17 | Cook Medical Technologies Llc | Biliary access sheath |
JP5777936B2 (en) | 2010-07-16 | 2015-09-09 | テルモ株式会社 | Suction catheter |
WO2012114333A1 (en) * | 2011-02-24 | 2012-08-30 | Ilan Ben Oren | Hybrid catheter for vascular intervention |
WO2012174431A1 (en) | 2011-06-17 | 2012-12-20 | Research Institute At Nationwide Children's Hospital | Endoscopic foreign body retrieval |
WO2013071173A1 (en) | 2011-11-11 | 2013-05-16 | Dacuycuy Nathan John | Devices for removing vessel occlusions |
US20150057517A1 (en) | 2012-03-27 | 2015-02-26 | University Of Utah Research Foundation | Sample capture device and systems and methods of using same |
WO2014089028A1 (en) | 2012-12-04 | 2014-06-12 | Endoclear Llc | Suction cleaning devices, systems and methods |
US9956383B2 (en) | 2013-03-15 | 2018-05-01 | Cook Medical Technologies Llc | Medical devices and methods for providing access to a bodily passage during dilation |
CN106714709B (en) | 2014-09-19 | 2019-10-15 | 恩多巧爱思股份有限公司 | Net is attached to the method for the band coating ring element of surgery snare device |
US10045758B2 (en) | 2014-11-26 | 2018-08-14 | Visura Technologies, LLC | Apparatus, systems and methods for proper transesophageal echocardiography probe positioning by using camera for ultrasound imaging |
US20160374700A1 (en) | 2015-06-26 | 2016-12-29 | Endovate Llc | Endoscope Device and Method of Use |
WO2017019965A1 (en) | 2015-07-29 | 2017-02-02 | Actuated Medical, Inc. | Devices for clearing blockages in artificial and natural lumens |
JP6941620B2 (en) | 2015-11-30 | 2021-09-29 | ピラーナ メディカル エルエルシーPiranha Medical, LLC | Blockage removal |
CN111132601A (en) | 2017-05-31 | 2020-05-08 | 皮兰哈医疗公司 | Blockage clearing device, system and method |
AU2019371413A1 (en) | 2018-11-03 | 2021-06-24 | Piranha Medical, LLC | Blockage clearing devices, systems, and methods |
-
2018
- 2018-05-31 US US15/995,112 patent/US11141177B2/en active Active
-
2021
- 2021-10-11 US US17/498,312 patent/US20220023563A1/en active Pending
Patent Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4898575A (en) * | 1987-08-31 | 1990-02-06 | Medinnovations, Inc. | Guide wire following tunneling catheter system and method for transluminal arterial atherectomy |
US6042593A (en) * | 1995-11-20 | 2000-03-28 | Storz Endoskop Gmbh | Shaving or cutting instrument |
US20090187098A1 (en) * | 2004-04-21 | 2009-07-23 | Acclarent, Inc. | Devices, Systems and Methods for Diagnosing and Treating Sinusitis and Other Disorders of the Ears, Nose, and/or Throat |
US20060074478A1 (en) * | 2004-09-28 | 2006-04-06 | Feller Frederick Iii | Thin film medical device and delivery system |
US20110275990A1 (en) * | 2008-07-02 | 2011-11-10 | Doron Besser | Balloon catheter system and methods of use thereof |
US20120004596A1 (en) * | 2010-07-02 | 2012-01-05 | Neurodynamics, LLC | Catheter for Use in Revascularization Procedures and Method of Using Same |
US20120071856A1 (en) * | 2010-09-22 | 2012-03-22 | Goldfarb Eric A | Medical Device and Method for Treatment of a Sinus Opening |
Also Published As
Publication number | Publication date |
---|---|
US20180280040A1 (en) | 2018-10-04 |
US11141177B2 (en) | 2021-10-12 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US20180344993A1 (en) | Blockage clearing devices, systems, and methods | |
US11167080B2 (en) | Balloon dilation catheter system for treatment and irrigation of the sinuses | |
US20210251645A1 (en) | Blockage clearing devices, systems, and methods | |
US10806849B2 (en) | Devices and methods for transnasal irrigation or suctioning of the sinuses | |
US20200297386A1 (en) | Material removal from a lung or bronchial tree | |
US20220023563A1 (en) | Blockage clearing devices, systems, and methods | |
US20090171369A1 (en) | Two-part extraction balloon | |
US20220226016A1 (en) | Material removal from within a patient |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
STPP | Information on status: patent application and granting procedure in general |
Free format text: NON FINAL ACTION MAILED |