WO2018144971A1 - Système de dispositif médical implantable et méthode d'utilisation - Google Patents
Système de dispositif médical implantable et méthode d'utilisation Download PDFInfo
- Publication number
- WO2018144971A1 WO2018144971A1 PCT/US2018/016798 US2018016798W WO2018144971A1 WO 2018144971 A1 WO2018144971 A1 WO 2018144971A1 US 2018016798 W US2018016798 W US 2018016798W WO 2018144971 A1 WO2018144971 A1 WO 2018144971A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- medical device
- implantable medical
- collar
- delivery system
- legs
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims abstract description 59
- 238000004873 anchoring Methods 0.000 claims abstract description 33
- 239000000463 material Substances 0.000 claims abstract description 18
- 238000003780 insertion Methods 0.000 claims abstract description 13
- 230000037431 insertion Effects 0.000 claims abstract description 13
- 210000000232 gallbladder Anatomy 0.000 claims description 75
- 210000000056 organ Anatomy 0.000 claims description 63
- 230000008878 coupling Effects 0.000 claims description 48
- 238000010168 coupling process Methods 0.000 claims description 48
- 238000005859 coupling reaction Methods 0.000 claims description 48
- 125000006850 spacer group Chemical group 0.000 claims description 35
- 210000003739 neck Anatomy 0.000 claims description 33
- 239000003550 marker Substances 0.000 claims description 20
- 201000001883 cholelithiasis Diseases 0.000 claims description 16
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 8
- 229910003460 diamond Inorganic materials 0.000 claims description 7
- 239000010432 diamond Substances 0.000 claims description 7
- 230000000994 depressogenic effect Effects 0.000 claims description 6
- 230000007246 mechanism Effects 0.000 claims description 6
- 230000000881 depressing effect Effects 0.000 claims description 3
- 238000001914 filtration Methods 0.000 claims description 3
- 239000002699 waste material Substances 0.000 claims description 2
- 238000013461 design Methods 0.000 description 10
- 239000007943 implant Substances 0.000 description 10
- 210000000941 bile Anatomy 0.000 description 8
- 208000001130 gallstones Diseases 0.000 description 8
- 210000004185 liver Anatomy 0.000 description 6
- 210000003484 anatomy Anatomy 0.000 description 5
- 238000003384 imaging method Methods 0.000 description 5
- 238000012800 visualization Methods 0.000 description 5
- 210000001096 cystic duct Anatomy 0.000 description 4
- 239000012530 fluid Substances 0.000 description 4
- 238000002594 fluoroscopy Methods 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 4
- 239000004696 Poly ether ether ketone Substances 0.000 description 3
- 230000001464 adherent effect Effects 0.000 description 3
- 230000006870 function Effects 0.000 description 3
- 238000002347 injection Methods 0.000 description 3
- 239000007924 injection Substances 0.000 description 3
- 229920002530 polyetherether ketone Polymers 0.000 description 3
- 229920000642 polymer Polymers 0.000 description 3
- 229910045601 alloy Inorganic materials 0.000 description 2
- 239000000956 alloy Substances 0.000 description 2
- 238000013459 approach Methods 0.000 description 2
- TZCXTZWJZNENPQ-UHFFFAOYSA-L barium sulfate Chemical compound [Ba+2].[O-]S([O-])(=O)=O TZCXTZWJZNENPQ-UHFFFAOYSA-L 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 210000003445 biliary tract Anatomy 0.000 description 2
- 230000036760 body temperature Effects 0.000 description 2
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 210000004303 peritoneum Anatomy 0.000 description 2
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 2
- 239000010935 stainless steel Substances 0.000 description 2
- 229910001220 stainless steel Inorganic materials 0.000 description 2
- 238000002604 ultrasonography Methods 0.000 description 2
- 230000000007 visual effect Effects 0.000 description 2
- 238000007794 visualization technique Methods 0.000 description 2
- ZCYVEMRRCGMTRW-UHFFFAOYSA-N 7553-56-2 Chemical compound [I] ZCYVEMRRCGMTRW-UHFFFAOYSA-N 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 102100025841 Cholecystokinin Human genes 0.000 description 1
- 101800001982 Cholecystokinin Proteins 0.000 description 1
- 208000033770 Device misuse Diseases 0.000 description 1
- 206010019027 Haemothorax Diseases 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- HZEWFHLRYVTOIW-UHFFFAOYSA-N [Ti].[Ni] Chemical compound [Ti].[Ni] HZEWFHLRYVTOIW-UHFFFAOYSA-N 0.000 description 1
- 210000001015 abdomen Anatomy 0.000 description 1
- 210000001557 animal structure Anatomy 0.000 description 1
- 230000002457 bidirectional effect Effects 0.000 description 1
- 239000000560 biocompatible material Substances 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229940107137 cholecystokinin Drugs 0.000 description 1
- 235000012000 cholesterol Nutrition 0.000 description 1
- -1 combinations thereof Substances 0.000 description 1
- 210000001953 common bile duct Anatomy 0.000 description 1
- 230000008828 contractile function Effects 0.000 description 1
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- 230000002440 hepatic effect Effects 0.000 description 1
- 238000011065 in-situ storage Methods 0.000 description 1
- 229910052740 iodine Inorganic materials 0.000 description 1
- 239000011630 iodine Substances 0.000 description 1
- 229910052741 iridium Inorganic materials 0.000 description 1
- GKOZUEZYRPOHIO-UHFFFAOYSA-N iridium atom Chemical compound [Ir] GKOZUEZYRPOHIO-UHFFFAOYSA-N 0.000 description 1
- 230000002262 irrigation Effects 0.000 description 1
- 238000003973 irrigation Methods 0.000 description 1
- 210000004731 jugular vein Anatomy 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 150000002739 metals Chemical class 0.000 description 1
- 238000013508 migration Methods 0.000 description 1
- 230000005012 migration Effects 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 210000004877 mucosa Anatomy 0.000 description 1
- 210000004400 mucous membrane Anatomy 0.000 description 1
- 230000003387 muscular Effects 0.000 description 1
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 description 1
- 231100000252 nontoxic Toxicity 0.000 description 1
- 230000003000 nontoxic effect Effects 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229910052697 platinum Inorganic materials 0.000 description 1
- HWLDNSXPUQTBOD-UHFFFAOYSA-N platinum-iridium alloy Chemical compound [Ir].[Pt] HWLDNSXPUQTBOD-UHFFFAOYSA-N 0.000 description 1
- 201000003144 pneumothorax Diseases 0.000 description 1
- 238000012552 review Methods 0.000 description 1
- 230000003248 secreting effect Effects 0.000 description 1
- IZTQOLKUZKXIRV-YRVFCXMDSA-N sincalide Chemical compound C([C@@H](C(=O)N[C@@H](CCSC)C(=O)NCC(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CC=1C=CC=CC=1)C(N)=O)NC(=O)[C@@H](N)CC(O)=O)C1=CC=C(OS(O)(=O)=O)C=C1 IZTQOLKUZKXIRV-YRVFCXMDSA-N 0.000 description 1
- 210000000813 small intestine Anatomy 0.000 description 1
- 210000002460 smooth muscle Anatomy 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 229910052715 tantalum Inorganic materials 0.000 description 1
- GUVRBAGPIYLISA-UHFFFAOYSA-N tantalum atom Chemical compound [Ta] GUVRBAGPIYLISA-UHFFFAOYSA-N 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 230000000451 tissue damage Effects 0.000 description 1
- 231100000827 tissue damage Toxicity 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2/011—Instruments for their placement or removal
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2/0105—Open ended, i.e. legs gathered only at one side
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2002/018—Filters implantable into blood vessels made from tubes or sheets of material, e.g. by etching or laser-cutting
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/005—Rosette-shaped, e.g. star-shaped
Definitions
- FIG. 1A is a side view of an implantable medical device in an expanded configuration, according to an embodiment.
- FIG. 2A is an outer view of a leg of an implantable medical device, according to an embodiment.
- FIG. 4B is a side view of a catheter of the delivery system of FIG. 4A, according to an embodiment.
- FIG. 4C is a side view of an implantable medical device released from the catheter of the delivery system of FIG. 4A, according to an embodiment.
- FIG. 4J is a top view of a handle of a delivery system, according to an embodiment.
- a distal facing design (wide part of cone facing the outlet) the implantable medical device 100 when implanted in the gallbladder of the subject is advantageous over a proximal facing design in order to minimize the surface area of the implantable medical device 100 in contact with the gallbladder wall.
- each leg 130 may include a radiopaque marker positioned on the leg 130 between the leg end 212 and the anchor end 216.
- the radiopaque marker includes a radiopaque band 222 coupled (wrapped or crimped) to the leg 130 between the leg end 212 and the anchor end 216.
- the radiopaque marker includes a radiopaque coiled wire 224 wrapped around the leg 130 between the leg end 212 and the anchor end 216.
- the radiopaque marker may be coupled to a waist region 228 of the leg 130. The waste region 228 is narrower in width than the leg end 212.
- the outer release shaft 422 is retracted to expose the coupling element 426 of the inner control shaft 424, and the one or more biased paddles 428 bias outward from the coupling element 426 and disengage from the at least one side slot on the side of the collar 110 to release the implantable medical device 100 from the delivery system 400.
- the catheter delivery system 400 may utilize a traditional guidewire access, and that guidewire access should not be allowed to interfere with the deployment of the implantable medical device 100. Additionally, it is advantageous to minimize the diameter of the catheter 420 as much as possible. Therefore, a guidewire insertion aid is described herein.
- a removable thin-walled, peel-away tube 430 may be used. The peel-away tube 430 is inserted through the distal end of the constrained implantable medical device 100 before the implantable medical device 100 is packaged in order to: a) protect the lumen of the implantable medical device 100 and b) provide a smooth conduit for a guidewire 445 to be inserted past the implantable medical device 100 during the delivery procedure.
- the stiff tip 442 of the guidewire 445 is inserted into the distal opening of the loading guide 432 and advanced into the delivery catheter. Once the tip 442 of the guidewire 445 is past the implantable medical device 100 and is sufficiently inside of the catheter 420, the loading guide 432 is removed by pulling it out of the catheter 420. A longitudinal slit is incorporated along the length of the loading guide 432 and the peel-away tube 430 so the loading guide 432 and the peel-away tube 430 can be peeled away from the guidewire 445.
- inserting the portion of the outer release shaft of the hollow catheter of the delivery system at least partially into the organ of the subject includes using a bend of about 1 degree to about 45 degrees in the hollow catheter to the portion of the outer release shaft of the delivery system at a neck of the organ while utilizing a straight transhepatic path from skin of the subject to the organ.
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
Des modes de réalisation de la présente invention concernent des systèmes de dispositifs médicaux implantables et des méthodes d'utilisation. Dans un mode de réalisation, un système de dispositif médical implantable comprend un dispositif médical implantable. Le dispositif médical implantable comprend un collier, un corps expansible et une pluralité de pieds. Le collier est configuré pour s'accoupler de manière amovible à au moins l'un d'un instrument de récupération ou d'un système de pose. Le corps expansible s'étend à partir du collier et comporte une ou plusieurs ouvertures lorsque le corps expansible est dans une configuration déployée. Le corps expansible comprend un matériau super-élastique et est configuré pour s'étendre à partir d'une configuration repliée pour une insertion dans un sujet à une forme sensiblement conique de la configuration déployée pour un ancrage à l'intérieur du sujet. La pluralité de pieds s'étendent à partir du corps expansible distal par rapport au collier.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201762455021P | 2017-02-06 | 2017-02-06 | |
US62/455,021 | 2017-02-06 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2018144971A1 true WO2018144971A1 (fr) | 2018-08-09 |
Family
ID=63040097
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2018/016798 WO2018144971A1 (fr) | 2017-02-06 | 2018-02-05 | Système de dispositif médical implantable et méthode d'utilisation |
Country Status (1)
Country | Link |
---|---|
WO (1) | WO2018144971A1 (fr) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20220039980A1 (en) * | 2018-09-21 | 2022-02-10 | Tricares SAS | Loading tool and method for loading a prosthesis |
Citations (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5709704A (en) * | 1994-11-30 | 1998-01-20 | Boston Scientific Corporation | Blood clot filtering |
US5972019A (en) * | 1996-07-25 | 1999-10-26 | Target Therapeutics, Inc. | Mechanical clot treatment device |
WO2001045592A1 (fr) * | 1999-12-23 | 2001-06-28 | Percusurge, Inc. | Filtres vasculaires dotes de marquages radio-opaques |
US6355058B1 (en) * | 1999-12-30 | 2002-03-12 | Advanced Cardiovascular Systems, Inc. | Stent with radiopaque coating consisting of particles in a binder |
US20020055767A1 (en) * | 2000-10-18 | 2002-05-09 | Forde Sean T. | Over-the-wire interlock attachment/detachment mechanism |
US20020143386A1 (en) * | 2001-03-29 | 2002-10-03 | Davila Luis A. | Radiopacity intraluminal medical device |
US20070198050A1 (en) * | 2006-02-22 | 2007-08-23 | Phase One Medica, Llc | Medical implant device |
US20100185230A1 (en) * | 2009-01-16 | 2010-07-22 | Steven Horan | vascular filter device |
US20130144322A1 (en) * | 2010-05-08 | 2013-06-06 | Matthew John Callaghan | Devices and methods to treat gallstone disease |
US20130178890A1 (en) * | 2004-01-22 | 2013-07-11 | Rex Medical L.P. | Vein filter |
US20140094901A1 (en) * | 2007-03-30 | 2014-04-03 | DePuy Synthes Products, LLC | Radiopaque marker for vascular devices |
-
2018
- 2018-02-05 WO PCT/US2018/016798 patent/WO2018144971A1/fr active Application Filing
Patent Citations (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5709704A (en) * | 1994-11-30 | 1998-01-20 | Boston Scientific Corporation | Blood clot filtering |
US5972019A (en) * | 1996-07-25 | 1999-10-26 | Target Therapeutics, Inc. | Mechanical clot treatment device |
WO2001045592A1 (fr) * | 1999-12-23 | 2001-06-28 | Percusurge, Inc. | Filtres vasculaires dotes de marquages radio-opaques |
US6355058B1 (en) * | 1999-12-30 | 2002-03-12 | Advanced Cardiovascular Systems, Inc. | Stent with radiopaque coating consisting of particles in a binder |
US20020055767A1 (en) * | 2000-10-18 | 2002-05-09 | Forde Sean T. | Over-the-wire interlock attachment/detachment mechanism |
US20020143386A1 (en) * | 2001-03-29 | 2002-10-03 | Davila Luis A. | Radiopacity intraluminal medical device |
US20130178890A1 (en) * | 2004-01-22 | 2013-07-11 | Rex Medical L.P. | Vein filter |
US20070198050A1 (en) * | 2006-02-22 | 2007-08-23 | Phase One Medica, Llc | Medical implant device |
US20140094901A1 (en) * | 2007-03-30 | 2014-04-03 | DePuy Synthes Products, LLC | Radiopaque marker for vascular devices |
US20100185230A1 (en) * | 2009-01-16 | 2010-07-22 | Steven Horan | vascular filter device |
US20130144322A1 (en) * | 2010-05-08 | 2013-06-06 | Matthew John Callaghan | Devices and methods to treat gallstone disease |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20220039980A1 (en) * | 2018-09-21 | 2022-02-10 | Tricares SAS | Loading tool and method for loading a prosthesis |
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