WO2014070136A1 - Barrière contre l'absorption des nutriments et procédé de délivrance - Google Patents
Barrière contre l'absorption des nutriments et procédé de délivrance Download PDFInfo
- Publication number
- WO2014070136A1 WO2014070136A1 PCT/US2012/062486 US2012062486W WO2014070136A1 WO 2014070136 A1 WO2014070136 A1 WO 2014070136A1 US 2012062486 W US2012062486 W US 2012062486W WO 2014070136 A1 WO2014070136 A1 WO 2014070136A1
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- WIPO (PCT)
- Prior art keywords
- internal wall
- agent
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- exposing
- cross
- 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.)
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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
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
- A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
- A61F5/0013—Implantable devices or invasive measures
- A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
-
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
Definitions
- the present invention relates generally to medical apparatus and methods for temporarily disabling a certain section of that organ, such as a stomach, intestine or gastrointestinal tract to reduce nutrient absorption.
- BMI Body Mass Index
- Laparoscopic adjustable gastric banding (LAGB) is considered a purely restrictive procedure that involves the placement of an adjustable band around the cardia of the stomach, creating a 15 ml pouch.
- LSG Laparoscopic sleeve gastrectomy
- BPD Bilio-pancreatic diversion
- Roux-en-Y gastric bypass traditionally combines both mechanisms, partitioning a small pouch from the proximal stomach and diverting the ingested nutrients to the jejunum with a roux-en-Y gastro-jejunostomy.
- RYGB Roux-en-Y gastric bypass
- the 'hindgut' proposes that rapid delivery of partially digested nutrients to the distal bowel up-regulates the secretion of incretins such as glucagon-like peptide-1 (GLP-1 ).
- GLP-1 glucagon-like peptide-1
- the result of the increased incretin secretion is an enhanced glucose- dependent insulin secretion, as well as a number of other changes causing improved glucose tolerance.
- the exclusion of the duodenum results in the inhibition of a 'putative' signal that is responsible for insulin resistance (IR) and/or abnormal glycaemic control.
- IR insulin resistance
- glycaemic control In a non-obese diabetic rat model, surgical diversion of the proximal bowel caused rapid improvement of diabetes without reduction of food intake or change in weight.
- the sleeve gastrectomy has increased in popularity. This is a procedure in which 70-80% of the stomach is effectively removed. This results in a "full" sensation for the patient, plus it is suspected that there is a positive effect on the hormones produced, such as ghrelin, having the effect of reducing hunger.
- the present invention provides for improved methods and apparatus for trans- orally providing a barrier to nutrient absorption in the gastro-intestinal tract, most specifically the small intestine.
- the physician passes the device beyond the pylorus.
- the physician then uses the described delivery device to treat a pre-determined length of the Gl tract.
- the treatment can be a physiological change to the local tissue, rendering it non-functional or very limited in function as to its absorption capabilities. This change is temporary as the body will heal the affected area over time, returning to full functionality.
- the benefit above other devices comes from the lack of a required anchoring mechanism, eliminating a major cause of complications and limitations to implant duration. Equally beneficial is the self-correcting aspect, eliminating the need for re-intervention for device retrieval. Secondarily, this approach offers the ability for re-treatment as warranted by the patient's behavioral modifications or lack thereof.
- the length of the treated section may be adjusted by device selection or subsequent treatments by the physician, providing an effective barrier to caloric absorption and which is highly directed and individualized based on the patient's specific needs.
- the end result is a change in the mucosal surface of the Gl tract which results in temporary loss of function of the nutrient absorbing qualities of the treated section. This loss of function provides similar mal-absorption as with the surgical RYGB procedure, without the surgical intervention or permanence, or the inserted barrier devices, but without an implant being left behind, and without the subsequent trauma of anchors and retrieval.
- Figure 1 is a plan view of an embodiment of a device of the invention
- Figure 2 is a section view of section A-A of Figure 1 ;
- Figure 3 depicts the section of the gastro-intestinal tract being treated with one implementation of the present invention shown.
- Figure 4 depicts a section of a Gl tract targeted for treatment using an embodiment of a method of the invention
- Figure 5 is a detail view of portion of Figure 4.
- Figure 6 shows view of tissue targeted for treatment by an embodiment of a method of the invention.
- the present invention described herein describes trans-oral methods to treat obesity and metabolic disease by providing a topical treatment to the mucosal layer of a segment of the gastro-intestinal tract (Gl tract) that significantly reduces nutrient absorption in the treated area.
- Gl tract shall include, but not be limited to, the proximal five feet of the small intestine.
- greatly reducing the absorption of nutrients, specifically in the upper small intestine can have a profound effect on weight loss and the elimination in many patients of T2DM.
- Device 100 is generally a catheter-style device that is designed for advancement over a guidewire 108 and through a delivery catheter ( Figure 3). Beginning from a proximal end 102, the device 100 includes a manifold 1 16 defining a guidewire port 1 17, and a plurality of fluid ports 1 18 and 1 19. [0022] Moving along the device 100 in a distal direction, the manifold 102 is connected to a catheter 1 15, which fluidly connects the manifold 102 with the distal, treatment segment 1 13 of the device 100.
- the treatment segment 1 13 includes a catheter length defined by a plurality of small treatment fluid ports 1 14, and separated by a pair of balloons 109.
- the treatment fluid ports 1 14 comprise multiple axial rows of ports. The ports of each row may be aligned such that no port is directly across from another port.
- An inflation port 1 10 fluidly connects each of the balloons 109 with an inflation lumen 121 , internal to the catheter 1 15, shown in Figure 2.
- the inflation lumen 121 is proximally terminates at fluid port 1 19.
- Multi-lumen catheter 1 15 also includes a central lumen 122 that carries treatment fluid from fluid port 1 18 to the small treatment fluid ports 1 14.
- Treatment fluid ports 1 14 run the entire length of the treatment section 1 13 and are spaced from 1 -10 cm, preferably 2 cm.
- Radiopaque markers 1 1 1 are provided to assist in visualizing one or both ends of the treatment segment 1 13.
- a conical tip 1 12 is provided to create a smooth, atraumatic transition between a guidewire 108 and the device 100.
- a guidewire lumen 120 runs the length of the device 100 between the tip 1 12 and the guidewire port 1 17.
- Figure 3 depicts an embodiment of the invention in which the mucosal surface is treated to cause reduced nutrient absorption.
- an imaging modality such as fluoroscopy
- a guidewire 108 and a sheath catheter 106 are passed through the Gl tract A across the pylorus B.
- the device 100 is then passed through the catheter 106 along the guide wire 108 and positioned to the proper location, using markers 1 1 1 , which are optimally located under the balloons 109 or adjacent thereto.
- the balloons 109 are then inflated to isolate the section of intestine to be treated.
- Proper placement and treatment area may include the entirety of the duodenum B and jejunum C with preference given to the section distal to the sphincter of oddi D. Further preferred location could locate the treatment area entirely within the jejunum, beginning immediately distal the ligament of trietz E.
- the balloons must be inflated significantly larger than the diameter of the intestine, up to an inflated diameter of up to 200% of the diameter of the intestine, preferably to 150% of the intestinal diameter.
- Techniques to produce balloons as are described are well understood. Inflation of the balloons involves infusion of (typically) normal saline through port 1 19.
- the inflation fluid may or may not contain a radiopaque dye for observation and confirmation of inflation and deflation.
- An acidic solution is formulated using an organic or inorganic acid.
- the solution is intended to digest the epithelial elements of the mucosa rendering them ineffective in absorption of nutrients.
- a second effect of the digestion process will be to disrupt the neural pathways affecting nutrition uptake distal to the affected location.
- the pH of the acidic solution may vary from 0.1 to 5, positive results have been achieved using a pH in the range of.5 to 1 .5.
- the pH is modified using NaOH using such that final pH is in the range of .5 to 1 .5.
- a volume of the modified solution is drawn into a syringe of appropriate size and fixed onto the proximal port 1 18 of the isolated intestine and the solution is introduced such that the isolated intestinal mucosa is entirely immersed with the solution.
- the residence time of the solution in the intestine may be from 30 seconds to 15 minutes.
- the isolated intestine is aspirated through the same infusion ports, then flushed to remove the acid solution.
- the first flush of the intestine is conducted using water and is intended only to remove the digesting solution from the intestinal lining.
- any residual acid is neutralized using a buffer system of adequate strength (molar concentration) and pH to affect neutrality, pH 7.0, of the intestinal environment.
- buffering solutions formulated from mono and dibasic phosphate salts such that the final buffering concentration is in the range of 0.01 - 3.0 molar concentration with positive results at approximately 0.2 M.
- the buffer is introduced into the proximal access port and the mucosal aspect of the intestine is flushed for a period of 30 seconds to 15 minutes. The lack of effervescence of the exiting buffer solution will indicate completion of the rinsing process.
- the resulting affect on the mucosal tissue is a mild erosion of the mucosal layer 302. This will be evidenced by the removal of part or all of the villi 305 and its components. Further, the erosion may go into the sub-mucosal layer 303. This would be appropriate when a longer lasting effect of treatment, (reduced nutrient absorption) is warranted. Deeper tissue removal results in longer healing times and therefore longer interruption in normal tissue function. It is desired not to significantly treat into the muscular layer 304 so as not to impact the peristaltic function of the intestine, keeping the body's mechanism to move food along the Gl tract intact.
- a fixative solution is formulated such that the proteinaceous components of the mucosa and mucosal epithelium are crosslinked rendering them ineffective in supporting nutrition uptake. While crosslinking can be affected using varying agents such as carbodiimide, vitamin B12 / UV, and mono and dialdehydes.
- One preferred crosslinker is gluteraldehyde.
- a crosslinking solution is formulated using gluteraldehyde. Starting from a base solution of 25% gluteraldehyde the solution is diluted using a buffering solution such as 0.02 M phosphate such that the final concentration of 0.1 -5% v/v gluteraldehyde with a preferred concentration being 1 %. The pH of the solution is secondarily adjusted to 7.0.
- a volume of the crosslinker is loaded into a syringe and the solution is delivered into the proximal portion of the isolated intestinal section until the mucosa is fully immersed.
- the solution is left in contact with the mucosa for a period of 30 seconds to 30 minutes with a preferred time being approximately five (5) minutes.
- the gluteraldehyde solution is rinsed from the intestinal tract using a buffering solution such as 0.2 M phosphate buffer at pH 7.0.
- a buffering solution such as 0.2 M phosphate buffer at pH 7.0.
- an aldehyde scavenger is the amino acid glycine.
- an aqueous solution containing 1 % glycine v/v is passed through the isolated intestine to assure complete inactivation of any residual aldehyde.
- the resulting affect on the cross-linked mucosal tissue 302 will be to eliminate all or part of the nutrient absorption functionality of the treated section. Left to time, the treated area section is will heal, thereby making the procedure self-reversing. Deeper cross-linking into the sub-mucosal layer 30 would be appropriate when a longer lasting effect of treatment, (reduced nutrient absorption) is warranted. Deeper tissue cross- linking results in longer healing times and therefore longer interruption in normal tissue function. It is desired not to significantly treat into the muscular layer 304 so as not to impact the peristaltic function of the intestine, keeping the body's mechanism to move food along the Gl tract intact.
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- Health & Medical Sciences (AREA)
- Child & Adolescent Psychology (AREA)
- Obesity (AREA)
- Nursing (AREA)
- Orthopedic Medicine & Surgery (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)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
L'invention concerne des procédés et des dispositifs pour empêcher l'absorption de nutriments dans l'intestin grêle, selon lesquels on fait passer un dispositif médical par l'œsophage et on le place dans l'intestin grêle afin de traiter la surface muqueuse intérieure de l'intestin grêle, ce qui provoque une réduction de la capacité d'absorption des nutriments du segment traité. Dans un mode de réalisation, le dispositif contient un élément qui isole le segment à traiter et permet la délivrance et le retrait des agents de traitement et des agents de neutralisation.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/US2012/062486 WO2014070136A1 (fr) | 2012-10-29 | 2012-10-29 | Barrière contre l'absorption des nutriments et procédé de délivrance |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/US2012/062486 WO2014070136A1 (fr) | 2012-10-29 | 2012-10-29 | Barrière contre l'absorption des nutriments et procédé de délivrance |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2014070136A1 true WO2014070136A1 (fr) | 2014-05-08 |
Family
ID=50627841
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2012/062486 Ceased WO2014070136A1 (fr) | 2012-10-29 | 2012-10-29 | Barrière contre l'absorption des nutriments et procédé de délivrance |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2014070136A1 (fr) |
Cited By (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9757535B2 (en) | 2014-07-16 | 2017-09-12 | Fractyl Laboratories, Inc. | Systems, devices and methods for performing medical procedures in the intestine |
| US10232143B2 (en) | 2013-11-22 | 2019-03-19 | Fractyl Laboratories, Inc. | Systems, devices and methods for the creation of a therapeutic restriction in the gastrointestinal tract |
| WO2019089392A1 (fr) * | 2017-10-30 | 2019-05-09 | Metaboscopy Medical, Inc. | Procédés et dispositifs de traitement de diabètes |
| US10299857B2 (en) | 2013-06-04 | 2019-05-28 | Fractyl Laboratories, Inc. | Methods, systems and devices for reducing the luminal surface area of the gastrointestinal tract |
| US10349998B2 (en) | 2012-02-27 | 2019-07-16 | Fractyl Laboratories, Inc. | Heat ablation systems, devices and methods for the treatment of tissue |
| EP3496799A4 (fr) * | 2016-08-08 | 2020-03-11 | C.R. Bard Inc. | Procédé et appareil pour améliorer le taux de maturation d'une fistule artérioveineuse |
| US10765474B2 (en) | 2012-02-27 | 2020-09-08 | Fractyl Laboratories, Inc. | Injectate delivery devices, systems and methods |
| US10869718B2 (en) | 2014-07-16 | 2020-12-22 | Fractyl Laboratories, Inc. | Methods and systems for treating diabetes and related diseases and disorders |
| US10959774B2 (en) | 2014-03-24 | 2021-03-30 | Fractyl Laboratories, Inc. | Injectate delivery devices, systems and methods |
| US10973561B2 (en) | 2012-08-09 | 2021-04-13 | Fractyl Laboratories, Inc. | Ablation systems, devices and methods for the treatment of tissue |
| US10980590B2 (en) | 2011-01-19 | 2021-04-20 | Fractyl Laboratories, Inc. | Devices and methods for the treatment of tissue |
| US11185367B2 (en) | 2014-07-16 | 2021-11-30 | Fractyl Health, Inc. | Methods and systems for treating diabetes and related diseases and disorders |
| US11246639B2 (en) | 2012-10-05 | 2022-02-15 | Fractyl Health, Inc. | Methods, systems and devices for performing multiple treatments on a patient |
| US11439457B2 (en) | 2012-07-30 | 2022-09-13 | Fractyl Health, Inc. | Electrical energy ablation systems, devices and methods for the treatment of tissue |
| US11986235B2 (en) | 2013-09-12 | 2024-05-21 | Fractyl Health, Inc. | Systems, methods and devices for treatment of target tissue |
| US12364554B2 (en) | 2020-01-15 | 2025-07-22 | Fractyl Health, Inc. | Automated tissue treatment devices, systems, and methods |
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- 2012-10-29 WO PCT/US2012/062486 patent/WO2014070136A1/fr not_active Ceased
Patent Citations (6)
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| US20090240105A1 (en) * | 2002-04-03 | 2009-09-24 | Julie Ann Smit | Endoscope & tools for applying sealants and adhesives and intestinal lining for reducing food absorption |
| US20070014756A1 (en) * | 2003-03-29 | 2007-01-18 | Nicholas Touchot | Composition and method for treating the gastro-intestinal tract |
| US20060086362A1 (en) * | 2004-10-22 | 2006-04-27 | Stephen Solomon | Intestinal ablation to limit food absorption |
| US20070100369A1 (en) * | 2005-10-31 | 2007-05-03 | Cragg Andrew H | Intragastric space filler |
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Cited By (36)
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|---|---|---|---|---|
| US10987149B2 (en) | 2011-01-19 | 2021-04-27 | Fractyl Laboratories, Inc. | Devices and methods for the treatment of tissue |
| US10980590B2 (en) | 2011-01-19 | 2021-04-20 | Fractyl Laboratories, Inc. | Devices and methods for the treatment of tissue |
| US12201342B2 (en) | 2012-02-27 | 2025-01-21 | Fractyl Health, Inc. | Heat ablation systems, devices and methods for the treatment of tissue |
| US10349998B2 (en) | 2012-02-27 | 2019-07-16 | Fractyl Laboratories, Inc. | Heat ablation systems, devices and methods for the treatment of tissue |
| US10765474B2 (en) | 2012-02-27 | 2020-09-08 | Fractyl Laboratories, Inc. | Injectate delivery devices, systems and methods |
| US11419659B2 (en) | 2012-02-27 | 2022-08-23 | Fractyl Health, Inc. | Heat ablation systems, devices and methods for the treatment of tissue |
| US12178502B2 (en) | 2012-04-19 | 2024-12-31 | Fractyl Health, Inc. | Tissue expansion devices, systems and methods |
| US12303185B2 (en) | 2012-07-30 | 2025-05-20 | Fractyl Health, Inc. | Electrical energy ablation systems, devices and methods for the treatment of tissue |
| US11439457B2 (en) | 2012-07-30 | 2022-09-13 | Fractyl Health, Inc. | Electrical energy ablation systems, devices and methods for the treatment of tissue |
| US10973561B2 (en) | 2012-08-09 | 2021-04-13 | Fractyl Laboratories, Inc. | Ablation systems, devices and methods for the treatment of tissue |
| US12396777B2 (en) | 2012-08-09 | 2025-08-26 | Fractyl Health, Inc. | Ablation systems, devices and methods for the treatment of tissue |
| US12089887B2 (en) | 2012-08-09 | 2024-09-17 | Fractyl Health, Inc. | Ablation systems, devices and methods for the treatment of tissue |
| US11246639B2 (en) | 2012-10-05 | 2022-02-15 | Fractyl Health, Inc. | Methods, systems and devices for performing multiple treatments on a patient |
| US10299857B2 (en) | 2013-06-04 | 2019-05-28 | Fractyl Laboratories, Inc. | Methods, systems and devices for reducing the luminal surface area of the gastrointestinal tract |
| US11311333B2 (en) | 2013-06-04 | 2022-04-26 | Fractyl Health, Inc. | Methods, systems and devices for reducing the luminal surface area of the gastrointestinal tract |
| US12102380B2 (en) | 2013-06-04 | 2024-10-01 | Fractyl Health, Inc. | Methods, systems and devices for reducing the luminal surface area of the gastrointestinal tract |
| US11986235B2 (en) | 2013-09-12 | 2024-05-21 | Fractyl Health, Inc. | Systems, methods and devices for treatment of target tissue |
| US11826521B2 (en) | 2013-11-22 | 2023-11-28 | Fractyl Health, Inc. | Systems, devices and methods for the creation of a therapeutic restriction in the gastrointestinal tract |
| US10232143B2 (en) | 2013-11-22 | 2019-03-19 | Fractyl Laboratories, Inc. | Systems, devices and methods for the creation of a therapeutic restriction in the gastrointestinal tract |
| US10864352B2 (en) | 2013-11-22 | 2020-12-15 | Fractyl Laboratories, Inc. | Systems, devices and methods for the creation of a therapeutic restriction in the gastrointestinal tract |
| US12478426B2 (en) | 2014-03-24 | 2025-11-25 | Fractyl Health, Inc. | Injectate delivery devices, systems and methods |
| US11166761B2 (en) | 2014-03-24 | 2021-11-09 | Fractyl Health, Inc. | Injectate delivery devices, systems and methods |
| US10959774B2 (en) | 2014-03-24 | 2021-03-30 | Fractyl Laboratories, Inc. | Injectate delivery devices, systems and methods |
| US9757535B2 (en) | 2014-07-16 | 2017-09-12 | Fractyl Laboratories, Inc. | Systems, devices and methods for performing medical procedures in the intestine |
| US11565078B2 (en) | 2014-07-16 | 2023-01-31 | Fractyl Health Inc. | Systems, devices and methods for performing medical procedures in the intestine |
| US11878128B2 (en) | 2014-07-16 | 2024-01-23 | Fractyl Health, Inc. | Systems, devices and methods for performing medical procedures in the intestine |
| US10610663B2 (en) | 2014-07-16 | 2020-04-07 | Fractyl Laboratories, Inc. | Systems, devices and methods for performing medical procedures in the intestine |
| US12127785B2 (en) | 2014-07-16 | 2024-10-29 | Fractyl Health, Inc. | Methods and systems for treating diabetes and related diseases and disorders |
| US11185367B2 (en) | 2014-07-16 | 2021-11-30 | Fractyl Health, Inc. | Methods and systems for treating diabetes and related diseases and disorders |
| US11103674B2 (en) | 2014-07-16 | 2021-08-31 | Fractyl Health, Inc. | Systems, devices and methods for performing medical procedures in the intestine |
| US9844641B2 (en) | 2014-07-16 | 2017-12-19 | Fractyl Laboratories, Inc. | Systems, devices and methods for performing medical procedures in the intestine |
| US10869718B2 (en) | 2014-07-16 | 2020-12-22 | Fractyl Laboratories, Inc. | Methods and systems for treating diabetes and related diseases and disorders |
| US11464959B2 (en) | 2016-08-08 | 2022-10-11 | C. R. Bard, Inc. | Method and apparatus for enhancing the maturation rate of an arteriovenous fistula |
| EP3496799A4 (fr) * | 2016-08-08 | 2020-03-11 | C.R. Bard Inc. | Procédé et appareil pour améliorer le taux de maturation d'une fistule artérioveineuse |
| WO2019089392A1 (fr) * | 2017-10-30 | 2019-05-09 | Metaboscopy Medical, Inc. | Procédés et dispositifs de traitement de diabètes |
| US12364554B2 (en) | 2020-01-15 | 2025-07-22 | Fractyl Health, Inc. | Automated tissue treatment devices, systems, and methods |
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