CN-115349989-B - Devices, assemblies, and systems for delivering and deploying gastric restriction devices and methods of operation thereof

Abstract

Devices, assemblies, and systems for delivering and deploying gastric restriction devices and methods of operation thereof are disclosed. A system for deploying a gastric occluding device may include a housing including a gear mechanism, a control component connected to the gear mechanism, a delivery tube connected to the housing, wherein a distal end of the delivery tube is configured to be positioned in the gastric occluding device, and a control tube connected to the gear mechanism within the housing, wherein the control tube extends through a lumen of the delivery tube and is configured to engage the gastric occluding device, wherein the control tube is configured to rotate in response to rotation of the control component, and wherein rotation of the control tube is configured to rotate the gastric occluding device. The devices, components and systems may be introduced or implanted and removed by medical procedures that are safe and relatively simple to perform.

Inventors

• David Niedman
• Kobe Ikey

Assignees

• 南微医学科技股份有限公司

Dates

Publication Date

20260512

Application Date

20220513

Priority Date

20210517

Claims (20)

1. 1. A system for deploying a gastric restriction device, comprising: A housing including a gear mechanism; A control member connected to the gear mechanism; A delivery tube connected to the housing, wherein the delivery tube has a delivery tube distal end and a delivery tube lumen passing through the delivery tube, wherein the delivery tube distal end is configured to be positioned within the gastric occlusion device, and A control tube connected to the gear mechanism within the housing, wherein the control tube extends through the delivery tube lumen and is configured to engage with the gastric restriction device, wherein the control tube is configured to rotate in response to rotation of the control component, and wherein rotation of the control tube is configured to rotate the gastric restriction device; wherein the control tube comprises a control tube proximal section and a control tube distal section; Wherein the gastric occluding device comprises a coil member, a device cover defining a fillable cavity, and a distal hub positioned within the cavity and connected to the device cover, the control tube distal section being configured to engage the distal hub of the gastric occluding device prior to deployment of the gastric occluding device; Wherein rotation of the control tube is configured to rotate the distal bushing, rotation of the distal bushing is configured to rotate the device cover, rotation of the device cover is configured to rotate the coil member into a contracted widened configuration when the coil member enters a lumen of the device cover.
2. 2. The system of claim 1, wherein the delivery tube distal end comprises a flange, wherein the flange is configured to be positioned within a cavity defined by the device cover to connect the device cover to the delivery tube, wherein the flange is configured to seal a cover opening defined along a proximal end of the device cover.
3. 3. The system of claim 2, wherein an outer surface of the flange, an inner surface of the device cover, or a combination thereof is covered by a polymer coating to reduce friction between the outer surface of the flange and the inner surface of the device cover when the device cover is rotated.
4. 4. The system of claim 1, wherein the control tube distal section includes a key portion that mates with a locking feature of the distal bushing positioned within the gastric restriction device.
5. 5. The system of claim 4, wherein the key portion of the control tube and the locking member of the distal bushing each comprise a matching cross-sectional shape.
6. 6. The system of claim 5, wherein the cross-sectional shape is rectangular.
7. 7. The system of claim 5, wherein the cross-sectional shape is elliptical.
8. 8. The system of claim 1, wherein the gear mechanism comprises a first gear member and a second gear member, wherein the control member is connected to the first gear member, the control tube is connected to the second gear member, wherein the first gear member is configured to rotate about a first gear rotation axis and the second gear member is configured to rotate about a second gear rotation axis, and wherein the first gear rotation axis is perpendicular to the second gear rotation axis.
9. 9. The system of claim 1, wherein a section of the control tube is configured to bend into a curved configuration when the section of the control tube and the delivery tube surrounding the section of the control tube extend into a patient, and wherein the control tube is configured to rotate within the delivery tube when in the curved configuration.
10. 10. The system of claim 1, wherein the housing further comprises a spool and the control component is connected to the spool, wherein the control tube further comprises a control tube lumen and a plurality of tension wires extend through the control tube lumen, and wherein rotation of the control component is configured to wind in the tension wires extending through the control tube lumen.
11. 11. The system of claim 1, wherein the housing further comprises a spool and the control component is connected to the spool, wherein the control tube further comprises a control tube lumen and at least one anchor wire extends through the control tube lumen, and wherein rotation of the control component is configured to reel in the anchor wire extending through the control tube lumen.
12. 12. A gastric occluding assembly comprising: a control tube comprising a control tube proximal section and a control tube distal section, wherein the control tube distal section comprises a key portion; a delivery tube comprising a delivery tube lumen, wherein a section of the control tube is positioned within the delivery tube lumen and the control tube is rotatable within the delivery tube lumen, and A gastric occluding device comprising: a device cover comprising a cavity and a cover opening at a cover proximal end of the device cover; a distal closure member connected to the device cover by a strap extending from the device cover, and A distal bushing positioned within the cavity and connected to the device cover, Wherein the distal bushing comprises a locking member, Wherein the key portion of the control tube distal section mates with the locking feature of the distal bushing prior to deployment of the gastric occluding device; Wherein the gastric occluding device further comprises a coil member comprising a coil proximal end and a coil distal end, wherein the coil distal end extends into the cavity and is connected to the distal hub, The distal bushing is configured to rotate in response to rotation of the control tube; The device cover is configured to rotate in response to rotation of the distal bushing, wherein the device cover is configured to rotate in response to rotation of the control tube when the key portion of the control tube distal section is engaged with the locking feature of the distal bushing, and The coil member is configured to rotate to form a contracted widened configuration in response to rotation of the device cover when the coil member enters the cavity of the device cover.
13. 13. The gastric blocking assembly of claim 12 wherein the gastric blocking device further comprises a plurality of internal struts disposed within the cavity.
14. 14. The gastric blocking assembly of claim 13, wherein one end of each of the inner struts is connected to an inner surface of the device cover and at the other end of the inner strut is connected to the distal bushing.
15. 15. A system for deploying a gastric restriction device, comprising: A housing comprising a worm gear, wherein the worm gear comprises a worm wheel and a worm cylinder configured to rotate in response to rotation of the worm wheel; A delivery tube comprising a delivery tube proximal end, a delivery tube distal end, and a delivery tube lumen between the delivery tube proximal end and the delivery tube distal end, wherein the delivery tube is connected to a housing at the delivery tube proximal end, and the delivery tube distal end is configured to be connected to the gastric occlusion device; a control part connected to the worm wheel, and A control tube comprising a control tube proximal section and a control tube distal section, the control tube configured to extend through the delivery tube lumen; wherein the control tube proximal section is connected to the worm barrel, Wherein the gastric occluding device is connected to the distal section of the control tube, and Wherein the gastric occluding device is configured to rotate in response to rotation of the control component; Wherein the gastric occluding device comprises a coil member, a device cover defining a fillable cavity, and a distal hub positioned within the cavity and connected to the device cover, the control tube distal section being configured to engage the distal hub of the gastric occluding device prior to deployment of the gastric occluding device; Wherein the gastric occluding device is configured to rotate in response to rotation of the control component comprises rotating the distal hub in response to rotation of the control component, rotating the device cover in response to rotation of the distal hub, and rotating the coil member in response to rotation of the device cover to form a contracted, widened configuration when the coil member enters a lumen of the device cover.
16. 16. The system of claim 15, wherein each of the delivery tube and the control tube is bendable into a bent configuration, and wherein the control tube is configured to rotate when in the bent configuration within the delivery tube.
17. 17. The system of claim 15, wherein the control tube is made of a biocompatible polymeric material.
18. 18. The system of claim 15, wherein the worm gear comprises a plurality of wheel blades extending radially outward from a circumferential surface of a wheel disc, wherein the worm cylinder comprises a plurality of cylinder grooves protruding radially inward from a lateral face of the worm cylinder to define a plurality of groove faces, and wherein rotation of the worm gear causes at least one of the wheel blades to impart translational motion to at least one of the groove faces to rotate the worm cylinder.
19. 19. The system of claim 15, wherein the worm gear comprises a plurality of wheel blades radially protruding from a circumferential surface of a wheel disc, wherein each of the wheel blades has a blade ridge, and the blade ridges are aligned at an oblique angle relative to a midline bisecting the circumferential surface of the wheel disc, and wherein a length dimension of each of the wheel blades is less than a circumference of the wheel disc.
20. 20. The system of claim 15, wherein the worm barrel comprises a barrel proximal portion and a barrel distal portion, wherein the worm barrel further comprises a plurality of barrel grooves protruding radially inward from a lateral face of the worm barrel, wherein each of the barrel grooves is oriented substantially in a longitudinal direction such that each of the barrel grooves extends from the barrel proximal portion to the barrel distal portion.

Description

Devices, assemblies, and systems for delivering and deploying gastric restriction devices and methods of operation thereof Technical Field The present disclosure relates generally to the field of bariatrics, and more particularly, to devices, assemblies and systems for delivering and deploying gastric restriction devices and methods of operation thereof. Background In the united states, obese people are inundated with disasters. Recent government studies have shown that up to 40% of americans are obese, with almost 20% of the americans being morbid obese. Obese patients often suffer from cardiovascular disease, heart disease, stroke, diabetes, and obstructive sleep apnea. Recent studies have shown that obesity can reduce the life span of adults by an average of three years and children by an average of twenty years. Many attempts have been made in the prior art to provide medicaments, devices and surgical methods for treating obesity, however all of these have serious side effects or are essentially ineffective. For example, various diets, supplements and medicines have been developed and marketed, but to date, none of the medicines has shown any significant success in treating obesity, except for some medicines which have been unfortunately found to lead to a number of serious and life threatening medical conditions. To date, there are no commercially available supplements or medicines that have been demonstrated to be effective in promoting significant weight loss without serious side effects. Recognizing that no effective and safe procedure has been developed so far, the medical industry has introduced more extreme surgical procedures, one example of which is the Roux-En-Y gastric bypass procedure. This widespread invasive procedure is very effective, but potentially fatal, with a mortality rate of 1% -2%, a recovery period of 6 months, and a cost of tens of thousands of dollars, but is becoming increasingly popular because other available treatments do not produce the desired effect. Gastric reduction, or simply resecting a substantial portion of the stomach, is another procedure similar to gastric bypass, which, like gastric bypass, is also associated with potentially fatal complications. Recent study data indicate that even in the least-at-risk population, bariatric surgery results in an average annual mortality rate of approximately 5%. In another attempt to treat obesity, devices have been developed in the prior art that aim to provide a feeling of satiety to a patient. Such devices may be configured as stents for supporting the stomach or pyloric valve, or may be configured as permanent occluders. Unfortunately, these devices are essentially permanently implanted in the patient and often include complex mechanical or electrical features that may cease to function properly over time or may be serviced from time to time as needed. Examples of such devices in the prior art can be found in U.S. patent nos. 5,509,888, 6,067,991, 6,527,701, 6,689,046, 7,011,621, 7,037,344, 7,120,498, 7,122,058, and 7,167,750, and U.S. patent applications publication nos. 2004/0172142, 2005/0273060, 2007/0016262, 2007/0027548, and 2007/0083224. There is increasing evidence that reducing gastroduodenal flow can produce benefits. In unpublished but recently published data at the american society of weight loss surgery (American Society for Bariatric Surgery Conference) at 6 months 2003, stimulating the gastric vagus nerve and reducing gastric motility resulted in a body weight loss index of over 20% within 9 months. Furthermore, there are data indicating that gastric vagectomy is also effective in treating obesity by a similar mechanism. Unfortunately, these treatments require highly invasive, sometimes irreversible, surgery, which makes them undesirable for most obese people. Disclosure of Invention Devices, assemblies, and systems for delivering and deploying gastric restriction devices and methods of operation thereof are disclosed. In one variation, a system for deploying an occlusion device is disclosed. The system may include a housing including a gear mechanism, a control member connected to the gear mechanism, and a delivery tube connected to the housing. The delivery tube may have a delivery tube distal end and a delivery tube lumen therethrough. The delivery tube distal end may be configured to be positioned within a gastric occluding device. The system may also include a control tube connected to the gear mechanism within the housing. The control tube may extend through the delivery tube lumen and be configured to engage with a gastric occluding device. The control tube may be configured to rotate in response to rotation of the control component. Rotation of the control tube may be configured to rotate the gastric restriction device, including a device cover of the gastric restriction device. The delivery tube distal end may include a flange. The flange may be positioned within a cavity defined by the device cove