Delivery systems for inserting devices into body lumens
Inventors
Kelley, Scott T. • Kelley, Jill
Assignees
Publication Number
US-11986383-B1
Publication Date
2024-05-21
Expiration Date
2043-08-11
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Abstract
Systems and methods to prevent leakage of an intestine and/or provide support to an intestine. The systems can carry the leakage protection device on an external surface for delivery or carry the leakage protection device internally within a lumen. The device is delivered into the intestine portions to protect a site where a defect is repaired such as at an anastomotic site.
Core Innovation
The invention provides a biodegradable tubular straw-like device designed to prevent leakage and/or provide support to body lumens, particularly intestines, during and after surgical procedures such as anastomosis. The device has a thin wall, an open proximal and distal end, and a lumen extending through its length enabling passage of body fluids and substances. It can be secured to body lumens via adhesives that additionally provide sealing to prevent leakage, and the device is preferably bioabsorbable, designed to degrade or be absorbed by the body over time.
The device can be inserted internally into lumens or positioned externally over luminal tissue and may have an enlarged rim providing a radial force to hold the device in place and prevent backflow. The device can be formed from tissue-engineered materials, including colon cells, and can be asymmetrical or have configurations such as a condom shape with a rim. Various adhesives or securing methods including sutures or tacking devices can be used to maintain device position, and the device may carry substances that promote healing or treatment such as growth factors, antimicrobials, or chemotherapeutics.
The invention also addresses delivery systems and methods for placement of these devices within body lumens. Delivery can be performed with anastomotic instruments like circular staplers carrying the device externally on the shaft, with proctoscopes carrying the device externally, or by using delivery sheaths that carry the device internally with pushers to deploy the device in situ. These delivery methods facilitate precise placement of the device at an anastomotic or treatment site, enabling prophylactic prevention of leakage without requiring additional surgical procedures.
Claims Coverage
The patent contains three independent method claims relating to methods of preventing intestinal leakage and supporting intestines using tubular devices and delivery instruments.
Method of delivering a tubular device via an anastomotic stapling instrument
The method includes advancing an anastomotic instrument carrying a tubular straw-like device externally on the shaft through two intestine portions, actuating the instrument to form an anastomotic site by deploying staples, advancing the tubular device distally over the shaft into the lumens, and securing the device to the intestine such that its outer wall extends across the anastomotic site.
Method of delivering a tubular device via a proctoscope
The method involves advancing a proctoscope carrying a tubular straw-like device externally through two intestine portions, advancing the tubular device distally over the outer wall of the proctoscope into the lumens, and securing the device to the intestine so that its outer wall extends across the anastomotic site.
Method of delivering a tubular device from within an instrument lumen using a pusher
The method comprises advancing an instrument retaining a tubular straw-like device within an internal lumen through two intestine portions, advancing the device through the lumen of the instrument exiting the distal end into the lumens, securing the device to the intestine so that its outer wall extends across the anastomotic site, and applying a healing or treatment substance to the outer wall of a rim of the device prior to insertion near the anastomotic site.
The independent claims cover methods of preventing leakage and supporting intestines by delivering a tubular straw-like device either externally on instruments such as staplers and proctoscopes or internally through their lumen, and securing the device to the intestinal lumens, optionally using adhesives, pushers, and alignment markers, and using devices formed of tissue engineered materials.
Stated Advantages
The invention prophylactically prevents leakage at anastomotic sites thereby reducing the risk of complications such as contamination, sepsis, and death.
The biodegradable nature of the device eliminates the need for invasive mechanical removal after healing.
The device provides structural support and stability to body lumens, potentially reducing scarring and strictures post surgery.
Delivery systems allow placement of the device during surgical procedures, avoiding the need for separate delivery steps.
The device can carry healing or treatment substances such as growth factors, antimicrobials, and chemotherapeutics to promote tissue healing or treat diseases.
Use of an adhesive that also functions as a sealant helps inhibit leakage and secures the device in place.
The device can be configured with a rim to provide a radial force to help retain the device and prevent backflow.
Documented Applications
Providing support and reducing leakage at anastomotic sites in gastrointestinal tract surgeries involving the esophagus, stomach, small intestine, large intestine, or colon.
Sealing perforations, tears, rips, or ulcers in intestines or other body lumens, including perforations due to diverticulitis or iatrogenic causes.
Supporting and protecting luminal tissue during and after treatments such as radiation to limit tissue damage.
Insertion across luminal obstructions such as tumors or strictures to provide scaffold support and deliver therapeutic agents including chemotherapeutics or growth inhibitors.
Delivery of therapeutic substances to anastomotic or other luminal sites for healing and disease treatment.
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