US-12622775-B2 - Hiatal hernia repair mesh with starlock configuration for hiatal hernia repairs and methods thereof

Abstract

A hiatal hernia repair mesh with starlock configuration for providing structural reinforcement to hiatal hernia repairs and a mechanism to prevent esophageal sliding. The hiatal hernia repair mesh includes a mesh frame configured to provide structural support to a repaired hiatus when positioned against the repaired hiatus. The hiatal hernia repair mesh includes a central opening disposed within the mesh frame, configured to surround an esophagus and allow the esophagus to pass through the mesh frame. A starlock configuration is disposed around the central opening, including a plurality of flexible leaflets extending inwardly from a perimeter of the central opening. Each of the flexible leaflets is configured to allow movement of the esophagus in a first direction to allow esophageal dilation during peristalsis while providing resistance against movement of the esophagus toward a chest cavity to prevent recurrence of a hiatal hernia.

Inventors

• David Syn

Assignees

• Syn LLC

Dates

Publication Date

20260512

Application Date

20240821

Claims (8)

1. 1 . A method of repairing a hiatal hernia, comprising: repairing a hiatal hernia by suturing one or more portions of a hiatus; positioning a hiatal hernia repair mesh against the hiatus such that the mesh frame provides structural support to the repaired hiatus, wherein the hiatal hernia repair mesh includes a mesh frame with a central opening and a starlock configuration disposed around the central opening, wherein the starlock configuration includes a plurality of flexible leaflets extending inwardly from a perimeter of the central opening; wrapping the hiatal hernia repair mesh around an esophagus such that the central opening of the mesh frame surrounds the esophagus and the plurality of flexible leaflets of the starlock configuration contact the esophagus; securing the hiatal hernia repair mesh in position, wherein the plurality of flexible leaflets of the starlock configuration are configured to allow movement of the esophagus in a first direction to allow esophageal dilation during peristalsis while providing resistance against movement of the esophagus toward a chest cavity to prevent recurrence of the hiatal hernia; and securing a fundus of a stomach to a left portion of a diaphragm and the hiatal hernia repair mesh, wherein securing the fundus of the stomach to the left portion of the diaphragm and the hiatal hernia repair mesh facilitates reestablishment of an angle of His and positions gastric clasp fibers and gastric sling fibers in an anatomically correct position to reestablish a competent gastric flap valve.
2. 2 . The method of claim 1 , wherein the hiatal hernia repair mesh has a diamond shape with four corners.
3. 3 . The method of claim 2 , wherein positioning the hiatal hernia repair mesh includes aligning one of the corners with an anterior portion of the hiatus, wherein the corner aligned with the anterior portion of the hiatus has a rounded or truncated shape.
4. 4 . The method of claim 1 , wherein the plurality of flexible leaflets have sufficient rigidity to resist a sliding force of the esophagus toward the chest cavity.
5. 5 . The method of claim 1 , wherein tips of one or more of the plurality of flexible leaflets have a non-pointed shape to provide increased surface area for contacting an esophageal wall.
6. 6 . The method of claim 5 , wherein the tips of the one or more of the plurality of flexible leaflets include a gripping surface configured to enhance contact with the esophageal wall.
7. 7 . The method of claim 1 , wherein the plurality of flexible leaflets are oriented at an angle away from the central opening.
8. 8 . The method of claim 1 , wherein wrapping the hiatal hernia repair mesh around the esophagus includes separating a first mesh limb from a second mesh limb along a cut line extending from the central opening to an outer edge of the mesh frame.

Description

TECHNICAL FIELD The present disclosure relates generally to medical devices, and more particularly to a hiatal hernia repair mesh with starlock configuration for hiatal hernia repair and methods thereof. BACKGROUND The human digestive system is a remarkable biological mechanism that enables the conversion of food into essential energy for the body. However, this complex system can sometimes experience issues that affect its normal functioning. One such problem is the occurrence of hiatal hernias, which involve a disruption in the normal anatomy of the junction between the esophagus and the stomach. In typical human anatomy, as illustrated in FIG. 1A, the stomach 170 is separated from the chest cavity by a muscular structure called the diaphragm 160. The esophagus 175, which is the tube that carries food from the mouth to the stomach, passes through an opening in the diaphragm known as the hiatus 165. Under normal circumstances, as shown in FIG. 1A, the hiatus 165 is adequately sized to allow only the passage of the esophagus 175. The junction of the esophagus 175 to the stomach 170, the esophagogastric or gastroesophageal junction includes the lower esophageal sphincter. This sphincter acts as a valve and, when it is positioned at the hiatus, functions normally to prevent reflux. The support structures in the area of the hiatus that correctly position the sphincter and support the gastric flap valve include the phrenoesophageal ligament 168, the gastric sling fibers 169, and the gastric clasp fibers 167. However, in cases of hiatal hernias, as shown in FIG. 1B, this opening becomes dilated or weakened, allowing a portion of the stomach 170, and sometimes other organs, to protrude into the chest cavity as a hiatal hernia 180. The hernia direction 182 in FIG. 1B indicates the upward movement of the stomach through the enlarged hiatus 165. Additionally, in a hiatal hernia, not only is the hiatus dilated but the support structures at the hiatus, such as the phrenoesophageal ligament 168, the gastric sling fibers 169, and the gastric clasp fibers 167, are compromised causing the lower esophageal sphincter to become ineffective as it is no longer positioned properly to be supported by the hiatus and making the gastric flap valve innefective. Typically, hiatal hernias can be classified into different types. The most common form, accounting for the vast majority of cases, is known as a type 1 or sliding hiatal hernia. In this type, the stomach intermittently slides up into the chest through the enlarged hiatus. Less common are types II, III, and IV, collectively referred to as paraesophageal hernias. These occur when a portion of the stomach and sometimes other organs push up into the chest cavity adjacent to the esophagus. While many individuals with hiatal hernias may remain asymptomatic, those who do experience symptoms often present with issues related to chronic acid reflux, also known as gastroesophageal reflux disease (GERD). The symptoms of GERD can include heartburn, a burning sensation in the chest (particularly after eating), non-cardiac chest pain, a taste of acid in the back of the mouth, difficulty swallowing, dry cough, bad breath, nausea or vomiting, and/or other symptoms such as globus, which causes the patient to experience the sensation of having something stuck in their throat. In severe cases, persistent long-term reflux may lead to more serious complications, including an increased risk of esophageal cancer. While hiatal hernias can affect individuals across various demographics, they are more commonly observed in older adults and individuals who are obese. In fact, the prevalence of hiatal hernias is particularly high in the bariatric population, with up to 90% of obese individuals potentially affected. The relationship between obesity and hiatal hernias becomes even more complex when considering bariatric surgery as a treatment for obesity. For example, vertical sleeve gastrectomy, which is currently the most common form of bariatric surgery, can potentially exacerbate existing hiatal hernias or increase the risk of developing them. This is because the procedure increases pressure within the stomach, which can aggravate reflux issues and complicate hiatal hernia management in a population already prone to these problems. Despite the high incidence of hiatal hernias in obese individuals, these hernias are not typically addressed during sleeve gastrectomy procedures. This is partly due to the lack of a standardized, effective solution and the difficulties associated with accurate diagnosis. Additionally, the fat tissue that often supports the hiatus in obese individuals tends to disappear following bariatric surgery, which can lead to the development or worsening of hiatal hernias post-operatively. The typical initial approach to treating hiatal hernias involves the use of medication, particularly acid reduction drugs. However, when medication proves ineffective or intolerable, surgical interv