Background:

Conventional minimally invasive medical procedures, such as laparoscopic and interventional procedures, often require the surgeon to deliver a securing element, such as a clip, into the body. Many medical procedures require these securing elements to fix an implant, such as a stent-graft or mesh material, in a specific location in the body. For example, securing a stent-graft in place using a plurality of clips helps to prevent leaks in the stent-graft, which can compromise the efficacy of the surgical repair. Frequently, due to the imprecision of these conventional securing element delivery techniques, the elements tend to migrate, resulting in leakage in the stents. As such, it is a goal to improve the precision with which the securing elements are placed and fixed.

Summary:

The present invention relates to a device and a method for the controlled delivery and placement of one or more securing elements in the body. The securing elements may be placed in a desired configuration to securely and fixedly hold an implant in place at a target region in the body during. The present invention relates to a remotely operated clip delivery device that delivers a number of clips to securely fix an implant to a target region in the body.

According to an embodiment of the invention, following the placement of an implant at a target region in a patient, the clip-delivery device is inserted into the patient and navigated up to the location of the implant and target region. Once the device is in place, it positions itself against the wall of the structure and secures itself in place, using an inflatable device/mechanism, such as a balloon. The portion of the device inserted into the body includes a plurality of pre-loaded securing elements, herein referred to as "clips.” The device delivers and places the plurality of clips such that the clips penetrate the target region. Following delivery of each clip, the device is maneuverer to deliver the next clip loaded on the device, until all the clips have been delivered.

The clip-delivery device according to an embodiment of the present invention includes three primary devices: 1) a distal device inserted into the patient, 2) a proximal device used by the surgeon to control the operation of the distal device, and 3)a connecting system that connects the proximal device and distal device together, allowing for interaction between the two devices.

According to an embodiment of the present invention, the distal device includes a series of cooperative concentric tele scoping sleeves. The sleeves possess various preformed shapes (bends) and interact with one another in such a manner that they may be mechanically extended from one another and pulled back into relation with one another. The telescoping sleeves are arranged so as to allow precise manoeuvrability of the portion of the distal device upon reaching the target region.

The clips are pre-loaded onto a screw-like extension or screw of the distal device prior to insertion into the body. The tip of the distal device may be articulated to an appropriate position for deployment of the one or more securing clips. The outside of the distal device includes an inflatable material, or balloon, inflated in order to hold the distal device in place during operation of the clip-delivery device. The clips are made of a suitable shape-memory wire material and are curled or spirally-shaped around an oval profile. In operation of the device, the clips may be moved through and out of the distal device by rotating the screw.

Rotation of the clips is blocked by a sleeve surrounding the screw. As such, as the screw rotates, the clips are translated upward and out of the tip of the distal device. The clip exits the device via a needle which guides the clip straight out to penetrate into the target region. The clip initially emerges from the tip of the needle in a straightened orientation, penetrates the target, and then forms a secure loop by assuming its memory shape once it is free from the constraints of the sleeve and needle of the distal device. The self-assembly or transformation of the clip into its curled memory shape causes the clip to firmly embed itself into the target region. Next, the distal device is retracted to embed the remaining portion of the clip in the stent wall, thus securing the stent and target region together.

Benefits:

- Controlled placement of securing elements in the body

- Allows multiple placement of securing elements at once

Applications:

- Minimally invasive surgeries

- Laparoscopic procedures

- Vascular surgeries

Full Patent: Method And Device For The Controlled Delivery And Placement Of Securing Elements In A Body