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Videos= Friction Slippage, Rip-Through, stabilization button/capture.
Market Friction Devices-Suture Slippage |
Rip-Through-without knot fixation |
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Some friction hold devices have been shown to slip as low as 60 newtons |
This Video shows how the sutures which are very strong fishing line type sutures , when passed through tissue can potentially cut through the tissue. |
This video shows how stabilizing the suture when it passes through tissue with a surgical button/capture/pledget stabilzies the effects and negates the efforts to cut through tissue. |
Bench Testing-
With some of our ZipE® captures, distributed force per suture exceeds 160 Newtons. See below. |
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ZipE® knotless soft-tissue repair and attachment solution devices have, with some suture captures, distributed force per suture exceeds 160 Newtons and some captures hold 120 newtons individually. |
ZipE® technology development platform can convert knotless rotator cuff repair from 50 percent knotless to 100 percent knotless devices for double row repairs. |
ZipE® technology does not use friction to hold the suture in place, a technology that has been shown to prone to slippage as low as 60 Newtons in some devices. |
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The first device that Ziptek LLC is commercializing is the rotator cuff ZipE® repair device. There are 3 sizes offered, 3.5, 4.5 and 5.5mm bone anchors with suture bridge. The 4.5mm and 5.5mm screws will come with a 6.5mm x 2.4mm suture capture. The 3.5mm screw will come with a 4.5mm suture capture and in some indications can be utilized for labral repair. These 3 device systems can be utilized for soft tissue attachment in various parts of the body like the ankle and in some situations the hip and knee. The ZipE® screw is a standard Cancellous thread screw which allows for very good holding power in cancellous bone. More importantly , for lateral row rotator cuff repairs, it can allow for the sutures to be shuttled through the screw after setting the screw in bone thus allowing the system to perform double row rotator cuff repairs. |
ZipE® technology for double row rotator cuff repair is shown below in a cadvaer model illustrating how the suture capture can be placed on the bone side after shuttling the suture through the screw. |
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The differences in technology between the main knotless devices on the market which crimp or crush the suture and use friction to hold the suture in place and ZipE® technology which uses an engineered suture/capture construct allow for oviating any concerns for suture slippage which has been shown in some devices. |
ZipE®- the suture/capture construct aspect, has been engineered to allow the suture to travel through its entrance aperture with low "Go" forces- the upper limit is 6 lbs or about 25 newtons. When the suture is pulled in the reverse direction, the exit aperture prevents the suture from pulling back through with high "No-Go" forces. Finite Element Analysis engineers have exceeded 5:1 ratios of the "NO-GO" to "GO" forces and with 2 suture captures per suture total forces exceed 160 newtons.
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Simple Suture-One Suture-One Screw |
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Horizontal Suture with button fixation |
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The above sawbone shoulder models illustrate the versatility of ZipE® capture solution devices. They can be placed directly on tendon or on the bone side. It can perform simple suture, horizontal suture and double row constructs. |
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