Magnamosis

The Harrison Ring™

Procedure using rare earth magnets to endoscopically create surtureless anastomoses in the bowel.

The Problem

Sutureless Anastomosis. Surgeons perform many thousands of anastamoses procedures every week in the United States alone. An anastamosis is an operative union of two hollow or tubular structures. Repairing bowel obstruction and bariatric surgery for obesity are common anastomoses procedures. At present, they require either open or laparoscopic (minimally invasive) surgery. Staples and sutures are commonly used.

Anatomic reconstruction of the disrupted intestine (cancer, trauma, weight loss, inflammatory disease, congenital malformations) requires a surgical anastomosis. There are over 2 million procedures worldwide, with 450,000 performed in the United States alone. Use of sutures is time honored (200 years) but requires surgical skill and is gradually being replaced by the use of automatic stapling devices. The market for stapling device has consolidated in the hands of major medical device companies (Covidien, Ethicon, etc).

The Solution

The Harrison Ring™ is an alternative to surgical staplers that is proving to be more effective, and much less expensive. The Harrison Ring™ creates an anastomois using magnetic force applied between concentric rings. The force gradually remodels the tissue into a strong anastomosis. This compression anastomosis has proven effective in humans using mechanical systems designed for open surgery. Limited experience exists with magnetic compression anastomosis in humans, but no system has been optimized and commercialized. The Harrison Ring™ has a unique design that creates a strong reliable anastomosis, can be delivered with available endoscopic and laparoscopic tools, and can be made for less than 1/10th the cost of staplers. It has the potential to revolutionize the stapler market with increased versatility at significantly less cost.

We have performed 4 rounds of animal experiments (pigs) to test proof of concept, develop delivery strategies, and test the quality of the resulting compression anastomosis. Based on these tests we believe that the Harrison Ring™ will be:

Easier and faster to use than existing anamstomosis devices
Ideal for MIS strategies: Laparoscopic, Endoscopic
Less likely to leak after the anastomosis is created
10 times less expensive to manufacture than any of its competitors

Device Description

The Harrison Ring™ is a single use sterile device. Each ring consists of a rare earth magnet encased in a composite polymer molded covering with a textured surface. (Figures 1+2)

Figures 1 & 2

Each Harrison Ring™ can be introduced into the intestine using standard flexible GI endoscopic or laparoscopic instruments. (Figure 3)

This figure shows what the endoscopist sees when the ring is held in the snare that has been passed through the biopsy channel of the endoscope. The snare is passed through the biopsy channel and the magnetic ring captured prior to introducing the endoscope into the patient.The two pieces of intestine containing the magnets are brought into magnetic proximity. (Figure 4) The two rings come together and compress the intervening tissue to produce a secure anastomosis in about a week. If needed, the tissue in the center of the rings can be punctured to allow for the immediate flow of fluids and solids. The magnets are passed in the stool.

Figure 4

Market for the Harrison Ring™

The Harrison Ring™ has the potential to replace a large number of sutured or stapled anastomoses. We believe the market will include:

Colon anastomosis after sigmoid low anterior resection
Gastro jejunostomy anastomosis for obesity surgery
Jejunojejunostomy for roux Y limb for various surgeries
Esophageal anastomosis after resection for cancer or benign disease
Bowel reconstruction of congenital diseases (atresias, etc)
Small bowel anastomosis after resection for cancer or benign disease
Closure of colostomy or ileostomy

The overall market for staplers is dominated by Covidien and Ethicon Endosurgery. The market was $1.2 Billion in 2009. The anticipated market with increased endoscopic procedures is estimated to be $1.55 Billion in 2014, with an annual growth rate of 9.6% driven by increases in bariatric surgery. (Source: MedMarket Diligence LLC). The stapler market is divided into linear staplers that are primarily used to cut and divide tissues and circular staplers that are primarily used to create an anastomosis. The circular stapler market was $250 Million in 2009. Circular staplers from Covidien and Ethicon are sold for $400-$800 with a COGS of approximately $180.

Under Development