THE SCREW-DEVICE FOR ANASTOMOSIS

Receptor- bloodvessel

ASDSD

A new revolutionary Sutureless Technique & Device

developed by Dr. Erwin De Winter

A New Revolutionary Sutureless Technique & DeviceDr Erwin De Winter

1. Studies:

– Doctor in Veterinary Medicine (University Gent, 1982)

– Doctor in Tropical Veterinary Medicine and Zootechnique (ITM, 1984)

– Human and Veterinairy Mycology (ITM, Antwerp, 1985)

– Medical Doctor (University Gent, 1990)

– Specialist Neurosurgery 2001

2. Residencies

– Assistent in General Surgery (orthopaedic, gynaecology, urology, gastro-enteral

surgery and general vascular surgery)(1990 -1993)

• Basic techniques in vascular surgery, anastomosis - and bypass surgery,

• occlusive and non – occlusive methods

• microsurgical techniques: “Basic Course Microsurgery” (Erasmus, Rotterdam,

1993)

– Resident Cardiovascular Surgery, assisted in more than 100 Coronary Artery

Bypass-Graft (CABG)

– Resident Neurosurgery, AZ Sint-Jan Brugge: learning basic neurovasculair

microsurgical techniques in approach of aneurysm- and AVM operations.

A new revolutionary Sutureless Technique & Device, developed by Dr. Erwin De Winter © 2008 all rights reserved

HistoryAs a neurosurgeon I have gained vast experience in neurovascular surgery. During my

residency I also operated in the fields of

– General vascular surgery

– Heart surgery, bypass operations (CABG)

I discovered that the present vascular techniques are far from perfect:

• The suturing techniques demand an extermely high technical competence from the surgeon and therefore require a long training period.

• Suturing blood vessels causes a lot of mircotrauma to the vessel wall, which may lead to deformation and even to stenosis of the vessel.

• Bypass operations take a long time as a result of the suturing technique.

• The suturing technique is primitive: it has been around for more than 100 years.

As a result, I realized that different techniques and devices were needed to improve vascular surgery.

• From 1995 onward, I have designed and developed different anastomosis devices to replace classic suturing techniques.

• Starting from my experimental work on blood vessels and artificial vessels, I developed the idea to screw blood vessels (and other hollow anatomical structures) together end-to-side.

• Experimental implementation showed that this new technique took only seconds, whereas minutes are needed with the traditional suturing methods.

• Moreover, the new technique is much easier to learn and to apply.

My two inventions, the Screw-Device (SD) and the Anchoring Screw Device, (ASD) were filed in Brussels on April 28 2003 as patent applications PCT/BE2003/00074 and PCT/BE2003/00126.


The Bloodvessel morphology plays a essential role


BLOODVESSELDiameter: normal

BLOODVESSELDiameter: changed

-Stenosis

- Occlusion

NutrientsOxigenGlucose

Normal temperature

NutrientsOxigenGlucose

Normal temperature

Target Cell – Tissue

- Nerve cell

- Muscle cell: Heart, Muscles- Other Cells: Liver, Kidney, Hormonal Tissue

Target Cell – TissueCeldysfunction, Cell death

- Nerve cell < 3 min.

- Muscle cell < 10-30 min.

- Other cells: Liver, Kidney, Hormonal Tissuel.


Stenosis (critical) of the bloodvessel

Nearly occlusion of the bloodvessel

TREATMENTPATHOLOGY

- Medication- Diet- Endovascular therapy: balloon dilatations,

Stent

- Vascular SurgeryBypass

Suture-technique

Sutureless-technique= “Screw” technique with

Screw-Device & ASD

Blood vessel pathology and treatment options

Bypass Operations

Global bypass operations performed: more than 2 million

worldwide/year

– Cardiac surgery coronary artery bypass graft (CABG) more

than1 million ww/year

– Vascular surgery, (bypass) more than 1 million ww/year

– neurosurgery , neurovascular bypass-operations

c. 1000- ww/year?

Classical bypass-operations are performed by suturing the

bloodvessels together.

– In more than 2 million bypass-operations performed ww./year,

the anastomosic site is opened mechanically, with a surgical

instrument, punch or a bistoury.

A new revolutionary Sutureless Technique & Device , developed by Dr. Erwin De Winter © 2008 all rights reserved

Suture Sutureless

sutureless

1. Screwing bloodvessels together is

much faster (seconds instead of

minutes)

2 . The anastomosis has a rigid form,

cannot collapse

3. Less microtrauma of the

bloodvessel wall, fewer deformations

of the bloodvessel wall

4. Easy to learn, smaller learning

curve for the surgeon

suture

1. A longer operation time, more

sutures(4 – 8)

2 The anastomosis site may

collapse

3. More microtrauma of the

bloodvessel wall, manipulations,

punctures by the needle, all this

may cause deformations

4. Difficult technique, longer

learningcurve for the surgeon


The use of my new sutureless technique and devices has a lot of advantages for vascular surgery and bypass procedures .

SUTURING

“Screw-technique“

Anchoring S. D.

ASD


ANASTOMOSIS, END-TO-SIDE

Suturing Sutureless

SUTURING

“Screw-technique“ with

Anchoring Screw-Device

ASD

THE SCREW-DEVICE FOR ANASTOMOSIS

SD

SDSD

SD


THE SCREW-DEVICE & ANCHORING SCREW-DEVICE

Receptor- bloodvessel

ASDSD



ANASTOMOSIS, END-TO-SIDE, suturing sutureless

SUTURING

Screw technique withAnchoring Screw-Device

ASD














SculptorRonald De Winter


Coronary Artery

Bypass Graft

with Screw-Device

THE SUCCESS OF THIS INVENTION

- Technical advantages

- Commercial advantages


TECHNICAL ADVANTAGES,

suturing sutureless

SUTURING

“Screw-technique“

Anchoring S. D.

1. It takes less time to perform vascular

bypass operation with this sutureless

technique and devices.

2. It is very easy to apply this device, and

the technique is easy to learn.

3. It causes far less microtrauma and

requires fewer manipulations than

traditional suturing.

4. The anastomosic site remains open and

will not collapse. Collapse is prevented

by the rigid structure of the anastomis

devices (SD & ASD)


ASD

Commercial advantages• The product is market driven, it is in demand

• The product and the technique are both inventive, novel and patented

• The product is significant to the business and to employment

• The product is functional, capable of being produced and economical

• The product has a suitable level of technology

• The product can be launched quickly

• Personal commitment by the inventor Dr. E. De Winter, neurosurgeon

• Investors and different academic departments are interested


MARKET Bypass-operations

Global bypass operations performed: more than 2 million

worldwide/year

– Cardiac surgery: coronary artery bypass graft (CABG) more than

1 million ww/year

– General vascular surgery (bypass) more than 1 million ww/year

– Neurosurgery: neurovascular bypass-operations c. 1000-

ww/year

Classical bypass-operations are performed by suturing the bloodvessels together. In

more than 2 million bypass-operations performed ww./year, the anastomosic site is

opened mechanically, with a surgical instrument, punch or a bistoury.


FUTURE MARKET GROWTH

• Size of the total market:

Only 1.5 billion out of 6 billion people have access to

Modern Medicine.

• Number one mortality cause in the world: Vascular diseases, cardiovascular diseases, and

strokes. Worldwide, 1 out of 3 persons die of a vascular

disease.

• In industrialised countries:life expectancy is much longer


Number %

Population 6,400,000,000

Total deaths per year 57,000,000 0,9

Cardiovascular deaths 16,600,000 31

Coronary heart disease 43

Stroke 32

Not in high income countries 78

AIDS 2,850,000

Tuberculosis 1,700,000

Malaria 1,140,000

(mostly in Africa)

(*)(“The prevention of cardiovasular disease worldwide: whose task and WHO’s task?”, Philip Poole-Wilson, Clinical Medicine vol 5 No 4

july/augustus 2005)

Most important causes of mortality

Vascular diseases, like blood vessel stenosis, aneurysms (fusiform, saccular,...) dilatations of the bloodvessel, are the most important causes of disability and death. Worldwide 1/3rd of global deaths is due to a cardiovascular disease. 43% of these deaths are caused by coronary artery (heart bloodvessel) and 32% by a “stroke “ (brain-infarct).


The prevention of cardiovascular disease worldwide: whose task and WHO’s task? Philip Poole-Wilson, Clinical Medicine vol 5 No 4 july/August 2005

Most important causes of mortality

MARKET LEADERSHIP

Radical innovation: breakthroughs : New-to-the world product; SD and ASD

New technique

will launch the company into new markets

will make the company a market leader

Sustainable Competitive advantageunique, difficult to replicate, superior to competitors’ innovation

new product development is the key driver to competitive advantage

growth and profitability

Creates a revolutionary change that will tranform existing markets

and will create new ones

Enables rapid growth and creates high return on investment


1. PATENTED WORLDWIDE: for both technique and devices

2. IMPROVEMENT: The new device and technique are much better than the gold standard for anastomosis:

Suturing versus screwing bloodvessels together

3. POTENTIAL MARKET for vascular surgery and bypass procedures: more than 2 million operations

wordwide/year

4. FUTURE MARKET: - only 1.5 billion out of 6 billion people have access to modern medicine

- vascular disease is n 1 mortality cause

- life expectancy in industrialised world is much longer

5. POTENTIAL SALES: for bypass operations: 2 million operations x 2 ( at least 2 sutures needed) x cost

price material

6. MANUFACTURABILITY the device is very easy to manufacture and can be made in different materials

7. TECHNIQUE: very easy to learn for the surgeons

DEVICE: very easy to apply

8. COMPETITION: New-to-the world product and technique: no compettion

9. SYNERGY: can be combined with existing techniques and devices, thereby creating new inventions.

10. APPROPRIATE for any medical company dealing with vascular surgery, suture materials,

artificial vessels, etc.


Criteria to determine success

Health & Medicine

THE SCREW-DEVICE FOR ANASTOMOSIS