spasy tm - balloon expander & catheter spasy tm...st. cox catalogue 2011. 7. 1 (rev.0) (epidural...

Part NoInitial

Length(mm)

PSIRating

MaximumDiametar

(mm)

MaximumLength

(mm)

MaximumVolume

(cc)

SWS10 10 300 14 16 4

SWS15 15 300 17 22 4

SWS20 20 300 19 34 6

Balloon Specification

Part No Description EA / Kit

Balloon CatheterSWS10SWS15SWS20

1 EA

Balloon Expander SWMP 1EA

Bone Marrow Needle SWMVP 1Set

Guide Wire SWM-1 1EA

Cannular SWM-2 1Set

Bone Drill SWM-3 1EA

Bone Cement Filler SWM-4 2Sets

1Kit Composition

Part No Description EA / Kit

Balloon CatheterSWS10SWS15SWS20

2 EA

Balloon Expander SWMP 2EA

Bone Marrow Needle SWMVP 1Set

Guide Wire SWM-1 2EA

Cannular SWM-2 2Sets

Bone Drill SWM-3 1EA

Bone Cement Filler SWM-4 6Sets

2Kit Composition

SpecOrdering

No.

10mm SWS10

15mm SWS15

20mm SWS20

Ordering Information

33, Bucheon-ro 298beon-gil, Wonmi-gu, Bucheon-si, Gyeonggi-do, Rep. of Korea (Zip Code: 420-803)TEL. +82 32 684 7071~7074 FAX. +82 32 684 7075e-mail : [email protected] Homepage : www.seawonmt.com

Spinal Alignment System for VCFSPASYTMSurgical Technique - Balloon Expander & CatheterSPASYTM

Filling the cylinder with contrast agent

Removing air from the cylinder

Connecting Balloon Catheter/ Removing residual air from the system

Pull the handle of the balloon expander(SWMP) to fill the cylinder with approx. 20cm3 of contrast agent.Then move the seal to the “lock” position.

The seal of the balloon expander (SWMP) remains locked Turn the handle to the right just before”0” marking to remove air from the cylinder.

Remove the cover of the balloon Catheter(SWS10 or SWS15 or SWS20). The 3way valve points to the open connection with “off)

To remove the remaining air, turn the handle of the balloon expander(SWMP) to the right. The balloon inflates.

Step-1“Lock” Position

Remove the Cover

“OFF” Position

Step-2

Step-4

To Remove the air from the balloon Catheter(SWS10 or SWS15 or SWS20), move the locking mechanism to the “unlock”position. Pull the handle of the balloon catheter and move the locking mechanism to the “lock” position.

“Unlock” Position

Step-5

Step-3

Seawon Meditech Co.,Ltd.

SPASY

TM -Cat. (R

ev.03, 2012.05.01)

1 Forrest Units, Hennock Road East, Marsh Barton, Exeter EX2 8RU, U.KTEL. +44 1392 829500 FAX. +44 1392 823232

Dongbang Acuprime Inc.


Spinal Alignment System for VCF

SPASYTM

IndicationVCF(Vertebral compression fracture)due to OsteoporosisOsteolytic fractureMetastatic bone fractures

HubBalloon

Pressure Gauge indicates the pressure of the ballonRelease Buttun helps to control compression anddecompression by turning on “LOCK” and “UNLOCK”.

Special Feature

Pressure GaugeRelease Button

SWS10 : 10mm

SWS15 : 15mm

SWS20 : 20mm

SWMP Balloon ExpanderSPASYTM

SWS10/15/20 Balloon CatheterSPASYTM

Bone Marrow Needle

SWMVP

Guide Wire

SWM-1

Cannula

SWM-2

Bone Drill

SWM-3

Bone Cement Filler

SWM-4

Pusher

Filler

[SWM-2] trocar

[SWM-2]working cannula

Surgical Technique - Bone Access SystemSPASYTM

Positioning the working cannula

Remove the bone puncture needle(SWMVP) from the vertebral body, Insert the cannula(SWM-2) over the guide wire(SWM-1) into vertebral body.

Step-4

Removing theGuide wire옵옵옵옵&Cannula(trocar)

Remove the guide wire(SWM-1) & trocar(SWM-2), only the working cannula(SWM-2) remains in the vertebral body.

Step-5

Inserting the bone drill

Insert the bone drill (SWM-3) into the working cannula and make the room in the vertebral body for the balloon catheter.Check under C-arm and ensure the lumen of the working cannula to be free of bone particles.

Step-6

Smoothing/deburringthe cavum

Move the bone cement applicator(SWM-4) back and for th through the cannula(SWM-2) several times to prevent the balloon from bursting due to sharp bone fragments.The bone cement applicator (SWM-4) must then be removed.

Step-7

TranspedicularAcess

Transpedicular with the bone puncture needle(SWMVP) up to 5mm into the vertebral body.

Step-1

Removingthe stylet

Pull the stylet out the bone puncture needle(SWMVP)

Step-2

Insertingguide wire

Insert the guide wire(SWM-1).

Step-3

Surgical Steps

1st StepNo General Anesthetic But Local Anesthetic.

2nd StepInsert an epidural needle(15 Gauge) through Hiatusto make a small hole to be the pathway with guideonly for the catheter. Then, take out the styletleaving the introducer & needle in the hiatus.

3rd StepInject the contrast medium to see whether or notthe epidural needle is well placed.

4th StepTake out the needle leaving introducer in the hiatus.

5th StepInsert the catheter from the introducer to thetargeted treatment.

6th StepInject the mixed medicine into the catheter throughthe infustion port for the targeted injections. Theguide wire may be removed per the user’s preferance.

7th StepTake out catheter & introducer.

Typical IndicationsChronic Back PainSpinal StenosisPost-Laminectomy SyndromeHerniated Nucleus pulposusFailed Back surgery(except the fibrosis which has become serious after total laminectomy)

AdvantagesLow risk therapy Minimally invasive No general anesthetic High success rates No scar formation No open surgery No long hospitalization Quick recovery Repeatable at any time Also ideal for patients who have undergone previous surgery Targeted treatment of causes

ContradictionsLack of patient’s consentPatient with inflammation of the skin around the puncture sitePatient with inflammation in the bloodstreamPatient with Hemorrhagic diathesisPatient with hypovolemiaPatient who takes the bleeding disorder(coagulopathy) or anticoagulant meditation[e.g. warfarin, aspirin, plavix]

St.Reed(Steerable Neurolysis Catheter System)

“Steerable Neurolysis Catheter Technique”, this proven method has been

used to decompress spinal nerves without open surgery and lastingly

alleviate the pain associated with acute and chronic spine disorders. St.Reed

which is a sort of steerable neurolysis catheter technique systems for the

foresaid proven method has the control handle to steer and ideally target

with precision through the spinal canal for precise treatment of pathology.

FeaturesRadiopaque & soft aromatic ShaftSteerable Aromatic distal tipEasy to handleEasy to steer precisly No need to withdrawn the stylet to inject the medication

A. E-Catheter (SWCATH 30)

B. Bone Marrow Needle (SWVP-30A)

<Unit : mm, Tolelrance : ± 5%>

Catheter (SWCATH30) SWVP30A

Whole Length OD Gauge Length

300.0 1.6 15 103

Surgical Steps

An epidural needle (15G) is inserted into the epidural space of the spine through Hiatus above the coccyx.

See whether or not the epidural needle (15G) is well placed through the use of the contrast medium.

The entire procedure takes only 30-40 minutes. In as little as an hour after the procedure the patient can stand up and move around. An in-patient stay usually lasts three to four days. During this time the patient receives four further injections of pain medication, saline solution and enzymes through the catheter

Take out the stylet leaving the introducer in the hiatus.Insert the catheter from the introducer to the targeted treatment point.Check where the catheter is placed with C-Arm.Inject the mixed medicine into the catheter through the injection hole of the body.


www.seawonmeditech.com

(Epidural Catheter System)

EpiduralSpace

Needle

St.CoxCatheter

EU representativeDONGBANG ACUPRIME1 Forrest Units, Hennock Road East, Marsh Barton, Exeter EX2 8RU, U.KTEL. +44 1392 829500 FAX. +44 1392 823232

33, Bucheon-ro 298beon-gil, Wonmi-gu,Bucheon-si, Gyeonggi-do, Rep. of Korea (Zip Code: 420-803)TEL. +82 32 684 7071~7074 FAX. +82 32 684 7075


St. cox Catalogue 2011. 7. 1 (Rev.0)

(Epidural Catheter System)

• Acute disc herniation • Recurring disc protrusion and herniation • Disc protrusion with nerve root irritation • Chronic back pain • Spinal canal stenosis (spinal canal narrowing) • Foraminal stenosis

• Spondylolithesis • Nerve irritation syndrome (associated with degenerative spinal conditions) • Failed back surgery • Chronic pain after disc surgery (post-nucleotomy syndrome)

Typical Indications

• The stylet is making the soft catheter less soft and to cut the dura mater more easily.• No need to withdrawn the stylet to inject the medicaiton• Surgical grade stainless steel• Flelxible araumatic tip design• Kink & collapse registant• Radiopaque for distinct images and placement accracy• Non-reactive with neruolytics:Phenol, alchol, glycerol,etc.• Tensile spring guded catheter• Stimulation

Features

• Low risk therapy • Minimally invasive • No general anesthetic • High success rates • No scar formation • No open surgery

• No long hospitalization • Quick recovery • Repeatable at any time • Also ideal for patients who have undergone previous surgery • Targeted treatment of causes

Advantages

• Lack of Patient’s consent• Patient with inflammation adjacent to the targeted treatment of causes• Patient with inflammation in the bloodstream• Patient with Hemorrhagic diathesis• Patient with hypovolemia• Patient who takes the bleeding disorder(coagulopathy) or anticoagulant meditation (e.g. warfarin, aspirin,plavix)

Contradictions


What is “Epidural Catheter Technique” and what is “ ”

“Epidural Catheter Technique”, this proven method has been used to decompress spinal nerves without open surgery and lastingly alleviate the pain associated with acute and chronic spine disorders. St.Cox is a sort of Epidural Catheter Systems for the foresaid proven method by enabling the physician to combat the pain at its source in the spine by enhancing the capability to steer to the target site.

Length Diameter GripLength

GripWidth

Needle

Stylet

Wing

120.6

125.8

Φ1.8

Φ1.2

9.8

10.3

40.5

23.0

10.9

13.1

Sort

Guide Wire Catheter

Length Cap Diameter

Catheter Length

Body Width

Body Length Outer

Diameterinner

Diameter

TipDiameter

630.0 Φ10.5 Φ0.3 600.0 32.9 33.0 Φ1.2 Φ0.9

Sound oFFEMAILHoMpAgE

Seawon Meditech.co.,Ltd. Copyright(c) 2012 purecon all right reserved.

platelet Rich plasma

platelet Rich plasmaSW-PRP

The Axis of your Health Life



Platelet Rich Plasma(PRP) is a concentrated source of autologous platelets. It contains several different growth factors and other cytokines that stimulate healing of bone and soft tissue.

definition of PRP


growth Factor of PRP


Epidermal growth factor

Regulation of cell proliferation, differentiation, and survival

Insulin-like growth factor

Key regulator of cell metabolism and growthStimulates proliferation and differentiation functions in osteoblasts

Platelet-derived growth factor

Major mitogen for connective tissue cells and certain other cell types. promotes the synthesis of collagen and structural proteins Transforming growth Factor (ie, alpha, beta)Regulation of cell

Transforming growth factor (ie, alpha, beta)

Regulation of cell proliferation, differentiation, and apoptosisInduction of intimal thickening

Vascular endothelial growth factor

Regulation of angiogenesis

Sound oFFEMAILHoMpAgEAbout PRP product Customer Service

What is pRp? Function Application


Function of PRP

promotion of soft tissue healing

Acceleration of endothelial, epithelial and epidermal regeneration

Stimulation of angiogenesis

Enhancement of collagen synthesis & the haemostat-ic response to injury

decrease of dermal scarring

Reversing the inhibition ofwound healing caused by glucocorticoids




Application of PRP PRP therapy is one of state-of-the-art treatments available which is based

on the healing power of a patient’s own platelets which contain growth

promoting qualities.

Pain Clinic AestheticClinic, etc.


AestheticClinic, etc.



pain Clinic Pain Clinic

Shoulder injuries

• Rotator cuff tendonitis and partial tears• Ant. & Post. band of IGHL• ACJ, SCJ and C-C ligament• SLAP lesion

Wrist & Hand

• Ligament sprains• TFCC

Knee

• Patellar tendonitis• Meniscus• Ligament(MCL, LCL, ACL, PCL)• Cartilage defects

Ankle & Foot

• Plantar Fasciitis• Achilles tendonitis• Ankle sprains

Elbow

• Lateral epicondylitis• Medial epicondylitis

Back & Hip injuries

• Facet joint arthritis• Sacroiliac joint pain• Hip girdle muscle pain• Hamstring tendonitis




Pain Clinic AestheticClinic, etc.

WrinklesHair Loss

Dark circles

Acne marks, Scars

Loose skin, Skin tonePerioral zones

Nasolabial folds

Malar and Cheek area

Under Eye

Eye

Forehead

Aesthetic Clinic, etc.


Sound oFFEMAILHoMpAgEAbout pRp Product Customer Service

Structure How to use Advantages of SWpRp

Structure of SW-PRPSW-PRP has been devised to extract PRP for pain and cell regeneration treatments.

◀ 3 Way Valve

◀ RBC Chamber

PRP Chamber

◀ RBC Locking Bar

◀ RBC Chamber Cap

PRP Chamber Cap

◀ Plasma Chamber

◀ PRP Extraction

Pathway

Plasma Extraction Pathway

▶

Plasma Extraction Point

▶ ◀

PRP Extraction Point


Structure How to use Advantages of SWpRp


07 080605

03 0402

How to USE

Extract the blood into the syringe (Please follow the 3 way valve direction presented on the above image.)

Inject the blood in the syringe to the device (Please follow the 3 way valve direction presented on the above image.)

Centrifugation at first time for the separation

Turn the Red Blood Cell chamber capto adjust RBC level till the red line

Close RBC locking bar Extract plasma at the plasma extraction point

Centrifugation at the second time for the concentration of the PRP

Extract PRP at the PRP extraction point

01


• Most of other pRp devices consist of two tubes to extract pRp. While blood is transferring to the other tube, it may be exposed in the air and con-taminated. on the other hand, SW-pRp consists of one tube which is no need for blood to be transferred to other tube.

• It is one step process to inject the extracted blood from a patient to the device.

• While most of other pRp devices require syringes with needles to inject the blood in to device and extract pRp from the device, SW-pRp does not require a syringe with needles thanks to two built-in path ways for extraction of pRp & plasma.

▶ Easy use

Advantages of SW-PRP


Structure How to use Advantages of SWPRP

▶ One tube system

▶ One step process




Advantages of SW-PRP• Most of other pRp devices consist of two tubes to extract pRp. While blood is transferring to the other tube, it may be exposed in the air and contaminated. on the other hand, SW-pRp consists of one tube which is no need for blood to be transferred to other tube.



▶ Easy use

▶ One tube system





Advantages of SW-PRP• Most of other pRp devices consist of two tubes to extract pRp. While blood is transferring to the other tube, it may be exposed in the air and con-taminated. on the other hand, SW-pRp consists of one tube which is no need for blood to be transferred to other tube.



▶ Easy use


▶ One tube system


Sound oFFEMAILHoMpAgEAbout pRp product Customer Service

Company pRp Report & Study pRp Video

Company InfoRmatIon

was founded in November 2008 to utilize the expertise

in know-how from the medical industry where the key

founders of our company have been dedicated for over

the past ten years.

Since its establishment, there have been being one main

value & two sub values to be applied on the management.

The main value is “an axis of good” and the other two sub

values are “Trust” and “Harmony”.

Our final goal is to be the axis of the good for our customers,

employees and business collaborative partners. For that, we

always try to give them full trust and to be harmonized with

all around people.

Our specialty in the catheter technology has allowed us to be dedicated to VCF(Vertebral Compression Fracture) by developing & commercializing the Balloon Kypohplasty System with our own brand name of SPASY to both domestic & overseas markets as of May 2009. We are proud of the brand value “SPASY” available now in the world wide as well as the domestic market.

Our catheter technology has also brought the opportunity to be dedicated to pain management products by developing & commercializing St.Reed & St.Cox as of October 2010.

We continue to research & develop to apply all our expertise on disposable products focusing on worldwide patients to have well being lives.

Organization Contact Us

Seawon Meditech Co., Ltd.

Overview Quality


Organization



Quality has never been negotiated by anybody and been at the core of Seawon Meditech. Our

management team gives our QRM team the full supports to set up quality procedures in all

research & business activities which must be operated by a state-of-the art quality system.

We do not have any doubt about that our QRM team with extensive experience from the

international medical device field has been in full commitment for this mission.

The quality system within Seawon Meditech complies with the international standard

ISO13485;2003 “Medical devices” – Quality management systems.

Contact UsOverview Quality

EU Veiw/Download certificate(PDF)

Company InfoRmatIon


Quality Organization Contact Us



Quality MangementRepresentative

Marketing Dept. Management Dept.Quality Control

Dept

Research &Development

Dept.Production Dept.

CEO & Founder

Overview

Company InfoRmatIon




Organization Contact Us

Seawon Meditech Co., Ltd.

▶ Address

409, Sihwa Hightech, Industrial Complex,#1234-7, Jeongwang-dong, Shiheung-si, Kyunggi-do, 429-848, South Korea

▶ Phone : + 82 (0)31 8041 3388

▶ Fax : +82 (0)31 8041 3390

▶ Mail : [email protected]

▶ Web : www.seawonmt.com

Location

QualityOverview

예문테크

조일제지 사거리

새한실리켐

동원특수화학고무공업사

서해안로동아레이저

서울특수강

이마트시화물류센터

옥구공원궁도장

남광산업

에이스텍스에코서비스코리아

로엑스시화물류센터

백산아세아페이퍼텍

Company InformatIon


http://www.falloplastica.net/fp/pdf/prp05.pdf

http://ajs.sagepub.com/content/34/11/1774.short

http://jama.jamanetwork.com/article.aspx?articleid=185200

http://www.prolotherapyinstitute.com/prp-research

http://www.journalofprolotherapy.com/pdfs/issue_07/issue_07_03_prp_research_harvard.pdf

http://www.ncbi.nlm.nih.gov/pubmed/21570659


Company PRP Report & Study pRp Video

http://vdisk.univille.edu.br/community/depto_odontologia/get/ODONTOLOGIA/RSBO/RSBO_v8_n3_julhosetembro2011/RSBO-v8n3-artigo09.pdf<동물실험>

http://www.orthop.com/pdfs/PRP_-_Accelerates_Healing.pdf

http://www.healio.com/orthopedics/biologics/journals/ORTHO/%7B60A4C6E2-52E7-47A4-9F0E-3E96785844EC%7D/Platelet-Rich-Plasma-A-Review-ofthe-Science-and-Possible-Clinical-Applications

Reference

v

Report & study of PRP


Company pRp Report & Study PRP Video


Video of SW-PRP

33, Bucheon-ro 298beon-gil, Wonmi-gu, Bucheon-si, Gyeonggi-do, Rep. of Korea (Zip Code: 420-803)

TEL. +82 32 684 7071~4 FAX. +82 32 684 7075E-mail:[email protected]

VeelerVideo Guided CatheterDianosis and surgical procedure in the epidural spaceMinimally invasiveRapid recovery time

www.seawonmt.com

Indications

Video Guided Catheter forback pain relief

A. Chronic Back Pain

B. Post- Laminectomy Syndrome

C. Spinal Stenosus

D. Herniated Nucleus Pulposus

• Minimize impact on patient’s musculoskeletal structure

• Deliver pain treatment to the exact point of pain

• Diagnose conditions inside the spinal column

The Video Guided Catheter has been designed to allow the

delivery of pain medication precisely within the lower spinal

column. Appropriate for patients with chronic back pain not

responsive to conservative treatment.

• Lightweight, ergonomic design

• Catheter outer diameter is 3mm

• Soft, atraumatic tip

• Radiopaque shaft

• Dual working channels

• Dual infusion ports

• Direct visualization via endoscope

• 2-way steering

Feature

Benefits

Ordering Information

Radiopaque Shaft

Direct visualization via endoscope

Dual Direction Steering

VeelerVideo Guided Catheter

VeelerVideo Guided Catheter

Part No Description EA/Kit

SWV30 Manipulator(Video Guided Catheter)

1EA

SWV30T 1EA

SWVP-30V

Catheter Introducer

1KITSheath / Stylet

Dilator

Guide Wire

spasy tm - balloon expander & catheter spasy tm...st. cox catalogue 2011. 7. 1 (rev.0) (epidural...

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