Part No Initial Length (mm) PSI Rating Maximum Diametar (mm) Maximum Length (mm) Maximum Volume (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 Catheter SWS10 SWS15 SWS20 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 Catheter SWS10 SWS15 SWS20 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 Spec Ordering 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 7075 e-mail : [email protected]Homepage : www.seawonmt.com Spinal Alignment System for VCF SPASY TM Surgical Technique - Balloon Expander & Catheter SPASY TM 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. 20cm 3 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. (Rev.03, 2012.05.01) 1 Forrest Units, Hennock Road East, Marsh Barton, Exeter EX2 8RU, U.K TEL. +44 1392 829500 FAX. +44 1392 823232 Dongbang Acuprime Inc. Seawon Meditech Co.,Ltd. Spinal Alignment System for VCF SPASY TM Indication VCF(Vertebral compression fracture)due to Osteoporosis Osteolytic fracture Metastatic bone fractures
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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.
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.
• 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
Seawon Meditech Co.,Ltd.
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
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platelet Rich plasma
platelet Rich plasmaSW-PRP
The Axis of your Health Life
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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
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growth Factor of PRP
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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
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What is pRp? Function Application
Seawon Meditech.co.,Ltd. Copyright(c) 2012 purecon all right reserved.
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
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What is pRp? Function Application
Seawon Meditech.co.,Ltd. Copyright(c) 2012 purecon all right reserved.
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.
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AestheticClinic, etc.
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What is pRp? Function Application
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
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What is pRp? Function Application
Seawon Meditech.co.,Ltd. Copyright(c) 2012 purecon all right reserved.
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.
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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
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Structure How to use Advantages of SWpRp
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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
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• 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
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Structure How to use Advantages of SWPRP
▶ One tube system
▶ One step process
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Structure How to use Advantages of SWPRP
Seawon Meditech.co.,Ltd. Copyright(c) 2012 purecon all right reserved.
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.
• 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
▶ One tube system
▶ One step process
Seawon Meditech.co.,Ltd. Copyright(c) 2012 purecon all right reserved.
Sound oFFEMAILHoMpAgEAbout pRp Product Customer Service
Structure How to use Advantages of SWPRP
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.
• 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
▶ One step process
▶ One tube system
Seawon Meditech.co.,Ltd. Copyright(c) 2012 purecon all right reserved.
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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
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Organization
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Company pRp Report & Study pRp Video
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