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A unique, efficient and accurate method for suprapubic catheter placement…

…starts at the target, inside the bladder. Swan Valley Medical’s patented single-use T-SPeC® instrument precisely places a large-bore 18 Fr. suprapubic silicone catheter without the need for bladder distension, palpation, ultrasound, fluoroscopy, guidewires, and/or obturator depth control.

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The instrument employs a reliable transurethral method for localizing the bladder dome in the preferred location for a suprapubic catheter, directly adjacent to the symphysis pubis on the abdominal midline.

The surgical tract is initiated from inside the bladder with the aid of a patented guidance and control system. T-SPeC® provides predictable catheter placement and reliable suprapubic drainage in a wide range of patient types and sizes.


The capture housing receives

The positioning arm provides

T-SPeC Features and Specifications ®

the blade after completion of

the surgeon w  ith the location of

the incision. A simple twisting

the blade exit point at the skin

motion releases the blade and

surface. It is firmly attached t o

capture housing for disposal.

the mast to prevent movement during advancement of the surgical blade.

The mast locates the positioning arm over the patient’s abdomen during the creation of the surgical tract. The graduations allow for measurement of the surgical tract at the cystostomy site.

The surgical blade makes a small incision (15 Fr.) through the bladder wall, fascia, subcutaneous tissue and skin. The blade is safely housed within the stainless steel sound and is covered by a urethane tip. It is deployed by The rear handle advances

The locking mechanism for the

the cutting blade to create

rear handle - covered with a

advancing the rear handle.

the surgical tract and retracts

safety cap - is disengaged or

the catheter for placement in

engaged by rotating the wheel

the bladder.

lock forward or backward, respectively.

Patented Method and Technology Swan Valley Medical, Incorporated has been issued both technology and method patents for the T-SPeC® instrument and cystostomy method of creating a surgical pathway from inside the bladder through abdominal tissue to the external abdomen along a predetermined path. Additional U.S. and international patents pending.

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T-SPeC Surgical System Models and Functional Dimensions - Selection Criteria ®

Catalog Number

Device Model

Surgical Blade Width

Surgical Blade Extension

Urethral Sound

Silicone Catheter

Outside Diameter

Length

Outside Diameter

Shaft Length

Balloon Volume

(Fr./mm)

(cm)

(Fr./mm)

(cm)

(Fr./mm)

(cm)

(cc/ml)

107

T-SPeC T7

15/5

7

21/7

28

18/6

44

10

114

T-SPeC T14

15/5

14

21/7

28

18/6

44

10

®

®

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Simple & Fast Five-Minute Procedure

Procedure Steps

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1

3

2

4

1. Insert T-SPeC速 Sound The stainless steel T-SPeC速 sound with embedded blade is inserted into the urethra and advanced into the bladder. The urethane tip of the sound facilitates smooth insertion. The pubic bone is detected against the inside bend of the T-SPeC速 sound.

2. Attach and Adjust Positioning Arm

The T-SPeC速 is equipped with a positioning arm and blade capture mechanism in alignment with the distal tip of the instrument sound. These features reliably control the location of the surgical tract.

3. Advance Blade

4. Remove Blade

The blade is advanced

by sliding the rear handle forward. The smooth action of the cutting mechanism ensures a precise surgical tract, created from the bladder dome to the skin surface.

The blade and capture mechanism are removed with a simple twisting motion, leaving only the catheter bayonet connection and coil above the skin surface.


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Accuracy and Speed Swan Valley Medical, in the course of developing the T-SPeC速 Surgical System, performed hundreds of cadaveric and simulated tissue tests to verify surgical cut accuracy and instrument performance. Live case experience has demonstrated accurate and reliable cystostomy procedure results typically performed in 5 minutes for both male and female patients, including large patients.*

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8 12 9

3 6

2.54 cm

5. Connect Catheter

The catheter is attached to the bayonet connector with a simple clockwise twisting motion.

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6. Remove Positioning Arm

7. Remove T-SPeC速 and Cut Catheter

8. Position Catheter and Inflate Balloon

The positioning arm is removed by opening the latch and lifting the assembly from the handle.

The T-SPeC速 is withdrawn from the patient and the catheter is cut in the designated area between the drainage holes and the sound tip. The open end allows for use of a guidewire during Councill catheter replacement.

TIME IN MINUTES

Learn more about the simple surgical technique of T-SPeC速 and view live patient procedures on our website at: t-spec.swanvalleymedical.com. *Data on file.

Precise surgical tract creation ensures optimal placement of the catheter balloon at the bladder dome. The 18 Fr. silicone suprapubic catheter is now properly positioned and ready for use.

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Percutaneous Trocar Punch Suprapubic Cystostomy Complications

INJURY to peritoneal cavity and small bowel

The inability to precisely locate the pubic bone

Loss of needle/trocar depth control leading

from misplaced needle/trocar.

and control the correct angle of needle/trocar

to INJURY at base of bladder, colon and

contribute to inaccurate placement, puncture of

adjacent pelvic organs.

peritoneal cavity and/or small bowel.* Indicates optimal catheter placement in the bladder dome.

Suprapubic cystostomy (SPC) is a common method for treating acute or chronic urinary retention, as well as urinary incontinence in patients who are unable or unwilling to rely on urethral catheterization. SPC is also frequently utilized to provide drainage during and following surgical procedures in the lower urinary tract. Clinical studies have shown that patients with SPC have lower rates of urinary tract infection1,2 and superior treatment satisfaction and 6

tolerance3,4 when compared to long-term indwelling and clean intermittent urethral catheterization. In addition, SPC eliminates potential injury to the urethra from catheterization. Despite the clinical advantages, however, SPC is not as widely used as urethral catheterization. This is largely due to high rates of bowel injury and mortality associated with blind percutaneous “trocar punch” cystostomy—currently the most prevalent technique for placing a suprapubic catheter.

BAUS SPC Guidelines The British Association of Urological Surgeons (BAUS) has created SPC practice guidelines based on a 2010 audit directed by the National Patient Safety Agency. The audit was initiated because of the number of adverse events and studies confirming high morbidity and mortality rates relating to percutaneous trocar puncture techniques. As a result, the guidelines recommend ultrasonography by individuals who have received specific training and are experienced during the SPC procedure. The full BAUS report can be reviewed on-line at: swanvalleymedical.com/clinical/baus. *BAUS Suprapubic Catheter Practice Guidelines.

Documented Percutaneous Trocar Punch SPC Complication Rates: Ahluwalia Sheriff 20065 19986

NPSA 20097

Cases

219

157

259

Malpositioning/ Expulsion

2.7%

-

-

Exit Site Complications

5.5%

-

-

Catheter Blockage

25%

18%

-

Bowel Injury

2.4%

2.7%

3.5%

Mortality

1.8%

0.8%

1.2%


Clinical Advantages of Transurethral Cystostomy

The T-SPeC® works amazingly well and was simple to use. I found the T-SPeC® created a faster, easier, and safer tract for suprapubic cystostomy

1.3% vs. 29% complication rate for SPC performed with substantially equivalent predicate device8 versus percutaneous trocar punch.5

catheter placement. It required less anesthesia when compared to other cystotomy kits I have used for more than 10 years. I had a lot of optimism for the T-SPeC® device when I first heard about an ‘insideto-out’ cystotomy kit — T-SPeC® exceeded my expectations. The device will play an important role in my practice to allow a safe and minimally invasive procedure to place a suprapubic catheter in my patients with urinary retention and incontinence. The current cystotomy kits use an ‘outside-to-in’ technique that does not always allow accurate placement of the catheter and has been shown to cause rare but serious complications such as small bowel perforation that can result in sepsis and even death. The T-SPeC® utilizes the safer and innovative passageway, ‘insideto-out’ technique, allowing reliable catheter placement and equally important — virtually eliminates the risk of small bowel injury.

Dr. Brian Flynn Director of Female Pelvic Medicine and Reconstructive Surgery Associate Professor of Urology University of Colorado Health Science Center

SwanValleyMedical.com

Swan Valley Medical recently prepared a Clinical Evaluation Report documenting the safety and performance of transurethral cystostomy, utilizing published literature and safety data for transurethral cystostomy devices similar to T-SPeC®. Clinical outcomes for 2,299 suprapubic catheter patients were analyzed in the Report, 557 of which were performed with the transurethral method. The transurethral cystostomy data include cases commonly contraindicated for

percutaneous cystostomy, such as obese patients and patients with spastic neurogenic bladders. Of the 557 equivalent cases, only 8 of the patients experienced complications9-18. When adjusting for cases contraindicated for T-SPeC® specifically bowel adhesions from previous pelvic surgery and existing infection - the complication rate falls to 1.3% (complications experienced in 7 of 556 cases). It should be noted that the cited minor complications

are common to all suprapubic catheterization procedures such as: hematuria, dislodged catheter, and bleeding at the catheter insertion site. Significant reductions in procedure time and cost are expected for T-SPeC® when compared to percutaneous “trocar punch” cystostomy. The T-SPeC® also eliminates risks to the physician and patient resulting from radiation exposure during image guided percutaneous cystostomy.

For more information on T-SPeC®, visit: t-spec.swanvalleymedical.com.

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Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Caution: Refer to package insert provided with the product for complete Instructions for Use, Contraindications, Warnings and Precautions prior to using this product.

Clinical References 1 De Ruz AE, Leoni EG, Cabrera RH. Epidemiology and risk factors for urinary tract infection in patients with spinal cord injury. Journal of Urology. 2000; 164:1285-1289

5 Ahluwalia RS, e. a. The surgical risk of suprapubic catheter insertion and long-term sequelae. The Royal College of Surgeons of England – Urology. 2006; (88): 210-213.

2 Mitsui T, Minami K, Furuno T, Morita H, Koyanagi T. Is suprapubic cystostomy an optimal urinary management in high quadriplegics?. A comparative study of suprapubic cystostomy and clean intermittent catheterization. Eur Urol. 2000;38 (4):434-8.

6 Sheriff MKM, e. a. Long-term suprapubic catheterization: clinical outcome and satisfaction survey. Spinal Cord. 1998; (36): 171-176.

3 Ichsan J, Hunt DR. Suprapubic Catheters: a comparison of suprapubic versus urethral catheters in the treatment of acute urinary retention. ANZ Journal of Surgery. 1986; 57 (1): 33-36 4 McPhail MJ, Abu-Hilal M, Johnson CD. A meta-analysis comparing suprapubic and transurethral catheterization for bladder drainage after abdominal surgery. Br J Surg. 2006 Sep;93 (9):1038-44.

7 UK National Patient Safety Agency. (2009). Minimizing risks of suprapubic catheter insertion. Rapid Response Report NPSA/2009/RRR005 . 8 Swan Valley Medical. Clinical Evaluation Report for T-SPeC® Surgical System Prepared in Conformance with Annex X to Directive 93/47/EEC as amended. 2011 Nov 9 Edokpolo LU. Suprapubic cystostomy for neurogenic bladder using Lowsley Retractor method. Urology. 2011; 78(5):1196-8. 10 Zeidman EJ. Suprapubic cystostomy using Lowsley Retractor. Urology. 1988; 32 (1):54-5

11 Cromie WJ. The Lowsley Cystostomy. Urology. 1978;11 (1):78 12 Blum JA. Suprapubic cystostomy utilizing the Lowsley Tractor. J Urology. 1967;97:478 13 Golomb J, et al. Percutaneous suprapubic cystostomy using a modified urethral sound. J of Urology. 1991; 146:813-14. 14 Lyell MS. The Lyell Sound: a new instrument for suprapubic cystostomy. Urology. 1998; 51 (1):103-4. 15 Sawant AS. Suprapubic cystostomy using optical urethrotome in female patients. J Endourology. 2009; 23 (8):1325-7. 16 Flock WD, et al. Evaluation of closed suprapubic cystostomy. Urology. 1978; XI (1):40-2. 17 Howerton LW and Holbrook E. The utility of closed suprapubic cystostomy. So Med J. 1971; 64 (12):1446-8. 18 Gottesman JE and Flanagan MJ. Suprapubic cystostomy: a simplified technique. Urology. 1978; XI (5):478-9.

www.swanvalleymedical.com Ordering Information: The T-SPeC® Surgical System is a patented medical device. U.S. and International Patents Pending. ©2013 Swan Valley Medical, Incorporated. All Rights Reserved. Printed in the USA.

1 (855) 792-7926 (USA) +1 (303) 371-0431 (International)

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Founded in 2006, with headquarters in Bigfork, Montana, manufacturing in Denver, Colorado, Swan Valley Medical specializes in developing innovative, single-use instruments for endourologic surgery.


T-SPeC® Suprapubic Cystostomy