Project Description

ATOMS – Adjustable Transobturator Male System

Hydraulic system substitutes urinary sphincter function in incontinent males

  • Long-term, adjustable implant
  • Hydraulic system with no mechanical parts
  • Anatomical 4-point fixation

ATOMS is suitable for all degrees of urinary incontinence, and can also be used after radiotherapy.

The suburethral substitute sphincter cushion

  • is the central part of the implant and filled via the port-catheter connection after the operation. Patient-specific adjustment requires no surgical intervention and can be made at any time to counteract either continuing incontinence or urinary retention.

  • ensures a gentle, evenly-distributed pressure on the bulbospongiosus muscle to reduce the risk of urethral erosion. There is no specific point of maximum compression on the urethra.

4-point fixation

  • the integrated mesh arms are drawn back around the inferior pubic ramus to the middle of the implant to secure ATOMS in place. This eliminates the need for additional fasteners or screws, and ensures a symmetrical 4-point fixation.

  • exact fixation of implant in steps of millimeters is possible: reduction of implant fill volume.

The flexibility

  • efficient improvement of incontinence in male patients with SUI 1

Functional independency of patient’s mental and/or physical abilities (no manual activation/deactivation necessary):

  • patients can urinate freely without having to activate a mechanical component. This means ATOMS is also suitable for patients suffering from dementia, or whose cognitive skills may be expected to regress over time. Patients with joint pain (e.g. gout) also benefit from not having to operate the implant manually.

Hydraulic System

ATOMS is made up entirely of components that function hydraulically. Patients are therefore spared the difficulties caused by defects which may occur in mechanical components months or years after the implantation.

Increase in volume
Individual, long-term adjustment of pressure on urethra

Features of ATOMS

Why a mesh that loops around the inferior pubic ramus?
Firmer hold and infection prophylaxis.

The ingenious, patented idea of looping the mesh around the bone as a holding structure is worth mentioning. The integrated mesh will be placed around the inferior pubic ramus, which leads to several advantages: The macroporous mesh integrates well into the tissue. The engraftment leads to an extra firm hold, which is relevant for optimal surgical results. In addition to the firm hold, the macroporous mesh also offers the advantage of reduced foreign body reactions. Tissue ingrowth and revascularization of the surrounding tissue reduce the risk of an infection spreading in the pelvis operatively or post-operatively.

Why a large cushion?
Atrophy reduction and erosion prophylaxis.

The effect of the implant is simple: The urologist determines the fill volume of the cushion. A compression of the bulbospongiosus muscle, indirectly of the urethra, increases the urethral resistance. The contraction of the bladder will make a physiological urination possible, but an involuntary loss of urine is reduced or ideally avoided. The size of the cushion determines the pressure on the bulbospongiosus muscle, and the smaller the cushion, the more punctate the pressure is. The soft compression of the large ATOMS cushion allows a low pressure, and a low tissue pressure leads to low atrophy. Limited tissue atrophy means lower risk of erosion. A very limited number of urethral erosions is known to A.M.I. after 15 years of experience with ATOMS, and those few cases were usually associated with a difficult patient situation (e.g. following previous cuff erosion of an artificial urinary sphincter).1

Why does the catheter attach lateral and exit dorsal?
Compliant with the anatomy.

The catheter outgoing, laterally on top of the cushion, displays straight in the direction of the scrotum. It proceeds without kinks and it touches no other parts of the implant. It proceeds the shortest way on the left side of the scrotum. If necessary, the implant can be adjusted post-operatively by means of a simple percutaneous puncture of the port – even years after the implantation.

Parts of ATOMS

  1. Suburethral substitute sphincter cushion
  2. Catheter
  3. Scrotal Port
  4. Mesh arms for fixation
  5. Fixation sutures
  6. Tunneller

Placement of ATOMS

The distal, suburethral placement of the implant underneath the bulbospongiosus muscle allows for use of ATOMS even after radiotherapy. The symmetrical positioning below the urethra is achieved by a 4-point fixation. The small, pre-attached scrotal port is palpated with ease by the urologist. Filling the implant with saline solution or emptying it is performed with a simple percutaneous needle puncture.

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Order Code Product Technical Details

ATS5041
U-ATOMS Scrotal-Port zugeschnitten

ATOMS

Adjustable implant to substitute urinary sphincter function in incontinent males

Width of tape: 12 mm
Dimensions of cushion: 40 x 45 mm

Materials:
Mesh and sutures made of polypropylene, catheter and cushion made of medical grade silicone, adjustment port made of medical grade silicone and titanium

1 implant, delivered sterile

TOA5130

A.M.I. TOA Tunneller

For transobturatoric 4-point fixation

Instrument length: 244mm
1 pair of tunnellers (l. and r.)
delivered non-sterile,
steam autoclavable

ATS5051

U-ATOMS-Scrotal-Port zugeschnitten

Scrotal Port for ATOMS

Silicone-wrapped titanium port with cathether connection (tubing connector) for placement in the scrotum during port revision surgery

Diameter: 11 mm
1 unit, delivered sterile

SFN 0930 G
SFN-Port Needle

SFN-Port Needle 0,9/20G x 30 mm

20 G x 30 mm
25 needles / box, delivered sterile

1 Esquinas, C., & Angulo, J. C. (2019). Effectiveness of Adjustable Transobturator Male System (ATOMS) to Treat Male Stress Incontinence: A Systematic Review and Meta-Analysis. Advances in Therapy, 36(2), 426–441. https://doi.org/10.1007/s12325-018-0852-4

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