Technical Presentation – Amy Dendulk

Main Projects:

•14 Fr Unable to Pass

• 23 Fr 2 Year Aging

• 23 Fr New Valve Design

14 Fr Introducer – Unable to Pass Overview of Issue 3

- Design Requires 14Fr Tip to expand to accommodate CP

- 16 SPRs due to unable to pass tip Dec-Apr

Unable to pass tip

Flow Back Length (mm)

Unable to Pass SPRs

Insertion/Removal Force4

Purpose• Evaluate insertion/removal forces of Impella CP through distal tip of

sheath

Verification Test• No changes to current setup

• Water at 37°C • Impella device (Large OD)

Additional Testing• Water replaced with porcine blood at 37°C • 3 insertions/removals – Multiple Insertions increases force• Evaluated w/ introducers at varying conditions (MDX, Silicone Oil, FB

Length)• Impella device

• Pin with formed cannula, to set dimensions• Impella device (Large OD)

Step Height Insertion Evaluation5

Inse

rtio

n F

orce

(N

)

Insertion Distance (mm)

Dilator Tip

Dilator Body

Sheath Tip

SheathBody

Dilator Tip Dilator body

Purpose• Use silicone media to compare sheath tip (step transition)

insertion forces of current and new tip profile.• No link to clinical application• Used for comparison to current design only

Test Description• Dilator and dilator/sheath combination inserted into silicone

substrate using Instron machine. • Measure force of silicone media to “overcome” tip step. • ID of silicone media varied

Force Profile Example

Impella CP Dispensed Cannula OD6

- 113 Impella CPs w/ dispensed cannula

- Measured w/ Keyence- Maximum OD measured on

cannula at inlet + motor transitions

Impella CP – KeyenceParts that failed 5.05 ring gauge

Current 14Fr Spec. [BACK]

Proposed Design – Tip ID7

• n=113 Cannula Max OD (CP) • Theoretical spread w/ single mandrel

Current Tip ID Spec

Proposed Tip Spec

• Proposed tip ID would reduce interference w/ CP OD

• Maintain single tipping mandrel at Oscor Inc to control spread of tip ID

• To increase the tip ID, taper length reduced

• (10-13% or 0.017” - .022“)

Current Tip ID Spec

C-66 (C1-08222) – Horizontal Method8

A-1 (C1-08224) – Horizontal Method9

23 Fr 2 Year Aging (29 Samples)

Testing done:

-Leak

-Insertion/Removal Forces

-Sheath Kink

-Sidearm Flush Force

Reports Written:

-Sheath Kink

-Sidearm Flush Force

11

Sheath Kink Test• Acceptance Criteria: Sheath must pass through the 50°

insertion angle with a radius of 7.1cm without forming an obstructive kink after dilator is removed.

Status: Pass

Average (cm) StDev (cm) Min (cm) Max (cm)

Insertion radius 3.49 0.82 2.0 4.5

12

Hub Sidearm Flush Force Test• Acceptance Criteria: Maximum force required to flush 8 ml of

saline through sidearm must be no more than 12N.

Status: Pass

Average (N) StDev (N) Min (N) Max (N)

Flush Force 9.68 0.93 7.86 11.44

RP Pump Insertion/Removal Test13

Condition Average (N)

StDev (N) Min (N) Max (N)

Insert dilator 11.4 3.4 4.4 19.2

Remove dilator 12.3 2.0 7.0 17.0

Remove 6Fr diagnostic catheter

1.5 0.9 0.5 5.0

Insert pump through valve/hub

13.9 5.2 7.6 23.8

Insert pump through sheath

3.4 1.0 1.7 5.3

Remove guidewire

3.1 1.7 0.6 10.7

Remove pump 10.7 2.5 7.1 20.8

RP Pump Insertion/Removal Test

14

Condition Rationale

Remove 6Fr diagnostic catheter

DIR to be updated to 5.0N to be consistent with CP and 2.5 platforms

Insert pump through valve/hub

2 sample t-test: p-value = 0.389

Remove guidewire DIR to be updated to 5.0N to be consistent with CP and 2.5 platforms

Remove pump N/A per the IFU; sheath peeled away before removal

Valve Short-Term Leak Test15

Condition Average (g)

StDev (g) Min (g) Max (g)

Nothing across valve

0.0 0.0 0.0 0.0

Dilator in valve 0.0 0.0 0.0 0.0

Dilator removed 0.0 0.0 0.0 0.0

6Fr Diagnostic Catheter

8.3 15.6 0.0 66.4

0.025” Placement GW

0.4 1.5 0.0 8.2

Pump inserted 6.1 2.6 3.6 18.1

RP Pump & 0.025” GW

9.5 16.5 0.1 68.1

Pump Catheter 2.5 3.9 0.0 13.3

Total Leakage 26.8 34.7 4.3 145.3

Valve Short-Term Leak Test16

Condition P-Value Statistical Difference?

6Fr Diagnostic Catheter

0.537 No

0.025” Placement GW 0.446 No

RP Pump & 0.025” GW

0.466 No

Pump Catheter 0.307 No

• Two-sample t-test performed comparing each step to data from T=0 verification testing

Axillary Implant Kit – New Valve Design

Valve Options18

Current 14Fr/23Fr Valve• 2 Stacked Valves• Thickness: 0.060” each (1.52mm)• Opposing slits (horizontal/vertical)

Helix Valve• Single Valve• Thickness: 0.120” (3.05mm)• Helix center cut, with two peel-away

cuts on outside

Primary Valve Functions for Axillary1) Hemostasis – Prevent blood leakage during insertion procedure2) Allow for easy pump insertion (insertion/removal force)

Current 14Fr/23Fr Valve

Helix Valve (Variations)

Variation in helix width

Valve Leakage19

Test SetupTest Media: WaterTest Temperature: 37°CTest Pressure: 180 ±10 mmHg

Test Steps

Step Leak ConditionProposed Leakage

Requirement 14Fr Requirement

1 Nothing in valve Should be < 2.5g in 1 min Must be < 2.5g in 1 min

4 6Fr Diagnostic Catheter in Valve Should be < 25g in 3 minShould be < 15g in 3

min

5 0.018" Guidewire in Valve Should be < 10g in 1 min Must be < 5g in 1 min

6 9Fr and 0.018" GW in Valve Should be < 30g in 3 minShould be < 15g in 3

min

7 9Fr in Valve Should be < 5g in 1 min Must be < 2.5g in 1 min

8 Nothing in Valve (pump removed) Should be < 2.5g in 1 min Must be < 2.5g in 1 min

  Total 75g 42.5g

Proposed RequirementTotal 200mL volume of blood loss during Axillary Implant procedure (per IFU) including:- Leakage from introducer valve- Leakage through pump during insertion (when graft clamped)- Leakage from graft/sheath connection

Valve Leakage (nominal)20

Leakage volume per minute should requirement

Blood Density- 1.06g/mL

Sample Size – 4 / group

Valve Leakage (extreme)21

Leakage volume per minute should requirement

Blood Density- 1.06g/mL

Sample Size – 4 / group

SETUP

Valve Leakage (Extreme Test Setup)22

Insertion/Removal Testing23

Test SetupTest Media: WaterTest Temperature: 37°CSilicone Oil: MED400 1 drop (0.01mL)Speed: 120in/min

Insertion Test Steps

Step Pump Section

1 Pigtail (1.5”)

2 Inlet (1”)

3 Cannula (0.75”)

4 Cannula (0.75”)

5 Pump Housing (1”)

6 Motor Housing (1”)

7 Catheter (1”)

Proposed Requirement• Insertion force of the Impella 5.0 through hemostasis valve

must be less than 20N, should be less than 15N.• Insertion force of the Impella 5.0 through sheath and

graft must be less than 10N.

Pigtail Inlet Cannula Cannula Pump Housing

Motor Housing

Catheter

MED-400 Application to Helix

Insertion/Removal Testing24

20N Must15N Should

Sample SizeHelix – 4 (each)Current - 6

Insertion/Removal Testing25

20N Must15N Should

Sample SizeHelix – 4 (each)Current - 8

S.E.M. Work

Lumen Stem

50x

100x

Pigtail Loop

50x

100x

The End!