"Nighttime Home Dialysis (HHD) is on the rise, and the design of AVF needles is being rewritten by 'patient self-insertion'."

Over the past 5 years in Europe and the United States, the penetration rate of home hemodialysis (HHD) has risen from 2-3% to 5-8% (12% or more in Australia, and even higher in New Zealand). The reason for this is the good evidence-based data for "nighttime long-term dialysis (nocturnal HHD, 5-6 nights per week, 6-8 hours per night)," which results in better outcomes in terms of blood pressure, cardiac function, and fistula lifespan compared to 4-hour sessions of central dialysis three times a day. However, there is a hard constraint for HHD: the patient or their family member performs the puncture, not a nurse.

This leads us to conclude that the design of the AVF needle has been modified in several aspects, which is different from the central dialysis model:

The wings should be large

The anti-slip patterns should be deep

The central dialysis nurse puts on gloves, fixes the fist with one hand, and inserts the needle with the other. There is no problem with the small needle wings. For self-insertion by patients (especially for elderly patients or those with diabetes who have shaky hands), it is necessary for the "needle wings to be firmly held + after the puncture, the wings should be able to adhere to the skin and remain fixed without shaking." The special line wings of Terumo's HHD are 40% larger in area than the standard model, and the anti-slip patterns on the wings have been increased from 0.3 mm deep to 0.5 mm.

1. Returnable Visible Window

The patient is most afraid of "not fully inserting the catheter into the fistula." When the central dialysis nurse observes "blood return + tremors," the patient refuses. Therefore, the HHD type AVF needle holder is equipped with "transparent window + pre-filled extension tube," so that as soon as the needle enters the fistula, the blood return can be immediately seen in the window - this is a psychological anchor. Currently, domestic factories have not adopted this design, but Fresenius' HHD package already includes this as a standard feature.

2. Safety Sleeve is Placed in Front

The needle removal is also done by the patients themselves. After the central dialysis needle removal, the nurse immediately presses it for 10 minutes. After the patient self-inserts the needle, they may first tidy up the tubing before pressing it. The needle tip wiggling could easily prick the patient. The safety sleeve of the HHD model "locks the needle tip with a push of the thumb at the same time" is simpler than the third-generation safety needle of central dialysis (it doesn't require a retraction spring and has a lower cost).

3. Segmenting by Length Becomes More Detailed

Central dialysis: There are two sizes available - 17G×25 mm and 17G×27 mm (suitable for thin or obese patients). The fistula conditions of HHD patients vary greatly (elderly patients have shallow fistulas, and diabetic patients have deep and calcified fistulas). The needle lengths need to be 22/25/27/32 mm, and each size is equipped with a "puncture depth marking ring" (similar to the black ring on IO needles) - when the patient inserts the needle themselves, they will know the depth is sufficient when they "see the ring outside the skin."

4. The Window of the Chinese Factory

In China, HHD is still almost non-existent (with dialysis center models accounting for over 95%). However, in Southeast Asia (Thailand, Malaysia) and the Middle East (Saudi private dialysis), HHD is starting to gain traction, and these markets have a high acceptance rate for Chinese OEM products. If a factory like Manners were to develop a product first based on the "HHD-specific wing + window + four-length needle," it would have a better chance than competing with the standard dialysis products at $0.35 for 17G.

?? Manufacturing Note: HHD is AVF's cleanest incremental product in the coming 5 years - the total quantity is not large but the unit price is high (with window + safety sliding sleeve FOB $2.0–3.5), and the patent walls of Chinese factories and Terumo/JMS in the "transparent window + simple sliding sleeve" area are not tight, so it can be cut.