A New Tool for Collecting Colostrum: Jules Sherman

Primo-LactoA Closed System For Colostrum Collection

Confidential Maternal Life LLC © 2017 All Rights Reserved

Team

CEO: Jules Sherman, MFA

Strategy Team: Ryan Van Wert, MD

Rush Bartlett, PhD MBA

Clinical Advisors William Rhine, MD Director, Neonatal ICU, Lucile Packard Children's Hospital

Jane Morton, MD Burgess Pediatrics, Expert in Breastfeeding Medicine

Nancy Wight, MD Neonatologist, San Diego Neonatology, Inc., Medical Director,

Sharp HealthCare Lactation Services, Sharp Mary Birch Hospital for Women and

Newborns

Jae Kim, MD, PhD Professor of Clinical Pediatrics Rady’s Children’s Hospital UCSD

Director, Neonatal Perinatal Medicine Fellowship, Nutrition Director SPIN Program

New England Pediatric Device Consortium (NEPDC)

The National Capital Consortium For Pediatric Surgical Innovation


Jules Sherman, BFA Industrial Design, MFA DesignProfessional product designer for 22 years.

1990-1994 Rhode Island School of Design-ID

Clients/Employers:

1994-2010:Newell/RubbermaidLimited BrandsRestoration HardwareCOSTCO WAL-MARTCrate & Barrel

2010-2012 Stanford Graduate School Of Design

2012-2017:Maternal Life LLCStanford UniversityThe Clorox Co.Whole BiomeSalutronQ-Medic HealthGreat Call Confidential

Maternal Life LLC © 2017 All Rights Reserved

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eiusmod tempor

incididunt ut labore et

dolore magna aliqua.

Current Practice


* Journal of Perinatology (2009) 29, 757–764; doi:10.1038/jp.2009.87; published online 2 July 2009 Combining hand techniques with electric pumping increases milk production in mothers of preterm infantsJ Morton1, J Y Hall1, R J Wong1, L Thairu1, W E Benitz1 and W D Rhine1

1Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA

1-3ml can usually be expressed

every 2-3 hours.

New moms are asked to express

their colostrum 8x per day the first

1-3 days after birth.

*Best practice is to alternate

pumping with hand expression.


http://www.nature.com/jp/journal/v29/n11/full/jp200987a.html#aff1




• Colostrum gets stuck in the valve of a pump.

• Containers for hand expression set inappropriate expectations

and are awkward to use.

• Transfer is inefficient and results in colostrum loss.

PROBLEM


INSIGHTS

• Colostrum gets stuck in the valve of a pump

FRUSTRATING FOR MOM & NURSE.

• Containers for hand expression are awkward

CONTAINERS DON’T SET APPROPRIATE EXPECTATIONS WHICH

INCREASES ANXIETY.

• Transfer is inefficient resulting in lost colostrum and disappointment.

“I’M NOT ENOUGH.”

“I’M NOT A GOOD MOTHER.”

“I COULD HURT MY BABY.”


25% of mothers do not breastfeed

immediately after birth in the US.


• Pre-term births (9.8%)

• Low birth weight but not pre-term

• Births for babies with tongue tie

• Births for babies with cleft palate

• Births with trauma to the head/jaw (vacuum assist births due to

shoulder dystocia often lead to this condition)

• Babies unable to feed after birth due to narcotics being passed

from the mother who had them intravenously administered

during birth

• Diabetic mothers giving birth (1 in 25 worldwide)*

• Midwives/clinicians collecting colostrum antenatally to

encourage labor

• Moms who don’t breastfeeding due to cultural

pressures/preference

*Advising women with diabetes in pregnancy to express breastmilk in late pregnancy (Diabetes and Antenatal Milk Expressing (DAME): a multicentre, unblinded, ramdomised controlled trial Della A Forster, Anita M Moorhead, Susan E Jacobs, Peter G Davis, Susan P Walker, Kerri M McEgan, Gillian F Opie, Susan M Donath, Lisa Gold,Catharine McNamara, Amanda Aylward, Christine East, Rachael Ford, Lisa H Amir Lancet 2017; 389: 2204–13

(“At Risk Babies”10%)

(Min.

5%)

Primo-Lacto: A Closed System For Colostrum Collection Slip-Fit Oral Syringe Design


SOLUTION

Adapter Assembly Hand-Expression Funnel

Primo-Lacto: A Closed System For Colostrum Collection ENFit® Enteral Syringe Design


Adapter Assembly Hand-Expression Funnel


The Medela assembly


Primo-Lacto adapter connected to Medela‘s assembly

Key Invention(s) in the PatentDescription

Application

NumberFiling Date Publication No. Patent No. Issue Date Status Independent Claim / Summary

Method 1 - use of a breast pump system with an adaptor that allows for connection to a syringe to extract and then

dispense the colostrum

DEVICE AND METHOD FOR

COLLECTING AND

DISPENSING COLOSTRUM

13/945751 7/18/2013 8979819 3/17/2015Granted

1. A method of collecting colostrum from a breast of a human and dispensing the colostrum to a newborn, using an electric breast pump system and an

adapter, the method comprising: coupling a first end of the adapter with a distal end of a syringe; positioning a second, open end of the adapter in contact

with or near the breast; manually expressing colostrum from the breast into the second end of the adapter; coupling the second end of the adapter with a

connector of a breast pump shield of the electric breast pump system by engaging helical threads on an outer surface of the second end of the adapter

with complementary threads on an inner surface of the connector, wherein the coupling step is performed while the adapter remains attached to the distal

end of the syringe; expressing additional colostrum from the breast, using the breast pump shield and the electric breast pump system attached to the

breast pump shield; retracting a plunger of the syringe while the syringe is attached to the adapter, to cause the colostrum to move into the syringe from

the adapter; detaching the first end of the adapter from the distal end of the syringe; and dispensing the colostrum to the newborn from the syringe.

Method 2 - use of a breast pump system with an adaptor that allows for connection to a syringe to extract and then

dispense the colostrum


COLLECTING AND


13/923264 6/20/2013 8998879 4/7/2015Granted

1. A method of using a system to collect colostrum from a breast of a human and using at least part of the system to dispense the colostrum to a newborn,

the method comprising: coupling together an interface member, an adapter and a syringe, all of which are part of the system, by threading at least one

thread on an outer surface of a first end of the adapter into at least one complementary thread on the syringe, and coupling a second end of the adapter

with the interface member to form at least part of the system; positioning the interface member in contact with or near the breast; expressing colostrum

from the breast, into the interface member; applying suction force to the interface member, using the syringe, to draw the colostrum into the syringe;

detaching the interface member from the syringe; and dispensing the colostrum to the newborn from the syringe.

Method 3 - use of a funnel with a connector to collect colostrum with a syringe


COLLECTING AND


14/624363 2/17/2015US20150196696 9782526 10/10/2017Granted

1. A method of collecting colostrum from a breast of a human and dispensing the colostrum to a newborn, the method comprising: coupling a narrow end

of a funnel-shaped colostrum collection device with a syringe; manually expressing colostrum from the breast into a wide end of the colostrum collection

device that is opposite the narrow end; retracting a plunger of the syringe to create a suction force and thus cause the colostrum to move from the

colostrum collection device into a barrel of the syringe; detaching the colostrum collection device from the syringe; and dispensing the colostrum to the

newborn from the syringe without transferring the colostrum to any other colostrum container.

Device 1 - A side port in the adapter and the adapter

includes a blocking member in the suction line to prevent

flow into the back of the system

CONNECTOR FOR

COLLECTION AND

DISPENSING OF BREAST MILK

OR COLOSTRUM

14/478713 9/5/2014US20150065996

Next Response to

Patent Office :

10/14/2017

1. An adapter for use in a system for collecting colostrum and/or milk from a breast, the adaptor comprising: a body having a predominantly cylindrical

shape; a first open end of the body for connecting to a funnel device; a second open end of the body for connecting to a source of suction; a side port

between the first and second ends for connecting to a fluid collection device; a catchment area at or near the side port; and a blocking member between

the side port and the second end, for preventing colostrum from passing beyond the side port and through the second end, wherein the blocking member

includes at least one aperture for allowing suction force to be transmitted from the second end to the first end.

Device 2 - A reservoir in the adapter and the adapter

includes a blocking member in the suction line to prevent

flow into the back of the system

CONNECTOR FOR

COLLECTION AND


OR COLOSTRUM

14/611693 2/2/2015US20150148783

Next Response to

Patent Office :

10/17/2017

1. An adapter for use in a system for collecting colostrum and/or breast milk, the adapter comprising: a body having a predominantly cylindrical shape; a

first open end of the body for connecting to a funnel device; a second open end of the body for connecting to a source of suction; a blocking member

inside the body, between the first open end and the second open end, for preventing colostrum from passing from the first open end through the second

open end; an aperture in the blocking member to allow suction force applied at the second open end to generate suction at the first open end; a reservoir

extending off of a side of the body, between the first open end and the blocking member, for containing the colostrum and/or breast milk, wherein the

reservoir has a proximal end located at a junction of the reservoir with the side of the body and a distal end; and a port disposed on the distal end of the

reservoir for connecting the adapter to a fluid collection device.

Device 3 - A removable reservoir in the adapter and

the adapter includes a blocking member in the

suction line to prevent flow into the back of the system

CONNECTOR FOR

COLLECTION AND


OR COLOSTRUM

15/380155 12/15/2016US20170095600

First Office Action

Prediction January

2019

1. An adapter system for facilitating collection of colostrum from a breast, the adapter system comprising: an adapter, comprising: a first open end for

connecting to a breast shield of a breast pump system; a second open end for connecting to a breast pump connector of the breast pump system; and a

third open end, disposed between the first and second open ends, configured for allowing the colostrum to pass out of the adapter; a removable reservoir

comprising a wide end for removably attaching to the third open end and a narrow end for attaching to a colostrum delivery device; and a hand-

expression funnel comprising a wide end for receiving colostrum and a narrow end for attaching to the colostrum delivery device.

PCT 1 (Devices 1-3) - A removable or non-removable reservoir in the adapter and

the adapter includes a blocking member in the

suction line to prevent flow into the back of the system

CONNECTOR FOR

COLLECTION AND


OR COLOSTRUM

[PCT just filed - awaiting PCT number - Core specification comes from patent US20170095600]

1. An adapter system for facilitating collection of colostrum from a breast, the adapter system comprising: an adapter, comprising: a first open end for

connecting to a breast shield of a breast pump system; a second open end for connecting to a breast pump connector of the breast pump system; and a

third open end, disposed between the first and second open ends, configured for allowing the colostrum to pass out of the adapter; a removable reservoir

comprising a wide end for removably attaching to the third open end and a narrow end for attaching to a colostrum delivery device; and a hand-

expression funnel comprising a wide end for receiving colostrum and a narrow end for attaching to the colostrum delivery device.


2013 2014 2015 2016 2017

Initial design focused on connecting a funnel to the existing bottle port on the funnel. This proved to be less ideal since colostrum would get stuck in the suction valve

Next iteration included an adaptor with a side port for the syringe to attach as the reservoir

Next iteration included an adaptor with a side port and a separate reservoir

Last iteration included an adaptor with a side port and a separate reservoir that can detach easily to be cleaned

Each design iteration improvement was informed by experimentation and trials which included human factors feedback.


US Market Snapshot: 4M Annual Live Births

1M Moms & Babies Helped Annually.

9.8% Preterm Births10% High Risk (Drugs, Tongue Tie, Birth Trauma)

• 5% of moms decide not to breastfeed but will collect colostrum for baby’s health.

• % Unknown: Clinicians/midwives asking moms to do antenatal colostrum collection due to gestational diabetes, or in order to encourage labor.


The NEPDC Cares.


According to Dr. William Rhine, Director of Neonatal ICU at Lucile Packard Children’s Hospital, Stanford CA, “We currently have various work-arounds for collection and administering a mother’s colostrum to her baby. However, none of them are efficient, or promote confidence in either the mother or the nurses.”

Clinicians care.

Dr. William Rhine, Neonatologist


Dr. Robert WhiteAmber Sahloff, RN, Nancy Freitag, RNFemi Okanlami, MD, Mary Degeneffe, MDCynthia Werner, Lactation Consultant (LC)Pam Coquillard, LC, Emilia Ettl, LCKim Brassell, RN - NICU EducatorDiane Freel, RN - NICU Head Nurse

Nannette Mills Lactation Consultant IBCLCAndrea Higalgo Clinical Nurse Specialist for the NICUPatricia Baird-Hendrey RN BSN Staff NurseMichelle Dishman RN Manager NICUNatalie Dicks Lactation Educator & and RN


Dr. Jae Kim, MD, PhDPeggy J. Castor, RNC, IBCLCSherry McClure, RN

Kolaleh Eskandanian, PhD, MBA, PMPChildren’s National Health System

Debbie Groth RN MS NEA-BCStacey Breslin, RN IBCLCSuzanne DeSandre, RN IBCLC (took the photo)Indira Mackay RN BSN MSNJody Charles NICU manager RN,


Dr. Nancy Wight, MD, IBCLC, FABM, FAAPMary Ann Jones, RN, IBCLC,

Manager of Lactation

Nami Jhaveri, MDDr. Shannon Alexander, MDSandra Clark, RN NICU staff nurseDr. Michael Jennis, Assistant Chief, NICU DirectorDorothy Hutchinson, MSN, CNS

Oakland Clinical Nurse Specialist, NICU


Confidential Maternal Life LLC © 2017 All Rights Reserved Grants & Awards

•New England Pediatric Device Consortium

Pre-Seed and Full Seed Grant $60K

• The National Capital Consortium For Pediatric

Surgical Innovation (NCC-PDI Award) $50K

Award Number P50FD004895 from the FDA

• Stanford Med X Medical Device Award 2016

• Stanford Nursing Symposium

• Academy of Neonatal Nursing (ANN)


US Clinical Trial

The US clinical trial was run at three different hospitals:

•Sharp Mary Birch in San Diego, CA,•John Muir Hospital in Walnut Creek, CA•Indiana Memorial Hospital of South Bend, IN.

67 mothers and 91 nurses participated and submitted complete surveys across three hospitals. For patients, the main result is that ease and confidence were better with Primo-Lacto® for both hand and pump. For nurses, the main results are that ease was better and % captured is significantly more* with Primo-Lacto® for both hand and pump. The collection times were not significantly different.

*Primo-Lacto increased colostrum collected by 75% when hand-expressing and 45% when pumping, compared to standard practice in hospitals.

Ease P Satisfaction P Confidence P

Hand only

3.1 (1.2) (ref.) 3.1 (1.2) (ref.) 3.5 (1.1) (ref.)

Hand + PL

3.9 (1.0) < 0.0001 3.8 (1.0) < 0.0001 4.1 (1.0) 0.0003

Pump 3.1 (1.4) 0.88 2.9 (1.3) 0.71 3.6 (1.2) 0.57Pump + PL

4.1 (1.2) 0.0002 3.8 (1.3) 0.003 4.3 (1.1) 0.0001

Table 1. Patient Perspective

Ease P % Loss P Collection time (minutes)

P

Hand only

3.1 (1.2) (ref.) 13.0% (11.5%) (ref.) 6.6 (7.8) (ref.)

Hand + PL

4.2 (0.9) < 0.0001 7.6% (14.5%) < 0.0001 6.2 (6.6) 0.35

Pump 3.1 (1.4) 0.84 14.0% (15.7%) 0.86 8.1 (5.3) 0.003Pump + PL

4.1 (1.1) < 0.0001 9.4% (21.9%) 0.003 7.5 (5.5) 0.10

Table 2. Nurse Perspective

Scores are presented as mean (standard deviation).

Scores are presented as mean (standard deviation).


Table 1: Patient Perspective

Rated on 1 - 5 scale with 5 being the best rated.

Ease Satisfaction Confidence

Hands Only Control 3.15 3.11 3.51

Hand & Funnel + Syr inge (PL) 3.86 3.89 4.33

Pump Only Control 3.20 3.66 3.85

Pump & Adapter + Syr inge (PL) 3.01 4.11 4.25

Ease % Lost Collection Time

(min)

Hands Only Control 3.12 12.77% 6.46

Hand & Funnel + Syr inge (PL) 4.19 7.24% 6.08

Pump Only Control 3.13 13.51% 8.39

Pump & Adapter + Syr inge (PL) 4.14 9.33% 7.70

Table 1: Nurse Perspective

Ease of collection rated on 1-5 scale with 5 being the easiest, estimated colostrum loss, and

collection time in minutes.

Hand Expression Funnel Assembly:

+ =1 32

Maternal Life Pr imo -Lac to : A Cl o sed System Fo r Co l o str um Co l l ec t io nJules Sherman, MFA Design, Rush Bartlett, Ph.D., MBA, Ryan Van Wert, MD, Frank Wang, Ph.D.

Testing Hospitals: Sharp Mary Birch in San Diego, CA, Memorial Hospital of South Bend, IN and John Muir Hospital in Walnut Creek, CA.

Backg r o und

hypo thesis

metho ds

c l in ical pil o t study

study data: 67 pat ien ts

f unding

standar d pr ac t ice

pr imo -l ac to system

rich milk produced during the f rst few days

af er birth.

immunoglobulins, which protects newborns

stools called meconium. When a baby is fed

their mother’s colostrum, it is as if that baby is

produced each hour.

borns cannot nurse during the colostral

period due to prematurity, lack of sucking

ref ex, ankyloglossia or other health issue.

plastic spoons, cups and bottles. Transfer to a

feeding syringe causes signif cant colostrum loss,

and potential for contamination and infection.

work-f ow.

Inclusion Criteria:

below 34 weeks gestation will be approached one

breast milk to their infant). In addition,

mothers of non-latching infants or infants with

will be approached.

Study Design:

own control. T e sequence of the four lactation

procedures is the same for all mothers. T e study

uses scaled data from participants’ (mothers and

nurses) responses to questions comparing both

Primo-Lacto and traditional collection

procedures.

point in the study, there were 30 enrolled mothers

Instructions for Nurse or Lactation Consultant:

Suggest alternate method with each session.

Standard practice pumping and hand expression,

and then Primo-Lacto method (repeat)

Record:

EGA - estimated gestational age (at birth)

Birth weight

standard method.

*Primo-Lacto parts are packed sterile and were

hand-washed between sessions.

for this study.

Pump Adapter Connector Assembly:

1 32

+ =

Across all methods, mothers found the combination of hand expression funnel and syringe (Primo-Lacto) the easiest to use (F=8.68, p<.001).

T e combination of pump, adapter and syringe (Primo-Lacto) was found to be the most satisfying (F=9.16, p<.001) and gave mothers the most conf dence

(F=7.54, p<.001). T e adapter and syringe attachment with the breast pump (Primo-Lacto) improved ease of colostrum

collection by 32% (t=5.98, p<.001). Nurses observed that the Primo-Lacto adapter increased colostrum collected with the pump by 45% compared to regular pump

expression. Nurses observed that the Primo-Lacto funnel increased colostrum collected by 75% compared to standard hand expression practice (t=2.48, p=.007).

To analyze the results, we included data sets from

67 mothers from whom complete data was

data sets. Mothers with no milk expression were

excluded from analysis.

HOSPITAL SALES


SHARP MARY BIRCH FOR WOMEN & NEWBORNS

INTEGRIS MIAMI HOSPITAL

CURRENT TRIALS

Three major hospitals in Australia

have begun trials with Primo-Lacto:

• Royal Children’s Hospital,

Melbourne, Victoria

• Fiona Stanley Hospital, Perth,

Western Australia Sydney

• Children’s Hospital, Westmead,

New South Wales

DISTRIBUTOR AU/NZ


INVITATIONS TO SPEAK ABOUT PRIMO-LACTO

Stanford University:1) Biodesign Fellows Program 20162) Perspectives In Assistive Technology 2015/163) Center for Policy, Outcomes and Prevention (CPOP) 20174) Stanford d. School 2015/165) Stanford Medical School Grand Rounds 2015

Draper University: Entrepreneurship Program 2015Institute For Patient Centered Design 2015Society of Physician Entrepreneurs; Children’s Hospital of Orange Country (CHOC) 2017International Society for Pediatric Innovation 2017Breastfeeding Innovations Team 2018

https://www.cpqcc.org/qi-research/safety-learning-laboratory-neonatal-and-maternal-care

Projects:

-Developing an optimal, interactive neonatal data display-Developing an optimal data display for labor & delivery-Improving recognition of maternal clinical deterioration-Physical design of an optimal delivery suite-Electronic medical record use during C-Section-Neonatal resuscitation at the bedside and delayed umbilical cord clamping-Facilitating easier pelvic exams in the ER and low-resource clinicsConfidential Maternal Life LLC © 2017 All Rights Reserved

Thank you.

Jules Sherman, MFA Designwww.maternallife.cowww.redesignhealthcare.orghttps://www.linkedin.com/in/julessherman/

http://www.maternallife.co/

http://www.redesignhealthcare.org/

https://www.linkedin.com/in/julessherman/

A New Tool for Collecting Colostrum: Jules Sherman

Health & Medicine

Transcript of A New Tool for Collecting Colostrum: Jules Sherman