My 10/8/15 inquiry to the FDA re: the "Big John Heimlich Helper" includes 2004 patent granted to the late Louis M. Karpel of Honeoye Falls, NY

8/20/2019 My 10/8/15 inquiry to the FDA re: the "Big John Heimlich Helper" includes 2004 patent granted to the late Louis M…

1/11

Subject: request

From: Peter Heimlich

Date: 10/8/2015 11:22 AM

To: [email protected]

CC: "Alderton, Bonnie J."

Office of Compliance

U.S. Food and Drug Administration

To whom it may concern:

Per the October 6, 2015 e-mail copied directly below my signature, I was referred to your office by FDA

public health advisor Bonnie J. Alderton.

On October 4, 2015, I sent an inquiry to the FDA's Division of Industry and Consumer Education (DICE)

regarding the "Big John Heimlich Helper," a medical device marketed and sold by Big John Products, Inc.,

8533 Canoga Avenue, Suite D, Canoga Park, CA 91304. Please click here for an Amazon.com page selling

the device. Please find attached a pdf file of the patent for the device.

According to the October 6, 2015 e-mail to me from Ms. Alderton in response to my inquiry to DICE (page

down), "I find no record of (FDA) registration or listing for Big John Products."

This is to request that your office determine whether the "Big John Heimlich Helper" is in compliance with

your agency's regulations and to provide me with the results of your findings.

Thanks for your attention and I look forward to your reply.

Sincerely,

Peter M. Heimlich

3630 River Hollow Run

Peachtree Corners, GA 30096

ph: (208)474-7283

website: http://medfraud.info

blog: http://the-sidebar.com

e-mail: [email protected]

cc: Bonnie J. Alderton

encl: US6725863.pdf

On 10/6/2015 1:40 PM, Alderton, Bonnie J. wrote:

Please submit your complaint and concerns to our Office of Compliance at [email protected] I am

unable to provide you with a name as this mailbox is monitored by several Compliance employees. You should

clearly describe the device with links to the company web site, drawings, labeling, etc. Anything that will help that

office determine device classificaon.


2/11

I hope this informaon is helpful.

Sincerely,

Bonnie J. Alderton

Public Health Advisor

Postmarket and Consumer Branch

Division of Industry and Consumer Educaon ( formerly DSMICA)Office of Communicaon and Educaon

Center for Devices and Radiological Health

U.S. Food and Drug Administraon

Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer

service you have received by taking our Customer Service Survey

On 10/6/2015 11:43 AM, "DICE" wrote to [email protected]

Thank you for contacting the Division of Industry and Consumer

Education (DICE) at FDA's Center for Devices and Radiological

Health (CDRH) [email protected] e-mail account.

Upon further investigation, I have learned these devices, while theyare Class II, are EXEMPT from the premarket notification (510K)

process. Therefore, they are only required to register their

establishment and list their product. You can view the regulation

information by going to our web site

at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr

/cfrsearch.cfm?fr=880.6740 Again, Lifevac has registered and

listed with FDA, however I find no record of registration or listing for

Big John Products.

Feel free to write me back with any questions you may have. I hope

this information is helpful.

Sincerely,

Bonnie J. Alderton

Public Health Advisor

Postmarket and Consumer Branch


3/11

Division of Industry and Consumer Education

Office of Communication and Education

Center for Devices and Radiological Health

U.S. Food and Drug Administration

This communication is consistent with 21 CFR 10.85 (k) and

constitutes an informal communication that represents my best

judgment at this time but does not constitute an advisory opinion, doesnot necessarily represent the formal position of FDA, and does not

bind or otherwise obligate or commit the agency to the views

expressed. This communication is intended for the exclusive use of the

recipient(s) named in this correspondence. It may contain information

that is protected, privileged, or confidential, and it should not be

modified. It may not be disseminated, distributed, reproduced, or

copied to persons not authorized to receive such information. If you

are not the intended recipient, any dissemination, distribution, or

copying is strictly prohibited. If you think you have received this

communication in error, please immediately delete all copies from thesaved sources and notify DICE by email

at:[email protected] immediately.

Excellent customer service is important to us. Please take a moment to provide

feedback regarding the customer service you have received:

https://www.research.net/s/cdrhcustomerservice?O=800&D=870&B=870&

E=&S=E

Original Message

From: [email protected]

Sent: 10/4/2015

-------------------------------------------------------------------------------------------

Subject: request to review two medical devices -- LifeVac and Big

John Heimlich Helper

Message:

Division of Industry and Consumer Education (DICE)

U.S. Food and Drug Administration (FDA)

10903 New Hampshire Avenue

Silver Spring, MD 20993

To whom it may concern:

Please find attached a pdf consisting of my six-page letter

to your division dated today.

Thank you for your consideration and I look forward to your

reply.


4/11

Sincerely,

Peter M. Heimlich

3630 River Hollow Run

Peachtree Corners, GA 30096

ph: (208)474-7283

website: http://medfraud.info

blog: http://the-sidebar.come-mail: [email protected]

cc: Bonnie J. Alderton, FDA Public Health Advisor

encl: 15-10-4 PMH-DICE LifeVac + Heimlich Helper.pdf

Attachments:

US6725863.pdf 368 KB


5/11

US006725863B2

1 2 ) United

States

Patent 1 0 ) P a t e n t N 0 . 2 US 6 , 7 2 5 , 8 6 3

B2

K a r p e l

4 5 ) D a t e

o f P a t e n t :

A p r . 2 7 , 2 0 0 4

(54) CHOKINGASSISTANCE DEVICE 3 , 4 0 1 , 6 8 6 A 9/1968 Edwards . . . . . . . . . . . . . . . . . . . . . 1 2 8 / 2 8

4,059,099 11/1977

Davis

. . . . . . . . . .. 128/28

7 6 ) I n v e n t o r : Louis M.

arpel, 62

BuggyWhip

T r a i l ,

4 , 1 6 4 , 2 1 6 A 8 / 1 9 79 P e r s o n - - - - 1 2 8 / 2 8

Honeoye alls,

NYUS)

14472 4,182,317 1/1980

Ash

. . . . . . . . . . . . . . . . . . 128/28

4 ,726,357 A 2 / 1 9 88

DeStefano

. . . . . . 128/28

*

)

N o t i c e : S u b j e c t t o any d i s c l a i m e r , t h e term o f

t h i s 13321937

5 1 1 / 1 9 9 1 Young - - - - - -

D 2 4 / 1 3 3

patent i s extended o r adjusted under

35

D363,554

S

1 0 / 1 9 9 5 P s a r o s . . . . . . . . . . . . D24/200

U _ S _ C _

1 5 4 k ) )

by

0

days D 3 6 3 , 9 9 1 S 1 1 / 1 9 9 5 B e n w a r e e t a 1 . D 2 4 / 2 0 0

D381,754 S 7 / 1 9 9 7 Fani . . . . . . . . . . . . . . . D24/2OO

5 , 6 5 1 , 7 5 5

7/1997 Chen

. . . . . . . . . . . . . . . . . . . . . . . . . . 482/128

2 1 ) Appl NO

10/121’834

5 , 7 2 2 , 9 8 7 A 3 / 1 9 9 8

Witbeck

. . . . . . . . . . . . . . . . . . . . . 6 0 6 / 2 0 1

2 2 )

F i l e d : A p r . 1 2 , 2 0 0 2

6 5 )

P r i o r

P u b l i c a t i o n Data P r i m a r y

Examiner—Michael A . Brown

7 4 ) A t t o r n e y , A g e n t ,

o r

Firm—BroWn & M i c h a e l s

P C ;

US 2002 /0 156 405 A1 c t . 2 4 ,

2002

_

E u g e n e

S t e p h e n s &

s s o c i a t e s

R e l a t e d

US.

A p p l i c a t i o n

Data

6 0 )

P r o v i s i o n a l a p p l i c a t i o n N o .

6 0 / 2 8 4 , 6 4 6 , ? l e d o n A p r . 1 8 ,

2 0 0 1 . 5 7 ) ABSTRACT

5 1 ) I n t . C l . 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A61G / 0 4 A

hoking

a s s i s t a n c e d e v i c e i n c l u d e s

a

head s p e c i a l l y

5 2 ) US.

C l .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1 2 8 / 8 4 5 ; 6 0 6 / 2 0 1

d e s i g n e d

f o r

p l a c e m e n t

a g a i n s t

t h e

abdomen o f a c h o k i n g

5 8 ) F i e l d

O f

Search

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1 2 8 / 8 4 5 , 8 4 6 ; v i c t i m f o r

performance

o f

t h e Heimlieh Maneuver.

The

head

6 0 6 / 2 0 1 ; 4 8 2 / 1 2 1 , 1 2 2 , 1 2 6 , 1 2 8 h a s l a t e r a l e x t e n s i o n s a n d , i n

t h e

p r e f e r r e d

e m b o d i m e n t ,

a

c e n t r a l

b u l g e .

The c h o k i n g a s s i s t a n c e

d e v i c e

a l s o

h a s

a

5 6 )

R e f e r e n c e s C i t e d s p a c i n g r o d a t t a c h e d t o

t h e

h e a d W i t h

a p p r o p r i a t e l y l o c a t e d

h a n d l e s a n d

a

n o n - s l i p

b a s e p a d .

U . S . PATENTDOCUMENTS

1 , 5 3 5 , 8 2 2 A 4 / 1 9 2 5

G o o d w i n 1 8

C l a i m s , 3 Drawing

S h e e t s


6/11

U.S. Patent A p r . 2 7 , 2 0 0 4 S h e e t

1 o f 3

U S 6 , 7 2 5 , 8 6 3 B2

F I G

1


7/11


8/11

U.S. Patent A

. 2 7

2 0 0 4 S h e e t

3

o f 3

US

, 7 2 5 , 8 6 3 B 2


9/11

US 6 , 7 2 5 , 8 6 3 B2

1

CHOKINGASSISTANCE DEVICE

T h i s a p p l i c a t i o n

c l a i m s

t h e

b e n e ? t o f

US. P r o v i s i o n a l

A p p l i c a t i o n

N o .

6 0 / 2 8 4 , 6 4 6 ,

? l e d

o n A p r .

1 8 ,

2 0 0 1 ,

W h i c h

p r o v i s i o n a l

a p p l i c a t i o n

i s

i n c o r p o r a t e d

b y r e f e r e n c e h e r e i n .

TECHNICAL IELD

My n v e n t i o n

d e a l s

g e n e r a l l y W i t h a p p a r a t u s i n t e n d e d t o

a s s i s t

i n t h e p e r f o r m a n c e o f t h e

H e i m l i c h

Maneuver o h e l p

a c h o k i n g

v i c t i m . More

s p e c i ? c a l l y ,

i t d e a l s W i t h e q u i p m e n t

t h a t t h e

choking

v i c t i m

can

u s e W i t h o u t o u t s i d e a s s i s t a n c e t o

perform

t h e Heimlich Maneuver on h i m s e l f o r h e r s e l f .

BACKGROUND OF THE INVENTION

Thousands

o f

p e o p l e

i n

t h e U n i t e d S t a t e s d i e e a c h y e a r

f r o m a c c i d e n t a l c h o k i n g .

F o r

many y e a r s , m e d i c a l

o p i n i o n

d i f f e r e d

a s

t o

t h e

m o s t - e f f e c t i v e Way t o d e a l With a c c i d e n t a l

c h o k i n g . O f t e n s h a r p b l o W s t o

t h e

b a c k , ? n g e r s W e e p s o f

t h e

t h r o a t , a n d

manual h r u s t s

t o

t h e c h e s t Were

a t t e m p t e d .

These

m e t h o d s p r o v e d t o b e n o t o n l y

u s e l e s s

a n d i n e f f e c t u a l i n

most c a s e s ,

b u t

t o a c t u a l l y b e h a r m f u l t o t h e c h o k i n g v i c t i m .

I n 1 9 8 5 ,

t h e

American Red C r o s s ,

t h e

American H e a r t

A s s o c i a t i o n , a n d t h e

S u r g e o n G e n e r a l

o f t h e

U n i t e d

S t a t e s

d e t e r m i n e d t h a t methods o t h e r t h a n t h e H e i m l i c h Maneuver

c a n

b e d a n g e r o u s a n d

t h a t

o n l y t h e H e i m l i c h

Maneuver

s h o u l d be used t o t r e a t

a

choking v i c t i m .

H e n r y J . H e i m l i c h , M . D . ,

d e v i s e d

t h e H e i m l i c h

Maneuver

i n t h e e a r l y 1 9 7 0 s .

I t

depends f o r

i t s

s u c c e s s on t h e f a c t t h a t

a c h o k i n g

v i c t i m ’ s

l u n g s

h a v e

a l a r g e volume

o f

a i r i n them

e v e n i f t h e p e r s o n

Was e x h a l i n g

When t h e

c h o k i n g b e g a n . I f

a r e s c u e r p r e s s e s s h a r p l y

and

r e p e a t e d l y on t h e v i c t i m ’ s

a b d o m e n ,

W i t h o n e b a l l e d ? s t W r a p p e d i n t h e o p p o s i t e h a n d ,

a t

a

p o i n t

j u s t

a b o v e

t h e n a v e l ,

b u t

beloW

t h e

r i b

c a g e

a n d

t h e

d i a p h r a g m ,

t h a t r e s e r v o i r

o f

a i r i s e x p e l l e d

u p

t h e

a i r W a y

W i t h

a

g r e a t f o r c e .

T h i s s e r v e s t o d i s l o d g e t h e o b s t r u c t i o n

from t h e v i c t i m ’ s

t h r o a t .

The

H e i m l i c h

Maneuver

s

g e n e r a l l y

s a f e

a n d e f f e c t i v e . I n

a d d i t i o n , t h e

a v e r a g e

p e r s o n

u s u a l l y c a n m a s t e r

i t . HoWever,

i t

i s

f a r e a s i e r f o r a r e s c u e r

t o

perform t h i s maneuver

on

t h e

v i c t i m t h a n

f o r t h e

v i c t i m

t o

a s s i s t

h i m s e l f o r

h e r s e l f )

i n t h i s

W a y .

The

r e s c u e r ,

Who s t a n d s

b e h i n d t h e v i c t i m , h a s h i s

arms

p a r t i a l l y

e x t e n d e d

a n d i s

t h e r e f o r e p r o p e r l y p o s i t i o n e d t o

e x e r t t h e

s q u e e Z i n g

c o m p r e s s i v e f o r c e

r e q u i r e d

f o r t h e

s u c c e s s o f

t h e

Heimlich

Maneuver.

The i n d i v i d u a l v i c t i m ,

a c t i n g

a l o n e ,

m u s t t r y t o p r e s s h i s

? s t s

a n d h a n d s

a g a i n s t h i s

oWn abdomen W i t h o u t any e x t e n s i o n

o r

p r o p e r l e v e r a g e )

With

s u f f i c i e n t

f o r c e

t o e f f e c t

t h e

e x p u l s i o n o f food

o r

some

o t h e r

item

from

h i s

oWn

h r o a t . This

i s

rendered even

m ore

d i f ? c u l t

by

t h e

f a c t t h a t

t h e

v i c t i m i s i n

t h e

p r o c e s s o f

choking

and m y

be c l o s e

t o unconsciousness a s W e l l a s

s u b s t a n t i a l l y W e a k e n e d .

I n a d d i t i o n ,

many

c h o k i n g

v i c t i m s

a r e e l d e r l y p e o p l e Who

l i v e a l o n e . Not o n l y

a r e

t h e s e i n d i v i d u a l s t h e most

l i k e l y

t o

b e

a f f l i c t e d by a c h o k i n g

emergency

W i t h o u t

a n y

a v a i l a b l e

p e r s o n

t o

a s s i s t

n e a r b y , t h e y a r e o f t e n f r a i l a n d Would ?nd

i t

d i f ? c u l t

t o

perform t h e Heimlich

Maneuver on

t h e m s e l v e s

a t

t h e

b e s t

o f

t i m e s .

When h e y

a r e

i n t h e p r o c e s s o f c h o k i n g ,

a n d p o s s i b l y

p a n i c k e d ,

t h e i r c h a n c e s o f

s u r v i v a l a r e

e x t r e m e l y s m a l l . T h e r e

i s ,

t h e r e f o r e , a g r e a t n e e d f o r some

t y p e

o f

a p p a r a t u s t o

a s s i s t i n d i v i d u a l s i n p e r f o r m i n g

t h e

Heimlich

Maneuver

on

t h e m s e l v e s .

To d a t e , most d e v i c e s t h a t

h a v e

b e e n

d e v e l o p e d t o

a s s i s t

i n t h e p e r f o r m a n c e

o f


Maneuver

h a v e

f e a t u r e d

a b a l l o r dome-shaped

h e a d t o b e

p r e s s e d a g a i n s t t h e

v i c t i m ’ s abdomen. U s u a l l y some t y p e

o f h a n d l e s

a r e

a t t a c h e d t o t h e head t o f a c i l i t a t e t h e

d e v i c e ’ s

u s e by t h e

10

1 5

30

35

40

45

50

55

60

6 5

2

r e s c u e r . These d e v i c e s

m y a s s i s t

t h e

r e s c u e r

and

h e l p t o

p r e v e n t b r u i s i n g o f

t h e

v i c t i m ’ s a b d o m e n , b u t t h e y d o n o t

p r o v i d e t h e

l e v e r a g e

a n d p o s i t i o n i n g n e e d e d

b y

t h e

v i c t i m

i n

p e r f o r m i n g t h e Heimlich

Maneuver

on h i m s e l f .

Only tWo

d e v i c e s

knoWn

t o

t h e

a p p l i c a n t

h a v e b e e n

a d a p t e d

f o r

u s e

by

a

v i c t i m

by

i n c l u d i n g

a

s p a c i n g

r o d

t o

p r o v i d e l e v e r a g e

f o r

s e l f u s e . US. a t . N o . 4 , 1 6 4 , 2 1 6 ,

i s s u e d

t o

P e r s o n

i n

1 9 7 9 ,

f o r a

“ T h r o a t O b s t r u c t i o n E x p u l s i o n

D e v i c e ” , f e a t u r e s a s p a c i n g r o d W i t h a

s l i d i n g

t u b e

mounted

t h e r e o n . The t u b e

h a s

h a n d l e s and a

d i s c - s h a p e d

h e a d . The

s p a c i n g

r o d h a s a f o o t f o r r e s t i n g

o r

mounting on a t a b l e t o p

o r o t h e r s u r f a c e .

I n

o r d e r t o

u s e t h e

d e v i c e , t h e choking

v i c t i m

p l a c e s t h e

h e a d o f

t h e

d e v i c e a g a i n s t h i s abdomen

a n d

u s e s t h e h a n d l e s on h e s l i d i n g t u b e

t o

t h r u s t t h e head

inWard

and upWard

s o

a s t o perform t h e Heimlich Maneuver. U S .

P a t .

N o .

4 , 1 8 2 , 3 1 7 , i s s u e d t o Ash i n 1 9 8 0 , f o r a n “ O b j e c t

D i s l o d g i n g Method

a n d A p p a r a t u s ” ,

u s e s

a d u m b b e l l - s h a p e d

a r r a n g e m e n t W i t h tWo h e a d s c o n n e c t e d by a s p a c i n g r o d . I n

t h i s d e v i c e , o n e h e a d i s g r i p p e d

i n

o r d e r t o

f o r c e

t h e o t h e r

h e a d

a g a i n s t

t h e

u s e r ’ s

a b d o m e n . A l t h o u g h

t h e

b a s i c

p r i n

c i p l e s u n d e r l y i n g

t h e s e

p r i o r

a r t a t t e m p t s

a r e s o u n d , n e i t h e r

d e v i c e h a s a head t h a t i s W e l l shaped o r p r o p o r t i o n e d f o r u s e

i n t h e

s e l f - p e r f o rm a n c e o f

t h e H e i m l i c h M a n e u v e r .

SUMMARY

OF THE INVENTION

My n v e n t i o n

i s c h a r a c t e r i Z e d b y

a h e a d

h a v i n g l a t e r a l

e x t e n s i o n s a n d , i n t h e p r e f e r r e d e m b o d i m e n t , a c e n t r a l

b u l g e . I t a l s o h a s a s p a c i n g r o d

W i t h

a p p r o p r i a t e l y l o c a t e d

h a n d l e s a n d a

n o n - s l i p

b a s e p a d .

The

d e s i g n

a n d

c o n s t r u c

t i o n

o f

my n v e n t i o n

o p t i m i Z e s i t s

p e r f o r m a n c e a s a Heim

l i c h

Maneuver

d e v i c e , t u r n i n g

i t i n t o a t r u l y

p r a c t i c a l

a p p a

r a t u s f o r t h e use

of

e i t h e r a victim or r e s c u e r .

DESCRIPTION

OF THE DRAWINGS

F I G . 1 p r o v i d e s a p e r s p e c t i v e

vieW

o f

my

n v e n t i o n .

F I G .

2

p r o v i d e s a n o v e r h e a d vieW o f my n v e n t i o n .

F I G . 3 p r o v i d e s a

s i d e vieW

o f my n v e n t i o n .

F I G .

4

p r o v i d e s a

p e r s p e c t i v e

vieW o f my

i n v e n t i o n

i l l u s t r a t i n g i t s

i n t e n d e d manner o f u s e .

DESCRIPTION OFTHE INVENTION

The

H e i m l i c h

Maneuver i s e f f e c t i v e

d u e

t o

t h e

e x p u l s i o n

o f a i r f r o m t h e l u n g s c a u s e d When t h e d i a p h r a g m i s

f o r c e d

u p W a r d . T h e d i a p h r a g m i s , i n t u r n , f o r c e d u p W a r d b y t h e

f o r c e

e x e r t e d d u r i n g

p e r f o r m a n c e

o f

t h e maneuver on

t h e

abdomen

a n d

u n d e r l y i n g

a b d o m i n a l

o r g a n s o f

t h e v i c t i m .

T h i s f o r c e must b e a p p r o p r i a t e l y

f o c u s e d

i n o r d e r t o b e

e f f e c t i v e . O n t h e o t h e r h a n d , s u c h a f o r c e must be e x e r t e d i n

a manner t h a t d o e s n o t

damage

t h e v i c t i m . My n v e n t i o n

h a s

b e e n d e v e l o p e d W i t h

t h e

e x p r e s s

p u r p o s e

o f p ro v i d i n g

a p p r o p r i a t e f o r c e

W i t h o u t

i n j u r y .

L i k e some

o t h e r d e v i c e s ,

i t

h a s a s p a c i n g r o d 1

W i t h

h a n d l e s 2 . I t a l s o p o s s e s s e s

a n

end

p a d

3 a n d

a

h e a d 4 . The

n o n - s l i p

e n d

pad 3 o f m y i n v e n t i o n

W h i c h c o u l d b e r e p l a c e d b y

a

n o n - s l i p e n d c a p ) c a n b e ? a t ,

r o u n d e d , o r i n c l i n e d . I t c a n be p l a c e d a g a i n s t a t a b l e t o p o r

W a l l

t o

p r o v i d e

a d d i t i o n a l

a s s i s t a n c e a n d l e v e r a g e t o a

c h o k i n g v i c t i m u s i n g m y d e v i c e . H o W e v e r , i t i s i n t h e d e s i g n

o f

t h e

h e a d 4 t h a t m y n v e n t i o n

m o s t c l e a r l y

s u p e r c e d e s p r i o r

e f f o r t s i n t h i s ? e l d .

The

a t t e m p t e d

e x e r t i o n

o f

f o r c e

o v e r

t o o

l a r g e

an

a r e a

(eg u s i n g a l a r g e

d i s c - s h a p e d

h e a d ) i s u n l i k e l y t o p e n e t r a t e

d e e p l y a n d

e x p e l s u f ? c i e n t b r e a t h t o b e e f f e c t i v e . The

r e s i s t a n c e

p r o v i d e d

b y

t h e s u p p o r t i v e m u s cu l a t u r e a n d t i s

s u e s

o f

t h e a b d o m i n a l

W a l l

a n d by t h e u n d e r l y i n g i n t e r n a l

o r g a n s

W i l l

r e s i s t t h e

a p p l i c a t i o n

o f

f o r c e

a p p l i e d o v e r t o o


10/11

US 6 , 7 2 5 , 8 6 3 B2

3

l a r g e a n a r e a . F u r t h e r , t o t h e e x t e n t such compression

can be

f o r c e d , i t i s l i k e l y

t o

b e t o o

g r a d u a l t o

f o r c e f u l l y e x p e l

m a t e r i a l

f r o m t h e

v i c t i m ’ s

W i n d p i p e .

I n a d d i t i o n ,

s u c h

b r o a d ly s y m m e t r i c a l h e a d s h a p e s W i l l

b e

o u t s i Z e d

f o r

some

v i c t i m s . C o n v e r s e l y ,

a

s y m m e t r i c a l h e a d t h a t a p p l i e s f o r c e

i n

t o o

small

an

a r e a

may

t

more

v i c t i m s ,

but

W i l l

p e n e t r a t e t o o

d e e p l y W i t h

l i k e l y

d a m a g e t o u n d e r l y i n g t i s s u e ) a n d W i l l n o t

c a u s e t h e t y p e o f volume d i s p l a c e m e n t n e c e s s a r y f o r t h e

s u c c e s s

o f

t h e Heimlich

Maneuver.

I

h a v e

d i s c o v e r e d t h a t

a

h e a d

4

W i t h l a t e r a l h o r i z o n t a l )

e x t e n s i o n s

4 A

Works b e s t i n

p e r f o r m i n g


M a n e u v e r . A

e a d 4

o f t h i s t y p e c a n

e a s i l y

b e

p r o d u c e d

W i t h

a s m a l l v e r t i c a l c r o s s s e c t i o n

t h a t

a l l o W s i t

t o

? t betWeen t h e

n a v e l and sternum o f

v i c t i m s o f

many d i f f e r e n t s i Z e s . I t a l s o

c o m p r e s s e s

a

l a r g e enough a r e a d u e t o e x t e n s i o n s 4A) t o

c r e a t e t h e t y p e o f f o r c e f u l volume e x p u ls i o n o f a i r

n e c e s s a r y

f o r

t h e

s u c c e s s o f

t h e

Heimlich Maneuver. HoWever, i t i s

a l s o

a b l e t o

a v o i d

p r o b l e m s a s s o c i a t e d W i t h

t h e

r e s i s t a n c e

o f f e r e d by

t h e v e r t i c a l

b a n d s o f m u s c l e

i n

t h e v i c t i m ’ s

a b d o m i n a l

r e g i o n .

I t

d o e s

t h i s i n

a

s i m p l e

a n d

p r a c t i c a l

Way

by e x e r t i n g f o r c e a c r o s s t h e s e muscles

i n a

narroW h o r i Z o n

t a l band

v i a

e x t e n s i o n s 4A

n s t e a d o f s p r e a d i n g

t h e

f o r c e

i n

a b r o a d l y

s y m m e t r i c a l m a n n e r . I

h a v e

found t h a t f o r c e

e x e r t e d

i n a

narroW

h o r i Z o n t a l band

i s m u c h h a r d e r

f o r t h e

abdominal m u s c u l a t u r e t o r e s i s t o r b l u n t . I n t h i s r e s p e c t , t h e

abdominal

m u s c u l a t u r e

c a n

be

compared t o

a

r i g i d

b u t

bendable

b a r .

I t

i s e a s i e r t o

bend such

an

item a c r o s s

a

narroW l i n e a r edge

t h a n t o bend

t W i t h o u t s u c h a s s i s t a n c e .

I n l i k e m a n n e r ,

t h e

n a r r o W h o r i Z o n t a l

band p r o v i d e d

by

e x t e n s i o n s

4 A g r e a t l y

f a c i l i t a t e s

t h e f u n c t i o n i n g o f m y

i n v e n t i o n .

I

h a v e a l s o d i s c o v e r e d t h a t i t i s b e s t

t o

h a v e a p o r t i o n t h a t

c r e a t e s

an i n i t i a l

“ p o i n t

of a t t a c ”

r a t h e r

t h a n t o t r y

t o f o r c e

t h e

e n t i r e

Width o f

head 4

i n t o t h e

abdomen

t

t h e

same

t i m e .

T h u s ,

t h e

h e a d 4

i s n o t

o n l y p r o v i d e d W i t h

l a t e r a l e x t e n s i o n s

4 A ,

b u t

W i t h

a

l e a d i n g c e n t r a l b u l g e

5 .

T h i s b u l g e 5 , l i k e t h e

p o i n t o f a s h o v e l o r

t h e

proW o f a s h i p , p r o v i d e s a d d i t i o n a l

m e c h a n i c a l

a d v a n t a g e t o

t h e

u s e r ,

g r e a t l y

f a c i l i t a t i n g

t h e

e a s e With Which my n v e n t i o n

can

be u s e d .

My n v e n t i o n

can

be

manufactured i n

numerous Ways

u s i n g

a W i d e

v a r i e t y o f m a t e r i a l s .

I t

c a n ,

f o r e x a m p l e ,

b e

p r o d u c e d

f r o m

W o o d , e l a s t o m e r s , g e n e r a l r u b b e r p r o d u c t s ,

p l a s t i c s , m e t a l s , l a m i n a t e d

b o a r d s ,

p l a s t i c

f o a m s ,

a n d / o r a n y

o t h e r s u i t a b l e m a t e r i a l . I

p r e f e r

t h e u s e o f r i g i d p l a s t i c s f o r

s p a c i n g r o d

1

and h a n d l e s 2 W i t h

a

someWhat

more ? e x i b l e

s e m i - r i g i d f o a m p r o d u c t be i n g u s e d

f o r h e a d 4 .

T h e d i m e n

s i o n s

o f my n v e n t i o n

c a n a l s o

v e r y

W i d e l y . HoWever, h a v e

f o u n d

t h a t

t h e

h e a d 4

c a n a d v a n t a g e o u s l y

b e p r o d u c e d

W i t h

a t o t a l W i d t h

a c r o s s

e x t e n s i o n s 4 A ) o f

a p p r o x i m a t e l y

7 . 2 5

i n c h e s , a

t h i c k n e s s o f a p p r o x i m a t e l y 2

i n c h e s ,

a n d W i t h

a

c e n t r a l

b u l g e

5

e x t e n d i n g f o r W a r d o f

l a t e r a l

e x t e n s i o n s

4 A

b y

a p p r o x i m a t e l y 1 . 5 i n c h e s . T h e l e n g t h

o f

s p a c i n g r o d

1

b e t W e e n

h e a d 4 a n d

h a n d l e s

2 o f a p p r o x i m a t e l y 1 2 i n c h e s

h a s ,

l i k e

t h e

o t h e r d i m e n s i o n s d e s c r i b e d , p r o v i d e d

i d e a l

f o r

t h e

u s e o f most

p e o p l e .

Pad 3

i s a p p r o x i m a t e l y

2

i n c h e s

from

h a n d l e s

2 ,

W h i c h may

a d v a n t a g e o u s l y

b e

c o v e r e d W i t h

p l a s t i c

g r i p s t o make them

e a s i e r

t o g r a s p a n d h o l d .

H o W e v e r , a l l o f

t h e

a f o r e s a i d d i m e n s i o n s W h i l e r e p r e s e n t

i n g a f a i r a v e r a g e a p p r o p r i a t e f o r

m o s t

u s e r s ) a r e s u b j e c t t o

some v a r i a t i o n

t o

meet t h e

needs of

i n d i v i d u a l

u s e r s . Here,

a s

i n

a l l

o t h e r r e s p e c t s , t h e i n v e n t i o n

c a n b e

s u b j e c t

t o

Wide

v a r i a t i o n

W i t h o u t e x c e e d i n g

t h e

s c o p e

o f

t h e i n v e n t i v e

concept

a s

s e t

f o r t h h e r e i n .

I c l a i m :

1 . A h o k i n g a s s i s t a n c e d e v i c e ,

i n c l u d i n g

a h o r i Z o n t a l l y

e l o n g a t e d

h e a d W i t h

a

b o d y - e n g a g i n g s u r f a c e

u s e d f o r

c o m p r e s s i n g t h e

u p p e r abdomen o f a

c h o k i n g

v i c t i m a n d

10

1 5

25

35

45

55

6 5

4

t h e r e b y e x p e l l i n g a n o b j e c t

l o d g e d i n

t h e c h o k i n g

v i c t i m ’ s

t h r o a t ,

s a i d

b o d y - e n g a g i n g

s u r f a c e

h a v i n g a

h o r i Z o n t a l l y

e l o n g a t e d

a n d

v e r t i c a l l y

o b l a t e c e n t r a l b u l g e e x t e n d i n g

f o r W a r d

o f

t h e r e m a i n i n g

p o r t i o n s o f

s a i d

e l o n g a t e d

h e a d .

2 . A

e v i c e

a s d e s c r i b e d

i n c l a i m

1 , f u r t h e r c o m p r i s i n g

a

l i n e a r

member

a t t a c h e d

p e r p e n d i c u l a r l y

t o

s a i d h o r i Z o n t a l

e l o n g a t e d

h e a d o p p o s i t e s a i d b o d y - e n g a g i n g s u r f a c e .

3 . A e v i c e a s d e s c r i b e d i n

c l a i m 2 ,

f u r t h e r c o m p r i s i n g a n

e n d

p a d

a d a p t e d

f o r

f r i c t i o n a l

g r i p p i n g

a n d p l a c e m e n t

o n a

s u r f a c e , s a i d e n d

p a d

b e i n g

l o c a t e d

a t a n

e n d

o f

s a i d

l i n e a r

member o p p o s i t e s a i d h e a d .

4 . A e v i c e

a s

d e s c r i b e d

i n c l a i m 1 ,

f u r t h e r

c o m p r i s i n g

h o r i Z o n t a l h a n d l e s f o r m o v i n g

s a i d h o r i Z o n t a l l y

e l o n g a t e d

h e a d .

5 . A

e v i c e

a s

d e s c r i b e d i n c l a i m

1 , f u r t h e r

c o m p r i s i n g a

l i n e a r member

a t t a c h e d

p e r p e n d i c u l a r l y

t o s a i d h o r i Z o n t a l l y

e l o n g a t e d

h e a d

o p p o s i t e s a i d


s u r f a c e

a n d

h o r i Z o n t a l h a n d le s c o n n e c t e d t o s a i d h o r i Z o n t a l l y e l o n g a t e d

h e a d v i a s a i d l i n e a r member.

6 . A e v i c e a s d e s c r i b e d

i n c l a i m

5 ,

W h e r e i n s a i d c e n t r a l

b u l g e

l i e s

on

a n

a x i s

f o r

s a i d

l i n e a r

member.

7 . Adevice a s d e s c r i b e d i n

c l a i m

6 , f u r t h e r c o m p r i s i n g a n

e n d p a d a d a p t e d f o r f r i c t i o n a l g r i p p i n g


o n a

s u r f a c e ,

s a i d

e n d p a d

b e i n g l o c a t e d

a t a n e n d

o f s a i d

l i n e a r

member o p p o s i t e

s a i d

h e a d .

8 . A e v i c e a s d e s c r i b e d i n

c l a i m

6 , W h e r e i n s a i d c e n t r a l

b u l g e e x t e n d s

f o r W a r d

o f

t h e r e m a i n i n g

p o r t i o n s o f

s a i d

e l o n g a t e d

h e a d

b y a p p r o x i m a t e l y

1 . 5 i n c h e s .

9 .

A

e v i c e a s d e s c r i b e d i n c l a i m 6 , W h e r e i n

t h e d i s t a n c e

b e t W e e n

s a i d h e a d a n d s a i d h a n d l e s i s a p p r o x i m a t e l y 1 2

i n c h e s .

1 0 .

A

e v i c e a s d e s c r i b e d i n

c l a i m 5 , f u r t h e r

c o m p r i s i n g

a n e n d

p a d

a d a p t e d

f o r

f r i c t i o n a l g r i p p i n g a n d p l a c e m e n t o n

a

s u r f a c e , s a i d e n d pad b e i n g l o c a t e d a t a n e n d o f s a i d

l i n e a r

member

o p p o s i t e

s a i d

h e a d .

1 1 . A e v i c e a s d e s c r i b e d i n

c l a i m

1 , Wherein s a i d c e n t r a l

b u l g e l i e s on

a n a x i s

f o r s a i d l i n e a r member.

1 2 . A e v i c e a s

d e s c r i b e d

i n

c l a i m

1 1 , f u r t h e r c o m p r i s i n g

a n e n d

p a d

a d a p t e d

f o r

f r i c t i o n a l g r i p p i n g a n d p l a c e m e n t o n

a

s u r f a c e , s a i d end pad b e i n g l o c a t e d a t a n end

o f

s a i d l i n e a r

member o p p o s i t e s a i d h e a d .

1 3 . A h o k i n g a s s i s t a n c e d e v i c e , i n c l u d i n g a h o r i Z o n t a l l y

e l o n g a t e d

h e a d W i t h

a

b o d y - e n g a g i n g s u r f a c e u s e d f o r

c o m p r e s s i n g

t h e u p p e r abdomen o f a

c h o k i n g

v i c t i m

a n d

t h e r e b y e x p e l l i n g

a n

o b j e c t

l o d g e d i n

t h e c h o k i n g

v i c t i m ’ s

t h r o a t ,

W h e r e i n

s a i d h o r i Z o n t a l l y

e l o n g a t e d

h e a d

i s a p p r o x i

m a t e l y 7 . 2 5 i n c h e s l o n g

a n d

t h e


s u r f a c e o f

s a i d h e a d i s a p p r o x i m a t e l y 2 i n c h e s

W i d e .

1 4 .

A

e v i c e

a s

d e s c r i b e d

i n

c l a i m

1 3 , f u r t h e r

c o m p r i s i n g

a

l i n e a r

member

a t t a c h e d p e r p e n d i c u l a r l y t o s a i d

h o r i Z o n

t a l l y e l o n g a t e d

h e a d

o p p o s i t e s a i d

b o d y - e n g a g i n g s u r f a c e ;

h o r i Z o n t a l h a n d le s c o n n e c t e d t o s a i d h o r i Z o n t a l l y e l o n g a t e d

h e a d

v i a

s a i d

l i n e a r

member;

a

c e n t r a l b u l g e

i n

s a i d body

e n g a g i n g s u r f a c e l y i n g

on

a n a x i s f o r s a i d l i n e a r member;

a n d a n e n d p a d

a d a p t e d

f o r

f r i c t i o n a l g r i p p i n g


on a s u r f a c e s a i d end pad b e i n g l o c a t e d a t a n end o f s a i d

l i n e a r

member o p p o s i t e

s a i d

h e a d .

1 5 . Adevice

a s

d e s c r i b e d i n

c l a i m

1 4 , Wherein s a i d c e n t r a l

b u l g e e x t e n d s f o r W a r d o f t h e r e m a i n i n g p o r t i o n s o f s a i d

e l o n g a t e d

h e a d b y a p p r o x i m a t e l y 1 . 5 i n c h e s .


c l a i m

1 5 , Wherein t h e

d i s t a n c e

b e t W e e n

s a i d h e a d a n d s a i d h a n d l e s i s

a p p r o x i

m a t e l y 1 2

i n c h e s


c l a i m

1 4 , Wherein t h e

d i s t a n c e

b e t W e e n

s a i d h e a d a n d s a i d h a n d l e s i s

a p p r o x i

m a t e l y

1 2

i n c h e s

1 8 . A

h o k i n g

a s s i s t a n c e

d e v i c e

i n c l u d i n g

a

h o r i Z o n t a l l y

e l o n g a t e d h e a d W i t h a b o d y - e n g a g i n g

s u r f a c e

u s e d f o r


11/11

US 6 , 7 2 5 , 8 6 3 B2

5 6

c o m p r e s s i n g

t h e

u p p e r

abdomen o f

a c h o k i n g

v i c t i m a n d e x t e n d i n g f o r w a r d o f

t h e

r e m a i n i n g

p o r t i o n s

o f s a i d e l o n

t h e r e b y

e x p e l l i n g a n

o b j e c t l o d g e d i n t h e c h o k i n g

v i c t i m ’ s

g a t e d h e a d b y

a p p r o x i m a t e l y

1 . 5 i n c h e s .

t h r o a t , t h e body-engaging

s u r f a c e

having a c e n t r a l bulge * * * * *

Documents

My 10/8/15 inquiry to the FDA re: the "Big John Heimlich Helper" includes 2004 patent granted to the late Louis M. Karpel of Honeoye Falls, NY