DEVICE AND METHOD FOR PIERCING A PATIENT'S SKIN WITH AN INJECTOR WHILST REDUCING PAIN CAUSED BY THE PIERCING

• US 20100049126A1
• Filed: 07/01/2009
• Published: 02/25/2010
• Est. Priority Date: 01/01/2007
• Status: Abandoned Application

• Current Assignee: Sindolor Medical Ltd.
• Original Assignee: Sindolor Medical Ltd.
• Inventors: BRONFELD, Zeev, RAUCH, Yossi
• Application Number:
  US12/496,477
• Publication Number:
  US 20100049126A1
• Time in Patent Office: Days
• US Class Current: 604/113
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150114 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150129 by cooling
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150854 long distance, e.g. between patient's home and doctor's office
• CPC Class Codes: A61B 5/150954 Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• CPC Class Codes: A61B 5/150977 Arrays of piercing elements for simultaneous piercing
• CPC Class Codes: A61B 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61F 2007/0001 Body part
• CPC Class Codes: A61F 2007/0075 using a Peltier element, e.g. near the spot to be heated or cooled
• CPC Class Codes: A61F 2007/0285 Local anaesthetic effect
• CPC Class Codes: A61F 7/02 Compresses or poultices for effecting heating or cooling
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3553 : remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 : local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 : sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3606 : cooled
• CPC Class Codes: A61M 2205/3673 : thermo-electric, e.g. Peltier effect, thermocouples, semi-conductors
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 : by audible feedback
• CPC Class Codes: A61M 2205/583 : by visual feedback
• CPC Class Codes: A61M 5/1452 : pressurised by means of pistons
• CPC Class Codes: A61M 5/20 : Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/24 : Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/422 : Desensitising skin

Abstract

This invention generally relates to an injector for painlessly piercing a region of a patient'"'"'s skin. The injector comprises (a) piercing mechanism, comprises: (i) at least one reciprocating needle; said at least one needle is characterized by diameter K; said needle penetrates to depth D in said skin; said depth D is characterized by an initial temperature T; (ii) at least one container having a medicament to be delivered to said patient. The injector further comprises (b) cooling mechanism, comprises at least one attachable cooling means, especially a Peltier Cooled Cold Plate (PCCP), in connection with a radiator and sufficient DC power supply; said PCCP is characterized by an effective surface area S; said effective surface S is optimized such that said pain caused by said piercing is eliminated; said PCCP is characterized by temperature T_iPCCP; said PCCP adapted for cooling a portion of said skin prior to and/or during and/or after piercing thereof by said piercing mechanism such that the cooling is obtained at said depth D; said depth D is cooled from said initial temperature T to a final temperature T_D(ΔT) in a period of time t (dt) by said PCCP; said final temperature T_D Of said depth D is higher than about 0 and lower than about 13 degrees C.; said ΔT/dt is optimized such that said pain caused to said patient is eliminated. The injector further comprises (c) at least one aperture through which said needle is reversibly piercing said skin.

Claims

1. An injector for piercing a region of a patient'"'"'s skin comprising:

a. piercing mechanism, comprising;

i. at least one reciprocating needle;

said at least one needle is characterized by diameter K;

said needle penetrates to depth D in said skin;

said depth D is characterized by an initial temperature T;

ii. at least one container having a medicament to be delivered to said patient;

b. cooling mechanism, comprising;

i. at least one attachable cooling means, especially a Peltier Cooled Cold Plate (PCCP), in connection with a radiator and sufficient DC power supply;

said PCCP is characterized by an effective surface area S;

said effective surface S is optimized such that said pain caused by said piercing is eliminated;

said PCCP is characterized by temperature T_iPCCP;

said PCCP adapted for cooling a portion of said skin prior to and/or during and/or after piercing thereof by said piercing mechanism such that the cooling is obtained at said depth D;

said depth D is cooled from said initial temperature T to a final temperature T_D (Δ

T) in a period of time t (dt) by said PCCP;

said final temperature T_D of said depth D is higher than about 0 and lower than about 13 degrees C.;

said Δ

T/dt is optimized such that said pain caused to said patient is eliminated;

c. at least one aperture through which said needle is reversibly piercing said skin;

wherein said patient reported pain during said piercing is less than 2 on the SVAS scale.

2. The injector for painlessly piercing said region of said patient'"'"'s skin according to claim 1, wherein said PCCP is adapted for applying pressure P1 on said skin prior to during and/or after piercing thereof by said piercing mechanism;

said applied pressure P1 of said PCCP is optimized such that said pain caused by said piercing is eliminated.

3. The injector for painlessly piercing said region of said patient'"'"'s skin according to claim 2, additionally comprising controlling mechanism in communication with said injector;

wherein said controlling mechanism is adapted to control said depth D, said temperature T_iPCCP, said time t and said applied pressure P1;

said final temperature T_D at depth D;

said Δ

T/dt or any combination thereof, further wherein said controlling mechanism is adapted to prevent said final temperature T_D and/or said T_iPCCP from decreasing below about 0 degrees C.;

further wherein said controlling mechanism is adapted to control the distribution of said medicament in said depths D;

further wherein said controller is adapted to control a continuously or discrete;

homogeneously or non-homogeneously delivery of said medicament to said depths D

4. The injector for painlessly piercing said region of said patient'"'"'s skin according to claim 1, additionally comprising a sterile needle cover adapted to enclose at least a portion of said needle;

said sterile needle cover is used for protecting said needle and/or obtaining safety and sterilized piercing.

5. The injector for painlessly piercing said region of said patient'"'"'s skin according to claim 1, additionally comprising an automatically operating drive for automatically displacing said needle.

6. The injector for painlessly piercing said region of said patient'"'"'s skin according to claim 1, wherein said needle is selected from a group consisting of a hypodermic needle, an intramuscular needle and a skin pricking needle.

7. The injector for painlessly piercing said region of said patient'"'"'s skin according to claim 1, wherein said piercing mechanism is adapted to allow withdrawal of fluids from said patient.

8. The injector for painlessly piercing said region of said patient'"'"'s skin according to claim 1, additionally comprises a sensor system adapted to control and/or prevent the delivery of said medicament if said sensor system senses that said region of said patient skin is undesirable for delivery of said medicament;

further wherein said control and/or prevention of said delivery is based upon sensed thermal conductive and/or optical and/or electrical conductive and/or visual parameters of said skin.

9. The injector for painlessly piercing said region of said patient'"'"'s skin according to claim 1, additionally comprising (a) a memory into which medicament delivery parameters are stored;

said parameters are selected from a group consisting of amount of said medicament to be delivered, amount of said medicament that was delivered, time of said medicament delivery, properties of said medicament, said depth D, said initial temperature T, said T_iPPC, said pressure P1, said final temperature T_D at depth D, said Δ

T/dt or any combination thereof, (b) a controller in communication with said memory adapted to control and/or to prevent and/or to allow said piercing and/or medicament delivery based upon said parameters; and

, (c) a communication apparatus adapted to transfer the information sensed by said sensors to any medical personnel.

10. The injector for painlessly piercing said region of said patient'"'"'s skin according to claim 2, additionally comprising (i) storing means adapted to store in a communicable database predetermined parameter defining a painless piercing;

said parameters are selected from a group consisting of said depth D, said temperature T, said T_iPCCP, said pressure P1, said pressure P, said final T_D at depth D, said Δ

T/dt or any combination thereof, (ii) sensing means, adapted to sense parameters selected from a group consisting of said depth D, said temperature T, said T_iPCCP, said pressure P1, said pressure P, final T_D at depth D, said Δ

T/dt or any combination thereof, and (iii) processing means adapted to process said sensed parameters (iv) controlling means in communication with said processing means, adapted to allow or to prevent said piercing based upon said parameters.

11. A method for painlessly piercing a patient'"'"'s skin;

said method comprising steps of;

a. obtaining an injector comprising;

i. piercing mechanism, comprising;

a. at least one reciprocating needle;

said at least one needle is characterized by diameter K;

said needle penetrates to depth D in said skin;

said depth D is characterized by an initial temperature T;

b. at least one container having a medicament to be delivered to said patient;

ii. cooling mechanism, comprising;

a. at least one attachable cooling means, especially a Peltier Cooled Cold Plate (PCCP), in connection with a radiator and sufficient DC power supply;

said PCCP is characterized by an effective surface area S;

said effective surface S is optimized such that said pain caused by said piercing is eliminated;

said Δ

T/dt is optimized such that said pain caused to said patient is eliminated;

iii. at least one aperture through which said needle is reversibly piercing said skin;

b. cooling said PCCP to temperature T_iPCCP;

c. placing said cold PCCP on said skin for said period of time t thereby cooling a portion of said skin, such that the cooling is obtained at depth D;

d. attuning the temperature at said depth D to said final temperature T_D at a period of time t;

said T_D is higher than about 0 and lower than about 13 degrees C.; and

,

e. piercing said patient skin;

wherein said step of cooling is reducing said pain caused to said patient by said step of piercing by at least one stage of the SVAS scale.

12. A method for alleviating needle phobia and/or tension and/or anxiety whilst piercing a patient'"'"'s skin with an injector, comprising steps of:

a. obtaining an injector comprising;

i. piercing mechanism, comprising;

a. at least one reciprocating needle;

said at least one needle is characterized by diameter K;

said needle penetrates to depth D in said skin;

said depth D is characterized by an initial temperature T;

b. at least one container having a medicament to be delivered to said patient;

ii. cooling mechanism, comprising;

a. at least one attachable cooling means, especially a Peltier Cooled Cold Plate (PCCP), in connection with a radiator and sufficient DC power supply;

said PCCP is characterized by an effective surface area S;

said effective surface S is optimized such that said pain caused by said piercing is eliminated;

said Δ

T/dt is optimized such that said pain caused to said patient is eliminated;

iii. at least one aperture through which said needle is reversibly piercing said skin

b. cooling said PCCP temperature T_iPCCP;

c. placing said cold PCCP on said skin for a period of time t thereby cooling a portion of said ski, such that the cooling is obtained at depth D;

d. attuning the temperature at said depth D to said final temperature T_D at a period of time t;

said T_D is higher than about 0 and lower than about 13 degrees C.; and

,

e. piercing said patient skin;

wherein said step of cooling is reducing said pain caused to said patient by said step of piercing by at least one stage of the SVAS scale such that said patient'"'"'s needle phobia barrier and/or said patient'"'"'s tension and/or said patient'"'"'s anxiety is lowered.

13. The method according to claim 12, additionally comprising step of applying pressure P1 on said skin prior to, during and/or after said piercing.

14. The method according to claim 12, additionally comprising steps of (a) sensing a thermal parameter associated with said cooling mechanism of said skin;

and, (b) controlling the delivery of said medicament based upon the sensed thermal conductive and/or optical and/or electrical conductive and/or visual parameter of said skin.

15. The method according to claim 12, additionally comprising steps of (i) controlling parameters selected from a group consisting of the distribution of said medicament in said depths D, a continuously or a discretely;

homogeneously or non-homogeneously delivery of said medicament to said depths D, thermal parameter associated with said cooling mechanism of said skin selected from a group consisting of said depth D, said temperature T, said T_iPCCP, said pressure P1, said final T_D at said depth D, said Δ

T/dt, amount of said medicament to be delivered, amount of said medicament that was delivered, time of said medicament delivery, and properties of said medicament or any combination thereof, (ii) allowing or preventing said piercing based upon said parameters; and

, (iii) sensing if said region of said patient skin is undesirable for delivering said medicament based upon said parameters.

16. The method according to claim 12, additionally comprising steps of (a) sensing information related to the delivery of said medicament;

and (b) either online or offline transmitting said information sensed by said sensor to a medical personnel.

17. The method according to claims 12, additionally comprising step of inserting said needle into said injector with a needle'"'"'s cover such that a more safety and sterilized piercing is obtained.

18. The method according to claim 12, additionally comprising steps of (i) storing in a communicable database predetermined parameter defining a painless piercing;

said parameters are selected from a group consisting of said depth D, said temperature T, said T_iPCCP, said pressure P1, said pressure P, said final T_D at depth D, said Δ

T/dt or any combination thereof, (ii) sensing parameters selected from a group consisting of said depth D, said temperature T, said T_iPCCP, said pressure P1, said pressure P, said final T_D at depth D, said Δ

T/dt or any combination thereof, (iii) processing said sensed parameters;

(iv) controlling said piercing by allowing said piercing if said parameters are in the painless piercing, or preventing said piercing if said parameters are not within the painless piercing; and

, optionally, (v) either online or offline transmitting said information sensed by said sensor to a medical personnel.

19. The method according to claim 12, additionally comprising the step of selecting said needle from a group consisting of a hypodermic needle, an intramuscular needle and a skin pricking needle.

20. The method according to claim 12, additionally comprising step of withdrawing fluids from said patient.