MULTI-DIRECTIONAL NEEDLE

• US 20130281981A1
• Filed: 03/20/2013
• Published: 10/24/2013
• Est. Priority Date: 09/21/2010
• Status: Active Application

• Current Assignee: Israel Shamir Lebovitz
• Original Assignee: Israel Shamir Lebovitz
• Inventors: SHAMIR LEBOVITZ, Israel
• Application Number:
  US13/847,654
• Publication Number:
  US 20130281981A1
• Time in Patent Office: Days
• US Class Current: 604/511
• CPC Class Codes: A61B 1/32 Devices for opening or enlarging the visual field, e.g. of a tube of the body dilators A61M29/00
• CPC Class Codes: A61M 2005/341 angularly adjustable or angled away from the axis of the injector
• CPC Class Codes: A61M 2005/342 Off-center needles, i.e. needle connections not being coaxial with the longitudinal symmetry axis of syringe barrel
• CPC Class Codes: A61M 2210/14 Female reproductive, genital organs
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/322 Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston devices for protecting guide needles in combination with catheters A61M25/0612
• CPC Class Codes: A61M 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: A61M 5/3295 Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel

Abstract

The present invention provides a multi-directional needle assembly for injecting substance into at least one injection site of a patient'"'"'s body, comprising:

• • a. an elongated member having a distal end; said distal end having a plurality of openings disposed therein;
  • b. a plurality of needles disposable at least partially within said elongated member, adapted to be reconfigured from a FOLDED configuration to a DEPLOYED configuration; said FOLDED configuration being characterized by the position of said needles within said elongated member; said DEPLOYED configuration being characterized by the protrusion of said needles out of said openings;
  • the disposition of said openings is provided according to a predetermined scattering pattern such that (i) at least two separated areas within said distal end are provided for injection of said substance into at least two different injection locations at said injection site; and, (ii) a DEAD AREA between said two separated areas is obtained.

Claims

1. A multi-directional needle assembly for injecting substance into at least one injection site of a patient'"'"'s body, comprising:

c. an elongated member having a distal end;

said distal end having a plurality of openings disposed therein; and

,

d. a plurality of needles disposable at least partially within said elongated member, said needles adapted to be reconfigured from a FOLDED configuration to a DEPLOYED configuration and vice versa;

said FOLDED configuration being characterized by the position of said plurality of needles within said elongated member;

said DEPLOYED configuration being characterized by the protrusion of said needles out of said plurality of openings;

the disposition of said openings in said distal end is provided according to a predetermined scattering pattern such that (i) at least two separated areas within said distal end are provided for injection of said substance into at least two different injection locations at said injection site; and

, (ii) a DEAD AREA between said two separated areas is obtained, wherein at least one of the following is being held true;

(i) said DEAD AREA is characterized by a solid angle of at least at least about 1 steradian;

(ii) said DEAD AREA is characterized by a spreading angle in the range of 20 to 60 degrees from each other;

(iii) said DEAD AREA is characterized by a maximal length of at least 0.1 nanometer;

or,

(iv) said DEAD AREA is characterized by a geometrical area of at least 0.1 nanometer²;

(v) said DEAD AREA is characterized by a cross sectional area of at least 0.1 nanometer²;

or any combination thereof.

2. The multi-directional needle assembly according to claim 1, wherein in said DEPLOYED configuration, said needles are adapted to form at least two injection surfaces at said at least two separated areas, each of said at least two injection surfaces is adapted to conform to the anatomical shape of said at least two injection locations.

3. The multi-directional needle assembly according to claim 2, wherein at least one of the following is being held true (a) said at least two injection surfaces are adapted to mimic the anatomical shape of said at least two injection locations;

(b) each of said at least two injection surfaces is characterized by a predetermined spread angle ranging from about 100°

to about 170°

;

(c) each of said at least two injection surfaces is characterized by a predetermined spread angle ranging from about 150°

to about 160°

;

(d) said at least two injection surfaces are formed by different lengths of said needles; and

any combination thereof.

4. The multi-directional needle assembly according to claim 1, wherein at least one of the following is being held true (a) said at least two separated areas are adapted to be used for simultaneous injection of said substance into two injection locations;

(b) said two injection locations are;

the upper lip of the cervix and the lower lip of the cervix; and

any combination thereof.

5. The multi-directional needle assembly according to claim 1, wherein at least one of the following is being held true (a) said predetermined scattering pattern is selected from a group consisting of:

arbitrary, well organized, and any combination thereof;

(b) said needles are microneedles;

(c) said needles are 20 gauge to about 35 gauge needle;

(d) at least one of said needles is one of a group of;

nano-sized, micro-sized, milli-sized, or any combination thereof;

(e) said needles are characterized by widths ranging from about 0.5 micron to about 400 micron;

(f) said needles are characterized by widths ranging from about 100 nm to about 500 nm;

(g) said substance is for induction of labor; and

any combination thereof.

6. The multi-directional needle assembly according to claim 1, further comprising at least one spreading mechanism adapted to reconfigure said needles within said elongated member from a FOLDED configuration to a DEPLOYED configuration and vice versa;

further wherein said spreading mechanism is adapted to protract said needles when the same are converted from said FOLDED configuration to said DEPLOYED configuration, and to retract said needles when the same are converted from said DEPLOYED configuration to said FOLDED configuration.

7. The multi-directional needle assembly according to claim 1, wherein said substance is selected from a group consisting of a cervical-ripening amount of a collagenase or any naturally stimulating collagenase to prevent as well to treat preterm labor, Interleukin 1 beta, Interleukin 6, Interleukin 8, tissue inhibitors metalloproteinase 1-2, tumor necrosis factor, NAC n-acetyl cysteine TIMP tissue inhibitor metalloproteinases1-2, inhibition anti TNF antibodies anti IL 1 beta antibodies TIMP 1-2 Alfa 2 macroglobulin, alfa 2 macroglobulin IL-8 ETE IL 1beta antibodies TNF antibodies adapted to prevent and/or treat preterm labor.

8. The multi-directional needle assembly according to claim 1, wherein at least one of the following is being held true (a) said needles are made of a flexible material adapted to provide bending of said needles when the same are reconfigured from said FOLDED configuration to said DEPLOYED configuration;

(b) said elongated member is selected from a group consisting of;

a needle, a catheter, a lumen, or any combination thereof;

(c) at least two of said needles are aligned and oriented at substantially the same specific angle;

(d) at least two of said needles are aligned and oriented at different angles, said angles forming a predetermined pattern;

(e) at least two of said needles are randomly oriented;

(f) at least two of said needles are characterized by having the same length or thickness; and

any combination thereof.

9. A speculum for delivering a substance to the cervix, comprising a first blade having a distal end and a second blade having a distal end, said first blade and said second blade being pivotally connected to each other;

wherein said distal end of said first blade and of said second blade having a plurality of openings disposed therein, said openings are adapted to accommodate a plurality of needles adapted to be reconfigured from a FOLDED configuration to a DEPLOYED configuration and vice versa;

said FOLDED configuration being characterized by the position of said plurality of needles within said first and second blades;

said DEPLOYED configuration being characterized by the protrusion of said needles out of said plurality of openings of said first and second blades, said needles of said first and said second blades being fluidly connected to a substance reservoir and adapted to deliver said substance to the upper and the lower lips of the cervix, respectively.

10. The speculum according to claim 9, wherein at least one of the following is being held true (a) at least two said needles are disposed on a face of said blades, said face one of a group of:

inward-facing, outward-facing, or any combination thereof;

(b) at least two of said needles are aligned and oriented at substantially the same specific angle;

(c) at least two of said needles are aligned and oriented at different angles, said angles forming a predetermined pattern;

(d) at least two of said needles are randomly oriented;

(e) said needles are disposed along the entire length of said blades;

(f) said needles are disposed in at least one specific region along said blades;

(g) the disposition of said openings in said blades is provided according to a predetermined scattering pattern;

(h) wherein in said DEPLOYED configuration, said needles of said first and said second blades are adapted to form two separate injection surfaces for conforming to the anatomical shape of said upper and lower lips of said cervix;

(i) said injection surfaces are adapted to mimic the anatomical shape of said upper and lower lips of said cervix; and

any combination thereof;

(j) said substance reservoir also comprises an injection mechanism such that said injection mechanism may induce said substance to flow from said reservoir and therefore induce said substance to flow through said needles.

11. The speculum according to claim 9, wherein at least one of the following is being held true (a) each of said injection surfaces is characterized by a predetermined spread angle ranging from about 100°

to about 170°

;

(b) each of said injection surfaces is characterized by a predetermined spread angle ranging from about 150°

to about 160°

;

(c) said injection surfaces are formed by different lengths of said needles;

(d) said needles are adapted to be used for simultaneous injection of said substance into said upper and lower lips of said cervix;

(e) the said needles are microneedles;

(f) at least one of said needles is one of a group of;

nano-sized, micro-sized, milli-sized, or any combination thereof;

(g) said connecting mechanism is slidable;

(h) said injection element is positioned on a face of said blade, said face belonging to a group of;

inward-facing, outward-facing or any combination thereof;

(i) said substance is for induction of labor;

(j) said needles are made of a flexible material adapted to provide bending of said needles when the same are reconfigured from said FOLDED configuration to said DEPLOYED configuration;

(k) said speculum comprises a first lumen adapted to deliver said substance from said substance reservoir to said needles; and

any combination thereof.

12. The speculum according to claim 9, wherein said needles are characterized by lengths ranging from about 0.5 mm to about 4 cm;

further wherein said predetermined scattering pattern is selected from a group consisting of;

arbitrary, well organized, and any combination thereof.

13. The speculum according to claim 9, further comprising at least one spreading mechanism adapted to reconfigure said needles within said elongated member from a FOLDED configuration to a DEPLOYED configuration and vice versa;

further wherein said spreading mechanism is adapted to protract said needles when the same are converted from said FOLDED configuration to said DEPLOYED configuration, and to retract said needles when the same are converted from said DEPLOYED configuration to said FOLDED configuration.

14. The speculum according to claim 9, wherein said speculum comprises at least one injection element;

further wherein at least one of the following is being held true (a) said injection element is fluidly connected to said reservoir via one of a group of;

tubing, manifold, channels within said speculum, or any combination thereof;

(b) said injection element comprises a bracket, a front plate and a container therebetween, said front plate having said openings, said container being fluidly connected to said needles and to said reservoir, and said bracket being connected to one of said blades of said speculum;

(c) said injection element further comprises a spreading mechanism adapted to reconfigure said needles within said elongated member from a FOLDED configuration to a DEPLOYED configuration and vice versa;

said spreading mechanism is adapted to protract said needles when the same are converted from said FOLDED configuration to said DEPLOYED configuration, and to retract said needles when the same are converted from said DEPLOYED configuration to said FOLDED configuration.

15. The speculum according to claim 9, wherein said substance is a cervical-ripening amount of a collagenase or any naturally stimulating collagenase, Interleukin 1 beta, Interleukin 6, Interleukin 8, tissue inhibitors metalloproteinase 1-2, tumor necrosis factor, NAC n-acetyl cysteine TIMP tissue inhibitor metalloproteinases1-2, inhibition anti TNF antibodies anti IL 1 beta antibodies TIMP 1-2 Alfa 2 macroglobulin, alfa 2 macroglobulin IL-8 ETE IL 1beta antibodies TNF antibodies adapted to prevent and/or treat preterm labor.

23. The speculum according to claim 9, wherein said substance is selected from a group consisting of a cervical-ripening amount of a collagenase or any naturally stimulating collagenase adapted to be delivered into the birth canal around the Urethra to prevent stress incontinence.

16. A method for injecting substance into the upper and the lower lips of the cervix, comprising steps of:

a. providing a speculum for delivering a substance to the cervix, comprising a first blade having a distal end and a second blade having a distal end, said first blade and said second blade being pivotally connected to each other;

said distal end of said first blade and of said second blade having a plurality of openings disposed therein, said openings are adapted to accommodate a plurality of needles adapted to be reconfigured from a FOLDED configuration to a DEPLOYED configuration and vice versa;

said FOLDED configuration being characterized by the position of said plurality of needles within said first and second blades;

said DEPLOYED configuration being characterized by the protrusion of said needles out of said plurality of openings of said first and second blades, said needles of said first and said second blades being fluidly connected to a substance reservoir and adapted to deliver said substance to the upper and the lower lips of the cervix, respectively.

b. inserting said speculum proximally to said upper and lower lips of said cervix, such that said first blade is proximal to said upper lip and said second blade is proximal to said lower lip;

c. reconfiguring said plurality of needles from said FOLDED configuration to said DEPLOYED configuration; and

d. injecting said substance into said upper and lower lips of said cervix.

17. The method according to claim 16, additionally comprising at least one step selected from a group consisting of (a) piercing said upper and lower lips of said cervix via said plurality of needles;

(b) injecting said substance into the interior of said cervix without piercing said upper and lower lips of said cervix;

(c) disposing at least two said needles on a face of said blades, said face one of a group of;

inward-facing, outward-facing, or any combination thereof;

(d) aligning and orienting at least two of said needles at substantially the same specific angle;

(e) aligning and orienting at least two of said needles at different angles, said angles forming a predetermined pattern;

(f) randomly orienting at least two of said needles; and

any combination thereof;

(g) disposing said needles along the entire length of said blades;

(h) disposing said needles in at least one specific region along said blades.

18. The method according to claim 16, wherein at least one of the following is being held true (a) at least two of said needles are characterized by having the same length or thickness;

(b) the disposition of said openings in said distal end is provided according to a predetermined scattering pattern;

(c) each of said injection surfaces is characterized by a predetermined spread angle ranging from about 150°

to about 160°

;

(d) said injection surfaces are formed by different lengths of said needles;

(e) said needles are adapted to be used for simultaneous injection of said substance into said upper and lower lips of said cervix;

(f) said predetermined scattering pattern is selected from a group consisting of;

arbitrary, well organized, and any combination thereof;

(g) said needles are microneedles;

(h) at least one of said needles is one of a group of;

nano-sized, micro-sized, milli-sized, or any combination thereof;

(i) said substance is for induction of labor;

(j) said needles are made of a flexible material adapted to provide bending of said needles when the same are reconfigured from said FOLDED configuration to said DEPLOYED configuration;

(k) said speculum comprises a first lumen adapted to deliver said substance from said substance reservoir to said needles.

19. The method according to claim 16, wherein in said DEPLOYED configuration, said needles of said first and said second blades are adapted to form two separate injection surfaces for conforming to the anatomical shape of said upper and lower lips of said cervix;

further wherein said injection surfaces are adapted to mimic the anatomical shape of said upper and lower lips of said cervix;

further wherein each of said injection surfaces is characterized by a predetermined spread angle ranging from about 100°

to about 170°

.

20. The method according to claim 16, further comprising at least one step selected from a group consisting of (a) providing at least one spreading mechanism adapted to reconfigure said needles within said elongated member from a FOLDED configuration to a DEPLOYED configuration and vice versa;

(b) wherein said spreading mechanism is adapted to protract said needles when the same are converted from said FOLDED configuration to said DEPLOYED configuration, and to retract said needles when the same are converted from said DEPLOYED configuration to said FOLDED configuration;

(c) providing a substance reservoir which also comprises an injection mechanism such that said injection mechanism may induce said substance to flow from said reservoir and therefore induce said substance to flow through said needles.

21. The method according to claim 16, additionally comprising at least one step selected from a group consisting of (a) providing at least one injection element;

(b) fluidly connecting said injection element to said reservoir via one of a group of;

tubing, manifold, channels within said speculum, or any combination thereof;

(c) providing said injection element comprising a bracket, a front plate and a container therebetween, said front plate having said openings, said container being fluidly connected to said needles and to said reservoir, and said bracket being connected to one of said blades of said speculum;

(d) providing for said injection element a spreading mechanism adapted to reconfigure said needles within said elongated member from a FOLDED configuration to a DEPLOYED configuration and vice versa; and

, adapting said spreading mechanism to protract said needles when the same are converted from said FOLDED configuration to said DEPLOYED configuration, and to retract said needles when the same are converted from said DEPLOYED configuration to said FOLDED configuration.

22. The method according to claim 16, wherein said substance is a cervical-ripening amount of a collagenase or any naturally stimulating collagenase, Interleukin 1 beta, Interleukin 6, Interleukin 8, tissue inhibitors metalloproteinase 1-2, tumor necrosis factor, NAC n-acetyl cysteine TIMP tissue inhibitor metalloproteinases1-2, inhibition anti TNF antibodies anti IL 1 beta antibodies TIMP 1-2 Alfa 2 macroglobulin, alfa 2 macroglobulin IL-8 ETE IL 1beta antibodies TNF antibodies adapted to prevent and/or treat preterm labor.