WO2022245969A1

WO2022245969A1 - Iron ion detecting aspirating dental cartridge system

Info

Publication number: WO2022245969A1
Application number: PCT/US2022/029867
Authority: WO
Inventors: Brian L. Norling
Original assignee: Acies Medical Llc
Priority date: 2021-05-19
Filing date: 2022-05-18
Publication date: 2022-11-24

Abstract

A cartridge-based injection system that can include a chemiluminescent matrix disposed within the cartridge. The cartridge may be combined with an aspirating syringe or a self- aspirating syringe to provide enhanced visualization of blood from a patient's injection site when the syringe first aspirates prior to injection of the contents of the cartridge into the patient. Enhanced visualization of blood can thereby indicate the placement of an aspirating syringe's needle to be within the patient's vasculature. With such an enhanced visualization, the user of the aspirating syringe may remove the needle to prevent accidental injection of the cartridge contents into the patient's vasculature.

Description

IRON ION DETECTING ASPIRATING DENTAL CARTRIDGE SYSTEM

FIELD OF THE DISCLOSURE

The present disclosure relates to systems and methods for detecting biological substances. More particularly, it relates to systems and methods for detecting hemoglobin in conjunction with medical devices, such as hypodermic syringes, aspirating syringes, and self-aspirating syringes that can be advanced into a patient’s tissues. These systems and methods may be useful in conjunction with a dental cartridge system.

BACKGROUND

Efforts to improve surgical outcomes and cost structure, particularly with spinal surgery or dental procedures, have led to increased use of minimally invasive procedures. These procedures often use image-guided modalities such as fluoroscopy, CT, nerve stimulators, and, more recently, the Doppler ultrasound test. While often involving less risk than surgery, minimally invasive spinal procedures, pain management procedures, nerve blocks, ultrasound-guided interventions, biopsy, and percutaneous placement or open intra-operative placement continue to carry risks of ineffective outcome and iatrogenic injuries, such as infection, stroke, paralysis and death due to penetration of various structures including, but not limited to, organs, soft tissues, vascular structures, and neural tissue such as, catastrophically, the spinal cord. Injuries can occur regardless of practitioner experience because a surgical instrument must proceed through several layers of bodily tissues and fluids to reach the desired space in the spinal canal.

To illustrate, the intrathecal (or subarachnoid) space of the spinal region, where many medications are administered, houses nerve roots and cerebrospinal fluid (CSF) and lays between two of the three membranes that envelope the central nervous system. The outermost membrane of the central nervous system is the dura mater, the second is the arachnoid mater, and the third, and innermost membrane, is the pia mater. The intrathecal space is in between the arachnoid mater and the pia mater. To get to this area, a surgical instrument may need to first get through skin layers, fat layers, the interspinal ligament, the ligamentum flavum, the epidural space, the dura mater, the subdural space, and the intrathecal space. Additionally, in the case of a needle used to administer medication, the entire needle opening must be within the subarachnoid space.

Because of the complexities involved in inserting a surgical instrument into the intrathecal space, penetration of the spinal cord and neural tissue is a known complication of minimally invasive spine procedures and spine surgery. Additionally, some procedures require the use of larger surgical instruments. For example, spinal cord stimulation, a form of minimally invasive spinal procedure wherein small wire leads are inserted in the spinal epidural space, may require that a 14-gauge needle be introduced into the epidural space in order to thread the stimulator lead. Needles of this gauge are technically more difficult to control, posing a higher risk of morbidity. Complications can include dural tear, spinal fluid leak, epidural vein rupture with subsequent hematoma, and direct penetration of the spinal cord or nerves with resultant paralysis. These and other high-risk situations, such as spinal interventions and radiofrequency ablation, can occur when a practitioner is unable to detect the placement of the needle or surgical apparatus tip in critical anatomic structures.

At present, detection of such structures is operator-dependent, wherein operators utilize tactile feel, contrast agents, anatomical landmark palpation, and visualization under image-guided modalities. The safety of patients can rely upon the training and experience of the practitioner in tactile feel and interpretation of the imagery. Even though additional training and experience may help a practitioner, iatrogenic injury can occur independently of practitioner experience and skill because of anatomic variability, which can arise naturally or from repeat procedures in the form of scar tissue. Fellowship training in some procedures, such as radiofrequency ablation, may not be sufficiently rigorous to ensure competence; even with training, outcomes from the procedure can vary considerably. In the case of epidural injections and spinal surgery, variability in the thickness of the ligamentum flavum, width of the epidural space, dural ectasia, epidural lipomatosis, dural septum, and scar tissue all can add challenges to traditional verification methods even for highly experienced operators. Additionally, repeat radiofrequency procedures done when nerves regenerate, often a year or more later, are often less effective and more difficult because the nerves’ distribution after regeneration creates additional anatomic variability.

During dental procedures, anesthetic agents have been used to allay or eliminate pain associated with invasive operations, i.e., oral and maxillofacial surgery. The infratemporal fossa is a highly vascular area containing the largest artery of the external head, the maxillary artery, and its multiple named branches, as well as an extensive plexus of veins known as the pterygoid plexus. When injecting into such a richly vascular area, a dentist faces the risk of intravascular injection.

No device exists that provides objective, reliable, consistent, real-time feedback of critical tissues and bodily fluids. Further, even the concept of objective device feedback has not been accepted by proceduralists, even though millions of spinal and dental procedures are performed annually as a standard of care throughout the world. SUMMARY OF THE INVENTION

Provided is a medical device useful in medical and dental procedures that augments aspirating and self-aspirating syringe systems by detecting iron ions within hemoglobin, thereby indicating the presence of blood, and providing clear evidence that a needle in the syringe system is within a blood vessel or has damaged a blood vessel.

The disclosed system presents an enhanced method for verifying the presence of blood during the introduction of medicinal solutions during medical procedures. One such embodiment may include a chemiluminescent cartridge system having an aspirating syringe that includes an opening for the cartridge. The cartridge can include a tubular body of transparent material having a distal end and a proximal end. The cartridge may also include a diaphragm disposed at the distal end. The syringe and can also include a chemiluminescent matrix affixed to at least a portion of the inner surface; wherein the chemiluminescent matrix may be structured and configured to be at least partially visible through the opening of the aspirating syringe. In a further embodiment the cartridge may also comprise an integral recess disposed within the tubular body behind the diaphragm. Such a further embodiment may also include an integral recess that can be visible from the opening and where the chemiluminescent matrix may be affixed to the inner surface of the integral recess.

Additional embodiments may also include the cartridge further comprising a wide, long main body, then the integral recess followed by a wide, short collar; and a narrow neck extension having an opening on a distal end upon which the diaphragm can be disposed. This embodiment may further include the diaphragm that can be held in place with a cap that may be positioned around the diaphragm and around the end of the neck extension. This embodiment may also include the cartridge that can be structured and configured to fit within the opening.

Other embodiments of the chemiluminescent cartridge system may include a chemiluminescent matrix that may include 3-Aminophthalhydrazide and a binding agent. Such an embodiment may also include the binding agent that may consist of a group that includes polyethylene glycol, chitosan acetate, okra polysaccharide, egg whites, carrageenan, guar gum, polyacrylamides, polyoxazoline, or agar and combinations thereof. In some further embodiments, the syringe can be a self-aspirating, and the cartridge may contain an anesthetic solution.

A further embodiment may include a cartridge having a tubular body with a distal end and a proximal end and which can be constructed of a transparent material. The cartridge can be configured to retain a solution within its body. The cartridge may also include an integral recess disposed within the tubular body near the distal that can defined an inner surface where a chemiluminescent matrix may be affixed. The chemiluminescent matrix may be visualized through the body. Such an embodiment may also include a diaphragm disposed on the distal end. In other forms of this embodiment, the chemiluminescent matrix may include 3- Aminophthalhydrazide and a binding agent. The binding agent of this embodiment may come from a group consisting of polyethylene glycol, chitosan acetate, okra polysaccharide, egg whites, carrageenan, guar gum, polyacrylamides, polyoxazoline, or agar and combinations thereof. Such embodiments may further include a solution that is an anesthetic.

A method for using an embodiment of a chemiluminescent cartridge can include the steps of providing a chemiluminescent cartridge having a tubular body with a distal end and a proximal end wherein the tubular body can be constructed of a transparent material, and wherein the tubular body may be structured and configured to retain a solution therein. This cartridge may also include an integral recess disposed within the tubular body near the distal end, wherein the integral recess may define an inner surface where a chemiluminescent matrix may be affixed, leaving the chemiluminescent matrix is visible. The next step may be providing an aspiration syringe having an opening and where the combining of the chemiluminescent cartridge with the aspiration syringe may occur while leaving the matrix visible through the opening. This may be followed by attaching a needle to the aspiration syringe, wherein the needle may be simultaneously inserted into the chemiluminescent cartridge. Upon which the needle may be inserted into a patient’ s tissue. Once inserted, performing an aspiration with the aspiration syringe into the tissue may occur, thus providing an opportunity where visualizing the chemiluminescent matrix may occur. In such a method, the chemiluminescent matrix may comprise 3-Aminophthalhydrazide and a binding agent that might consist of a group including polyethylene glycol, chitosan acetate, okra polysaccharide, egg whites, carrageenan, guar gum, polyacrylamides, polyoxazoline, or agar and combinations thereof. This method may also include an anesthetic as the solution. Such a method may also include the additional step of removing the aspiration syringe from the tissue if there is a chemiluminescent reaction.

The above summary is not intended to describe each and every example or every implementation of the disclosure. The description that follows more particularly exemplifies various illustrative embodiments

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an embodiment of a cartridge with an iron ion detection system. FIG. 2 is a side view of an embodiment of a cartridge with an iron ion detection system.

FIG. 3 is a cross-section view of the embodiment of FIG. 2.

FIG. 4 is a perspective view of an embodiment of a cartridge combined with an aspirating syringe.

FIG. 5 is a side view of an embodiment of a cartridge combined with an aspirating syringe.

FIG. 6A is a partial cross-sectional view as marked in the embodiment of FIG. 5.

FIG. 6B is a partial cross-sectional view as marked in the embodiment of FIG. 5 illustrating aspirated blood.

DETAILED DESCRIPTION

The present disclosure relates to biomarker detector systems and methods used to detect biological substances, such as bodily fluids and tissues, including blood. More specifically, the present disclosure relates to a chemiluminescent cartridge system and method of use. Various embodiments of chemiluminescent cartridge systems are described in detail with reference to the drawings, wherein like reference numerals may represent like parts and assemblies throughout the several views. Reference to various embodiments does not limit the scope of the chemiluminescent cartridge system disclosed herein. Additionally, any examples set forth in this specification are not intended to be limiting and merely set forth some of the many possible embodiments for the chemiluminescent cartridge system. It is understood that various omissions and substitutions of equivalents are contemplated as circumstances may suggest or render expedient, but these are intended to cover applications or embodiments without departing from the spirit or scope of the disclosure. Also, it is to be understood that the phraseology and terminology used herein are for the purpose of description and should not be regarded as limiting.

Local anesthetics can have undesirable systemic effects if injected into a blood vessel, such as hypertension, bradycardia, and respiratory slowdown. It would be desirable to have a quick, reliable way to determine if the syringe needle has entered a blood vessel. A chemiluminescent chemical may be added to the sidewall of a cartridge syringe system, for example, a dental cartridge syringe system. The chemiluminescent chemical can undergo a chemical reaction with the iron in the blood aspirated from the injection site of a patient with such a system and emit a visible signal (chemiluminescence). In this type of chemiluminescence, electrons are excited by a chemical reaction between blood and the chemiluminescent chemical, producing visible luminescence. In this type of chemiluminescence, electrons are excited by a chemical reaction between blood and the chemiluminescent chemical, producing visible luminescence. The response from this reaction is very bright and is superior to attempted detection of blood visually or spectrophotometrically. This signal may indicate that the needle is in a blood vessel.

Regarding FIG. 1, in this perspective view of an embodiment of a chemiluminescent cartridge system, cartridge 100 can include a tubular body 120 having a distal end and a proximal end. The tubular body 120 may also include a recessed region 110 near the distal end where the diaphragm 112 is disposed. Such a recessed region 110 may be integral to the tubular body 120 such that the tubular body 120 has a roughly hourglass shape to it, wherein the neck of the overall hourglass shape is the recessed region 110 and is located closer to one end (for example, the distal end) rather than centered on the body. Further, the distal end may include a neck extension onto which the diaphragm 112 can be disposed, as illustrated in FIG. 3. Therefore, the entire cartridge 100 may include: a wide, long main body; a narrow, short recessed region 110; a wide, short collar; and a narrow neck extension having an opening on a distal end upon which the diaphragm 112 is disposed. The diaphragm 112 may be held in place with a cap that is positioned around the diaphragm 112 and around the end of the neck extension.

The entire cartridge, or a portion thereof (for example, the tubular body 120), can be constructed of a transparent material, for example, borosilicate glass. However, other materials are contemplated for the construction of the tubular body 120 and are well known within the art. All such contemplated materials may be transparent for the purpose of enhancing the visualization of any chemiluminescent reactions that may occur within the interior of the tubular body 120. Such chemiluminescent reactions, which will be discussed in detail infra, may arise when the cartridge 100 is combined with an aspirating syringe 200, illustrated in FIG. 4, where the recessed region 110 may be visualized through an opening 230, such as a window, in the side of the aspirating syringe 200. Opening 230 may be a standard cartridge loading slot within the side of a syringe 200, and such an opening may allow loading of cartridge 100 as well as visualization of a majority of a cartridge 100 including the recessed region 110. While the tubular body 120 may be transparent, the diaphragm 112 may be opaque since it can be constructed from a flexible material, such as rubber, that may allow the cartridge to be pierced with the proximal end of needle 220 that can reside within the distal end of syringe 200. Other flexible materials that can be used as the pierceable material that is non-reactive to the stored solution can be comprised of Polytetrafluoroethylene (PTFE), PTFE/Rubber, PTFE/Silicone, PTFE/Natural, silicone, Teflon^®, and combinations thereof. Regarding FIG. 2 and 3, the cartridge 100 is illustrated with the cross-sectional line 3, where FIG. 3 is the cross-sectional view of FIG. 2. The recessed region 110 may define an inner surface of the sidewall of the tubular body 120, where a chemiluminescent matrix 115 may be applied. More specifically, the chemiluminescent matrix 115 can be applied and fixed to the inner surface of the tubular body 120. While FIG. 3 illustrates application of the chemiluminescent matrix 115 along the inner surface of the recessed region 110, this is not limiting, and the chemiluminescent matrix 115 can be applied at any location along the inner surface of the sidewall of the tubular body 120, such as closer to the diaphragm 112 (for example, along the inner surface of the neck extension) or closer to the proximal end (for example, along a portion, or the entirety, of the wide, long main body). In some embodiments, the chemiluminescent matrix 115 may be applied along the entirety of the inner surface of the tubular body 120.

The chemiluminescent matrix can be a luminol-based polymer. The chemiluminescent matrix 115 may be derived by combining Polyethylene glycol (PEG), where PEG acts as a binder, with a compound containing 3-Aminophthalhydrazide; otherwise known as Luminol. PEG remains the gold standard in polymer-based biomedical applications based on its low dispersity, biocompatibility, and limited recognition by the immune system. An example PEG that may be used for the creation of the chemiluminescent matrix 115 is Sigma-Aldrich 729159, with an average Mn of about 6,000. The binder and chemiluminescent material can be combined with an oxidizing agent to produce a hygroscopic mixture. Therefore, the chemiluminescent matrix 115 can be a mixture of a binder (for example, a luminol-based polymer), 3-Aminophthalhydrazide or a compound containing 3-Aminophthalhydrazide, and an oxidizing agent.

Other binding agents are also considered for use in producing the chemiluminescent matrix 115. These binding agents can include: chitosan acetate, okra polysaccharide, egg whites, carrageenan, guar gum, polyacrylamides, polyoxazoline, and agar; these binding agents may also be combined with each other when producing the chemiluminescent matrix 115. Chitosan acetate is a deacetylated chitin / Poly(D-glucosamine) with no salts. It may be produced by Sigma Aldrich and have a medium molecular weight; product number: 448877 (CAS Number: 9012-76-4). These binding agents may also be combined with iron-chelating chemicals such as deferoxamine, salicylaldehyde iso-nicotinoyl hydrazone, edetate calcium disodium anhydrous, potassium permanganate, calcium carbonate, or manganese dioxide.

Luminol (3-Aminophthalhydrazide) has the ability to produce a chemiluminescent reaction. More specifically, compounds in a luminol solution (for example, hydrogen peroxide) can react with the iron in hemoglobin to create oxygen. When the newly created oxygen then reacts with the luminol that is in the luminol solution, the structure of the luminol molecule changes, photons can be emitted and visible light created. Emissions of photons may occur for up to thirty seconds after the exposure of blood to basic mixtures containing luminol and an oxidizer. Other commercially available compounds that contain luminol are contemplated for use in creating a chemiluminescent matrix 115. For example, the chemiluminescent matrix 115 may include BLUESTAR® FORENSIC, a blood visualizing agent. The main components capable of catalyzing this reaction for emitting light are the transition metals haem and peroxidase. Haem is a biochemical structure that forms an integral part of peroxidase and is equally present in hemoglobin.

One example of a chemiluminescent matrix 115 can be created by starting with one part PEG 4000 (laboratory grade dry powder) and combining it with two parts distilled water to create a clear, viscous solution. Three-tenths part of the PEG mixture may then be combined with a one- tenth part fluorescein sodium salt dry powder (such as Luminol or BLUESTAR® FORENSIC). The combination may be applied to the inner surface defined by the recessed region 110 (or elsewhere along the inner surface of tubular body 120) and exposed to Ultraviolet light to create cross-link polymerization. After the Ultraviolet exposure, the mixture is dried for a period of time ranging from about twelve hours to about eight minutes at a temperature from about 65°F to about 200°F. Humidity may vary, but some embodiments were created with humidity levels of around 50%.

FIG. 4 illustrates a cartridge 100 that may be combined with an aspirating syringe 200. In some embodiments, the aspirating syringe 200 may be a standard self-aspirating syringe where a bump-out feature within the self-aspirating syringe at the distal end will force the diaphragm 112 to compress when the plunger 240 is depressed by a user. Once the user releases the plunger 240, the diaphragm 112 will decompress, thereby aspirating fluids from the injection site. Prior to use, the cartridge 100 may be filled with the desired injectable, i.e., an anesthetic such as lidocaine. Once filed, the combined cartridge 100 and aspirating syringe 200 may form a chemiluminescent cartridge system which then may be inserted into a desired injection site on a patient via the needle 220. Once inserted, the aspiration feature of the syringe may be activated. If blood is aspirated into the cartridge 100, then the chemiluminescent matrix 115 will luminesce, giving a visual indication of the presence of blood within the cartridge 100.

Regarding FIG. 5, this top view of an embodiment of the combined cartridge 100 and aspirating syringe 200 includes a cross-sectional line 6. The illustrations in FIGs. 6A and 6B are the partial views derived from the cross-sectional line 6. FIG. 6A partially illustrates a combined cartridge 100 and aspirating syringe 200 where the plunger 240 has been depressed, causing the flow of the contents of the cartridge 100 to move in an outward direction, indicated by arrow 224, through the proximal end of the needle 222 that is within the inner cavity of cartridge 100 to the open end of the needle 220 that may be within an injection site of a patient. In this particular embodiment, the diaphragm 112 may be compressed in a proximal direction, thereby increasing the pressure within the cartridge 100.

As illustrated in FIG. 6B, when the plunger 240 is no longer depressed by the user, the increased pressure caused by the movement of the diaphragm 112 in the proximal direction may cause the aspiration of fluid from the injection site to flow into the cartridge 100 as the pressure will be relieved when the plunger 240 is no longer depressed and the diaphragm 112 moves back to its original position in a distal direction. If the fluid aspiration 226 includes blood from the patient’s injection site, the blood may then combine with the chemiluminescent matrix 115 and cause a chemiluminescent reaction, thereby generating the emission of blue light. The emitted light may then be visible to the user and may indicate that the needle 220 is within a blood vessel at the patient’s injection site. With such an indication, the user may then remove the needle 220 from the injection to prevent an accidental injection of the majority of the remaining contents of the cartridge 100 from entering the patient’s bloodstream through a blood vessel. This indication may be more readily visible to the user than the visualization of the red color of blood being aspirated into a non-chemiluminescent cartridge of current aspiration systems.

Persons of ordinary skill in arts relevant to this disclosure and subject matter hereof will recognize that embodiments may comprise fewer features than illustrated in any individual embodiment described by example or otherwise contemplated herein. Embodiments described herein are not meant to be an exhaustive presentation of ways in which various features may be combined and/or arranged. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the relevant arts. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted. Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless stated that a specific combination is not intended. Furthermore, it is also intended to include features of a claim in any other independent claim, even if this claim is not directly made dependent on the independent claim.

Claims

1. A chemiluminescent cartridge system comprising: an aspiration syringe having an opening; a cartridge comprising: a tubular body having a distal end, a proximal end, and an inner surface, wherein the tubular body is comprised of a transparent material; a diaphragm disposed at the distal end; and a chemiluminescent matrix affixed to at least a portion of the inner surface, wherein the chemiluminescent matrix is structured and configured to be at least partially visible through the opening.

2. The chemiluminescent cartridge system of claim 1, the cartridge further comprising an integral recess disposed within the tubular body behind the diaphragm.

3. The chemiluminescent cartridge system of claim 2, wherein the integral recess is visible from the opening and the chemiluminescent matrix is affixed to an inner surface of the integral recess.

4. The chemiluminescent cartridge system of claim 2, the cartridge further comprising a wide, long main body; the integral recess; a wide, short collar; and a narrow neck extension having an opening on a distal end upon which the diaphragm is disposed.

5. The chemiluminescent cartridge system of claim 4, wherein the diaphragm is held in place with a cap that is positioned around the diaphragm and around the end of the neck extension.

6. The chemiluminescent cartridge system of claim 4, wherein the cartridge is structured and configured to fit within the opening.

7. The chemiluminescent cartridge system of claim 1, wherein the chemiluminescent matrix comprises 3-Aminophthalhydrazide and a binding agent.

8. The chemiluminescent cartridge system of claim 7, wherein the binding agent is selected from the group consisting of polyethylene glycol, chitosan acetate, okra polysaccharide, egg whites, carrageenan, guar gum, polyacrylamides, polyoxazoline, agar, and combinations thereof.

9. The chemiluminescent cartridge system of claim 7, wherein the aspiration syringe is self- aspirating.

10. The chemiluminescent cartridge system of claim 8, wherein the cartridge contains an anesthetic solution.

11. A chemiluminescent cartridge comprising: a tubular body having a distal end and a proximal end, wherein the tubular body is constructed of a transparent material, and wherein the tubular body is structured and configured to retain a solution therein; an integral recess disposed within the tubular body near the distal end, wherein the integral recess defines an inner surface therein; and a chemiluminescent matrix affixed to the inner surface, wherein the chemiluminescent matrix is visualizable.

12. The chemiluminescent cartridge of claim 11, further comprising a diaphragm disposed at the distal end.

13. The chemiluminescent cartridge of claim 11, wherein the chemiluminescent matrix comprises 3-Aminophthalhydrazide and a binding agent.

14. The chemiluminescent cartridge of claim 13, wherein the binding agent is selected from the group consisting of polyethylene glycol, chitosan acetate, okra polysaccharide, egg whites, carrageenan, guar gum, polyacrylamides, polyoxazoline, agar, and combinations thereof.

15. The chemiluminescent cartridge of claim 11, wherein the solution is an anesthetic.

16. A method of using a chemiluminescent cartridge system comprising: providing a chemiluminescent cartridge comprising: a tubular body having a distal end and a proximal end, wherein the tubular body is constructed of a transparent material, and wherein the tubular body is structured and configured to retain a solution therein; an integral recess disposed within the tubular body near the distal end, wherein the integral recess defines an inner surface therein; and a chemiluminescent matrix affixed to the inner surface, wherein the chemiluminescent matrix is visible; providing an aspiration syringe having an opening; combining the chemiluminescent cartridge with the aspiration syringe, wherein the chemiluminescent matrix is visible through the opening; attaching a needle to the aspiration syringe, wherein the needle is simultaneously inserted into the chemiluminescent cartridge; inserting the needle into a tissue; performing an aspiration with the aspiration syringe; and visualizing the chemiluminescent matrix.

17. The method of claim 16, wherein the chemiluminescent matrix comprises 3- Aminophthalhydrazide and a binding agent.

18. The method of claim 17, wherein the binding agent is selected from the group consisting of polyethylene glycol, chitosan acetate, okra polysaccharide, egg whites, carrageenan, guar gum, polyacrylamides, polyoxazoline, agar, and combinations thereof.

19. The method of claim 17, wherein the solution is an anesthetic.

20. The method of claim 17, comprising the further step of removing the aspiration syringe from the tissue if there is a chemiluminescent reaction.