Patent Application
20240237884
The aforementioned patent applications are hereby incorporated by reference, such incorporation being limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein.
The present disclosure relates to a fiber optic sensor retraction system useful for extracting a fiber optic waveguide from a hollow bore needle in medical procedures.
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 sub-arachnoid 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 can be 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 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.
A fiber optic sensor retraction system is disclosed that provides a methodology for a mechanism for rapidly extracting a fiber optic waveguide sensor from the interior of a hollow needle when the needle is properly placed in a medical or surgical procedure.
In one aspect, a retraction system for a fiber optic sensor is disclosed. The retraction system includes a hollow needle, such as a hypodermic needle, for administering medical fluids. The hollow needle can be in fluid communication with a y-junction. The y-junction can have a first input arm, a second input arm, and an output arm. The fiber optic sensor (waveguide) may be in one embodiment at least partially contained within the hollow needle and extend through the y-junction into the first input arm of the y-junction. A syringe can include a medical fluid in fluid communication with the second input arm of the y-junction. The disclosed retraction system can also include a retraction spring within the first input arm that is in mechanical communication with the fiber optic sensor. In some embodiments, the disclosed retraction system also includes a trigger in mechanical communication with the retraction spring.
More specifically, the fiber optic sensor retraction system may include a distal end, a proximal end, a hollow needle located at the distal end of the retraction system, an opening at the proximal end of the retraction system, a spring housing connected between the distal and proximal ends of the retraction system, an optical system comprising a fiber optic waveguide, a syringe containing medical fluids, and a spring that is in mechanical communication with the fiber optic waveguide. The opening can be configured to receive medical fluids through a fluid channel. The fiber optic waveguide can be at least partially contained within the hollow needle, can extend through a Y-junction, and can be configured to detect light from a biomarker luminescent material at a distal end of the hollow needle. The syringe can be in fluid communication with the Y-junction.
In some cases, the spring can be a retraction spring, the hollow needle can be in fluid communication with the Y-junction, and the fluid channel can be comprised of a first input arm, a second input arm, and an output arm, wherein the spring is connected to the first input arm. Further, the fiber optic waveguide can be located within a lumen of the fluid channel and can be further comprised of at least an optical fiber, an optical coupler, or both.
In some cases, the fiber optic sensor retraction system is further comprised of a retraction trigger in mechanical communication with the spring. The fiber optic sensor retraction system may be comprised of a notification system in communications with the optical system that informs a clinician that a target biomarker has been detected. The fiber optic sensor retraction system may be comprised of the medicinal fluid that is delivered through the fluid channel in the syringe to a biological system.
In some cases, the optical system can deliver light to biomarker luminescent material and simultaneously transmit emitted light from the biomarker luminescent material to a detector in the optical system. And in some cases, the proximal end can comprise a luer lock that is configured to receive the syringe. In some cases, the optical system further comprises an optical receiver having a filter that can selectively prevent frequencies other than the frequency of emitted light from the biomarker luminescent material from reaching the optical receiver. The optical system may be configured to send optical signals from the needle through the fiber optic waveguide. The optical fiber can be located within a lumen of the output arm and can be retracted allowing medicinal fluid to flow through the fluid channel and into a biological system.
In some cases, the spring can be at least one of a helical coil, solenoid based, disc, Belleville washer, wave spring or any combination thereof. A spring recoil rate may be preselected based on a spring tension. The spring housing can be configured to house the spring and at least a portion of the optical fiber. The retraction spring can be held retracted by a pin.
And in some cases, the proximal end of the retraction system can contain a luer lock configured to connect with the syringe. The fiber optic sensor retraction system can be further comprised of a barrel connected to the optical fiber, wherein the optical fiber can have a smaller diameter than the barrel. In some cases, the fiber optic sensor retraction system can be further comprised of a detector having a circuit board that includes one or more wireless interfaces.
In another aspect, a fiber optic fluid delivery device is disclosed, wherein the device is comprised of a fluidic delivery system comprising a delivery device, the delivery device having a distal end, and a detection system in communication with a target biomarker. The fluidic delivery system can be configured to detect the target biomarker in a biological system, the fluidic delivery system can be in contact with the target biomarker, and the delivery device can include a lumen and a fluid channel. The detection system can detect bioluminescent light for determining the presence of the target biomarker.
In another aspect, a method for retracting a fiber optic sensor is disclosed that includes providing a fiber optic sensor retraction system according to the disclosure above. The method further includes inserting the needle containing the fiber optic wavelength sensor into a patient and using the fiber optic wavelength sensor to properly place the needle. The method includes retracting the fiber optic wavelength sensor and then administering medical fluids through the hollow needle.
The present disclosure relates to fiber optic sensor retraction systems and methods used to detect biological substances, such as bodily fluids and tissues, including blood. Various embodiments of fiber optic sensor retraction systems and methods are be 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 fiber optic sensor retraction 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 fiber optic sensor retraction 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.
Fiber optic waveguides can be placed in the interior of hollow needles useful in medical procedures. The proper placement of the needles can be critical in the success of medical procedures such as surgical procedures on the nervous system (i.e. spinal surgery) or dental procedures. The fiber optic waveguide can be used as part of a sensor system that can detect important biological structures. For example, when trying to inject an anesthetic into a patient in a dental setting, it can be desirable to avoid injecting the medication into a blood vessel which can cause negative undesirable systemic reactions in a patient. A fiber optic sensor in the injection needle can be a part of a detection system that detects iron ions (in blood, for example) and can indicate the improper placement of the needle. In this case the needle can be relocated so that the anesthetic is properly injected. In some embodiments, the sensor may be located level with the needle tip or bevel. This location may allow the sensor to detect blood or other biomarkers at or near the tip of the needle.
In another example, spinal surgeons may want to locate various biological structures when placing a needle for administration of a medicament. In these cases, the surgeon may wish to find spinal fluid or avoid other physiological structures. A fiber optic detector can be placed into the needle which can be part of a detection system that can identify biological tissues in contact with the needle opening.
In normal operation, the surface of the fiber optic waveguide sensor within a hollow needle can be roughly coplanar with the tip of the Quincke needle. The fiber optic waveguide can be much smaller than the needle bore, allowing for injection of fluids, such as medicaments, to flow past the fiber optic waveguide. In some modalities, the entire needle bore can be filled with the fiber optic waveguide. In these cases, it can be necessary to retract or remove the fiber optic waveguide prior to the injection of fluids.
The removal of fiber optic waveguides can be done by hand by pulling the optical fiber waveguide into a Y-junction of guided syringe placement and delivery system until the fiber optic waveguide clears the needle bore. Hand removal of the optical fiber waveguide can be a significant operation by the surgeon or surgical staff at the precise point of injection, when movement of the needle tip is undesirable. Such a manual procedure also can require extra time for the whole procedure. Additionally, if a hard stop for fiber retraction is not included in the delivery system, it is possible for a leak to be created. However, this is unlikely based upon the approach of using a flexible polymer membrane similar to that used on a sealed medicine bottle or vial.
The present disclosure is to a novel fiber optic waveguide sensor retraction system and method to enable rapid extraction of the fiber optic waveguide when needle placement is finalized. The objective is to extract the fiber rapidly with a minimal action by the surgeon or surgical staff member and with minimal or negligible movement of the needle tip.
In the simplest embodiment disclosed herein, a spring is employed with a trigger release to rapidly extract the fiber. This embodiment is illustrated in
In
As mentioned above, another part of fiber optic sensor retraction system 100 can be a branching of fluid channel 124 into a Y-junction configuration. Hollow needle 126 may be an output arm 134 connecting to a bifurcation of fluid channel 124 into two parts: a first arm 136 with, or connecting to, spring barrel 106 as described herein, and a second arm 138 at proximal end 130. Second arm 138 may connect to a lure lock 128 as in
When fiber optic sensor retraction system 100 is in a first position, as illustrated in
The bifurcated configuration may allow for delivery of medicine in the target location while avoiding improper delivery areas of the patient. When used, a physician or health care professional may connect a syringe of fluid to lure lock 128 on second arm 138, before or after hollow needle 126 is placed into tissue of the patient. Optical fiber 102 may use light to detect the present of biomarkers, such as blood or other biological elements in a biological system. Detection of such biomarkers may help the physician or clinician to determine that hollow needle 126 was placed in the wrong location. In one embodiment, an illumination diode (not pictured in
Such a diode may be a waveguide or waveguide sensor, which can detect light. In this case, the diode can detect the light produced by the reaction between iron ions from a patient's blood and the biomarker luminescent material. Hollow needle 126 may have sensing, such as with a waveguide sensor, at the opening of the needle tip, and the electrons present in the luminescent, fluorescent, phosphorescent, or chemiluminescence material may be excited to a higher state when put into contact with the biological tissue (for example, blood). More specifically, if, during the insertion of the needle into tissue, blood is released from a patient's blood vessel and the iron ions from the blood comes into contact with the electrons from the biomarker luminescent material, the electrons may become excited, photons may be emitted, and a visual signal may be generated based on the reaction between the iron ions and the biomarker luminescent material. In other embodiments, ions or photons may react to be in a higher, energized state.
In one embodiment, fluorescence can be on the tip of optical fiber 102 and can react with iron ions and, optionally, added light through optical fiber 102. The light produced by the reaction between the blood and the iron-ion detecting substrate may be transmitted toward the needle opening. More specifically, the emitted light from the reaction of the biomarker luminescent material to the iron ions may cause light to travel back through optical fiber 102 and into a computing device that detects light. In some embodiments, optical fiber 102 may add light as well. In one such way, fiber optic sensor retraction system 100 can deliver light to biomarker luminescent material and simultaneously transmit emitted light from the biomarker luminescent material to a detector, such as a computing device connected to optical fiber 102 for receiving light and signals. The generated visual signal may be a result of the luminescent, fluorescent, phosphorescent, or chemiluminescent light produced by the interaction between blood and the iron-ion detecting substrate as described above.
In one embodiment, the light emitted along optical fiber 102 is blue light, and contacting iron from the biomarker, such as blood, may cause emitted photons, which can be green light. The green light can be sent into a splitter, and half of the green light can go to a detector that measures luminosity. In one embodiment, Photo Darlington detector, or a similar type, may convert light intensity to voltage level. In one embodiment, the output may be a voltage reading related to the biomarker concentration at the tip of hollow needle 126. The voltage reading may be visible to the user to determine placement of the needle in the patient. When the voltage reaches a certain level or passes a threshold, then a notification may be given to alert the clinician of the presence of a certain biomarker material.
Coating thicknesses and permeability of the different layers of the biomarker luminescent material can be adjusted to modify the ion sensing response time. In some embodiments, coating compositions are substantially transparent to the light wavelength emitted by the florescent coating so that emitted light can enter the fiber optic wave guide or selected optical transmission medium. Another contemplated embodiment can incorporate nanoparticles in the fluorescence coating itself, wherein the fluorescent media coating can slowly release chemicals to consume the iron ions over time, but not so fast as to inhibit the florescent coating from illuminating in the presence of the target ion.
In one embodiment, fiber optic sensor retraction system 100 further has an optical receiver (not illustrated) having a filter to selectively prevent frequencies, other than the frequency of emitted light from the biomarker luminescent material, from reaching the optical receiver. Therefore, in this embodiment, the physician or health care professional may not receive any alerts or notifications until a predetermined frequency of emitted light is detected by the system.
In one embodiment, once a desired placement of hollow needle 126 has occurred, then the medicine may be delivered. The user may cause optical fiber 102 to vacate fluid channel 124 by moving on retraction trigger 118. Retraction trigger 118 may be pulled, releasing retraction pin 116 from opening 140 of spring barrel 106. Because retraction pin 116 can directly or indirectly hold spring 110 in a first compressed position, as illustrated in
As illustrated in
Once optical fiber 102 is retracted, then sensing of biomarkers may cease. In some embodiments, the optical fiber waveguide may sense the presence of biological material by using sensors. Therefore, when optical fiber 102 is retracted into the second position, such as in
Optical fiber 102 may be a waveguide, which may moveably or slidably fit within the lumen of fluid channel 124 and may further have an optical coupler. The slide-ability of optical fiber 102 retracting out of fluid channel 124 may be due to a cylinder outside of optical fiber 102. More specifically, because optical fiber 102 may have a smaller diameter than a cylinder or cylindrical housing, such as spring barrel 106, optical fiber 102 may slide within the cylinder, or spring barrel 106. Optical fiber 102 of
Other embodiments of the fiber optic sensor retraction system may use other retraction methods that do not require a spring for retraction, such as hydraulics. For example, as the plunger of the syringe is depressed, the pressure of the syringe can be felt equally by the fiber optic waveguide/optical fiber and a fiber optic extraction cylinder, which can be used in place of the spring barrel that is illustrated in
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.
This application claims the benefit of U.S. provisional Application No. 63/191,627, filed May 21, 2021 and titled FIBER OPTIC SENSOR RETRACTION SYSTEM.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2022/030270 | 5/20/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63191627 | May 2021 | US |
