OPTO genetic delivery device and methods of using the same

Abstract

A surgical catheter including a first end, a second end, a main tube connecting the first end to the second end, a fluid delivery tube connected to the main tube, a fiber optic cable extending from the second end through the main tube, a button positioned near the fluid delivery tube and a needle base unit in the first end having a needle extending through the needle base unit into the main tube.

Description

BACKGROUND OF THE PRESENT INVENTION

[0001] Optogenetics is a method in biological research involving the combination of optics and genetics in technologies that are designed to control events in cells of living animal tissue. Optogenetic procedures involve injecting a marker that is used to identify targeted cells for gene therapy. Laser light at a predetermined wavelength is applied to the area to assist in the absorption of gene therapy into the targeted cell.

[0002] Optogenetic procedures require a large amount of skill and precision to mark the targeted cell, deliver the therapy and administer the laser light. Contemporary methods require the removal of the injection device and the positioning of a laser to complete the procedure. The removal of the injection device before the application of the laser light reduces the accuracy of the procedure due to the repositioning of the laser after the injection is made.

[0003] A need exists for a device that would allow for injection and laser administration without requiring the removal of the injection or laser device from the treatment area during the procedure. SUMMARY OF THE PRESENT INVENTION

[0004] One embodiment of the present disclosure includes a modular plug system including a plug housing including a top surface, bottom surface and two opposing side surfaces, a front end and an opening opposite the front end, and a cavity extending from the front end to the opening in the back end, and a load bar sized to engage the cavity in the modular plug, the load bar including two extensions on an upper surface of the load bar, the extensions sized to engage two openings in the top surface of the plug housing when the load bar is inserted into the cavity.

[0005] . One embodiment of the present disclose includes a surgical catheter that may have a first end, a second end, a main tube connecting the first end to the second end, a fluid delivery tube connected to the main tube, a fiber optic cable extending from the second end through the main tube, a button positioned near the fluid delivery tube, and a needle base unit in the first end having a needle extending through the needle base unit into the main tube.

[0006] In another embodiment, the button may be connected to a light source that transmits a light through the fiber optic cable.

[0007] In another embodiment, the fiber optic cable may include an inner core and a protective film around the inner core.

[0008] In another embodiment, the protective film may be removed from the fiber optic cable before it is inserted into the catheter.

[0009] In another embodiment, guides on the second end of the catheter may position the fiber optic cable in a channel in the main tube.

[0010] In another embodiment, the fiber optic cable may be positioned in a first position that allows fluid to flow from the fluid delivery tube into the needle.

[0011] In another embodiment, the fiber optic cable may be positioned in a second position where the fiber optic cable extends through the main tube and the needle such that the end of the fiber optic cable extends past the end of the needle.

[0012] In another embodiment, the fiber optic cable may have a diameter that allows fluid to flow around the fiber optic cable in the needle.

[0013] In another embodiment, an FGNRs / Plasmid fluid may be injected through the fluid delivery tube.

[0014] In another embodiment, the needle may be sized to accept the fiber optic cable without the protective film.

[0015] In another embodiment, the fiber optic cable is sealed within a metallic tube that slides along the seals of the injection device allowing the fiber optic cable to move through the needle so the seals are not on the fiber optic cable, but instead on the metallic tube.

[0016] Another embodiment of the present disclosure includes a method of performing a gene treatment using a surgical catheter including the steps of inserting a fiber optic cable into a main tube connecting a first opening and a second opening in the catheter via the second opening, injecting a fluid into a patient through the main tube via a fluid delivery tube connected to the main tube and a needle connected to the first opening via a needle base unit, positioning the fiber optic cable in the needle after injection of the fluid, and pressing a button positioned near the fluid delivery tube to transmit light through the fiber optic cable.

[0017] Another embodiment includes the step of pressing the button may activate a light source that transmits a light through the fiber optic cable.

[0018] In another embodiment, the fiber optic cable may include an inner core and a protective film around the inner core.

[0019] Another embodiment includes the step of removing the protective film from the fiber optic cable before it is inserted into the catheter.

[0020] Another embodiment includes the step of guiding the fiber optic cable into the main tube via guides on the second end of the catheter.

[0021] Another embodiment includes the step of positioning the fiber optic cable in a first position that allows fluid to flow from the fluid delivery tube into the needle.

[0022] Another embodiment includes the step of positioning the fiber optic cable in a second position where the fiber optic cable extends through the main tube and the needle such that the end of the fiber optic cable extends past the end of the needle.

[0023] In another embodiment, the fiber optic cable may have diameter that allows fluid to flow around the fiber optic cable in the needle.

[0024] In another embodiment, an FGNRs / Plasmid fluid may be injected through the fluid delivery tube.

[0025] In another embodiment, the needle may be sized to accept the fiber optic cable without the protective film.

[0026] Another embodiment may include the step of waiting a predetermined time to transmit light onto the injection location wherein the predetermined time is sufficient for the distribution of the fluid into the patient prior to the transmission of light. DRAWING SUMMARY

[0027] A more complete appreciation of the invention and many of the attendant advantages thereof will be readily obtained as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein:

[0028] FIG. 1 depicts a perspective view of a catheter used to inject a fluid during a surgical procedure;

[0029] FIG. 2 depicts a cut away side view of the catheter.

[0030] FIG. 3 shows an expanded view of the needle base unit engaging the opening in the first end of the catheter;

[0031] FIG. 4 depicts an expanded view of the needle base unit;

[0032] FIG. 5 depicts the inner core of the fiber optic cable in a first position in the catheter;

[0033] FIG. 6 depicts the inner core of the fiber optic cable in a second position in the catheter; and

[0034] FIG. 7 depicts a schematic representation of a method of using the surgical catheter. DETAILED DESCRIPTION

[0035] The detailed description set forth below is intended as a description of various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The appended drawings are incorporated herein and constitute a part of the detailed description. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. However, the subject technology is not limited to the specific details set forth herein and may be practiced using one or more implementations. In one or more instances, structures and components are shown in simplified form in order to avoid obscuring the concepts of the subject technology.

[0036] In the drawings referenced herein, reference numerals designate identical or corresponding parts throughout the several views or embodiments.

[0037] FIG. 1 depicts a perspective view of a catheter 100 used to inject a fluid during a medical procedure. The catheter 100 includes a first end 102, a second end 104, a main tube 106 connecting the first end 102 to the second end 104, a fluid delivery tube 108 connected to the main tube 106, a fiber optic cable 110 extending from the second end 104 through the main tube 106 and a button 112 positioned near the fluid delivery tube 108. A needle base unit 114 is inserted into the first end 102 with a needle 116 extending through the needle base unit 114 into the main tube 106. The catheter 100 may be made from any material acceptable for surgical instruments including, but not limited to, plastic, polyvinyl chloride, silicone rubber, polyurethane, polyethylene, terephthalate, latex and thermoplastic elastomers.

[0038] The catheter 100 allows for the injection of a fluid from the fluid delivery tube 108 though the main tube 106, needle base unit 114 and needle 116 into a region on a patient’s body. After injection, the fiber optic cable 110 is moved to allow the end of the fiber optic cable 110 to extend through the needle 116 to deliver a light to the injected region. The button 112, when pressed, emits the light through the fiber optic cable 116 to the injected region without requiring the removal of the surgical catheter 100 from the area of injection or removing the fiber optic cable 110 from the surgical catheter 100. Because the surgical catheter 100 remains in the region where the patent is injected with fluid, the light emitted from the fiber optic cable 110 is concentrated on the exact area of injection, thereby increasing the effectiveness of the light treatment.

[0039] FIG. 2 depicts a cut away side view of the catheter 100. The fiber optic cable 110 enters into a channel 202 in the main tube 106 via an opening 204. The fiber optic cable 110 is comprised of an inner core 206 made of a transparent material such as glass that is surrounded by an outer coating made of a solid material such as plastic or rubber. The opening 204 is sized to accommodate the inner core 206 of the fiber optic cable 110 with the outer portion of the opening 204 sloping towards the channel 202 to form a guide 208 to guide the optical cable into the channel 202. In one embodiment, the channel 202 includes a material that creates a fluid tight seal with the fiber optic cable 110 inner core 206. The channel 202 extends from the second end 104 to the first end 102 of the catheter 100. The needle base unit 114 engages an opening 210 in the first end 102 of the catheter 100. In one embodiment, the needle base unit 114 has a threaded end that engages the threaded inner wall of the opening 210. The needle base unit 114 is positioned in the opening 210 such that a needle channel 212 is concentric with the channel 202. The needle channel 212 extends through the needle base unit 114 and through the needle 116 such that inner core 206 of the fiber optic cable 110 extends beyond the end of the needle 116.

[0040] The fluid delivery tube 108 is positioned at an angle theta (0) from the top surface of the main tube 106. In one embodiment, the angle theta (0) is forty-five degrees. In another embodiment, the angle (0) is less than forty-five degrees. In another embodiment, the angel (0) is greater than forty-five degrees and less than ninety degrees. The fluid delivery tube 108 is secured to the main tube 106 by a support unit 214 that is connected to a lower surface of the fluid delivery tube 108 and a top surface of the main tube 106. In one embodiment, the edge of the support unit 214 furthest from the needle 216 is curved in a concave shape to accept the form of a finger. In another embodiment, the button 112 is positioned on the support unit 214 such that a user of the catheter may press the button during use of the catheter 100. A tube channel 216 extends through the center of the needle delivery tube 108 along the entire length of the fluid delivery tube 108. The tube channel 216 extends into the channel 202 such that fluid may be delivered through the tube channel 216 and into the main channel 202 for insertion through the needle 116. An injection unit 218 is positioned on the end of the fluid delivery tube 108 to allow for a syringe to inject fluid into the channel 202 for delivery by the needle 116.

[0041] In one embodiment, the fiber optic cable 110 inner core 206 engages a tube 220 positioned in the channel 202. The tube 220 is sized such that the tube can move freely in the channel 202. The fiber optic cable 110 inner core 206 engages an inner channel in the tube 220 such that the fiber optic cable 110 inner core 206 and the inner channel of the tube 220 form a liquid tight seal preventing liquid injected into the channel from moving through the inner channel of the tube 220. In one embodiment, the tube 220 is made of metal. In another embodiment, the inner channel of the tube 220 includes a compressive material that engages the inner core 206 of the fiber optic cable 110. In another embodiment, the inner core 206 of the fiber optic cable 110 engages the inner channel of the tube 220 such that the inner core 206 extends to the end of the needle 116 in a first position and to a position where the inner core 206 in positioned in the channel 202 without extending into the needle in a second position. The position of the tube 220 is controlled by a user moving the fiber optic cable 110 in and out of the channel 202. In another embodiment, the tube 220 forms a seal with the channel 202 to prevent fluid from moving around the tube 220 in the channel 202.

[0042] FIG. 3 depicts an expanded view of the needle base unit 114 engaging the opening 210 in the first end 102 of the catheter 100. The inner core 206 of the fiber optic cable 110 extends through the channel 202 and into needled channel 212. In one embodiment, the needle channel 212 is formed from the inner opening of the needle 116 that is sized to accommodate the inner core 206 of the fiber optic cable 110. By passing the inner core 206 of the fiber optic cable 110 though the needle, the inner core 206 is supported by the needle. In addition, the needle 116 prevents light from being disbursed from the inner core 206 reducing the effectiveness of the fiber optic cable 210. The needle base unit 114 includes a rim 302 that extends around the periphery of the portion of the needle base unit 114 that engages the opening 210. The opening 210 includes threads 304 on the inner surface of the opening 210 that engage the rim 302 to secure the needle base unit 114 in the opening 210.

[0043] FIG. 4 depicts an expanded view of the needle base unit 114. The inner core 206 of the fiber optic cable 110 extends through the needle base unit 114 and the needle 116 such that the end 402 of the inner core 206 extends past the end of the needle 116. In one embodiment, the end 402 of the inner core 206 is dome shaped to control light dispersion onto the treated region. The inner core 206 is positioned in the channel 202, needle base unit 114 and needle 116 such that the inner core 206 can move towards the needle 116 and away from the needle 116 in the channel 202. By moving the inner core 206 to different positions in the channel 202, the operator of the catheter 100 can inject fluid while also delivering light to injected regions without removing the catheter 100.

[0044] FIG. 5 depicts the inner core 206 of the fiber optic cable 110 in the first position in the catheter 100. With the inner core 206 in the first position in the channel 202, a fluid can be delivered through the fluid delivery tube 108 and channel 202 to the needle base unit 114 and needle 116. In one embodiment, the user of the catheter 100 moves the inner core 206 of the fiber optic cable 110 to the first position in the channel. The user injects a fluid into the fluid delivery tube 108 with a force adequate to push the fluid into the channel 202 and through the needle base unit 114 and needle 116. The fluid exits the needle 116 and enters the location for treatment in a patient’s body. In one embodiment, the fluid injected into the patient is a FGNRs / Plasmid fluid. In one embodiment, the diameter of the inner core 206 of the fiber optic cable 110 is sized to allow a fluid to flow around the inner core 206 and through the needle base unit 114 and needle 116.

[0045] FIG. 6 depicts the inner core 206 of the fiber optic cable 110 in a second position in the catheter 100. In the second position, the inner core 206 of the fiber optic cable 110 extends through the channel 202 into the needle base unit 114 and through the needle 116. The end 402 of the inner core 206 extends past the end of the needle 216 to allow the application of light onto the area previously injected with fluid. In one embodiment, the light passed through the inner core 206 operates at 620-750nm. In one embodiment, a mechanical stop is positioned inside the channel 202 to limit the movement of the fiber optic cable 110 between the first position and second position.

[0046] FIG. 7 depicts a schematic representation of a method of using the surgical catheter 100. In step 702, a fiber optic cable 110 is inserted into a channel 202 in the catheter 100. The fiber optic cable 110 includes a core surrounded by an insulated layer. In one embodiment, guides in the opening where the fiber optic cable 110 is inserted, guide the fiber optic cable 110 into a channel 202 in the catheter 100. In step 704, the fiber optic cable 110 is positioned at a first position in the channel 202. The first position allows fluid to flow from a fluid delivery tube, through the channel 202 and into a needle 116 for injection into a patient. In step 706, the needle 116 is positioned over the location for injection. In step 708, fluid is injected into the fluid delivery tube 108 with enough force to push the fluid through the fluid delivery tube 108 into the main channel 202 and through the needle 116. In step 710 the fluid is injected into the treatment area by the force created by the injection of the fluid into the fluid delivery tube 108.

[0047] In step 712, the fiber optic cable 110 is moved into a second position. In one embodiment, the second position is a position where the end of the fiber optic cable 110 extends beyond the end of the needle 116. In another embodiment, the second position is a position where the fiber optic cable 110 is inside the needle, but allows for light to transmit out the open end of the needle 116 towards the treatment area. In step 714, the button 112 on the catheter is pressed and light is emitted out of the fiber optic cable 110 onto the treatment area. In another embodiment, the movement of the fiber optic cable 110 to the second position forces fluid remaining in the needle 116 out of the needle 116 and into the injection area. In one embodiment, light is transmitted through the fiber optic cable 110 simultaneously with the injection of fluid into the injection area such that the FGNRs assist the fluid in crossing a tissue barrier.

[0048] In one embodiment, the process of moving the fiber optic cable 110 is automated such that the fiber optic cable 110 is moved to the first position and second position in a predetermined manner. In another embodiment, the transmission of the light is automated to turn on and off the light a predetermined amount of time after an injection is made into the patient. In another embodiment, the predetermined time is based on the type of material in the fluid, the length and type of FGNRs, the amount of light needed to enhance the injection, the amount of time for the fluid to disburse into the patient and the effects of the light on the patient after injection. In another embodiment, the automation of the injection prevents extended exposure to the light to avoid negative effects to the injection and burning of the injection location.

[0049] Various embodiments of the invention are contemplated in addition to those disclosed hereinabove. The above-described embodiments should be considered as examples of the present invention, rather than as limiting the scope of the invention. In addition to the foregoing embodiments of the invention, review of the detailed description and accompanying drawings will show that there are other embodiments of the present invention. Accordingly, many combinations, permutations, variations and modifications of the foregoing embodiments of the present invention not set forth explicitly herein will nevertheless fall within the scope of the present invention.

[0050] In an embodiment, a catheter, including a surgical catheter comprises a first end; a second end; a main tube connecting the first end to the second end; a fluid delivery tube connected to the main tube; a fiber optic cable extending from the second end through the main tube; a button positioned near the fluid delivery tube; and a needle base unit in the first end having a needle extending through the needle base unit into the main tube. In an embodiment, the catheter, including a surgical catheter comprises a fiber optic that is multi lumen.

[0051] In an embodiment, the invention comprises a surgical catheter where the fiber optic cable is hollow and the needle can be retracted through the hollow opening in the fiber optic cable. In another embodiment, a surgical catheter comprises a catheter lumen that is used to inject a therapeutic, wherein the catheter body is the light conducting fiber optic cable. In an embodiment, a therapeutic is a protein, a peptide, a nucleic acid or a small molecule. In a further embodiment, a therapeutic is a genetic element (AAV, lentivirus or other nucleic acid) that is used for gene therapy. In another embodiment, a therapeutic is a pain medication, including, an NS AID, an opioid, aspirin or other pain therapeutic.

[0052] In an embodiment, the catheter, including a surgical catheter has a reflective coating on the exterior to contain the transmitted light. In a further embodiment, the catheter, including a surgical catheter contains a reflective coating that is coated with a biocompatible film. In a further embodiment, a catheter, including a surgical catheter contains a reflective coating on the exterior to contain the transmitted light.

Claims

1. A surgical catheter including:a first end;a second end;a main tube connecting the first end to the second end;a fluid delivery tube connected to the main tube;a fiber optic cable extending from the second end through the main tube;a button positioned near the fluid delivery tube; anda needle base unit in the first end having a needle extending through the needle base unit into the main tube.

2. The surgical catheter of claim 1 wherein the button is connected to a light source that transmits a light through the fiber optic cable.

3. The surgical catheter of claim 1 wherein the fiber optic cable includes an inner core and a protective film around the inner core.

4. The surgical catheter of claim 3, wherein the protective film is removed from the fiber optic cable before it is inserted into the catheter.

5. The surgical catheter of claim 1, wherein guides on the second end of the catheter position the fiber optic cable in a channel in the main tube.

6. The surgical catheter of claim 1, wherein the fiber optic cable is positioned in a first position that allows fluid to flow from the fluid delivery tube into the needle.

7. The surgical catheter of claim 6, wherein the fiber optic cable is positioned in a second position where the fiber optic cable extends through the main tube and the needle such that the end of the fiber optic cable extends past the end of the needle.

8. The surgical catheter of claim 6 wherein the fiber optic cable has a diameter that allows fluid to flow around the fiber optic cable in the needle.

9. The surgical catheter of claim 1, wherein an FGNRs / Plasmid fluid is injected through the fluid delivery tube.

10. The surgical catheter of claim 1, wherein any FGNRs and drug product is injected thorough the fluid delivery tube.

11. The surgical catheter of claim 1, wherein the light wavelength is corresponding to the length of the FGNR for maximum effectiveness.

12. The surgical catheter of claim 4 wherein the needle is sized to accept the fiber optic cable without the protective film.

13. A method of performing a gene treatment using a surgical catheter including the steps of: inserting a fiber optic cable into a main tube connecting a first opening and a second opening in the catheter via the second opening;injecting a fluid into a patient through the main tube via a fluid delivery tube connected to the main tube and a needle connected to the first opening via a needle base unit;positioning the fiber optic cable in the needle after injection of the fluid; and pressing a button positioned near the fluid delivery tube to transmit light through the fiber optic cable.

14. The method of claim 13, wherein the step of pressing the button activates a light source that transmits a light through the fiber optic cable.

15. The method of claim 13, wherein the fiber optic cable includes an inner core and a protective film around the inner core.

16. The method of claim 15, including the step of removing the protective film from the fiber optic cable before it is inserted into the catheter.

17. The method of claim 13, including the step of guiding the fiber optic cable into the main tube via guides on the second end of the catheter.

18. The method of claim 13, including the step of positioning the fiber optic cable in a first position that allows fluid to flow from the fluid delivery tube into the needle.

19. The method of claim 18, including the step of positioning the fiber optic cable in a second position where the fiber optic cable extends through the main tube and the needle such that the end of the fiber optic cable extends past the end of the needle.

20. The method of claim 18, wherein the fiber optic cable has a diameter that allows fluid to flow around the fiber optic cable in the needle.

21. The method of claim 13, wherein an FGNRs / Plasmid fluid is injected through the fluid delivery tube.

22. The method of claim 16 wherein the needle is sized to accept the fiber optic cable without the protective film.

23. The method of claim 13 where the injection of the fluid is automated.

24. The method of claim 13 including the step of waiting a predetermined time to transmitlight onto the injection location wherein the predetermined time is sufficient for the distribution of the fluid into the patient prior to the transmission of light.

25. The method of claim 13 where the laser light is activated while the fluid is injected such that the FGNRs assist the fluid in crossing a tissue barrier.

26. The surgical catheter of claim 1 wherein the fiber optic is hollow and the needle can be retracted.

27. The surgical catheter of claim 1, wherein the catheter lumen is used to inject the gene therapy and catheter body is the light conducting fiber.

28. The surgical catheter of claim 26, wherein the catheter has a reflective coating on the exterior to contain the transmitted light.

29. The surgical catheter of claim 26, wherein the catheter reflective coating is coated with a biocompatible film.

30. The surgical catheter of claim 1, wherein the fiber optic is multi lumen.

31. The surgical catheter of claim 26, wherein the catheter is multi lumen.

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