Integrated epidural injection device and system

Abstract

The present disclosure relates to the medical device field and discloses a system including a medical puncture device and a medical device configured to be incorporated into the medical puncture device. In some embodiments, the present disclosure has particular application to enabling injection, entry, expansion, and / or implantation of devices into apparent or potential tissue voids, cavities, or vessels (e.g., the epidural space), and providing precise control over puncture depth and needle placement, as well as stable and limited volume injections (e.g., for epidural anesthesia).

Description

Detailed Description of the Invention

[0001] [Technical field] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to International Patent Application No. PCT / CN2022 / 131455, entitled "DEVICE AND SYSTEM FOR EPIDURAL INJECTION," with an international filing date of November 11, 2022. The entire contents of this disclosure and the above-referenced applications are incorporated herein by reference for all purposes.

[0002] The present disclosure relates in some aspects to the medical device and instrumentation field, and specifically to epidural injection devices, kits, assemblies or systems.

[0003] [Background technology] In conventional epidural anesthesia treatment methods, local anesthetics are generally injected into the epidural space using a standard syringe. When performing the puncture, the puncture position and depth of the syringe needle must be manually controlled, and medical professionals must rely on experience to determine whether the needle has entered the epidural space. However, the depth and structure of various tissues around and within the epidural space for different patients generally vary from person to person, and medical professionals' determination of the needle depth may be inaccurate and unreliable. Therefore, accurate placement of the needle relative to the epidural space cannot be guaranteed. Furthermore, medical professionals have difficulty confirming whether the needle tip has reached the target injection site (e.g., the epidural space). There is a need for an apparatus and method for improving medical puncture (e.g., injection into the epidural space). The present disclosure addresses these and other needs.

[0004] [Summary of the Invention] In some embodiments, the present disclosure provides an injection system. In any one of the above embodiments, the injection system may include a syringe barrel extending from a proximal end to a distal end. In any one of the above embodiments, the injection system may include a first hollow needle extending from the proximal end to a distal end including an end opening, wherein the needle distal end is connected to the distal end of the syringe barrel. In any one of the above embodiments, the hollow needle may include markings on an outer wall of the hollow needle to indicate the insertion depth of the hollow needle. In any one of the above embodiments, the injection system may include a floating seal located inside the syringe barrel, forming a lumen between the floating seal and the distal end of the syringe barrel and including a hollow passage configured to align with the first hollow needle. In any one of the above embodiments, the injection system may include a push shaft having a hollow passage extending from a proximal end to a distal end, wherein the distal end of the push shaft is proximal to and in contact with the floating seal, and the hollow passage of the push shaft is configured to align with the hollow passage of the floating seal and the first hollow needle to form a central hollow passage extending from the proximal end of the push shaft to a distal opening of the first hollow needle. In any one of the above embodiments, the injection system may include a proximal seal at the proximal end of the central hollow passage. In any one of the above embodiments, the injection system may include an actuation unit including an actuation member configured to elastically couple with the push shaft by an energy storage member, and an energy storage member.

[0005] In any one of the above embodiments, the energy storage member may include a spring between the floating seal and the push shaft. In any one of the above embodiments, the spring may resiliently join a proximal portion of the floating seal and a distal portion of the push shaft. In any one of the above embodiments, a distal end of the push shaft may resiliently join to the floating seal. In any one of the above embodiments, the push shaft may be configured to be directly or indirectly connected to a pathway trigger member (e.g., an alarm and / or an optical sensor) to emit a signal when the needle reaches a predetermined depth or a predetermined position.

[0006] In any one of the above embodiments, the injection system may further include a puncture unit including a proximal needle and a needle guide structure. In any one of the above embodiments, the proximal needle may be configured to be advanced distally within a hollow needle guide passage within the needle guide structure to puncture the proximal seal. In any one of the above embodiments, the needle guide structure may include a side port configured to align with the catheter guide passage such that a catheter within the catheter guide passage is configured to be advanced through the side port, enter the hollow needle guide passage within the needle guide structure, pass through the punctured proximal seal, and enter the central hollow passage.

[0007] In any one of the above embodiments, the injection system may further include an injection syringe including a second hollow needle, the second hollow needle configured to be inserted into the central hollow passage to inject the composition. In any one of the above embodiments, the first hollow needle may be configured to be positioned in the epidural space. In any one of the above embodiments, the injection system may further include a catheter configured to be inserted through the first hollow needle and enter the epidural space. In any one of the above embodiments, the second hollow needle may be configured to be withdrawn from the central hollow passage after injecting the composition. In any one of the above embodiments, the catheter may be configured to be withdrawn from the epidural space through the first hollow needle.

[0008] In some embodiments, the present specification discloses a method for epidural injection. In any one of the above embodiments, the method may include injecting a composition into the epidural space using any injection system disclosed herein. In some embodiments, the present specification discloses a method for epidural injection. In any one of the above embodiments, the method may include placing a catheter into the epidural space using any injection system disclosed herein, and injecting the composition into the epidural space through the catheter.

[0009] In some embodiments, the present disclosure provides a device including a syringe barrel extending from a proximal end to a distal end, the distal end of the syringe barrel including a needle seat configured to be connected to a needle having a needle lumen, and the needle seat including a passage configured to be in fluid communication with the needle lumen. In any one of the above embodiments, the device may include a gasket seal, the gasket seal and an inner wall of the syringe barrel forming a fluid-tight seal, a flowable composition lumen formed between the gasket seal and the distal end of the syringe barrel, the gasket seal including a through hole along the axis of the syringe barrel, the through hole configured to align with the passage in the needle seat. In any one of the above embodiments, the device may include a push shaft extending from a proximal end to a distal end, the distal end of the push shaft abutting the gasket seal, the push shaft including a central passage having a distal end aligned with the through-hole of the gasket seal, and a valve aligned with the proximal end of the central passage. In any one of the above embodiments, the device may include an elastic element configured to actuate the push shaft, thereby moving the gasket seal distally along the axis of the syringe barrel. In some embodiments, when the gasket seal moves distally, the central passage connects to the passage in the needle seat. In any one of the above embodiments, the device may include a catheter configured to be inserted through the valve and into the central passage. In any one of the above embodiments, the needle may be an epidural needle. In any one of the above embodiments, the needle may be a Tuohy epidural needle, a Hustead epidural needle, a Crawford epidural needle, or a Weiss epidural needle. In any one of the above embodiments, the needle specification may be between about 17 G and about 22 G (ISO-9626). In any one of the above embodiments, the needle specification may be between 17 G and 18 G (ISO-9626). In any one of the above embodiments, the needle specification may be between 19 G and 20 G (ISO-9626).In any one of the above embodiments, the needle length may be between about 2.5 inches and about 6 inches. In any one of the above embodiments, the needle length may be between about 3 inches and about 3.5 inches. In any one of the above embodiments, the needle may include a straight distal tip. In any one of the above embodiments, the needle may include a curved distal tip. In any one of the above embodiments, the needle may include a distal tip including a blunt bevel. In any one of the above embodiments, the needle may include a side port. In any one of the above embodiments, the side port of the needle may be configured to allow for injection of an anesthetic agent through the needle lumen.

[0010] In any one of the above embodiments, the gasket seal may be configured to allow a catheter to be advanced distally through the through-hole. In any one of the above embodiments, the gasket seal may be configured to allow a catheter to be retracted proximally through the through-hole. In any one of the above embodiments, the through-hole may be configured to close when a catheter or central passage is not inserted into the gasket seal. In any one of the above embodiments, the through-hole may be configured to allow a catheter or central passage to pass through the gasket seal.

[0011] In any one of the above embodiments, the central passage can pass through the through hole of the gasket seal. In any one of the above embodiments, the distal end of the central passage can be flush with the distal end of the through hole. In any one of the above embodiments, the distal end of the central passage can be flush with the proximal end of the through hole. In any one of the above embodiments, the push shaft can further include a central chamber in fluid communication with the central passage. In any one of the above embodiments, at least a portion of the central chamber can be between the valve and the proximal end of the central passage. In any one of the above embodiments, the valve can be configured to allow unidirectional passage of the catheter. In any one of the above embodiments, the push shaft can include a catheter guide passage. In any one of the above embodiments, the valve can be positioned at the distal end of the catheter guide passage. In any one of the above embodiments, the valve can be at the distal end of the catheter guide passage. In any one of the above embodiments, the push shaft may include a side port configured to allow a catheter to pass through the side port and enter the catheter guide passage. In any one of the above embodiments, the push shaft may include a locking mechanism configured to maintain the position of the gasket seal in the syringe barrel and the compressed or expanded state of the elastic element.

[0012] In any one of the above embodiments, the elastic element may include a spring, a rubber band, a bungee cord, memory foam, an airbag, or a combination thereof. In any one of the above embodiments, a distal end of the elastic element may be joined to a portion of the push shaft or the gasket seal, and a proximal end of the elastic element may be joined to a portion of the syringe barrel. In any one of the above embodiments, a distal end of the elastic element (e.g., a spring) may be joined to a portion of the push shaft, and a proximal end of the elastic element (e.g., a spring) may be joined to a structure of or within the syringe barrel, such as a baffle of or within the syringe barrel. In any one of the above embodiments, the elastic element may be configured to be compressed. In any one of the above embodiments, decompressing the compressed elastic element applies a force to actuate the push shaft or the gasket seal, thereby moving the gasket seal distally along the axis of the syringe barrel. In any one of the above embodiments, a distal end of the elastic element can be joined to a portion of the syringe barrel, and a proximal end of the elastic element can be joined to a portion of the push shaft or the gasket seal. In any one of the above embodiments, the elastic element can be configured to be expanded. In any one of the above embodiments, contraction of the expanded elastic element can apply a force to actuate the push shaft or the gasket seal, thereby moving the gasket seal distally along the axis of the syringe barrel.

[0013] In any one of the above embodiments, the catheter may have a specified size between about 19 G and about 20 G (ISO-9626). In any one of the above embodiments, the device may include a housing that houses at least a portion of the syringe barrel, at least a portion of the push shaft, and at least a portion of the catheter. In any one of the above embodiments, the device may include a catheter storage mechanism and a catheter actuation mechanism. In any one of the above embodiments, the housing may define the outer boundary of the device, all of which are contained within the housing. In any one of the above embodiments, at least a portion of the catheter may be insertable through the valve. In any one of the above embodiments, at least a portion of the catheter may be insertable into the central passage. In any one of the above embodiments, at least a portion of the catheter may pass through a through-hole in the gasket seal. In any one of the above embodiments, at least a portion of the catheter may pass through a passage in the needle seat. In any one of the above embodiments, at least a portion of the catheter may be insertable into the needle lumen. In any one of the above embodiments, the catheter may include a distal end configured to form a coil. In any one of the above embodiments, the catheter may include markings on an outer wall of the catheter to indicate the insertion depth and / or insertion position of the distal end of the catheter.

[0014] In any one of the above embodiments, the device includes: (a) a syringe barrel extending from a proximal end to a distal end, the distal end of the syringe barrel including a needle seat connected to a needle including a needle lumen, the needle seat including a passage in fluid communication with the needle lumen; (b) a gasket seal, the gasket seal and an inner wall of the syringe barrel forming a fluid-tight seal, the gasket seal adjacent to the distal end of the syringe barrel, the gasket seal including a through hole along the axis of the syringe barrel, the through hole aligning with the passage in the needle seat; and (c) a push shaft extending from the proximal end to the distal end, the distal end of the push shaft joining the gasket seal, the push shaft connecting the gasket seal to the gasket seal. and a valve aligned with a proximal end of the central passage; (d) a spring, the distal end of which is attached to a portion of the push shaft and the proximal end of which is attached to a structure within or on the syringe barrel (e.g., a baffle), the spring configured to be compressed, and decompression of the compressed spring actuating the push shaft or the gasket seal, thereby moving the gasket seal distally along the axis of the syringe barrel; (e) a catheter, the catheter configured to be inserted through the valve and enter the central passage; and (f) a housing, the housing enclosing at least a portion of the syringe barrel, at least a portion of the push shaft, and at least a portion of the catheter.

[0015] In any one of the above embodiments, the device includes: (a) a syringe barrel extending from a proximal end to a distal end, the distal end of the syringe barrel including a needle seat connected to a needle having a needle lumen, the needle seat including a passage in fluid communication with the needle lumen; (b) a gasket seal, the gasket seal and an inner wall of the syringe barrel forming a fluid-impermeable seal, the flowable composition lumen being formed between the gasket seal and the distal end of the syringe barrel, the gasket seal including a through-hole along the axis of the syringe barrel, the through-hole aligning with the passage in the needle seat; and (c) a push shaft extending from the proximal end to the distal end, the distal end of the push shaft joining the gasket seal, the push shaft (d) a spring, the distal end of which is attached to a portion of the push shaft and the proximal end of which is attached to a structure within or on the syringe barrel (e.g., a baffle), the spring being compressed and decompressing the compressed spring actuating the push shaft or the gasket seal, thereby moving the gasket seal distally along the axis of the syringe barrel; (e) a catheter, the catheter being configured to be inserted through the valve and enter the central passage; and (f) a housing, the housing containing at least a portion of the syringe barrel, at least a portion of the push shaft, and at least a portion of the catheter. In any one of the above embodiments, the flowable composition lumen may contain a gas. In any one of the above embodiments, the gas may be air. In any one of the above embodiments, the flowable composition lumen can be liquid-free.

[0016] In any one of the above embodiments, the device includes: (a) a syringe barrel extending from a proximal end to a distal end, the distal end of the syringe barrel including a needle seat connected to a needle having a needle lumen, the needle seat including a passage in fluid communication with the needle lumen; (b) a gasket seal, the gasket seal and an inner wall of the syringe barrel forming a fluid-tight seal, the gasket seal including a through hole along the axis of the syringe barrel, the through hole aligning with the passage in the needle seat; and (c) a push shaft extending from the proximal end to the distal end, the distal end of the push shaft joining the gasket seal, and the distal end of the push shaft aligning with the through hole of the gasket seal. and a valve aligned with a proximal end of the central passage; (d) a spring, the distal end of the spring being attached to a portion of the push shaft and the proximal end of the spring being attached to a structure within or on the syringe barrel (e.g., a baffle), the spring being configured to apply a force to the push shaft or the gasket seal, thereby causing the gasket seal to abut the distal end of the syringe barrel and connecting the central passage with a passage in the needle washer; (e) a catheter, the catheter being configured to be inserted through the valve and enter the central passage; and (f) a housing, the housing containing at least a portion of the syringe barrel, at least a portion of the push shaft, and at least a portion of the catheter.

[0017] In any one of the above embodiments, the device includes: (a) a syringe barrel extending from a proximal end to a distal end, the distal end of the syringe barrel including a needle seat connected to a needle having a needle lumen, the needle seat including a passage in fluid communication with the needle lumen; (b) a gasket seal, the gasket seal and an inner wall of the syringe barrel forming a fluid-tight seal, the gasket seal including a through hole along the axis of the syringe barrel, the through hole aligning with the passage in the needle seat; (c) a push shaft extending from the proximal end to the distal end, the distal end of the push shaft joining the gasket seal, the push shaft including a central passage with a distal end aligned with the through hole of the gasket seal; The syringe may include: (a) a push shaft including a valve aligned with the proximal end of the passage; and a catheter guide passage, wherein the valve is aligned with the distal end of the catheter guide passage; (d) a spring, wherein the distal end of the spring is attached to a portion of the push shaft and the proximal end of the spring is attached to a structure (e.g., a baffle) within the syringe barrel or within the syringe barrel, the spring applying a force to the push or gasket seal, causing the gasket seal to be adjacent to the distal end of the syringe barrel, and wherein the central passage and the passage in the needle seat form a connection; (e) a catheter, wherein a portion of the catheter is within the catheter guide passage; and (f) a housing, wherein the housing accommodates at least a portion of the syringe barrel, at least a portion of the push shaft, and at least a portion of the catheter. In any one of the above embodiments, the distal end of the catheter may be within the catheter guide passage of the push shaft. In any one of the above embodiments, the distal end of the catheter can be inserted through the valve of the push shaft. In any one of the above embodiments, the distal end of the catheter may be located within the central passage of the push shaft or the through-hole of the gasket seal. In any one of the above embodiments, the distal end of the catheter may be located within the passage of the needle washer.In any one of the above embodiments, the distal end of the catheter may be within the needle lumen of the needle.

[0018] In some embodiments, the present disclosure provides a method for accessing the epidural space of a subject. In any one of the above embodiments, the method may include (a) connecting a needle to an apparatus, wherein the needle includes a needle tip, a needle lumen, and a needle hub, and the apparatus includes: (i) a syringe barrel extending from a proximal end to a distal end, wherein the distal end of the syringe barrel includes a needle seat configured to be connected to a needle, and wherein the needle seat includes a passage configured to be in fluid communication with the needle lumen; and (ii) a gasket seal, wherein the gasket seal and an inner wall of the syringe barrel form a fluid-tight seal, wherein the gasket seal is adjacent to the distal end of the syringe barrel, and wherein the gasket seal includes a through hole along an axis of the syringe barrel, and wherein the through hole is (iii) a push shaft extending from a proximal end to a distal end, the push shaft including a central passage having a distal end that aligns with a through-hole in the gasket seal, and a valve that aligns with the proximal end of the central passage, (iv) a spring, the distal end of the spring aligning with a portion of the push shaft and the proximal end of the spring aligning with a structure (e.g., a baffle) within the syringe barrel or within the syringe barrel, the spring configured to be compressed, and (v) a catheter configured to be inserted through the valve and enter the central passage. In any one of the above embodiments, the method may include (b) actuating the push shaft proximally to compress the spring and form a flowable composition lumen containing gas between the gasket seal and the distal end of the syringe barrel. In any one of the above embodiments, the method may include the step of (c) locking the push shaft to maintain the compressed state of the spring and to maintain the position of the gasket seal in the syringe barrel.In any one of the above embodiments, the method may include (d) advancing the needle tip within the subject's body toward a position within the subject's ligamentum flavum when the user does not need to grasp the push shaft to maintain the spring in a compressed state. In any one of the above embodiments, the method may include (e) unlocking the push shaft when the needle tip is within the ligamentum flavum. In any one of the above embodiments, the method may include (f) advancing the needle tip through the ligamentum flavum and entering the subject's epidural space, thereby enabling decompression of the compressed spring and moving the gasket seal distally to connect the central passage and the passage in the needle seat. In any one of the above embodiments, the method may include (g) injecting an anesthetic agent into the needle lumen through a side port of the needle, thereby injecting the anesthetic agent into the subject's epidural space. In any one of the above embodiments, a second needle can be inserted through the side port of the needle to reach the subject's subarachnoid space. In any one of the above embodiments, the second needle can be inserted through the side port of the needle, enter the needle lumen, and then pass through the distal opening of the needle, thereby placing the distal end of the second needle in the subarachnoid space of the subject. In any one of the above embodiments, an anesthetic can be injected into the subarachnoid space through the second needle. In any one of the above embodiments, after the anesthetic is injected, the second needle can be withdrawn from the subarachnoid space. In any one of the above embodiments, the method may include the step of (h) inserting a catheter through the valve, the central passage, the through-hole, the passage, and the needle lumen, thereby placing a distal portion of the catheter in the epidural space. In any one of the above embodiments, the method may include the step of (i) disconnecting the needle from the needle seat to remove the catheter from the device and retaining the distal portion of the catheter in the epidural space. In any one of the above embodiments, the proximal portion of the catheter may be fixed to the outside of the subject (e.g., on the skin).In any one of the above embodiments, the method may include using the catheter for epidural anesthesia by continuous infusion or intermittent bolus, optionally manually delivered intermittent bolus (MIB) and programmed intermittent bolus (PIB). In any one of the above embodiments, the method may include using the catheter for intraoperative epidural anesthesia and / or postoperative analgesia.

[0019] In some embodiments, the present specification discloses a multifunctional anesthesia device for use in spinal anesthesia. In some embodiments, the multifunctional anesthesia device for use in spinal anesthesia includes a puncture needle, a first injection member (e.g., an injection member including a syringe, a plunger, a pull rod or push shaft, and / or a check valve), a pressure member (e.g., a pressure member including a spring, a main rod, and / or a pull rod or push shaft), a catheter deployment mechanism (e.g., a catheter deployment mechanism including a gear set, a roller, a clamp, and / or a catheter), a second injection member (e.g., an injection member including an injection needle and / or a fixed base), and a casing / housing. In some embodiments, the material of one or more of the components of the device includes, but is not limited to, a medical-grade polymer material, an aluminum alloy, stainless steel, etc. In some embodiments, the outer surface of the casing or housing may be designed with a pattern or a matte effect for easy gripping during operation. In some embodiments, the device may include one or more transmission members including, for example, gears and rollers. In some embodiments, the catheter can be positioned inside the syringe by any one or more of the transmission members, and in some embodiments, clockwise rotation of the gear can propel the catheter through the injection syringe and puncture needle and into the epidural space.

[0020] In some embodiments, before using the device disclosed herein, the patient is instructed to assume an appropriate position, an appropriate puncture site is selected, the skin at the selected site is sterilized, a sterile drape is placed, and then the puncture site can be locally infiltrated with anesthesia. In some embodiments, during use, the operator can grasp the outer shell and align the epidural needle at the puncture site. In some embodiments, the puncture path is from the skin to the subcutaneous tissue, to the supraspinous ligament, to the interspinous ligament or ligamentum flavum, and into the epidural space. In some embodiments, when the needle punctures the ligamentum flavum, a spring within the device senses a loss of resistance and automatically releases pressure, thereby indicating that the needle has reached the epidural space. In some embodiments, an intrathecal needle can be inserted (e.g., through a side port) to administer intrathecal anesthesia. The intrathecal injection needle can then be withdrawn, and the knob can be rotated (e.g., clockwise) to advance the catheter through the puncture needle and into the epidural space to the appropriate length. The operator can then grasp the outer shell / casing / housing and remove the puncture needle, fix the catheter, and the patient can turn over or lie down. Epidural anesthesia can be administered through the catheter, if desired.

[0021] In some embodiments, the devices disclosed herein are integrated devices that integrate a syringe, an anesthetic needle, and an epidural anesthesia catheter into one device, thereby reducing operational steps and saving surgical time. In some embodiments, the devices disclosed herein are configured to implement an automatic pressure release function, such that when the anesthetic needle passes through the ligamentum flavum, the device can sense the loss of thrust resistance and automatically release pressure via a spring, indicating that the needle has been inserted to the appropriate location, thereby reducing the risks associated with human judgment. In some embodiments, the devices disclosed herein are configured to achieve continuous drug delivery, such that continuous and repeated drug administration can be achieved via an epidural anesthesia catheter and a drug delivery pump, thereby achieving postoperative pain relief.

[0022] [Brief description of the drawing] The drawings illustrate some embodiments of the features and advantages of the present disclosure. These embodiments are not intended to limit the scope of the appended claims in any way.

[0023] [Figures 1A-1E] Schematic diagrams of different stages of operating an exemplary medical puncture device, for example, during epidural anesthesia and / or injection into the epidural space 14. [Figure 1F] Steps of operating an exemplary medical puncture device that does not have a contact member (e.g., 1b shown in Figures 1A-1E), of which the distal seal (e.g., 8 shown in Figures 1A-1E) can be in direct contact with tissue.

[0024] [Figures 2A-2G] Schematic diagrams of different stages of operating an exemplary medical puncture device, for example, during epidural anesthesia and / or injection into the epidural space 14. [Figure 2F] Steps for operating an exemplary medical puncture device without a contact member (e.g., 1b shown in Figures 2A-2E), of which the distal seal (e.g., 8 shown in Figures 2A-2E) can be in direct contact with tissue. [Figure 2G] Steps for operating an exemplary medical puncture device, which includes an additional actuating member 2' joined to the floating seal 3 by another spring 4', while the actuating member 2 is joined to the floating seal 3 by a spring 4.

[0025] [FIGS. 3A-3F] Topographical structural views of an exemplary medical puncture device, which includes a floating seal 3, and one or more needle body openings (6b or 6b1, 6b2 and / or 6b3) and a needle distal opening 6a.

[0026] 4A to 4C are partial structural views of an exemplary medical puncture device, which includes a floating seal 3 and a needle body opening 6b.

[0027] [FIGS. 5A-5F] Topographical structural views of an exemplary medical puncture device, which includes floating seals 3a and 3b and one or more needle body openings (6b or 6b1 and / or 6b2).

[0028] FIG. 6 shows a top view of an exemplary medical puncture device, which includes a through angled guiding groove 3 a and a check valve 9 .

[0029] FIG. 7 shows a top view of an exemplary medical puncture device, which includes a through angled guiding groove 3 a and a check valve 9 .

[0030]

[0023] FIG. 8 shows a top view of an exemplary medical lancing device, which includes a non-through angled guiding groove 3a.

[0031] FIG. 9 shows a top view of an exemplary medical puncture device, which includes an angled guide needle hole 6c and a check valve 9.

[0032] FIG. 10 shows a top view of an exemplary medical puncture device, which includes an angled guide needle hole 6c and a needle hole plug 10.

[0033] [Figure 11] A schematic diagram of implanting a catheter 11 into the epidural space 14 using an exemplary medical device assembly including a central guide channel 2c.

[0034] The reference numerals and exemplary corresponding structures in the drawings provided below are for illustrative purposes only and should not be considered limiting.

[0035] 1 - syringe barrel, 1a - axial stopper, 1b - circular contact element, 2 - pressing element, 2c - central guide groove, 3 - floating seal, 3a - angled guide groove, 4 - elastic sheath, 5 - spring, 6 - hollow puncture needle, 6a - needle distal opening, 6b - needle body opening, 6c - angled guide needle hole, 7 - flowable composition lumen, 8 - distal seal, 9 - check valve, 10 - needle hole plug, 11 - catheter, 12 - auxiliary guide needle, 13 - dense tissue (e.g., ligamentum flavum), 14 - potential or obvious tissue void, cavity or vessel (e.g., epidural space).

[0036] 12A-12C show schematic diagrams of different stages of operating an exemplary medical lancing device.

[0037] [Figure 13] An example of epidural injection (e.g., epidural anesthesia) is shown.

[0038] 14A-14B show schematic diagrams of an exemplary injection system, [Fig. 14A] an external view of an exemplary injection system, and [Fig. 14B] an internal view of an exemplary injection system.

[0039]

[0033] FIG. 15 shows a schematic diagram of different stages of operating an exemplary injection system.

[0040] The drawing reference numbers and exemplary corresponding structures provided below are for illustrative purposes only, see, for example, FIGS. 14A-14B and 15, and should not be considered limiting.

[0041] 1 - syringe barrel, 2 - push shaft, 2a - control knob, 3 - floating seal, 5 - spring, 6 - hollow needle structure, 6' - puncture unit (for puncturing the proximal seal), 8a - proximal seal, 11 - catheter, 12a - stabilizing structure, 12b - catheter guide passage, 40 - main housing, 41 - handle, 42 - rotating wheel of catheter insertion unit, 43 - needle guide structure, 44 - side port, 50 - syringe for drug injection.

[0042] [Figures 16A-16B] Schematic diagrams of an exemplary integrated device are shown. [Figure 16A] An external view of an exemplary integrated device is shown. [Figure 16B] An internal view of an exemplary integrated injection system is shown.

[0043]

[0033] FIG. 17 shows a structural diagram of an exemplary integrated device.

[0044] The drawing reference numbers and exemplary corresponding structures provided below are for illustrative purposes only, see, for example, FIGS. 16 and 17, and should not be considered limiting.

[0045] 1 - syringe barrel, 2 - push shaft, 3 - gasket seal, 4 - needle seat, 5 - needle, 6 - needle lumen, 7 - passage, 8 - flowable composition lumen, 9 - through hole, 10 - central passage, 11 - valve, 12 - elastic element, 13 - catheter guide passage, 14 - needle hub, 15 - needle side port, 16 - catheter, 17 - stabilizing structure, 18 - distal tip, 19 - side port, 20 - central chamber, 21 -, 40 - housing, 41 - handle, 42 - rotating wheel of catheter insertion unit, 43 - catheter storage mechanism.

[0046]

[0033] FIG. 18 shows a schematic diagram of different stages of operating an exemplary integrated device.

[0047] [Mode for Carrying Out the Invention] The following is a detailed description of some embodiments of the present disclosure. It should be understood that the specific implementations described herein are intended to illustrate and interpret the embodiments of the present disclosure and should not be considered limiting.

[0048] It should be noted that, unless inconsistent, the embodiments and features of the embodiments of the present disclosure may be combined in any suitable manner.

[0049] In some embodiments, descriptions of positions such as "front," "rear," "forward-facing," "rearward-facing," "distal," and "proximal" are based on the perspective of an operator of the medical lancing device or medical device assembly, i.e., a forward direction is a direction away from and relatively away from the operator when the operator is using the medical lancing device or medical device assembly, and a rearward direction is a direction toward and relatively towards the operator.

[0050] As used herein, the terms "proximal" and "distal" refer to directions closer to and further away from, respectively, an operator (e.g., surgeon, physician, nurse, technician, etc.) inserting a medical device into a patient's body, with the tip (distal end) of the device being inserted into the patient's body first. Thus, for example, the end of a needle (e.g., a microneedle) described herein that is inserted into the patient's body first is the distal end, while the opposite end of the needle (e.g., the end of the medical device that is manipulated by the operator) is the proximal end of the needle.

[0051] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. For example, "one" or "one" means "at least one" or "one or more." Similarly, the term "element" is intended to mean a single element or a combination of elements, and "material" is intended to mean one or more materials or combinations thereof.

[0052] As used herein, the terms "about" or "approximately" refer to a typical error range for the corresponding value, as known to those of ordinary skill in the art. A "about" value or parameter referred to herein includes (and describes) embodiments related to the value or parameter itself. For example, "about" may mean within one or more standard deviations, in accordance with the practice in the relevant art. Alternatively, "about" may refer to a range of up to 20%, up to 10%, up to 5%, or up to 1% of a given value.

[0053] Throughout this disclosure, various aspects are presented in range form. It should be understood that the description in range form is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the disclosure. Accordingly, the description of a range should be considered to specifically disclose all possible subranges and each numerical value within that range. For example, when a range of values ​​is provided, it should be understood that each intermediate value between the upper and lower limits of that range, and any other intermediate value within the stated range, is encompassed within the disclosure. The upper and lower limits of these smaller ranges may independently be included in the smaller range and are also encompassed within the disclosure, limited by any specific exclusion within the stated range. When a stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure. This is true no matter how broad the range.

[0054] The use of ordinal numbers such as "first," "second," "third," etc. in the claims to modify a claim element does not, in itself, imply that the element of one claim has priority over, precedes, or sequences before the element of another claim or the chronological order of acts performing a method, but rather merely serves as a label to distinguish one claim element having a certain name from another element having the same name (but using ordinal numbers) to distinguish between claim elements. Similarly, the use of a), b), etc., or i), ii), etc., does not, in itself, imply any priority, precedence, or order of steps in a claim. Similarly, the use of these terms in the specification does not, in itself, imply any necessary priority, precedence, or order.

[0055] As used herein, the terms "puncture member" and "piercing member" can be used interchangeably and refer to an article, such as a needle or microneedle, configured to puncture a tissue layer and deliver a substance to a target tissue layer.

[0056] As used herein, the terms "drug container" and "drug chamber" can be used interchangeably and refer to an article (e.g., a syringe) configured to contain a volume of a substance (e.g., a drug or medication).

[0057] All publications referred to in this application (including patent documents, scientific articles, and databases) are incorporated by reference in their entirety for all purposes to the same extent as if each individual publication was individually incorporated by reference. To the extent that a definition set forth herein conflicts or is otherwise inconsistent with a definition set forth in a patent, application, published application, or other publication incorporated herein by reference, the definition set forth herein takes precedence over the definition incorporated herein by reference.

[0058] The section headings used herein are for organizational purposes only and should not be construed as limiting the subject matter described.

[0059] I. Overview The medical puncture device and medical device assembly of the present invention can be used to penetrate, dilate, and / or inject a cavity (e.g., the epidural space) and implant drugs, catheters, or other medical devices into the epidural space. Currently, injecting drugs and / or medical devices into the epidural space is widely used for various treatments, such as epidural anesthesia. Currently, epidural anesthesia is achieved by injecting one or more local anesthetics into the epidural space to block the transmission function of several spinal nerves and temporarily paralyze or anesthetize the areas innervated by these spinal nerves, and this method is usually called epidural block anesthesia. To perform epidural block anesthesia, an anesthesiologist must perform a dural puncture. During the dural puncture, the puncture needle passes through the skin, subcutaneous tissue, supraspinous ligament, interspinous ligament, and ligamentum flavum in this order, and then reaches the epidural space. When the tip of the puncture needle reaches the epidural space, the anesthesiologist usually feels a decrease in pressure at the tip of the needle. After feeling this pressure drop, the anesthesiologist then inserts the epidural catheter into the epidural space, withdraws the needle, leaving one side of the catheter in the epidural space, and fixes the catheter, so that the drug can be administered in several doses through the catheter to provide continuous anesthesia. Optionally, continuous anesthesia can also be achieved using an infusion pump connected to the catheter to achieve the desired postoperative pain relief effect.

[0060] In some cases, targeted injection of a therapeutic agent into the epidural space is desirable. However, in this case, particularly when it comes to placing the distal end of the needle at a desired depth, the complex structure of the tissues around and within the epidural space and the difficulty in viewing these complex structures during injection usually pose significant challenges in placing the needle at the target location using known devices and methods. Therefore, during epidural anesthesia, accurately determining whether the distal end of the puncture needle has reached the epidural space is an important issue.

[0061] Conventional anesthesia devices and methods basically rely on the physician's experience and intuition to determine whether the distal end of the puncture needle has entered the epidural space, which is relatively unreliable, requires the physician to have high operating skills, and cannot ensure the accuracy and safety of each puncture site. In addition, current methods are usually complicated, require high material and labor costs, have low efficiency, are prone to anesthesia failure or postoperative complications, and always cause pain to the patient, and may even result in spinal cord or nerve damage in some cases.

[0062] For example, the main device commonly used for epidural anesthesia is a low-resistance syringe. Because the pressure in the epidural space is relatively low, medical professionals can sense the pressure at the distal opening of the low-resistance syringe through the resistance felt during injection, allowing them to determine the location of the distal opening of the puncture needle. When the distal opening of the needle enters the subcutaneous tissue and reaches the dense ligamentous tissue, the dense tissue blocks the needle, causing the medical professional to feel significant pressure and resistance when pushing the push rod distally. When the medical professional feels a sudden drop in pressure or resistance, they can roughly determine that the distal opening of the needle has reached the epidural space. However, to confirm this, the medical professional must pull or push the push rod and check whether any fluid is drawn into the syringe. If such resistance is maintained very low when pulling or pushing the push rod, and no fluid is drawn into the syringe, the distal opening of the needle has reached the desired injection site. If some cerebrospinal fluid is drawn into the syringe, it means that the puncture needle has entered the subarachnoid space and must be repositioned. Because the catheter must be placed in the epidural space after epidural puncture, if the epidural puncture fails or the distal needle opening is not at the correct position or depth, the inserted catheter may enter the subarachnoid space or a blood vessel, which may result in complete spinal block or systemic toxicity, severe hypotension, loss of consciousness, and even respiratory arrest. If appropriate action is not taken promptly, cardiac arrest may occur after the operation. In some cases, the catheter has a long main stroke and is inconvenient to operate. Therefore, the accuracy and safety of injecting drugs into the epidural space using a low-resistance syringe depend heavily on the experience and operating skills of the medical professional and are difficult to control or improve.

[0063] Therefore, to provide an epidural anesthesia device and method that allows precise puncture positioning, simple and quick operation, and a high success rate of anesthesia for epidural anesthesia, has great clinical benefits and practical significance.

[0064] In order to address the problems and shortcomings of the prior art and reduce the surgical risks and operational difficulties of epidural anesthesia, a dedicated epidural anesthesia device has been developed that has an integrated design and integrated structure with a pressure sensor indication function. The pressure sensor element determines the pressure difference between the ligament and the epidural space, thereby accurately locating the epidural needle placement position. The epidural catheter control mechanism allows the built-in catheter to be easily pushed out and enter the epidural space along with the needle. This device has the advantages of automatically and accurately positioning the tip of the epidural needle in the epidural space, simplifying catheter placement, simplifying the operation process, and increasing the success rate and efficiency of the surgery.

[0065] In some embodiments, the epidural anesthesia puncture device disclosed herein includes a puncture needle, a syringe member (syringe, push rod, sealing piston, sealing gasket), an elastic member (spring, sleeve), a knob, a catheter mechanism (holder, flow channel, fixed shaft), a guide rod assembly (guide rod, needle), and an operating handle. In some embodiments, the needle is used to puncture the ligamentum flavum, and clear resistance can be felt. The knob then compresses the spring, pre-pressurizing the liquid / gas in the syringe, causing the sealing piston to move forward, and the liquid / gas in the syringe barrel is released, indicating that the tip of the puncture needle has entered the epidural space. At this point, the operator can stop advancing the needle. When the sealing piston reaches the bottom of the syringe, the guide rod can be advanced, and the needle will puncture the sealing gasket to form a passage. If necessary, the syringe can be connected to a 25 G lumbar puncture needle to anesthetize the subarachnoid space, and then the syringe and lumbar puncture needle can be withdrawn. In some embodiments, the catheter can be delivered forward and the appropriate position can be determined by observing the catheter scale. After the catheter is properly positioned, the operator can release the holder by pressing a button, secure the catheter with one hand, and remove the epidural anesthesia puncture device with the other, easily completing catheter placement. Multiple dose anesthesia or continuous anesthesia can then be administered as clinically required. In some embodiments, the epidural anesthesia puncture device disclosed herein can also be used to administer medication into the intraspinal space during intraspinal anesthesia. In some embodiments, the epidural anesthesia puncture device disclosed herein can also be used to administer medication into the intraspinal space during intraspinal anesthesia. Exemplary devices and steps are shown in FIGS. 14A-14B and 15.

[0066] In order to achieve one or more of the above-mentioned objects, the present disclosure provides a medical puncture device, the medical puncture device including: a syringe barrel including a distal closed end and a proximal open end; an actuation unit (e.g., an elastic movement unit) including an actuation member (e.g., a pushing element) and a floating seal positioned inside the syringe barrel and capable of elastically joining with the actuation member (e.g., the pushing element); a hollow puncture needle attached to the actuation member (e.g., the pushing element) and including a needle distal opening and a needle body opening, the needle body opening being proximal to the floating seal (the needle distal opening is proximal to the floating seal, e.g., the entire length of the needle is proximal to the floating seal, or alternatively, the needle passes through the floating seal, thereby causing the needle distal opening to be distal to the floating seal); and a flowable composition lumen (e.g., for a fluid or gel) formed by the distal closed end of the syringe barrel, the syringe barrel lumen wall (e.g., a portion of the syringe barrel), and the floating seal.

[0067] In some embodiments, the medical puncture device is configured to allow the hollow puncture needle to move forward by pressing an actuation member (e.g., a pressing element). In some embodiments, the hollow puncture needle sequentially punctures the floating seal and the distal closed end of the syringe barrel, thereby connecting with the flowable composition lumen, the needle body opening, and the needle distal opening. In some embodiments, the hollow puncture needle is pre-inserted into the floating seal. For example, the needle distal opening may be within and blocked by the floating seal, and the needle may be advanced through the flowable composition lumen to puncture the distal closed end of the syringe barrel. In some embodiments, the hollow puncture needle is pre-inserted through the floating seal. For example, the needle distal opening may be within the flowable composition lumen while the needle body opening may be proximal to or within the floating seal (e.g., the needle body opening may be blocked by the floating seal, as shown in FIG. 3E), and the needle may then be advanced to puncture the distal closed end of the syringe barrel. In some embodiments, the hollow puncture needle is inserted through the floating seal and into the closed distal end of the syringe barrel, or is inserted through the closed distal end of the syringe barrel. For example, the needle distal opening may be within the distal seal of the closed distal end of the syringe barrel (e.g., the needle distal opening may be blocked by the distal seal) or distal to the distal seal and / or the closed distal end of the syringe barrel, while the needle body opening may be proximal to the floating seal (e.g., 6b1 shown in FIG. 3D ), within the floating seal (e.g., the needle body opening may be blocked by the floating seal, 6b2 shown in FIG. 3D ), or within the flowable composition lumen (e.g., 6b3 shown in FIG. 3D ). The needle may then be advanced through the closed distal end of the syringe barrel, exposing the needle distal opening to puncture tissue.

[0068] Optionally, the medical puncture device includes a state in which the flowable composition lumen, the needle body opening, and the needle distal opening are in fluid communication. For example, in the fluid communication state, the needle body opening may be proximal to the floating seal, while the needle distal opening may be distal to the floating seal and within the flowable composition lumen. In the fluid communication state, the needle and / or the floating seal are movable. For example, the floating seal can move under elastic resilience between the floating seal and an actuation member (e.g., a pressing element), causing the floating seal to seal or block the needle body opening, thereby preventing or stopping the discharge of the flowable composition (e.g., a gel) from the needle body opening and / or the needle distal opening.

[0069] Optionally, when in fluid communication, the floating seal can seal the needle body opening when it moves forward and contacts the distal closed end of the syringe barrel, thereby preventing or stopping the discharge of a flowable composition (e.g., a gel) from the needle body opening and / or the needle distal opening.

[0070] Optionally, an S-shaped stopper (e.g., an axial stopper) may be located within the syringe lumen, distal to the floating seal. In some embodiments, the stopper may be used to limit the forward movement of the floating seal. In some embodiments, the medical puncture device includes a fluid communication state, in which the flowable composition lumen is connected to the needle body opening and the needle distal opening. When the medical puncture device is in fluid communication, the needle body opening may be at the distal end of the stopper (e.g., as shown in FIG. 2D ), and the floating seal can move forward by elastic engagement with an actuation member (e.g., a pushing element).

[0071] Optionally, the medical lancing device includes a manual control element attached to the floating seal and extending outside the syringe barrel.

[0072] Optionally, the medical lancing device includes a pre-lancing state after the hollow lancing needle punctures the distal closed end of the syringe barrel, a superficial tissue lancing state, and a post-lancing fluid communication state. In the pre-puncture state, the superficial tissue puncture state, and the fluid communication state, the length ranges of the hollow puncture needle extending out of the distal closed end of the syringe barrel can correspond to a pre-puncture length range, a superficial tissue puncture length range, and a fluid communication length range, respectively, whereby, when the length of the hollow puncture needle extending out of the distal closed end of the syringe barrel is within the pre-puncture length range, the needle body opening is maintained above the flowable composition lumen (e.g., the needle body opening is proximal to the floating seal and may be within the floating seal), and / or when the length of the hollow puncture needle extending out of the distal closed end of the syringe barrel is within the superficial tissue puncture length range, at least a portion of the needle body opening is connected to the flowable composition lumen, and / or when the length of the hollow puncture needle extending out of the distal closed end of the syringe barrel is within the fluid communication length range, the needle body opening is located within the flowable composition lumen.

[0073] Optionally, the closed distal end of the syringe barrel is formed with an axially extending circular contact element, wherein the difference between the upper and lower limits of the pre-puncture length range is equal to the axial length of the circular contact element.

[0074] Optionally, the elastic moving unit includes an elastic sheath that covers the exterior of the hollow puncture needle. The elastic sheath may seal the needle body opening when the needle body opening is proximal to the floating seal. In some embodiments, when the flowable composition is a gel and the needle body opening is proximal to the floating seal, it may not be necessary to seal the needle body opening.

[0075] Optionally, the medical puncture device includes a catheter guide structure for inserting a catheter into the cavity of the hollow puncture needle (eg, connected to the needle body passage of the needle distal opening and / or the needle body opening).

[0076] Optionally, the catheter guide structure includes an angled guide groove formed in the floating seal and extending at an angle towards the hollow puncture needle.

[0077] Optionally, the angled guide groove is configured to pass through the floating seal in the anterior-posterior direction. In some embodiments, the catheter guide structure further includes a check valve embedded in the angled guide groove and capable of being opened or closed and / or a guide groove plug inserted into the angled guide groove.

[0078] Optionally, the angled guide groove is set in the upper surface of the floating seal and is a non-through groove.

[0079] Optionally, the needle body opening is formed as an angled opening that opens obliquely rearward.

[0080] Optionally, the catheter guide structure includes an angled guide needle hole formed in the body wall of the hollow puncture needle and opening obliquely rearward. In some embodiments, the medical puncture device includes a fluid communication state, in which the flowable composition lumen is connected to the needle body opening and the needle distal opening. In the fluid communication state, the angled guide needle hole is located proximal to the floating seal.

[0081] Optionally, the catheter guide structure further comprises a check valve embedded in the angled guide needle bore and capable of being opened or closed, or a guide channel plug inserted into the angled guide needle bore.

[0082] Optionally, the catheter guide structure includes a puncturable central guide groove formed in a center of a proximal surface of the actuation member (e.g., pushing element). In some embodiments, the needle proximal opening is formed in the hollow puncture needle, and the needle proximal opening is configured to axially align with the central guide groove.

[0083] Optionally, the medical lancing device includes a lancing control module and a fluid storage module that are independently manufactured and formed, wherein the lancing control module includes a first syringe unit, an elastic movement unit and a hollow puncture needle installed inside the first syringe unit, and the fluid storage module includes a second syringe unit, a flowable composition lumen formed inside the barrel of the second syringe unit, and a module encapsulating member removably encapsulated in the proximal end of the second syringe unit, and a detachable connecting structure is formed between the first syringe unit and the second syringe unit.

[0084] In a second aspect, the present disclosure provides a medical device assembly. In some embodiments, the medical device assembly includes a catheter and the medical puncture device includes a catheter guide structure.

[0085] Optionally, the medical device assembly further includes a hollow auxiliary guide needle for use in combination with the catheter guide structure. In some embodiments, when the auxiliary guide needle is connected to the catheter guide structure, a catheter can pass through the needle body passage of the auxiliary guide needle and the catheter guide structure in sequence, and be passed through the needle body passage of the hollow puncture needle.

[0086] In some embodiments, when using the medical puncture device of the present disclosure, a user may first apply pressure to an actuation member (e.g., a pushing element) to drive the hollow puncture needle sequentially through the floating seal and the distal closed end of the syringe barrel. When the needle distal opening of the hollow puncture needle reaches an apparent or potential tissue gap, cavity system, or blood vessel, the needle body opening is positioned within the flowable composition lumen, and the floating seal forms an elastic bond with the actuation member (e.g., a pushing element). In some embodiments, the fluid pressure within the flowable composition lumen may be higher than the pressure within the apparent or potential tissue gap, cavity, or blood vessel.

[0087] In this case, fluid within the flowable composition lumen can flow through the needle body opening and the needle distal opening into an apparent or potential tissue void, cavity, or blood vessel. During the injection process, simply by maintaining the position of the actuating member (e.g., a pushing element), the elastic bond between the floating seal and the actuating member (e.g., a pushing element) allows fluid within the flowable composition lumen to flow into the needle body opening (and then through the needle body passage and out of the needle distal opening), thereby achieving injection, penetration, and / or dilation into an apparent or potential tissue void, cavity, or blood vessel. The medical device assemblies described in the present disclosure also enable implantation of catheters and other medical devices via a medical puncture device (e.g., via the catheter guide structure and needle lumen described herein).

[0088] In some embodiments, before the hollow puncture needle penetrates an obvious or potential tissue void, cavity, or blood vessel, the external pressure on the needle distal opening is higher than the fluid pressure within the flowable composition lumen, preventing fluid from flowing out of the needle distal opening. Therefore, by observing whether the floating seal has moved forward due to its elastic engagement with the actuating member (e.g., a pressing element), it is possible to determine whether the hollow puncture needle has penetrated an obvious or potential tissue void, cavity, or blood vessel, thereby informing the operator of the current penetration depth and ensuring accurate puncture. Because the injection is controlled by changes in the fluid pressure within the flowable composition lumen, the operator does not need to manually apply thrust or force during the injection process, thereby preventing fluctuations in flow rate and achieving stable injection.

[0089] Other features and advantages of the present disclosure are described in the detailed description that follows.

[0090] Several embodiments of the present disclosure will be described with reference to several figures of the drawings.

[0091] II. Systems and Devices In some embodiments, the present specification discloses a multi-function anesthesia device for use in spinal anesthesia, comprising: a puncture needle; a positioning member connected to the puncture needle for detecting when the puncture needle reaches a predetermined position; a pathway triggering member for establishing a pathway for introducing anesthetic fluid after the puncture needle reaches the predetermined position; an insertion and withdrawal member for injecting the anesthetic fluid into the predetermined position; and a catheter insertion device for propelling a catheter through the pathway and into the epidural space (which may also be located at a specific position and be included in a dependent claim), wherein the catheter insertion device, the insertion and withdrawal member, the pathway triggering member, and the positioning member are all located within a housing. In some embodiments, the multi-function anesthesia device for use in spinal anesthesia is characterized in that the catheter introducer is configured to propel the catheter through the introducer pathway and into the epidural space. In some embodiments, the multi-function anesthesia device for use in spinal anesthesia is characterized in that the positioning member includes one or more elastic members, such as springs. In some embodiments, the multi-function anesthesia device for use in intraspinal anesthesia is characterized in that the positioning member is configured to detect when the puncture needle reaches a predetermined position. In some embodiments, the outer shell of the multi-function anesthesia device for use in intraspinal anesthesia is molded as two half shells connected by a grommet.

[0092] In some embodiments, described herein are systems and devices that aid in the insertion of a puncture member (e.g., a needle or microneedle) into the epidural space and / or aid in the injection of a drug into a target ocular tissue. In some embodiments, described herein are systems and devices for controlling the insertion of a puncture member (e.g., a needle) into the epidural space for the delivery of an anesthetic agent and / or the insertion depth of a therapeutic agent. In some embodiments, described herein are systems and devices for introducing an implant into tissue (e.g., an obvious or hidden tissue void, cavity, or vessel). In some embodiments, the devices disclosed herein can also be used to administer drugs into the intraspinal space during intraspinal anesthesia. In some embodiments, the epidural anesthesia puncture device disclosed herein can also be used to administer drugs into the intraspinal space during intraspinal anesthesia.

[0093] In some embodiments, the present disclosure provides a system including a syringe barrel including a proximal end and a distal end, a floating seal within the syringe barrel, and a needle seat proximal to the floating seal (e.g., the needle seat is closer to the operator, while the floating seal is closer to the subject), where the floating seal and the needle seat are configured to resiliently interface with each other. In some embodiments, the system further includes a needle including a needle proximal end that interfaces with the needle seat and a needle distal end. In any embodiment herein, the needle proximal end may be fixed to the needle seat or releasably attached to (e.g., inserted into) the needle seat. In any embodiment herein, the needle may include (i) a needle distal opening, (ii) a needle body opening between the needle proximal end and the needle distal end, and (iii) a needle body passageway connecting the needle distal opening and the needle body opening. In any embodiment herein, the needle body opening may be proximal to the needle distal opening. In any embodiment herein, the needle seat may be configured to propel the needle distally toward the floating seal (e.g., when the needle distal end is proximal to the floating seal), through the floating seal (e.g., when the needle distal end enters or pierces the floating seal) and / or through the distal end of the syringe barrel.

[0094] In some embodiments, the devices disclosed herein include or are configured to be connected to a drug reservoir for containing a drug (e.g., a solution, liquid, suspension, gel, etc.), at least a portion of which may be formed by a syringe barrel.

[0095] Wherein a needle is connected to the distal end of the drug container (e.g., a needle is at the distal end of a syringe, e.g., a needle is at the distal end of a syringe, e.g., US 9,180,047, US 9,539,139, US 9,572,800, US 9,636,253, US 9,636,332, US 9,770,361, US 9,937,075, US 10,555,833 and US Unlike some prior devices, such as those described in US Pat. No. 10,517,756 (which patents are incorporated herein by reference for all purposes), in some embodiments the present disclosure utilizes a needle connected to an actuation member inside the syringe barrel. In some embodiments, at least a portion of the needle disclosed herein is inside the syringe barrel. In some embodiments, prior to use, the needle is neither exposed nor directly attached to the distal end of the syringe barrel.

[0096] In some embodiments, the devices disclosed herein include an energy storage member (e.g., one or more springs) configured to interface the needle seat and the floating seal. In some embodiments, a distal end portion of the energy storage member is configured to be positioned within the syringe barrel and directly or indirectly interface with the floating seal. In some embodiments, the energy storage member is configured to exert a force on the proximal end portion of the floating seal. In some embodiments, when the distal tip of the needle is positioned within an apparent or potential tissue void, cavity, or vessel, the force is sufficient to move the floating seal within the syringe barrel to deliver at least a portion of a substance from the drug container (e.g., the flowable composition lumen) through the needle. Also, when the distal tip of the needle is positioned within tissue adjacent to (e.g., above or below) the apparent or potential tissue void, cavity, or vessel, the force is insufficient to move the floating seal within the syringe barrel. In some embodiments, the apparent or potential tissue void, cavity, or vessel has a first density, and the adjacent tissue has a second density higher than the first density. In some embodiments, an apparent or potential tissue void, cavity, or vessel creates a first backpressure, and adjacent tissue creates a second backpressure that is higher than the first backpressure.

[0097] In some embodiments, devices disclosed herein include an energy storage member (e.g., one or more springs, e.g., spring 5 in FIGS. 1A-1E or 12) configured to apply a force to the floating seal directly (e.g., as shown in FIGS. 1A-1E) or indirectly (e.g., via a piston rod 15, as shown in FIG. 12). In some embodiments, the energy storage member is configured to apply a force to the floating seal between the pressure in the first tissue and the pressure in the non-compact second tissue or the apparent or potential tissue void, cavity, or vessel. In some embodiments, the energy storage member is configured to apply a force that is less than or equal to the pressure in the first tissue but greater than the pressure in the non-compact second tissue or the apparent or potential tissue void, cavity, or vessel. In some embodiments, the energy storage member is configured to apply a force directly or indirectly to the floating seal, and the effect of the force is sufficient to overcome the pressure difference between the pressure at the needle distal opening in the supraspinous / interspinous / ligamentum flavum and the pressure at the needle distal opening in the epidural space. Due to the pressure differential, when the needle distal opening is propelled through the first tissue and begins to penetrate the less dense second tissue, the energy stored in the energy storage member is automatically released (e.g., by the piston rod 15 of FIG. 12) to propel the floating seal, thereby expelling a volume of the flowable composition into the second tissue or into the space between the first and second tissues.

[0098] Unlike some conventional devices in which a needle is connected to a floating seal, in some embodiments, the present disclosure utilizes a needle whose proximal end is connected to an actuation member inside the syringe barrel, where the actuation member is separately located and proximal to the floating seal. In some embodiments, the proximal end of the needle disclosed herein is not connected to the floating seal. In some embodiments, prior to use, the needle may be distal to or pass through the floating seal, but the proximal end of the needle remains distal to the floating seal and is loosely attached to the floating seal.

[0099] In some conventional devices, a drug container (e.g., containing a liquid) is placed between a proximal seal and a distal seal, and the proximal seal and the distal seal can each move within the syringe barrel, as described, for example, in US 2020 / 0069883, which is incorporated herein by reference for all purposes. In these devices, force proximal to the proximal seal is transmitted via the liquid to the distal seal attached to the needle. Considering that liquid is typically incompressible, if an operator uses excessive force or suddenly applies force to the proximal seal (e.g., by a plug connected to the proximal seal), the force is transmitted to the needle. Because liquid is less compressible and cannot cushion the force impact, the needle may be inserted too deeply or too quickly, resulting in damage to the target tissue and / or surrounding tissue (e.g., causing a dural puncture). During injection, the position of the proximal and distal seals can be observed, but when a force is applied that causes the needle to overshoot, it may be too late to stop the needle movement due to poor ability to cushion the impact of the force.

[0100] Conversely, in some embodiments of the present disclosure, the drug container (e.g., the flowable composition lumen) is located between the floating seal and the distal end of the syringe barrel (which does not move relative to the syringe barrel). In some embodiments, the distal end of the syringe barrel includes a distal seal, and the flowable composition lumen is located between the floating seal and the distal seal. In some embodiments, the needle seat is resiliently connected to the floating seal (and thereby to the flowable composition), so the resilient connection can help the operator apply the correct force and cushion the impact of the force. Also, the operator can keep the needle seat stationary relative to the syringe barrel and observe the movement of the floating seal to assess the depth to which the needle has been placed. When fluid communication is established between the flowable composition and an apparent or potential tissue void, cavity, or vessel, and the pressure within the flowable composition is greater than the pressure within the apparent or potential tissue void, cavity, or vessel, the floating seal can move, while the needle and needle seat do not need to move, as the flowable composition enters the tissue. Therefore, precise needle placement and stable injection can be achieved, and the possibility of needle overshoot can be effectively reduced or eliminated.

[0101] In some embodiments of the present disclosure, the medication container (e.g., a syringe configured to contain the flowable composition) may be configured to have an adjustable volume, e.g., a volume between about 0 and about 0.2 mL, e.g., between about 0 and about 0.15 mL, particularly between about 0 and about 0.1 mL, including about 0.025 mL, about 0.05 mL, about 0.075 mL, about 0.1 mL, or any value between the above. The volume of the flowable composition delivered (e.g., by injection) using the devices disclosed herein can be selected depending on the condition of a particular subject and can be adjusted as the condition changes.

[0102] In some embodiments, the devices disclosed herein are provided and / or packaged as an integrated device including components that are joined together. In some embodiments, the devices disclosed herein do not require an operator to assemble one or more of the components prior to use. In some embodiments, the devices disclosed herein include a pre-filled drug reservoir (e.g., a flowable composition lumen) that contains a drug in the form of a flowable composition, e.g., a liquid, solution, suspension, gel, oil, ointment, emulsion, cream, foam, lotion, and / or paste.

[0103] Flowable compositions include liquids (e.g., solutions, suspensions, etc.) or semi-solid compositions (e.g., gels) that are easy to manipulate and can be injected, molded, and / or cast at or near the target tissue site upon solidification at the target tissue site. "Flowable" includes formulations with low viscosity or water-like consistency as well as formulations with high viscosity, e.g., viscoelastic or paste-like materials. In some embodiments, viscoelastic fluids are non-Newtonian fluids formed from viscous and elastic components, e.g., mixtures of solvents and polymeric materials.

[0104] In various embodiments, the flowability of the formulation allows it to conform to irregularities, slits, cracks, and / or voids within a tissue site. For example, in various embodiments, the formulation can be used to fill one or more voids, expand a tissue void (e.g., an apparent tissue void), and / or create a tissue void from a latent tissue void, and optionally expand a created void. In some embodiments, the flowable composition may harden to form a drug reservoir that controls drug release when contacted with an aqueous medium (e.g., bodily fluids, water, etc.).

[0105] In some embodiments, a therapeutic agent (eg, a drug) is added to the flowable composition.

[0106] In some embodiments, one or more components of a system or device disclosed herein are configured to be assembled together. For example, a system or device may include one or more syringe barrels.

[0107] In some embodiments, the system or device may include two or more units, such as a first syringe unit including a first syringe barrel, a needle seat within the first syringe barrel, and a needle including a needle distal end and a needle proximal end mating with the needle seat. In some embodiments, the system or device may include a second syringe unit configured to mate with the distal end of the first syringe unit, the second syringe unit including a second syringe barrel and a floating seal within the second syringe barrel configured to resiliently mate with the needle seat when the first syringe unit mates with the second syringe unit. In some embodiments, the system or device may include a third syringe unit configured to mate with the distal end of the second syringe unit and including a third syringe barrel enclosing a flowable composition, and the needle seat may be configured to urge the needle to position the needle proximal end and / or needle distal end within the flowable composition. In any embodiment herein, the system or device may include one or more syringe units, optionally a fourth syringe unit configured to mate to the distal end of a third syringe unit.

[0108] In some embodiments, the system or device may include a first syringe unit including a first syringe barrel, a needle seat and a floating seal proximal to the floating seal that resiliently mate with each other within the first syringe barrel, and a needle including a needle distal end and a needle proximal end that mates with the needle seat, the needle including: (i) a needle distal opening, (ii) a needle body opening between the needle proximal end and the needle distal end and proximal to the needle distal opening, and (iii) a needle body passageway connecting the needle distal opening and the needle body opening. In some embodiments, the system or device may further include a second syringe unit configured to mate with the distal end of the first syringe unit and including a third syringe barrel that encloses the flowable composition, and the needle seat may be configured to propel the needle to position the needle proximal end and / or the needle distal end within the flowable composition. In any embodiment herein, the device may include one or more syringe units, optionally a third syringe unit configured to mate to the distal end of a second syringe unit.

[0109] In some embodiments, the system or device may include a first syringe unit including a first syringe barrel, a needle seat within the first syringe barrel, and a needle including a needle distal end and a needle proximal end mating with the needle seat, the needle including: (i) a needle distal opening, (ii) a needle body opening between the needle proximal end and the needle distal end and proximal to the needle distal opening, and (iii) a needle body passageway connecting the needle distal opening and the needle body opening. In some embodiments, the system or device may include a second syringe unit configured to mate with the distal end of the first syringe unit, the second syringe unit including a second syringe barrel, a floating seal within the second syringe barrel configured to resiliently mate with the needle seat when the first syringe unit mates with the second syringe unit, and a flowable composition, the needle seat may be configured to urge the needle to position the needle proximal end and / or the needle distal end within the flowable composition. In any embodiment herein, the device may include one or more syringe units, optionally a third syringe unit configured to mate to the distal end of a second syringe unit.

[0110] In some embodiments, the present disclosure provides an injection system or device, the injection system or device including: a syringe barrel including a distal closed end and a proximal open end; an actuation unit (e.g., an elastic movement unit) including an actuation member (e.g., a pushing element) and a floating seal positioned inside the syringe barrel and capable of elastically joining to the actuation member (e.g., the pushing element); a hollow puncture needle attached to the actuation member (e.g., the pushing element) and including a needle distal opening and a needle body opening, the needle body opening being proximal to the floating seal (the needle distal opening is proximal to the floating seal, e.g., the entire length of the needle is proximal to the floating seal, or alternatively, the needle passes through the floating seal, thereby causing the needle distal opening to be distal to the floating seal); and a flowable composition lumen (e.g., for a fluid or gel) formed by the distal closed end of the syringe barrel, the syringe barrel lumen wall (e.g., a portion of the syringe barrel), and the floating seal.

[0111] In some embodiments, the medical puncture device is configured to allow the hollow puncture needle to move forward by pressing an actuation member (e.g., a pressing element). In some embodiments, the hollow puncture needle sequentially punctures the floating seal and the distal closed end of the syringe barrel, thereby connecting with the flowable composition lumen, the needle body opening, and the needle distal opening. In some embodiments, the hollow puncture needle is pre-inserted into the floating seal. For example, the needle distal opening may be within and blocked by the floating seal, and the needle may be advanced through the flowable composition lumen to puncture the distal closed end of the syringe barrel. In some embodiments, the hollow puncture needle is pre-inserted through the floating seal. For example, the needle distal opening may be within the flowable composition lumen while the needle body opening may be proximal to or within the floating seal (e.g., the needle body opening may be blocked by the floating seal, as shown in FIG. 3E), and the needle may then be advanced to puncture the distal closed end of the syringe barrel. In some embodiments, the hollow puncture needle is inserted through the floating seal and into the closed distal end of the syringe barrel, or is inserted through the closed distal end of the syringe barrel. For example, the needle distal opening may be within the distal seal of the closed distal end of the syringe barrel (e.g., the needle distal opening may be blocked by the distal seal) or distal to the distal seal and / or the closed distal end of the syringe barrel, while the needle body opening may be proximal to the floating seal (e.g., 6b1 shown in FIG. 3D ), within the floating seal (e.g., the needle body opening may be blocked by the floating seal, 6b2 shown in FIG. 3D ), or within the flowable composition lumen (e.g., 6b3 shown in FIG. 3D ). The needle may then be advanced through the closed distal end of the syringe barrel, exposing the needle distal opening to puncture tissue.

[0112] Optionally, the medical puncture device includes a state in which the flowable composition lumen, the needle body opening, and the needle distal opening are in fluid communication. For example, in the fluid communication state, the needle body opening may be proximal to the floating seal, while the needle distal opening may be distal to the floating seal and within the flowable composition lumen. In the fluid communication state, the needle and / or the floating seal are movable. For example, the floating seal can move under elastic resilience between the floating seal and an actuation member (e.g., a pressing element), causing the floating seal to seal or block the needle body opening, thereby preventing or stopping the discharge of the flowable composition (e.g., a gel) from the needle body opening and / or the needle distal opening.

[0113] Optionally, when in fluid communication, the floating seal can seal the needle body opening when it moves forward and contacts the distal closed end of the syringe barrel, thereby preventing or stopping the discharge of a flowable composition (e.g., a gel) from the needle body opening and / or the needle distal opening.

[0114] Optionally, a stopper (e.g., an axial stopper) may be located within the syringe lumen, distal to the floating seal. In some embodiments, the stopper may be used to limit the forward movement of the floating seal. In some embodiments, the medical puncture device includes a fluid communication state, in which the flowable composition lumen is connected to the needle body opening and the needle distal opening. When the medical puncture device is in fluid communication, the needle body opening may be at the distal end of the stopper (e.g., as shown in FIG. 2D ), and the floating seal can move forward by elastic engagement with an actuation member (e.g., a pushing element).

[0115] Optionally, the medical lancing device includes a manual control element attached to the floating seal and extending outside the syringe barrel.

[0116] Optionally, the medical lancing device includes a pre-lancing state after the hollow lancing needle punctures the distal closed end of the syringe barrel, a superficial tissue lancing state, and a post-lancing fluid communication state. In the pre-puncture state, the superficial tissue puncture state, and the fluid communication state, the length ranges of the hollow puncture needle extending out of the distal closed end of the syringe barrel can correspond to a pre-puncture length range, a superficial tissue puncture length range, and a fluid communication length range, respectively, whereby, when the length of the hollow puncture needle extending out of the distal closed end of the syringe barrel is within the pre-puncture length range, the needle body opening is maintained above the flowable composition lumen (e.g., the needle body opening is proximal to the floating seal and may be within the floating seal), and / or when the length of the hollow puncture needle extending out of the distal closed end of the syringe barrel is within the superficial tissue puncture length range, at least a portion of the needle body opening is connected to the flowable composition lumen, and / or when the length of the hollow puncture needle extending out of the distal closed end of the syringe barrel is within the fluid communication length range, the needle body opening is located within the flowable composition lumen.

[0117] Optionally, the closed distal end of the syringe barrel is formed with an axially extending circular contact element, wherein the difference between the upper and lower limits of the pre-puncture length range is equal to the axial length of the circular contact element.

[0118] Optionally, the elastic moving unit includes an elastic sheath that covers the exterior of the hollow puncture needle. The elastic sheath may seal the needle body opening when the needle body opening is proximal to the floating seal. In some embodiments, when the flowable composition is a gel and the needle body opening is proximal to the floating seal, it may not be necessary to seal the needle body opening.

[0119] Optionally, the medical puncture device includes a catheter guide structure for penetrating a catheter into a cavity of the hollow puncture needle, e.g., the epidural space (e.g., connected to the needle body passage of the needle distal opening and / or the needle body opening).

[0120] Optionally, the catheter guide structure includes an angled guide groove formed in the floating seal and extending at an angle towards the hollow puncture needle.

[0121] Optionally, the angled guide groove is configured to pass through the floating seal in the anterior-posterior direction. In some embodiments, the catheter guide structure further includes a check valve embedded in the angled guide groove and capable of being opened or closed and / or a guide groove plug inserted into the angled guide groove.

[0122] Optionally, the angled guide groove is set in the upper surface of the floating seal and is a non-through groove.

[0123] Optionally, the needle body opening is formed as an angled opening that opens obliquely rearward.

[0124] Optionally, the catheter guide structure includes an angled guide needle hole formed in the body wall of the hollow puncture needle and opening obliquely rearward. In some embodiments, the medical puncture device includes a fluid communication state, in which the flowable composition lumen is connected to the needle body opening and the needle distal opening. In the fluid communication state, the angled guide needle hole is located proximal to the floating seal.

[0125] Optionally, the catheter guide structure further comprises a check valve embedded in the angled guide needle bore and capable of being opened or closed, or a guide channel plug inserted into the angled guide needle bore.

[0126] Optionally, the catheter guide structure includes a puncturable central guide groove formed in a center of a proximal surface of the actuation member (e.g., pushing element). In some embodiments, the needle proximal opening is formed in the hollow puncture needle, and the needle proximal opening is configured to axially align with the central guide groove.

[0127] Optionally, the medical lancing device includes a lancing control module and a fluid storage module that are independently manufactured and formed, wherein the lancing control module includes a first syringe unit, an elastic movement unit and a hollow puncture needle installed inside the first syringe unit, and the fluid storage module includes a second syringe unit, a flowable composition lumen formed inside the barrel of the second syringe unit, and a module encapsulating member removably encapsulated in the proximal end of the second syringe unit, and a detachable connecting structure is formed between the first syringe unit and the second syringe unit.

[0128] In a second aspect, the present disclosure provides a medical device assembly. In some embodiments, the medical device assembly includes a catheter and the medical puncture device includes a catheter guide structure.

[0129] Optionally, the medical device assembly further includes a hollow auxiliary guide needle for use in combination with the catheter guide structure. In some embodiments, when the auxiliary guide needle is connected to the catheter guide structure, a catheter can pass through the needle body passage of the auxiliary guide needle and the catheter guide structure in sequence, and be inserted into the needle body passage of the hollow puncture needle.

[0130] In some embodiments, when using the medical puncture device of the present disclosure, a user may first apply pressure to an actuation member (e.g., a pushing element) to drive the hollow puncture needle sequentially through the floating seal and the distal closed end of the syringe barrel. When the needle distal opening of the hollow puncture needle reaches an apparent or potential tissue gap, cavity system, or blood vessel (e.g., the epidural space), the needle body opening is positioned within the flowable composition lumen, and the floating seal forms an elastic bond with the actuation member (e.g., a pushing element). In some embodiments, the fluid pressure within the flowable composition lumen may be higher than the pressure within the apparent or potential tissue gap, cavity, or blood vessel.

[0131] In this case, fluid within the flowable composition lumen can flow through the needle body opening and the needle distal opening into an apparent or potential tissue void, cavity, or blood vessel. During the injection process, simply by maintaining the position of the actuating member (e.g., a pushing element), the elastic bond between the floating seal and the actuating member (e.g., a pushing element) allows fluid within the flowable composition lumen to flow into the needle body opening (and then through the needle body passage and out of the needle distal opening), thereby achieving injection, penetration, and / or dilation into an apparent or potential tissue void, cavity, or blood vessel. The medical device assemblies described in the present disclosure also enable implantation of catheters and other medical devices via a medical puncture device (e.g., via the catheter guide structure and needle lumen described herein).

[0132] In some embodiments, before the hollow puncture needle penetrates an obvious or potential tissue void, cavity, or blood vessel, the external pressure on the needle distal opening is higher than the fluid pressure within the flowable composition lumen, preventing fluid from flowing out of the needle distal opening. Therefore, by observing whether the floating seal has moved forward due to its elastic engagement with the actuating member (e.g., a pressing element), it is possible to determine whether the hollow puncture needle has penetrated an obvious or potential tissue void, cavity, or blood vessel, thereby informing the operator of the current penetration depth and ensuring accurate puncture. Because the injection is controlled by changes in the fluid pressure within the flowable composition lumen, the operator does not need to manually apply thrust or force during the injection process, thereby preventing fluctuations in flow rate and achieving stable injection.

[0133] In some embodiments, the present disclosure provides methods for providing epidural injections and / or placing an implant (e.g., a catheter) in the epidural space, the methods comprising using an injection system, the injection system comprising: a syringe barrel, the syringe barrel extending from a proximal end to a distal end; a first hollow needle extending from a proximal end to a distal end including an end opening, the needle distal end being connected to the distal end of the syringe barrel; a floating seal located within the syringe barrel, forming a lumen between the floating seal and the distal end of the syringe barrel, the floating seal including a hollow passage aligned with the first hollow needle; a push shaft having a hollow passageway extending from a proximal end to a distal end, wherein the distal end of the push shaft is proximal to and in contact with the floating seal, and the hollow passageway of the push shaft is aligned with the hollow passageway of the floating seal and the first hollow needle to form a central hollow passageway extending from the proximal end of the push shaft to a distal opening of the first hollow needle; a proximal seal, the proximal seal being at a proximal end of the central hollow passage; an actuation unit including an actuation member and an energy storage member, the actuation unit being resiliently coupled to the push shaft by the energy storage member; Includes.

[0134] In some of the above embodiments, the injection system further includes a second syringe unit (e.g., 50 in FIG. 15 ) including a needle extending from a proximal end to a distal end, wherein the needle distal end of the second syringe can pierce the proximal seal, and the needle of the second syringe unit can be disposed within the central hollow passage. In some embodiments, the injection system further includes a piercing unit (e.g., 6′ in FIGS. 14B and 15 ) capable of piercing the proximal seal (e.g., 8a in FIGS. 14B and 15 ) and enabling the needle of the second syringe unit to be disposed within the central hollow passage. In some embodiments, when the needle of the second syringe is disposed within the central hollow passage, the distal end of the needle of the second syringe unit can be distal to the distal opening of the first hollow needle. In some embodiments, the second syringe unit includes a fluid lumen containing a fluid substance, and when the distal end of the first hollow needle is at the target injection site, the fluid substance can be injected into the epidural space through the needle of the second syringe. In some embodiments, when the injection of the fluid substance is completed, the needle of the second syringe can be withdrawn from the central hollow passage. In some embodiments, the injection system further includes a needle guide structure having a hollow needle guide passage extending from the proximal end to the distal end of the guide structure 43, wherein the distal end of the needle guide passage is connected to and aligned with the proximal end of the central hollow passage. In some embodiments that can be combined with any one of the above embodiments, the needle of the second syringe unit can be inserted into the central hollow passage through the needle guide passage, and the needle guide passage can stabilize the needle of the second syringe unit.

[0135] In some embodiments, an implant (e.g., a catheter) may be placed in the epidural space through the central hollow passage. In some embodiments, the injection system further includes a puncturing unit (e.g., 6' in FIGS. 14B and 15) that can puncture the proximal seal and allow placement of a catheter within the central hollow passage. In some embodiments, the injection system further includes a catheter guide structure (e.g., 12b in FIGS. 14B and 15) having a hollow catheter guide passage extending from a proximal end to a distal end, wherein the distal end of the catheter guide passage is connected to and aligned with the proximal end of the central hollow passage. In some embodiments, when the puncturing unit punctures the proximal seal, a catheter (e.g., 11 in FIGS. 14B and 15) may be placed within the central hollow passage through the catheter guide passage.

[0136] In some embodiments, the guide structure 43 may include a side port 44, such that when the guide structure 43 is advanced distally, the side port aligns with a catheter guide structure (e.g., 12b in Figures 14B and 15) having a hollow passage, and the catheter is inserted through the side port, enters the hollow needle guide passage within the guide structure 43, and further into the central hollow passage within the push shaft 2, into the hollow puncture needle 6, and finally into the epidural space.

[0137] In some embodiments, the injection system further includes a needle stabilization structure (e.g., 12a in FIGS. 14B and 15) connected to the catheter, preferably connected proximally to the catheter, to stabilize the catheter during insertion. In some embodiments, the catheter is manually moved distally during insertion into the central hollow passage. In some embodiments, the injection system further includes a catheter insertion unit (e.g., 42 in FIGS. 14B and 15), and the catheter is moved distally through the catheter insertion unit during insertion into the central hollow passage.

[0138] In some embodiments, the injection syringe further includes both a needle guide structure (e.g., 43 in FIGS. 14B and 15) having a hollow passage for forming a hollow passage with the central hollow passage of the needle of the second syringe, and a catheter guide structure (e.g., 12b in FIGS. 14B and 15) having a hollow passage for forming a hollow passage with the central guide passage of the catheter. In some embodiments, the sidewall of the needle guide structure includes an opening, and an angled hollow catheter guide structure (e.g., 12b in FIGS. 14B and 15) may be connected to the opening, further connected to the needle guide structure, and further connected to the central hollow passage to form a hollow passage for insertion of the catheter. In some embodiments, the needle of the second syringe can puncture the proximal seal and simultaneously open the needle guide passage and the catheter guide passage. In some embodiments, the puncture unit can puncture the proximal seal and simultaneously open the needle guide passage and the catheter guide passage.

[0139] In some embodiments, the present disclosure provides an integrated device, comprising: a) a syringe barrel (e.g., 1 in FIG. 17 ) extending from a proximal end to a distal end, wherein the distal end of the syringe barrel includes a needle seat (e.g., 4 in FIG. 17 ) configured to be connected to a needle (e.g., 5 in FIG. 17 ) having a needle lumen (e.g., 6 in FIG. 17 ), and wherein the needle seat includes a passageway (e.g., 7 in FIG. 17 ) configured to be in fluid communication with the needle lumen; and b) a gasket seal (e.g., 3 in FIG. 17 ) wherein the gasket seal and an inner wall of the syringe barrel form a fluid-impermeable seal, wherein a flowable composition lumen (e.g., 8 in FIG. 17 ) is formed between the gasket seal and the distal end of the syringe barrel, wherein the gasket seal includes a through-hole (e.g., 9 in FIG. 17 ), and wherein a gasket seal configured to align with the through-hole in the needle seat; c) a push shaft (e.g., 2 in FIG. 17 ) extending from a proximal end to a distal end, the distal end of the push shaft joining the gasket seal and including a central passage (e.g., 10 in FIG. 17 ) with a distal end that aligns with the through-hole in the gasket seal, and a valve (e.g., 11 in FIG. 17 ) aligned with the proximal end of the central passage; d) an elastic element (e.g., 12 in FIG. 17 ) configured to actuate the push shaft to move the gasket seal distally; and e) a catheter configured to be inserted through the valve and enter the central passage. In some embodiments, the gasket seal is configured to move distally (e.g., along the axis of the syringe barrel) to connect the central passage with the passage in the needle seat. For example, the central passage of the push shaft may be a tubular structure configured to puncture the gasket seal or pass through a through-hole (in the gasket seal), which may be along the axis of the syringe barrel. In some embodiments, the gasket seal is configured to move distally (e.g., along the axis of the syringe barrel) to abut the central passage and the passage in the needle seat.

[0140] Having an integrated device offers many advantages over assembling a device from individual components: (1) An integrated device ensures that all parts are optimized to work seamlessly together, improving overall reliability, performance, and the user experience. Because the device is designed and manufactured as a single unit, the overall process allows for tighter quality control, thereby reducing the chance of incompatibility or failure between individual components. This also simplifies the regulatory approval process because the integrated device is evaluated as a whole rather than as individual components. (2) An integrated device is also user-friendly and intuitive, making it easier for healthcare providers to train on the device and operate the equipment. Not only does an integrated device eliminate redundancy and inefficiencies that can occur when combining components from different sources, it also creates a less stressful environment in hospitals with fast rhythms and high risks. This makes medical devices more consistent, efficient, and effective, contributing to faster and safer healthcare delivery.

[0141] In some embodiments, the integrated device includes a needle (e.g., 5 in FIG. 17). In some embodiments, the needle is an epidural needle. In some embodiments, the epidural needle can be used to administer an anesthetic or analgesic agent epidurally during labor, delivery, diagnostic procedures, pain management, or other medical situations requiring a dose of medication into the epidural space. In some embodiments, the needle is a Tuohy epidural needle, a Hustead epidural needle, a Crawford epidural needle, or a Weiss epidural needle. These specialized epidural needles are designed for the epidural anesthesia or analgesia process and have specific features intended to improve the ease, safety, and effectiveness of the process. In some embodiments, the needle has a gauge between about 17 G and about 22 G (ISO-9626). In some embodiments, the needle has a gauge between 17 G and 18 G (ISO-9626). In some embodiments, the needle has a gauge between 19 G and 20 G (ISO-9626). "G" represents the gauge and is a measure of the needle's thickness. In accordance with standard ISO-9626, the gauge size of an epidural needle may typically range between 17 G and 22 G. The selection of the gauge size is based on balancing several factors, such as ease of insertion, minimization of complications, flow rate, visibility, patient comfort, and durability. In some embodiments, the needle length is between about 2.5 inches and about 6 inches. In some embodiments, the needle length is between about 3 inches and about 3.5 inches. The length of the epidural needle is designed to effectively reach the epidural space while minimizing the risk of complications. Factors influencing the selection of such needle length may include anatomical considerations, safety margins, maneuverability, or clinical experience. In some embodiments, the needle includes a straight distal tip. In some embodiments, the needle includes a curved distal tip. In some embodiments, the needle includes a distal tip with a blunt bevel. The design of the distal tip of the epidural needle can vary based on the specific medical need, type of procedure, and physician preference. Different tips offer different advantages and limitations. In some embodiments, the needle includes a side port.In some embodiments, the needle side port is configured to allow injection of a flowable composition through the needle lumen (e.g., 6 in FIG. 17). In some embodiments, the needle side port is configured to allow injection of an anesthetic agent through the needle lumen. Based on the above disclosure, one skilled in the art would know how to properly select an appropriate needle (e.g., FIGS. 16 and 17) when operating with an integrated device to maximize efficacy while minimizing complications and risks.

[0142] In some embodiments, the integrated device includes a gasket seal (e.g., 3 in FIG. 17). In some embodiments, the gasket seal is configured to allow a catheter to be advanced distally through the through-hole (e.g., 9 in FIG. 17). In some embodiments, the gasket seal is configured to allow a catheter to be retracted proximally through the through-hole. In some embodiments, the gasket seal is configured to prevent a catheter from being retracted proximally through the through-hole. In some embodiments, the gasket seal is configured to lock a catheter in place through the through-hole, thereby preventing proximal retraction or distal advancement of the catheter. Depending on the specific requirements of the medical procedure being performed, each of these embodiments may be further configured to allow an additional distance, e.g., 0 to about 10 centimeters distally or proximally, for fine adjustment after the catheter is locked in place. In some embodiments, the through-hole (e.g., 9 in FIG. 17) is configured to close when a catheter or central passageway (e.g., 10 in FIG. 17) is not inserted within the gasket seal. In some embodiments, the through-hole is configured to open when a catheter or central passage is not inserted into the gasket seal. In some embodiments, the through-hole is configured to seal when a catheter or central passage is not inserted into the gasket seal. In some embodiments, the through-hole is configured to allow a catheter or central passage to pass through the gasket seal. Each of these configurations satisfies specific clinical scenarios, availability considerations, and safety protocols for maintaining a controlled environment within a body cavity or surgical site. For example, in the case of abnormally high pressures within the epidural space of some patients, the sealing through-hole in the gasket seal can prevent accidental fluid leakage or backflow.

[0143] In some embodiments, the integrated device includes a central passageway (e.g., 10 in FIG. 17 ). In some embodiments, different configurations of the interaction between the central passageway and the through-hole (e.g., 9 in FIG. 17 ) of the gasket seal (e.g., 3 in FIG. 17 ) can meet specific clinical and surgical needs. In some embodiments, the distal end of the central passageway (e.g., 10 in FIG. 17 ) passes through or is adjacent to the through-hole in the gasket seal. In some embodiments, the distal end of the central passageway extends distally beyond the gasket seal. In some embodiments, for example, when a particularly thin and flexible catheter is used with the integrated device, the distal end of the central passageway may extend distally beyond the gasket seal and be positioned within the passageway (e.g., 7 in FIG. 17 ) of the needle seat (e.g., 4 in FIG. 17 ), thereby reducing the likelihood of the catheter becoming pinched at the interface between the needle seat and the central passageway. In some embodiments, a configuration in which the distal end of the central passageway passes completely through the through-hole can increase the convenience of catheter insertion and improve reproducibility. In some embodiments, the distal end of the central passage is flush with the distal end of the through-hole. In some embodiments, the distal end of the central passage is flush with the proximal end of the through-hole. These optional configurations, where the distal end of the central passage (e.g., 10 in FIG. 17) is flush with the proximal or distal end of the through-hole (e.g., 9 in FIG. 17), can significantly reduce the manufacturing costs of the integration device by eliminating a central passage extension from the integration device.

[0144] In some embodiments, the integrated device includes a valve (e.g., 11 in FIG. 17 ) at the proximal end of the central passage (e.g., 10 in FIG. 17 ). In some embodiments, the push shaft (e.g., 2 in FIG. 17 ) further includes a central chamber (e.g., 20 in FIG. 17 ) in fluid communication with the central passage (e.g., 10 in FIG. 17 ). The central chamber is optional, and in some embodiments, the push shaft does not include any chambers or passages other than the central passage configured to accommodate at least a portion of the catheter. In some embodiments, at least a portion of the central chamber is between the valve and the proximal end of the central passage. In some embodiments, the central chamber functions as a buffer space and allows the valve to open during catheter insertion. In some embodiments, the central chamber provides a buffer space distal to the central chamber for the material forming the valve. In some embodiments, the valve is configured to allow unidirectional passage of the catheter. In some embodiments, the valve is configured to allow bidirectional passage of the catheter. In some embodiments, the valve is configured to lock the catheter in place. In some embodiments, the valve is configured to allow further fine catheter movement, e.g., from 0 centimeters to approximately 10 centimeters distally or proximally, after the catheter is locked in place. In some embodiments, the push shaft includes a catheter guide passage (e.g., 13 in FIG. 17). In some embodiments, the valve is at the distal end of the catheter guide passage. In some embodiments, the inner diameter of the catheter guide passage is 20% larger than the outer diameter of the catheter, thereby reducing the resistance of the catheter as it moves through the catheter guide passage. In some embodiments, the valve is aligned with the distal end of the catheter guide passage. In some embodiments, the inner wall of the open valve is flush with the inner wall of the catheter guide passage, thereby preventing the catheter from becoming pinched at the interface as it passes through the valve. In some embodiments, the push shaft includes a side port (e.g., 19 in FIG. 17) configured to allow the catheter to pass through the side port and enter the catheter guide passage.In some embodiments, the side port passage and the catheter guide passage form an obtuse angle, allowing for easy catheter insertion. In some embodiments, the push shaft includes a locking mechanism configured to maintain the position of the gasket seal in the syringe barrel and the compressed or expanded state of the elastic element (e.g., 12 in FIG. 17 ). In some embodiments, the push shaft may be withdrawn proximally, compressing the elastic element in the process. In some embodiments, the locking mechanism allows the push shaft to be maintained in a proximal position, while the elastic element remains compressed. In some embodiments, the push shaft may be withdrawn proximally, while the elastic element remains expanded in the process. In some embodiments, the locking mechanism allows the push shaft to be maintained in a proximal position, while the elastic element remains expanded. In some embodiments, the locking mechanism is activated by rotating the push shaft clockwise or counterclockwise. In some embodiments, the rotation angle for activating the locking mechanism is 90 degrees. In some embodiments, the locking mechanism is deactivated by rotating the push shaft clockwise or counterclockwise. In some embodiments, the locking mechanism is deactivated by a 90-degree rotation. In some embodiments, the proximal position of the push shaft is maintained by activating the locking mechanism. In some embodiments, the proximal position of the push shaft is maintained by high pressure present in the flowable composition lumen (e.g., 12 in FIG. 17 ) without activating the locking mechanism. In some embodiments, the high pressure present in the flowable composition lumen is caused by the distal end of the needle in an anatomical tissue layer (e.g., skin, subcutaneous tissue, supraspinous ligament, interspinous ligament, or ligamentum flavum). In some embodiments, the high pressure present in the flowable composition lumen is reduced when the distal end of the needle enters the epidural space. In some embodiments, the reduced pressure in the flowable composition lumen allows the push shaft (e.g., 2 in FIG. 17 ) or gasket seal (e.g., 3 in FIG. 17 ) to move distally toward the needle seat (e.g., 4 in FIG. 17 ).

[0145] In some embodiments, the integrated device includes an elastic element (e.g., 12 in FIG. 17). The elastic element converts stored potential energy (from its compressed or expanded state) into kinetic energy, thereby providing a means for moving or actuating other components within the device, such as the push shaft (e.g., 2 in FIG. 17) or the gasket seal (e.g., 3 in FIG. 17). In some embodiments, the elastic element includes a spring, rubber band, bungee cord, memory foam, airbag, or a combination thereof. In some embodiments, a distal end of the elastic element is attached to a portion of the push shaft or gasket seal, and a proximal end of the elastic element is attached to a portion of the syringe barrel. In some embodiments, the elastic element is configured to be compressed, and decompressing the compressed elastic element applies a force that actuates the push shaft or gasket seal, moving the gasket seal distally along the axis of the syringe barrel. In some embodiments, a distal end of the elastic element is attached to a portion of the syringe barrel, and a proximal end of the elastic element is attached to a portion of the push shaft or gasket seal. In some embodiments, the elastic element is configured to expand, wherein contraction of the expanded elastic element applies a force that actuates the push shaft or gasket seal, moving the gasket seal distally along the axis of the syringe barrel (e.g., 1 in FIG. 17). In some embodiments, the elastic element is used as a mechanism for generating force or movement within the integrated device, specifically as a mechanism for actuating the push shaft or gasket seal by moving the gasket seal along the axis of the syringe barrel.

[0146] In some embodiments, a catheter (e.g., 16 in FIG. 17) is used with the integrated device. In some embodiments, the catheter has a specified size between about 19 G and about 20 G (ISO-9626). In some embodiments, the outer surface of the catheter is modified with features that indicate the catheter's position relative to the integrated device. In some embodiments, the features include extensions, depressions, protrusions, curves, ridges, grooves, markings, or joints. In some embodiments, the integrated device further includes a housing (e.g., 40 in FIG. 17) that houses at least a portion of the syringe barrel, at least a portion of the push shaft, and at least a portion of the catheter. The housing provides a protective outer shell for the internal components of the integrated device and ensures convenience and comfort for both medical professionals and patients. In some embodiments, the integrated device further includes a catheter storage mechanism (e.g., 43 in FIG. 17) and a catheter actuation mechanism (e.g., 42 in FIG. 17). In some embodiments, at least a portion of the catheter is inserted through a valve (e.g., 11 in FIG. 17). In some embodiments, at least a portion of the catheter is inserted into the central passage (e.g., 10 in FIG. 17 ). In some embodiments, at least a portion of the catheter passes through a through-hole in the gasket seal (e.g., 9 in FIG. 17 ). In some embodiments, at least a portion of the catheter passes through a passage in the needle seat (e.g., 4 in FIG. 17 ). In some embodiments, distal propulsion of the catheter (e.g., 16 in FIG. 17 ) is controlled by a catheter insertion unit (e.g., 42 in FIG. 17 ). In some embodiments, the catheter insertion unit is a pair of gears with the catheter positioned between the two gears. In some embodiments, distal propulsion of the catheter is achieved by moving the gears. In some embodiments, at least a portion of the catheter is inserted into the needle lumen (e.g., 6 in FIG. 17 ). In some embodiments, the catheter includes a distal end configured to form a coil, thereby reducing the risk of the catheter tip migrating away from the insertion site.The integration and interaction of the catheter with other components of the integrated device is customized to ensure smooth, efficient and safe operation, thereby meeting a variety of medical applications and needs.

[0147] In some embodiments, the present disclosure provides an integrated device. In some embodiments, the integrated device includes a syringe barrel (e.g., 1 in FIG. 17 ), a gasket seal (e.g., 3 in FIG. 17 ), a push shaft (e.g., 2 in FIG. 17 ), a spring (e.g., 12 in FIG. 17 ), a catheter (e.g., 16 in FIG. 17 ), and a housing (e.g., 40 in FIG. 17 ). In some embodiments, the syringe barrel extends from a proximal end to a distal end, wherein the distal end of the syringe barrel includes a needle seat connected to a needle having a needle lumen. In some embodiments, the needle seat includes a passageway in fluid communication with the needle lumen. In some embodiments, the gasket seal and an inner wall of the syringe barrel form a fluid-tight seal, wherein the gasket seal is adjacent to the distal end of the syringe barrel. In some embodiments, the gasket seal includes a through-hole aligned with the passageway in the needle seat. In some embodiments, the through-hole is along the axis of the syringe barrel. In some embodiments, the push shaft extends from a proximal end to a distal end, with the distal end of the push shaft mating with the gasket seal. In some embodiments, the push shaft includes a central passage. In some embodiments, the central passage includes a distal end that aligns with the through-hole of the gasket seal and a valve that aligns with the proximal end of the central passage. In some embodiments, the distal end of the spring is mated with a portion of the push shaft, and the proximal end of the spring is mated with a structure (e.g., a baffle) within or on the syringe barrel, with the spring configured to be compressed, and decompression of the compressed spring actuating the push shaft or the gasket seal to move the gasket seal distally along the axis of the syringe barrel. In some embodiments, the catheter is configured to be inserted through the valve and enter the central passage. In some embodiments, the housing contains at least a portion of the syringe barrel, at least a portion of the push shaft, and at least a portion of the catheter.

[0148] In some embodiments, the present disclosure provides an integrated device. In some embodiments, the integrated device includes a syringe barrel (e.g., 1 in FIG. 17 ), a gasket seal (e.g., 3 in FIG. 17 ), a push shaft (e.g., 2 in FIG. 17 ), a spring (e.g., 12 in FIG. 17 ), a catheter (e.g., 16 in FIG. 17 ), and a housing (e.g., 40 in FIG. 17 ). In some embodiments, the syringe barrel extends from a proximal end to a distal end, wherein the distal end of the syringe barrel includes a needle seat connected to a needle having a needle lumen. In some embodiments, the needle seat includes a passageway in fluid communication with the needle lumen. In some embodiments, the gasket seal and an inner wall of the syringe barrel form a fluid-tight seal, wherein a flowable composition lumen is formed between the gasket seal and the distal end of the syringe barrel. In some embodiments, the gasket seal includes a through-hole that aligns with the passageway in the needle seat. In some embodiments, the push shaft extends from a proximal end to a distal end, with the distal end of the push shaft mating with the gasket seal. In some embodiments, the push shaft includes a central passage having a distal end that aligns with the through-hole of the gasket seal, and a valve that aligns with the proximal end of the central passage. In some embodiments, the distal end of the spring mating with a portion of the push shaft, and the proximal end of the spring mating with a structure (e.g., a baffle) within or on the syringe barrel, with the spring being compressed, and decompression of the compressed spring actuating the push shaft or the gasket seal to move the gasket seal distally along the axis of the syringe barrel. In some embodiments, a catheter is configured to be inserted through the valve and enter the central passage. In some embodiments, a housing encloses at least a portion of the syringe barrel, at least a portion of the push shaft, and at least a portion of the catheter. In some embodiments, the flowable composition lumen contains a gas, optionally air. In some embodiments, the flowable composition lumen is free of liquid.

[0149] In some embodiments, the present disclosure provides an integrated device. In some embodiments, the integrated device includes a syringe barrel (e.g., 1 in FIG. 17 ), a gasket seal (e.g., 3 in FIG. 17 ), a push shaft (e.g., 2 in FIG. 17 ), a spring (e.g., 12 in FIG. 17 ), a catheter (e.g., 16 in FIG. 17 ), and a housing (e.g., 40 in FIG. 17 ). In some embodiments, the syringe barrel extends from a proximal end to a distal end, the distal end of the syringe barrel including a needle seat connected to a needle having a needle lumen. In some embodiments, the needle seat includes a passageway in fluid communication with the needle lumen. In some embodiments, the gasket seal and an inner wall of the syringe barrel form a fluid-tight seal. In some embodiments, the gasket seal includes a through-hole that aligns with the passageway in the needle seat. In some embodiments, the through-hole is along the axis of the syringe barrel. In some embodiments, the push shaft extends from a proximal end to a distal end, with the distal end of the push shaft mating with the gasket seal. In some embodiments, the push shaft includes a central passage having a distal end that aligns with the through-hole of the gasket seal, and a valve that aligns with the proximal end of the central passage. In some embodiments, the distal end of the spring is mated with a portion of the push shaft, and the proximal end of the spring is mated with a structure (e.g., a baffle) within the syringe barrel or in the syringe barrel, where the spring is configured to apply force to the push shaft or the gasket seal, causing the gasket seal to be adjacent to the distal end of the syringe barrel and connecting the central passage with the passage in the needle seat. In some embodiments, the catheter is configured to be inserted through the valve and enter the central passage. In some embodiments, the housing contains at least a portion of the syringe barrel, at least a portion of the push shaft, and at least a portion of the catheter.

[0150] In some embodiments, the present disclosure provides an integrated device. In some embodiments, the integrated device includes a syringe barrel (e.g., 1 in FIG. 17 ), a gasket seal (e.g., 3 in FIG. 17 ), a push shaft (e.g., 2 in FIG. 17 ), a spring (e.g., 12 in FIG. 17 ), a catheter (e.g., 16 in FIG. 17 ), and a housing (e.g., 40 in FIG. 17 ). In some embodiments, the syringe barrel extends from a proximal end to a distal end, the distal end of the syringe barrel including a needle seat connected to a needle having a needle lumen. In some embodiments, the needle seat includes a passageway in fluid communication with the needle lumen. In some embodiments, the gasket seal and an inner wall of the syringe barrel form a fluid-tight seal, the gasket seal including a through-hole aligned with the passageway in the needle seat. In some embodiments, the through-hole is along the axis of the syringe barrel. In some embodiments, the push shaft extends from the proximal end to the distal end, with the distal end of the push shaft mating with the gasket seal. In some embodiments, the push shaft includes a central passage having a distal end that aligns with the through-hole of the gasket seal, a valve that aligns with the proximal end of the central passage, and a catheter guide passage. In some embodiments, the valve aligns with the distal end of the catheter guide passage. In some embodiments, the distal end of the spring is mated with a portion of the push shaft, and the proximal end of the spring is mated with a structure within the syringe barrel or a structure (e.g., a baffle) of the syringe barrel, with the spring applying a force to the push shaft or the gasket seal to bring the gasket seal adjacent to the distal end of the syringe barrel and connecting the central passage with the passage in the needle seat. In some embodiments, a portion of the catheter is within the catheter guide passage. In some embodiments, the housing encloses at least a portion of the syringe barrel, at least a portion of the push shaft, and at least a portion of the catheter. In some embodiments, the distal end of the catheter is within the catheter guide passage of the push shaft, in some embodiments, the distal end of the catheter is inserted through the valve of the push shaft, in some embodiments, the distal end of the catheter is within the central passage of the push shaft or the through-hole of the gasket seal.In some embodiments, the distal end of the catheter is within the passageway of the needle seat.In some embodiments, the distal end of the catheter is within the needle lumen of the needle.

[0151] III. Methods for Medical Penetration In some embodiments, the present specification discloses a method of epidural injection, including injecting an anesthetic agent into the epidural space using an injection system described in any embodiment herein. In some embodiments, the present specification discloses a method of placing a catheter into the epidural space using an injection system described in any embodiment herein and injecting an anesthetic agent into the epidural space via the catheter.

[0152] In some embodiments, described herein are methods for medical puncture, for example, in the epidural space or other organs or tissues. In some embodiments, the methods disclosed herein can also be used to administer drugs to the intraspinal space during intraspinal anesthesia. In some embodiments, the epidural anesthesia puncture devices disclosed herein can also be used to administer drugs to the intraspinal space during intraspinal anesthesia.

[0153] In some embodiments, the present disclosure provides a medical puncturing or penetration device including a syringe barrel 1, an actuation unit (e.g., a resilient movement unit for propelling the needle), a hollow puncture needle 6, and a flowable composition lumen 7.

[0154] In some embodiments, the syringe barrel 1 includes a distal closed end and a proximal open end. In some embodiments, the syringe barrel 1 may be designed to have two open ends in the axial direction, and to seal the distal end by attaching a distal seal 8 to the distal opening of the syringe barrel 1. In some embodiments, the distal seal 8 may be made of a material that can be punctured by the hollow puncture needle 6, such as rubber.

[0155] In some embodiments, the actuation unit (e.g., elastic movement unit) includes an actuation member (e.g., a pressing element) 2 and a floating seal 3, wherein the floating seal 3 sealingly interfaces with the inner wall of the syringe barrel and is configured to move axially, e.g., toward the distal end or proximal end of the syringe barrel. In some embodiments, the actuation member (e.g., pressing element) 2 or a portion thereof is located outside the proximal opening of the syringe barrel so that an operator can manually press the actuation member (e.g., pressing element) or a portion thereof. In some embodiments, the floating seal 3 elastically interfaces with the actuation member 2, and when pressure is applied to the actuation member 2, the floating seal 3 can move forward or backward relative to the actuation member (e.g., pressing element). In some embodiments, the floating seal 3 is configured to move toward the distal end of the syringe barrel. In some embodiments, the floating seal 3 is configured to move toward the proximal end of the syringe barrel. In some embodiments, the actuating member (e.g., a pushing element) remains stationary relative to the position of the syringe barrel, and the floating seal 3 is configured to move forward (e.g., in a distal direction) with elastic resilience due to its elastic connection with the actuating member (e.g., a pushing element).

[0156] In some embodiments, the hollow puncture needle 6 is fixedly connected to the actuation member 2. When no pressure is applied to the actuation member 2, the hollow puncture needle 6 is maintained proximal to the floating seal 3 and the two do not contact each other. In some embodiments, the hollow puncture needle 6 itself includes a needle distal opening 6a and a needle body opening 6b. In some embodiments, the hollow puncture needle 6 is connected to the needle distal opening 6a and the needle body opening 6b via a needle cavity or needle body passage of the hollow puncture needle 6.

[0157] In some embodiments, the flowable composition lumen 7 is used to store, for example, medications and other flowable compositions, such as liquids or gels. In some embodiments, the flowable composition lumen 7 is sealed to the closed distal end of the syringe barrel, the lumen wall of the syringe barrel, and the floating seal 3; that is, the flowable composition lumen 7 occupies a distal portion of the syringe barrel lumen. In some embodiments, because the floating seal 3 can move axially, the flowable composition lumen 7 is configured to have a variable volume; therefore, the fluid pressure within the flowable composition lumen 7 can change due to the axial movement of the floating seal 3.

[0158] In some embodiments, use of the medical puncture device disclosed herein involves applying pressure to the actuation member 2 to propel the hollow puncture needle 6 forward in a distal direction, sequentially through the floating seal 3 (e.g., by puncturing the floating seal or by forcing open a pre-existing orifice or slit in the floating seal) and through the closed distal end of the syringe barrel (e.g., by puncturing the closed distal end or by forcing open a pre-existing orifice or slit in the closed distal end). The pre-existing orifice or slit may pass through the floating seal, such as from the proximal surface of the floating seal to the distal surface of the floating seal, thereby providing a through hole in the floating seal. The pre-existing orifice or slit may not pass through the floating seal, and propelling the needle distal end through the floating seal may include propelling the needle through a pre-existing orifice or slit in any suitable combination to puncture a portion of the floating seal. For example, the needle distal end may first be propelled from the proximal surface through a pre-existing orifice or slit and then puncture the floating seal until it is exposed from the distal surface of the floating seal, or vice versa. In some embodiments, the hollow puncture needle 6 penetrates an apparent or potential tissue void, cavity, or blood vessel, thereby disposing the needle distal opening 6a within the apparent or potential tissue void, cavity, or blood vessel. In some embodiments, the needle body opening 6b is positioned within the flowable composition lumen 7, and the floating seal 3 resiliently interfaces with the actuation member 2. In some embodiments, the fluid pressure within the flowable composition lumen 7 is greater than the pressure within the apparent or potential tissue void, cavity, or blood vessel.

[0159] In this case, the flowable composition within the flowable composition lumen 7 can flow through the needle body opening 6b and the needle distal opening 6a and into an apparent or potential tissue void, cavity, or blood vessel. In some embodiments, during the injection process, the user can simply maintain pressure on the actuation member 2, for example, without further increasing the pressure. Due to the elastic bond between the floating seal 3 and the actuation member 2, the flowable composition (e.g., a solution, suspension, or gel) within the flowable composition lumen 7 can enter the needle body opening 6b and pass through the needle body passage, thereby achieving injection, penetration, and / or dilation of an apparent or potential tissue void, cavity, or blood vessel.

[0160] In some embodiments, before hollow puncture needle 6 penetrates an apparent or potential tissue void, cavity, or blood vessel, the external pressure at needle distal opening 6a in tissue that is denser, harder, and / or less deformable than the apparent or potential tissue void, cavity, or blood vessel is greater than the fluid pressure within flowable composition lumen 7. Thus, the flowable composition within flowable composition lumen exits needle distal opening 6a and is unable to enter the surrounding tissue.

[0161] In some embodiments, by observing whether the floating seal 3 moves forward due to the elastic bond when the actuating member 2 remains stationary under pressure, the operator can determine whether the hollow puncture needle 6 has penetrated into an apparent or potential tissue void, cavity, or blood vessel, thereby informing the operator of the current needle depth and / or position of the needle distal opening and ensuring accurate needle placement. In some embodiments, because the injection is controlled by changes in fluid pressure within the flowable composition lumen 7, the injection process does not require the manual application of force transmitted through a relatively rigid medium (e.g., a solid or liquid) to propel the needle tip and accurately position it within an apparent or potential tissue void, cavity, or blood vessel. Conversely, the elastic bond between the actuating member 2 and the floating seal 3 buffers sudden forces applied to the actuating member 2, allowing for more controllable and stable movement of the floating seal. In some embodiments, the use of the devices disclosed herein can prevent or reduce fluctuations in flow rate and achieve stable injection.

[0162] It should be noted that the apparent or potential tissue gaps, spaces, cavities, cavity systems, or blood vessels of the present disclosure may include, but are not limited to, the epidural space, pleural cavity, peritoneal cavity, arteries, veins, joint spaces (e.g., knee joint space), etc. Thus, the medical puncture devices disclosed herein also have the advantage of being highly versatile for use in any suitable apparent or potential tissue gaps, spaces, cavities, cavity systems, or blood vessels. In some embodiments, the medical puncture device can be used for epidural puncture and drug delivery (e.g., epidural anesthesia), pleural puncture and intrapleural drug delivery, peritoneal puncture and intraperitoneal drug delivery, or intra-articular injection. For example, applications include access to the suprachoroidal space (eye), epidural injection (spinal access), access to large vessels (arteries / veins) for insertion of surgical lines (e.g., access to the heart through blood vessels), access to blood vessels for fistula access or catheter insertion, insertion through the heart wall without damaging the inner wall, access to the abdomen (e.g., trocar access for minimally invasive surgery), injection into subcutaneous fat, access into the amniotic sac without damaging the fetus, injection into the patellar sac without damaging the cartilage, injection into the meninges without damaging brain tissue (by drilling a hole in the skull and then using an automatic stop on the meninges), injection between the pericardium and the heart, injection between the fascia and the kidney, injection between a fibrous tissue layer and an implant (e.g., a breast implant), injection into other ocular spaces (e.g., used in deep lamellar keratoplasty (DALK) to separate the epithelial cell layer from the collagen layer), or access into an externally collapsed lung. The system can also be used to deliver gene therapies, including, but not limited to, viral vectors and / or transfected cells. In some embodiments, the flowable composition can include multiple therapeutic agents. By way of non-limiting example, therapeutic agents can include mRNA, CRISPR reagents, RNAi, antibodies, nanoparticles, proteins, peptides, small molecules, aptamers, cells, extracellular vesicles, microRNA, etc.

[0163] In some embodiments, when the hollow puncture needle 6 passes through and punctures the distal closed end of the syringe barrel, the medical puncture device may be in at least three states: a pre-puncture state, a superficial tissue puncture state, and a fluid communication state.

[0164] In some embodiments, the length range of the hollow puncture needle 6 extending from the distal closed end of the syringe barrel in the pre-puncture state is the pre-puncture length range, which is the length range within which the hollow puncture needle 6 has not yet started to puncture a living body or its tissue.

[0165] In some embodiments, a system or device of the present disclosure includes a flowable composition lumen pre-filled with a flowable composition. In some embodiments, prior to use of the system or device, a needle is passed through the floating seal. In some embodiments, prior to use of the system or device, a needle is passed through the floating seal and the distal end of the syringe barrel, e.g., a distal seal sealing the distal end of the syringe barrel.

[0166] In some embodiments, the flowable composition has a relatively high viscosity, such as a gel or paste-like material with a viscosity greater than water-like. The elastic sleeve or sheath 4 shown in the figures of the present disclosure is optional, particularly if the viscosity of the flowable composition is sufficient to prevent the flowable composition from exiting the needle body opening and / or the needle distal opening when these openings are within the flowable composition lumen. For example, as shown in FIG. 3A, the needle may pass through the floating seal such that the needle body opening 6b is proximal to the floating seal while the needle distal opening 6a is within the flowable composition lumen. The viscosity of the composition may prevent the flowable composition from exiting the needle body opening, and the elastic sheath is optional. Alternatively, as shown in FIG. 3B, the needle body opening 6b may be within the flowable composition lumen while the needle distal opening 6a is outside the flowable composition lumen. The viscosity of the composition may prevent the flowable composition from exiting the needle distal opening until the needle distal opening reaches a target tissue, such as an apparent or potential tissue void, cavity, or blood vessel.

[0167] In some embodiments, for example, before or during use of the system or device, the needle distal opening 6a is external to the flowable composition lumen, while the needle body opening 6b may be proximal to the floating seal (e.g., 6b1 as shown in FIG. 3C) or within the floating seal (e.g., 6b2 as shown in FIG. 3C). The viscosity of the composition may prevent the flowable composition from exiting the needle distal opening until the needle distal opening reaches the target tissue, such as an apparent or potential tissue void, cavity, or vessel.

[0168] In some embodiments, for example, before or during use of the system or device, the needle distal opening 6a is within the distal seal of the distal closed end of the syringe barrel (e.g., the needle distal opening is blocked by the distal seal), while the needle body opening 6b is proximal to the floating seal (e.g., 6b1 as shown in FIG. 3D), within the floating seal (e.g., 6b2 as shown in FIG. 3D), or may be within the flowable composition lumen (e.g., 6b3 as shown in FIG. 3D). Egress of the flowable composition from the needle distal opening and the needle body opening can be prevented.

[0169] In some embodiments, for example, before or during use of the system or device, the needle distal opening 6a may be within the flowable composition lumen, while the needle body opening 6b may be within the floating seal (e.g., 6b1 as shown in FIG. 3E) or within the flowable composition lumen (e.g., 6b2 as shown in FIG. 3E), preventing the flowable composition from exiting the needle body opening.

[0170] In some embodiments, for example, before or during use of the system or device, the needle distal opening 6a may be within the floating seal while the needle body opening 6b may be proximal to the floating seal (e.g., 6b, as shown in FIG. 3F), preventing the flowable composition from exiting the needle body opening.

[0171] In some embodiments, in the superficial tissue puncture state, the length range of the hollow puncture needle 6 extending from the closed distal end of the syringe barrel is the superficial tissue puncture length range. Within this range, the distal end of the hollow puncture needle 6 has entered the tissue but has not entered any obvious or potential tissue void, cavity, or blood vessel (e.g., has not penetrated the epidural space 14). In some embodiments, because the superficial tissue is relatively dense, the external pressure at the needle distal opening 6a is higher than the fluid pressure within the flowable composition lumen 7. Therefore, regardless of whether the needle body opening 6b is connected to the flowable composition lumen 7, the flowable composition does not enter the needle body opening 6b and / or leave the needle distal opening 6a.

[0172] In some embodiments, when in fluid communication, hollow puncture needle 6 is in fluid communication over a length extending from the closed distal end of the syringe barrel. Within this range, the distal end of hollow puncture needle 6 penetrates into an apparent or potential tissue void, cavity, or blood vessel. In some embodiments, the device may be designed such that, in fluid communication, the fluid pressure within flowable composition lumen 7 is higher than the pressure inside the apparent or potential tissue void, cavity, or blood vessel. In some embodiments, in fluid communication, needle body opening 6b is positioned inside flowable composition lumen 7, and due to the pressure difference between the inside (e.g., apparent or potential tissue void, cavity, or blood vessel) and the outside (e.g., within flowable composition lumen 7), the flowable composition inside lumen 7 can pass through needle body opening 6b, the needle body passage, and then flow out of needle distal opening 6a into an apparent or potential tissue void, cavity, or blood vessel.

[0173] In some embodiments, the floating seal 3 moves distally due to an elastic engagement with the actuation member 2 (e.g., because the pressure within the flowable composition lumen is higher than the apparent or potential backpressure at the needle distal opening within the tissue void, cavity, or vessel) until the floating seal seals the needle body opening 6b (e.g., as shown in FIGS. 4A-4B). In some embodiments, the axial dimension of the needle body opening is less than or equal to the thickness of the floating seal. In some embodiments, the needle body opening may be completely sealed or blocked by the floating seal, in which case the flowable composition does not leave the needle distal opening 6a and enter the tissue void. In some embodiments, when the floating seal blocks the needle body opening, only a portion of the total volume of the flowable composition is away from the needle distal opening 6a (e.g., as shown in FIG. 4A). In some embodiments, when the floating seal blocks the needle body opening, the total volume of the flowable composition within the lumen is away from the needle distal opening 6a (e.g., as shown in FIG. 4B).

[0174] In some embodiments, the flowable composition occludes the existing needle distal opening 6a (e.g., shown in FIG. 4C ) when the needle body opening is within the distal seal or within the target tissue. In some embodiments, the distance between the needle distal opening 6a and the needle body opening 6b may be maintained constant. In some embodiments, the distance between the needle distal opening 6a and the needle body opening 6b may be varied. For example, a needle having an appropriate distance between the needle distal opening 6a and the needle body opening 6b can be selected based on a known or estimated depth of the tissue to be penetrated. In some embodiments, a stopper 1a is positioned inside the syringe lumen and can be used to limit the forward movement of the floating seal 3 to achieve a precise injection, e.g., a predetermined volume.

[0175] In some embodiments, once the floating seal 3 contacts the stopper 1a, further distal movement of the floating seal is restricted, thereby stabilizing the floating seal 3 for subsequent manipulation.

[0176] In some embodiments, a system or device disclosed herein includes two or more floating seals. For example, as shown in FIG. 5A, a first lumen is formed between floating seal 3b and the distal seal of the syringe barrel, and a second lumen is formed between floating seal 3a and floating seal 3b. In some embodiments, the first lumen and the second lumen contain the same flowable material. In some embodiments, the first lumen and the second lumen contain different flowable compositions. In some embodiments, the first lumen and the second lumen contain the same drug (e.g., active drug component) in the same or different flowable carrier or excipient. In some embodiments, the first lumen and the second lumen contain different drugs (e.g., active drug components) in the same or different flowable carrier or excipient. In some embodiments, the first lumen contains the drug and the second lumen contains a pharmaceutically acceptable carrier or excipient, such as saline, or vice versa.

[0177] In some embodiments, the flowable compositions in the first and second lumens can be delivered sequentially to an apparent or potential tissue void, cavity, or vessel. In some embodiments, the flowable compositions in the first and second lumens can mix within an apparent or potential tissue void, cavity, or vessel. In some embodiments, the flowable composition in the first lumen enters an apparent or potential tissue void, cavity, or vessel to enter and / or expand into the tissue void, cavity, or vessel. The flowable composition in the second lumen, including the drug, can then enter the apparent or potential tissue void, cavity, or vessel. For example, as shown in FIG. 5A , when the needle distal opening 6a is within an apparent or potential tissue void, cavity, or vessel while the needle body opening 6b is within the first lumen (between the floating seal 3b and the distal seal of the syringe barrel), the flowable composition in the first lumen is delivered to the tissue. In Figure 5B, when floating seal 3b moves distally and needle body opening 6b contacts the second lumen (between floating seal 3a and floating seal 3b), needle distal opening 6a may remain stationary within an apparent or potential tissue void, cavity, or vessel. In this manner, as shown in Figure 5C, the flowable composition within the second lumen begins delivery to tissue until a certain volume is delivered and / or floating seal 3a (or floating seals 3a and 3b together) blocks needle body opening 6b. In some embodiments, a set (e.g., predetermined) volume of flowable composition within the first lumen and / or a set (e.g., predetermined) volume of flowable composition within the second lumen can be delivered to an apparent or potential tissue void, cavity, or vessel. In some embodiments, the dimension of the needle body opening 6b along the needle axis is greater than the thickness of the floating seal 3b, thereby allowing the first flowable composition (between the floating seal 3b and the distal seal of the syringe barrel) and the second flowable composition (between the floating seal 3b and the floating seal 3a) to be delivered sequentially and continuously through the needle distal opening into an apparent or potential tissue void, cavity or vessel.In some embodiments, the dimension of needle body opening 6b along the needle axis is less than or equal to the combined thickness of floating seal 3a and floating seal 3b. In some embodiments, the dimension of needle body opening 6b along the needle axis is greater than the thickness of floating seal 3b and less than the combined thickness of floating seal 3a and floating seal 3b. In some embodiments, a system or device disclosed herein includes one or more additional floating seals (e.g., a third floating seal 3c) proximal to floating seal 3a, distal to floating seal 3b, and / or between floating seals 3a and 3b, such that a third flowable composition can be delivered before the first flowable composition, after the second flowable composition, or between the first and second flowable compositions.

[0178] In some embodiments, the systems or devices disclosed herein include two or more needle body openings. In some embodiments, the systems or devices disclosed herein include two or more needle body openings and two or more floating seals. For example, as shown in FIG. 5D, if needle distal opening 6a is within an apparent or potential tissue void, cavity, or vessel, while needle body opening 6b1 is within a first lumen (between floating seal 3b and the distal seal of the syringe barrel) and needle body opening 6b2 is blocked by floating seal 3b, the flowable composition in the first lumen is delivered to the tissue. In FIG. 5E, when floating seal 3b moves distally to block needle body opening 6b1, needle distal opening 6a may remain stationary within an apparent or potential tissue void, cavity, or vessel, thereby allowing needle body opening 6b2 to contact a second lumen (between floating seal 3a and floating seal 3b). In this manner, as shown in FIG. 5F , the flowable composition in the second lumen begins to be delivered to tissue until a certain volume is delivered and / or floating seal 3a (or floating seal 3a and floating seal 3b together) blocks needle body opening 6b2 (and / or needle body opening 6b1). In some embodiments, a set (e.g., predetermined) volume of the flowable composition in the first lumen and / or a set (e.g., predetermined) volume of the flowable composition in the second lumen can be delivered to an apparent or potential tissue void, cavity, or vessel. In some embodiments, the distance along the needle axis between needle body opening 6b1 and needle body opening 6b2 is greater than the thickness of floating seal 3b, thereby allowing the first flowable composition (between floating seal 3b and the distal seal of the syringe barrel) and the second flowable composition (between floating seal 3b and floating seal 3a) to be sequentially and continuously delivered through the needle distal opening to an apparent or potential tissue void, cavity, or vessel. In some embodiments, the distance along the needle axis between needle body opening 6b1 and needle body opening 6b2 is equal to or less than the combined thickness of floating seal 3a and floating seal 3b.In some embodiments, the distance along the needle axis between needle body opening 6b1 and needle body opening 6b2 is greater than the thickness of floating seal 3b and less than or equal to the combined thickness of floating seal 3a and floating seal 3b. In some embodiments, a system or device disclosed herein includes one or more additional needle body openings (e.g., a third needle body opening, 6b3) that are proximal to needle body opening 6b2, distal to needle body opening 6b1, and / or between needle body openings 6b1 and 6b2, so that a third flowable composition can be delivered before the first flowable composition, after the second flowable composition, or between the first and second flowable compositions.

[0179] Described below are several embodiments for controlling the termination of an injection process using the medical lancing devices disclosed herein.

[0180] In some embodiments, when the medical puncture device is in fluid communication, the floating seal 3 moves forward due to its elastic engagement with the actuation member 2 until it seals the needle body opening 6b. Once the needle body opening 6b is sealed, the injection process stops. In some embodiments, the axial position of the needle body opening 6b within the flowable composition lumen 7 limits the maximum injection volume of the medical puncture device. In some embodiments, when the needle body opening 6b is blocked or sealed by the floating seal 3, the floating seal 3 is not in contact with the wall of the distal closed end of the syringe barrel. In some embodiments, the flowable composition lumen 7 is not completely emptied, and there is still flowable composition between the floating seal 3 and the wall of the distal closed end of the syringe barrel.

[0181] In some embodiments, when it is necessary to evacuate the flowable composition lumen 7, the floating seal 3 may be designed to seal the needle body opening 6b when the floating seal contacts the distal closed end of the syringe barrel. In some embodiments, the needle body opening 6b is at the distal end of the flowable composition lumen 7. In some embodiments, the floating seal 3 contacts the wall at the distal closed end of the syringe barrel, and the needle body opening 6b is blocked or sealed by the floating seal 3 and / or the wall at the distal closed end of the syringe barrel. In some embodiments, the flowable composition lumen 7 is evacuated, and there is little or no flowable composition between the floating seal 3 and the wall at the distal closed end of the syringe barrel.

[0182] In some embodiments, as the flowable composition within flowable composition lumen 7 gradually enters a tissue void, cavity, or vessel, whether apparent or potential, a condition may exist where the fluid pressure within flowable composition lumen 7 reaches equilibrium with the pressure within the tissue void, cavity, or vessel. In this case, floating seal 3 does not move any further due to the force equilibrium. To continue injecting and / or emptying flowable composition lumen 7 requires additional force on floating seal 3, thereby moving it forward of the distal closed end of the syringe barrel.

[0183] For example, as shown in FIGS. 2A-2E , one, two, or more axially extending sliding grooves (not shown) may be provided in the body wall of the syringe barrel 1. A sliding member matching the sliding groove may be provided in the actuating member 2 (e.g., the sliding member may include a portion of the actuating member 2 extending outside the syringe barrel 1), thereby increasing the upper limit of the travel distance or stroke of the actuating member 2 because movement is not limited by the proximal end of the actuating member 2. When the floating seal 3 is prevented from moving any further by a force balance (e.g., between the pressure inside the flowable composition lumen 7 and the pressure inside an apparent or potential tissue void, cavity, or vessel), a greater pressure can be applied to the sliding member of the actuating member 2 to drive the actuating member 2 forward and distally, thereby increasing the elastic resilience between the floating seal 3 and the actuating member 2 and thereby disrupting the force balance and moving the floating seal 3 forward toward the distal end of the syringe barrel. In this manner, more flowable composition may be expelled from flowable composition lumen 7, and in some embodiments, flowable composition lumen 7 may be emptied.

[0184] In some embodiments, other drive structures can be used to further move the floating seal 3 until it contacts the wall of the distal closed end of the syringe barrel. Exemplary drive structures are described below.

[0185] In some embodiments, an axially extending sliding groove may be located on the outer peripheral wall of the syringe barrel 1, proximal to the floating seal 3. In some embodiments, the manual control portion may include an actuating member 2' (which may be in the form of a sliding member) that slidably matches with the sliding groove on the outer peripheral wall of the syringe barrel. In some embodiments, a portion of the actuating member (e.g., sliding member) 2' extends through the sliding groove to the outside of the syringe barrel to facilitate user operation. In some embodiments, the floating seal 3 and the actuating member (e.g., sliding member) 2' form an elastic connection. For example, the floating seal 3 and the actuating member (e.g., sliding member) 2' may be joined to each other by an elastic member (e.g., spring) 4', as shown in step 1 of FIG. 2G. In some embodiments, the actuating member 2 may include a rod configured to be inserted through a space between portions of the actuating member 2' without the actuating members 2 and 2' interfering with each other. In some embodiments, the resilient member (e.g., spring) 4 and the resilient member (e.g., spring) 4' can function independently without interfering with each other. In some embodiments, the spring 4 may be smaller than the spring 4', e.g., the average diameter of the spring 4 may be smaller than the average diameter of the spring 4'. In some embodiments, the resilient member 4' is nested within the resilient member 4. In step 2 of FIG. 2G, a force can be applied to the actuating member 2 to move the needle distally while simultaneously maintaining the position of the floating seal 3. In some embodiments, as shown in step 3 of FIG. 2G, a force can be applied to the actuating member 2' to move the actuating member distally along the axial direction of the sliding groove in the outer circumferential wall of the syringe barrel. In this manner, the resilient member (e.g., spring) 4' between the floating seal 3 and the actuating member (e.g., sliding member) 2' can be resiliently compressed.In some embodiments, if the position of the actuating member (e.g., sliding member) 2' is maintained, the elastic force can cause the floating seal 3 to disrupt the force balance and continue to move distally until the volume of the expelled flowable composition reaches the target volume. In some embodiments, the actuating member (e.g., sliding member) 2' can move distally as shown in step 4 of FIG. 2G, thereby further moving the floating seal 3 distally to expel the flowable composition from the needle.

[0186] In some embodiments, the medical puncture device includes an element configured to allow an operator to manually control the movement of the floating seal with one or both hands. In some embodiments, the manual control element can be moved using one or more fingers (e.g., one finger on the same hand that grips the syringe barrel). In some embodiments, the manual control element is fixed to the floating seal 3 and extends partially outside the syringe barrel. In some embodiments, if the volume of the flowable composition injected into an apparent or potential tissue void, cavity, or blood vessel has not reached the target volume and the floating seal 3 is prevented from further movement by force balance, the operator can drive further movement of the floating seal 3 forward by moving that portion of the manual control element that extends outside the syringe barrel until the volume of the expelled flowable composition reaches the target volume. In some embodiments, the use of the manual control element aids in emptying the flowable composition lumen 7. These embodiments are not limited to cases where the flowable composition lumen 7 needs to be emptied.

[0187] In some embodiments, the medical puncture device can provide precise delivery (e.g., via injection) of a predetermined volume of the flowable composition and / or control of the delivered volume. In some embodiments, the predetermined volume is a preset volume before delivery. In some embodiments, the predetermined volume is one of multiple volumes selectable by the operator during delivery, and the delivered volume may be different from the preset volume. In some embodiments, as shown in FIGS. 1A-1F, 2A-2F, and 11, an axial stopper 1a is disposed inside the syringe lumen and distal to the floating seal 3 and is used to limit the forward movement of the floating seal 3. In some embodiments, when the medical puncture device is in fluid communication, the needle body opening 6b may be distal to the axial stopper 1a, and the floating seal 3 may move forward due to its elastic engagement with the actuation member 2.

[0188] In some embodiments, the floating seal 3 moves to a position limited by the axial stop 1 a. In some embodiments, when the floating seal 3 moves to a position limited by the axial stop 1 a, the pressure within the flowable composition lumen 7 is still equal to or greater than the apparent or potential pressure within the tissue void, cavity, or vessel. In some embodiments, the elastic resilience between the floating seal 3 and the actuation member 2 allows the floating seal 3 to be urged forward to the position limited by the axial stop 1 a, and does not require relying on an additional drive structure or force to move the floating seal 3 to the position limited by the axial stop 1 a.

[0189] In some embodiments, due to the elastic resilience between the floating seal 3 and the actuation member 2, the pressure within the flowable composition lumen 7 is equalized to the apparent or potential pressure within the tissue void, cavity, or vessel before the floating seal is moved to the position restricted by the axial stop 1a (i.e., due to force equilibrium, the floating seal 3 does not move any further before reaching the axial stop 1a). In this case, the floating seal 3 cannot be propelled forward to the position restricted by the axial stop 1a solely by the elastic resilience between the floating seal 3 and the actuation member 2. Therefore, in some embodiments, one or more additional drive structures or mechanisms can be used to further propel the floating seal 3 forward. For example, the additional drive structures or mechanisms may include the manual control elements described herein (e.g., shown in Figures 2A-2E). In some embodiments, the axial stop 1a provides a mechanism for achieving a set volume of fluid injection.

[0190] Described below are several embodiments of the lancing and injection timing of the medical lancing device disclosed herein.

[0191] In some embodiments, when the medical puncture device is in a pre-puncture state, i.e., when the length of the hollow puncture needle 6 extending from the distal closed end of the syringe barrel is within a pre-puncture length range (or when the hollow puncture needle 6 has punctured the distal closed end of the syringe barrel but has not yet begun to puncture the living body or its tissue), the needle body opening 6b is maintained above (e.g., proximal to) the flowable composition lumen 7. When positioned in this manner, premature exposure from the needle distal opening 6a can be prevented, and the reliability of the medical puncture device can be improved.

[0192] In some embodiments, a corresponding structure can be provided on the device to prevent premature exposure of the hollow puncture needle 6 before it punctures tissue and / or before the needle distal opening 6a reaches an obvious or potential tissue cavity, cavity, or blood vessel. For example, an axially extending circular contact element 1b may be formed at the distal closed end of the syringe barrel. In some embodiments, the axial length of the circular contact element 1b is set to be equal to the difference between the upper and lower limits of the pre-puncture length range of the hollow puncture needle 6 (i.e., the difference in pre-puncture length between when the hollow puncture needle 6 punctures the distal closed end of the syringe barrel and when the hollow puncture needle begins to puncture the living body or tissue). With this setting, premature exposure of the needle distal opening 6a does not occur as long as the distal end of the hollow puncture needle 6 remains within the axial length range of the circular contact element 1b. When puncturing, the circular contact element 1b may first contact the surface of the living body or tissue to stabilize the medical puncture device. Pressure may then be applied to the actuation member 2 to initiate the puncture operation.

[0193] In some embodiments, when the medical puncture device is in a superficial tissue puncture state, i.e., when the length of the hollow puncture needle 6 extending from the closed distal end of the syringe barrel is within the superficial tissue puncture length range (or when the distal end of the hollow puncture needle 6 has punctured the superficial tissue but has not entered an apparent or potential tissue void, cavity, or blood vessel), at least a portion of the needle body opening 6b is connected to the flowable composition lumen 7. In some embodiments, fluid communication between the flowable composition lumen 7, the needle distal opening 6a, and the needle body opening 6b is established before the distal end of the hollow puncture needle 6 enters an apparent or potential tissue void, cavity, or blood vessel. In some embodiments, the flowable composition in the lumen 7 can pre-enter the needle body passage of the hollow puncture needle 6 (through the needle body opening 6b) to remove at least a portion of the air that may be present in the needle body passage, thereby reducing the amount of air that has entered an apparent or potential tissue void, cavity, or blood vessel.

[0194] In some embodiments, when the distal end of hollow puncture needle 6 begins to penetrate superficial tissue, needle body opening 6b begins to connect to flowable composition lumen 7. In some embodiments, when the distal end of hollow puncture needle 6 penetrates an apparent or potential tissue void, cavity, or blood vessel, the needle body passage of hollow puncture needle 6 is filled with flowable composition, thereby eliminating or reducing the possibility of air entering the apparent or potential tissue void, cavity, or blood vessel.

[0195] In some embodiments, when the medical puncture device is in fluid communication, i.e., when the length of the hollow puncture needle 6 extending from the distal closed end of the syringe barrel is within the fluid communication length range (or when the distal end of the hollow puncture needle 6 has penetrated into an apparent or potential tissue void, cavity or blood vessel), the needle body opening 6b is positioned within the flowable composition lumen 7, achieving maximum flow rate at the needle body opening 6b, thereby improving injection speed.

[0196] The embodiments described herein may be implemented singly or in any suitable combination.

[0197] In some embodiments, the devices disclosed herein can prevent backflow and / or back-flooding of fluids that have passed through the needle body opening 6b.

[0198] In some embodiments, if the needle distal opening 6a is connected to the flowable composition lumen 7 but the needle body opening 6b is still at the proximal end of the floating seal 3, there is a risk of fluid backflow and / or backflow from the needle body opening 6b. In some embodiments, if the needle distal opening 6a is inside an apparent or potential tissue void, cavity, or blood vessel while the needle body opening 6b is still at the proximal end of the floating seal 3, there is a risk of fluid backflow and / or backflow from the needle body opening 6b. In some embodiments, the elastic sheath 4 covering the exterior of the hollow puncture needle 6 may be located within the actuation unit (e.g., elastic movement unit), for example, between the needle seat and the floating seal 3. In some embodiments, when the needle body opening 6b is at the proximal end of the floating seal 3 (e.g., when the needle body opening 6b is not connected to the flowable composition lumen 7), the elastic sheath 4 can maintain the sealing of the needle body opening 6b, thereby effectively avoiding backflow and / or back-overflow of the flowable composition, preventing contamination of the proximal area of ​​the floating seal 3, reducing fluid loss, and improving product reliability.

[0199] In some embodiments, the elastic sheath 4 is not used to seal the needle body opening 6b, but is simply used as an elastic joint between the floating seal 3 and the actuating member 2. In some embodiments, by moving the actuating member 2 forward, the elastic sheath 4 between the floating seal 3 and the actuating member 2 is compressed, thereby forming elastic resilience between the floating seal 3 and the actuating member 2 and thereby driving the floating seal 3 forward. In some embodiments, the elastic joint between the floating seal 3 and the actuating member 2 may include or be a spring 5 attached at two axial ends to the floating seal 3 and the actuating member 2, respectively. The attachment at any one or both ends of the spring may be direct or indirect. The attachment at any one or both ends of the spring may be releasable or non-releasable. The spring, floating seal, and actuating member (e.g., a pressing element) may be manufactured separately and then assembled in any suitable order. Alternatively, any two or more of the spring, the floating seal and the actuating member (e.g., the pressing element) may be integrally formed, e.g., manufactured as one part. The spring 5 and the elastic sheath 4 may be realized alone or in combination.

[0200] In some embodiments, the elastic connection between the floating seal 3 and the actuating member 2 can be achieved by other methods than providing one or more elastic connecting components. For example, the floating seal 3 and the actuating member 2 may be provided as an integral actuating unit (e.g., an elastic moving unit).

[0201] In some embodiments, the present disclosure provides devices and methods for implanting obvious or potential tissue gaps, cavity systems, and blood vessels using the medical puncture devices disclosed herein. For ease of understanding, a catheter is used as an example of an implantable medical device. In some embodiments, the methods disclosed herein include guiding a catheter 11 into a needle body passage of a hollow puncture needle 6 using a catheter guide structure. In some embodiments, the catheter guide structure is located within the medical puncture device disclosed herein.

[0202] In some embodiments, as shown in Figures 6-8, the catheter guide structure includes an angled guide groove 3a disposed within or connected to the floating seal 3 and extending at an angle toward the hollow puncture needle 6. In some embodiments, when the flowable composition lumen 7, the needle body opening 6b, and the needle distal opening 6a are connected, the flowable composition can enter and expand into an obvious or potential tissue void, cavity, or blood vessel. In some embodiments, the catheter 11 can pass through the angled guide groove 3a, the needle body opening 6b, the needle body passage of the hollow puncture needle 6, and the needle distal opening 6a and be implanted into the expanded obvious or potential tissue void, cavity, or blood vessel.

[0203] It should be noted that the angled guide groove 3a may be provided as a groove that penetrates the floating seal 3 in the proximal / distal direction, or may be provided as a non-penetrating groove formed on the proximal surface of the floating seal 3.

[0204] In some embodiments, the angled guide groove 3a is a through groove. In some embodiments, the catheter guide structure further includes a valve 9 disposed within or mated with the angled guide groove 3a, and the valve may be a check valve configured to open or close. In some embodiments, the valve includes multiple leaflets configured to open or close the valve. In some embodiments, in the absence of an external force, the check valve 9 closes and prevents the flowable composition within the flowable composition lumen 7 from leaking through the valve. In some embodiments, in the presence of an opening force, the multiple leaflets of the valve can be forced open, allowing the catheter 11 to penetrate into the needle body opening 6b through the open valve. In some embodiments, the catheter guide structure further includes a guide groove plug configured to be removably inserted into the angled guide groove 3a, and the guide groove plug can be withdrawn when it needs to be implanted into the catheter 11.

[0205] In some embodiments, the angled guide groove 3a is a non-through groove. In some embodiments, the angled guide groove is punctured directly by the implant-ready catheter 11. In some embodiments, the angled guide groove is punctured by a puncturing member other than a catheter, and the catheter 11 can penetrate into the needle body opening 6b through the puncture opening.

[0206] In some embodiments, to match the guide direction of the angled guide groove 3a, the needle body opening 6b may be configured as an angled opening that opens obliquely backward so that the needle body opening 6b aligns with the angled guide groove 3a, thereby accurately guiding the catheter 11 through the angled guide groove and into the needle body opening.

[0207] 9 and 10, the catheter guide structure includes an angled guide needle bore 6c formed or disposed in the body wall of the hollow puncture needle 6 and opening obliquely backward. In some embodiments, for example, when a medical puncture device is in fluid communication, the angled guide needle bore 6c is maintained proximal to the floating seal 3. In some embodiments, the catheter 11 can pass through the angled guide needle bore 6c and penetrate into the needle body passage of the hollow puncture needle 6. In some embodiments, the catheter 11 can be implanted into an apparent or potential tissue void, cavity, or blood vessel (or an apparent or potential tissue void, cavity, or blood vessel dilated with the flowable composition) through the needle distal opening 6a.

[0208] In some embodiments, the catheter guide structure may further include a valve 9 disposed within or interfaced with the angled guide needle bore 6c, and the valve may be a check valve configured to open or close. In some embodiments, the valve includes multiple leaflets configured to open or close the valve. In some embodiments, in the absence of an external force, the check valve 9 closes and prevents the flowable composition within the flowable composition lumen 7 from leaking through the valve. In some embodiments, in the presence of an opening force, the multiple leaflets of the valve can be forced open, allowing the catheter 11 to penetrate through the open valve and the angled guide needle bore 6c into the needle body passage (which may be connected to or separated from the needle body passage connecting the needle body opening 6b and the needle distal opening 6a). In some embodiments, the catheter guide structure may further include a needle bore plug 10 configured to be removably inserted into the angled guide needle bore 6c, and the needle bore plug 10 can be withdrawn to initiate implantation of the catheter 11. In some embodiments, the guide needle hole 6c is connected to the needle distal opening 6a. The needle body passage connecting the needle distal opening 6a and the needle body opening 6b may be the same as or separate from the needle body passage connecting the needle distal opening 6a and the guide needle hole 6c. In some embodiments, the guide needle hole 6c is connected to a needle distal opening other than the needle distal opening 6a connected to the needle body opening 6b. The needle body passage connecting the needle body opening 6b to the needle distal end may be completely separate from the needle body passage connecting the guide needle hole 6c to the needle distal end. The needle body passage connecting the needle body opening 6b to the needle distal end may overlap or be in fluid communication with at least a portion of the needle body passage connecting the guide needle hole 6c to the needle distal end.

[0209] In some embodiments, as shown in FIG. 11 , for example, the catheter guide structure includes a central guide groove 2c formed or located on the proximal surface of the actuating member 2. In some embodiments, the central guide groove 2c may include an orifice, or an orifice may be formed in the center of the proximal surface of the actuating member 2. In some embodiments, the central guide groove 2c can be punctured to provide the orifice. In some embodiments, the needle proximal opening is located on the hollow puncture needle 6 and is aligned with the central guide groove 2c along its axis. In some embodiments, when implantation of the catheter 11 is required, the central guide groove 2c can be punctured, and the catheter 11 can penetrate through the puncture opening of the central guide groove 2c and the needle proximal opening of the hollow puncture needle 6 into the needle body passage (which may be connected to or separate from the needle body passage connecting the needle body opening 6b and the needle distal opening 6a). In some embodiments, the catheter 11 can be implanted into an apparent or potential tissue void, cavity, or vessel (or an apparent or potential tissue void, cavity, or vessel dilated with the flowable composition) through a needle distal opening (e.g., needle distal opening 6a or another needle distal opening).

[0210] In some embodiments, the present specification discloses a kit that includes components configured to be assembled to form the medical lancing device disclosed herein.

[0211] In some embodiments, a kit for assembling a medical lancing device includes a lancing control module and a flowable composition storage module (e.g., a fluid storage module). In some embodiments, the lancing control module and the flowable composition storage module are manufactured and / or provided independently. In some embodiments, the lancing control module includes a first syringe unit, an actuation unit (e.g., an elastic movement unit) and a hollow puncture needle 6 disposed inside the syringe barrel of the first syringe unit. As can be seen based on embodiments disclosed herein, the lancing control module may further include other components or members, such as an elastic sheath 4 and a spring 5. In some embodiments, the fluid storage module includes a second syringe unit, a flowable composition lumen 7 formed inside the syringe barrel of the second syringe unit, and a module enclosure member removably disposed at the proximal end of the second syringe unit. In some embodiments, a detachable connection structure is formed between the first syringe unit and the second syringe unit. In some embodiments, the first syringe unit and the second syringe unit, after being connected to each other, form a syringe barrel 1. As can be seen based on the embodiments disclosed herein, the fluid storage module may further include other components, such as a distal seal 8.

[0212] In some embodiments, the puncture control module and the fluid storage module may be manufactured, assembled, and / or encapsulated separately and then assembled together, and optionally with other modules, members, and / or components, into the medical lancing device disclosed herein. In some embodiments, the module encapsulation member is used to seal the proximal end of the flowable composition lumen 7. In some embodiments, the module encapsulation member may be removed when assembling the puncture control module and the fluid storage module.

[0213] In some embodiments, the present disclosure provides a medical device assembly and a system including the medical device assembly. As shown in Figures 7 and 11, in some embodiments, the medical device assembly includes a catheter 11 and a medical puncture device including a catheter guide structure disclosed herein. In some embodiments, the catheter 11 can be implanted into an apparent or potential tissue void, cavity, or vessel by the medical puncture device. The medical device assemblies described herein can have all the technical effects provided by the medical puncture device.

[0214] In some embodiments, the medical device assembly includes a hollow auxiliary guide needle 12 matched for use with the catheter guide structure. In some embodiments, the needle body passage of the auxiliary guide needle 12 has a diameter large enough to accommodate the catheter 11 and allow penetration of the catheter. In some embodiments, during the catheter 11 implantation operation, the auxiliary guide needle 12 is connected to the catheter guide structure such that the catheter 11 passes through the needle body passage of the auxiliary guide needle 12, the catheter guide structure, the needle body passage of the hollow puncture needle 6, and then enters an apparent or potential tissue void, cavity, or blood vessel through the needle distal opening 6a. In some embodiments, prior to catheter implantation, the medical puncture device disclosed herein is used to dilate the apparent or potential tissue void, cavity, or blood vessel with the flowable composition. In some embodiments, the catheter is implanted while the medical puncture device disclosed herein is used to dilate the apparent or potential tissue void, cavity, or blood vessel with the flowable composition. In some embodiments, a catheter is implanted prior to using the medical puncture device disclosed herein to dilate an apparent or potential tissue void, cavity, or vessel with the flowable composition.

[0215] In some embodiments, as shown in FIG. 7 , the catheter guide structure includes an angled through-guide groove 3 a and a check valve 9, which is embedded in the angled guide groove 3 a and can be opened and closed. In some embodiments, the needle body opening 6 b is configured as an angled opening that opens obliquely backward. In some embodiments, when implanting the catheter 11, the auxiliary guide needle 12 is used to open the check valve 9, thereby positioning the auxiliary guide needle within the angled guide groove 3 a. In some embodiments, the distal end of the auxiliary guide needle 12 is advanced into the needle body opening 6 b, and the catheter 11 is advanced sequentially through the needle body passage of the auxiliary guide needle 12, the needle body passage of the hollow puncture needle 6, and the needle distal opening 6 a, and then implanted into an apparent or potential tissue void, cavity, or blood vessel.

[0216] 11 , the catheter guide structure includes a central guide groove 2c. In some embodiments, a needle proximal opening is formed in the hollow puncture needle 6 that is aligned with the central guide groove 2c along its axis. In some embodiments, when implanting the catheter 11, the central guide groove 2c may be pierced by the auxiliary guide needle 12 so that the auxiliary guide needle 12 is aligned axially with the proximal opening of the hollow puncture needle 6. In some embodiments, the catheter 11 is advanced through the needle body passage of the auxiliary guide needle 12 and the proximal opening of the hollow puncture needle 6 in sequence, thereby penetrating the needle body passage of the hollow puncture needle 6 and then implanting it through the needle distal opening (e.g., needle distal opening 6a) into an apparent or potential tissue void, cavity, or blood vessel.

[0217] In some embodiments, the push shaft includes a threaded portion configured to threadably mate with the control knob. For example, the control knob may include an internal helical thread configured to mate with the threaded portion of the push shaft. In some embodiments, the control knob can rotate along a central axis and be joined by a thread, and rotation of the control knob can drive translation of the push shaft in the axial direction. In some embodiments, the push shaft moves along a helical path having a rotational component and an axial translational component relative to the housing (or outer shell). In some embodiments, translation of the push shaft can be distal (e.g., toward the epidural space of the subject) or proximal (e.g., toward the operator) based on whether the control knob is rotated clockwise or counterclockwise. In some examples, clockwise rotation of the control knob advances the push shaft distally, and counterclockwise rotation of the control knob retracts the push shaft proximally. In another example, counterclockwise rotation of the control knob advances the pusher shaft distally, and clockwise rotation of the control knob retracts the pusher shaft proximally.

[0218] In some embodiments, the push shaft is connected to the syringe needle such that movement of the push shaft in the axial direction causes and / or achieves movement of the syringe needle. In some embodiments, the push shaft is directly connected to the syringe needle. In some embodiments, the push shaft is indirectly connected to the syringe needle. In some embodiments, the push shaft is elastically connected to the syringe needle. In some embodiments, the push shaft and the syringe needle are elastically joined to each other. In some embodiments, the push shaft is connected to the syringe needle by an elastic connection. In some embodiments, the push shaft is fixedly or detachably connected to the syringe needle. In some embodiments, the push shaft and the syringe needle are fixedly or detachably joined to each other. In some embodiments, the push shaft is connected to the syringe needle by a fixed connection. In some embodiments, the connection between the push shaft and the syringe needle is sufficiently rigid so that the push shaft can drive the advancement or retraction of the syringe needle. In some embodiments, the syringe needle is mounted as part of the push shaft on a needle seat or base that is directly or indirectly connected to the push shaft. In some embodiments, the needle seat or base is elongated in the axial direction and has a cross-sectional area that is smaller than the cross-sectional area of ​​the push shaft that directly abuts an adjacent portion of the needle seat or base. In some embodiments, the needle seat or base is fixedly connected to the push shaft. In some embodiments, the needle seat or base is integral with the push shaft. In some embodiments, the push shaft and the syringe needle are connected by a needle seat or base that is sufficiently rigid at least in the axial direction to allow the push shaft to be moved axially distally or proximally to advance or retract the syringe needle relative to the housing or outer shell.

[0219] In some embodiments, the pushing shaft (e.g., pushing shaft 2 in FIG. 12 ) is connected to the piston rod (e.g., push rod 15 in FIG. 12 ) by an elastic element or elastic member, such as a spring (e.g., spring 5 in FIG. 12 ). In some embodiments, the elastic element or elastic member is directly or indirectly connected to the pushing shaft and / or the needle seat or base or a portion thereof. For example, a portion (e.g., a proximal end) of the elastic element or elastic member may be directly or indirectly joined to the pushing shaft or a portion of the needle seat or base. The elastic element or elastic member may be fixedly or detachably joined to the proximal portion of the needle seat or base. In some embodiments, the elastic element or elastic member is directly or indirectly connected to the piston rod. For example, a portion (e.g., a distal end) of the elastic element or elastic member may be directly or indirectly joined to a portion (e.g., a proximal end) of the piston rod. In some embodiments, the elastic element or elastic member is fixedly or detachably connected to the piston rod. In some embodiments, the pushing shaft can be urged distally relative to the housing to apply a force to a resilient element or member (e.g., a spring), which in turn applies a force to the piston rod, and simultaneously the syringe needle is urged distally by the pushing shaft.

[0220] In some embodiments, the needle seat or base, or a portion thereof, is axially elongated, thereby providing a space between a portion of the pushing shaft and the piston rod that is configured to accommodate one or more elastic elements or members. In embodiments using multiple elastic elements or members, any two or more of these elastic elements or members may be arranged one behind the other or in parallel. Each elastic element or member may be in the form of a flexible sheath or tube, a spring, an annular ring, an elongated rod or strip, or any combination thereof. The elastic element or member may be positioned parallel to the needle seat or base and / or allow passage through the needle seat or base. For example, the elongated needle seat or base may pass through the coil of a spring, with the proximal end of the spring joining the proximal portion of the elongated needle seat or base and the distal end of the spring joining the proximal portion of the piston rod. The distal portion of the elongated needle seat or base may be inserted into the internal lumen of the piston rod, and all or part of the syringe needle may be housed within the internal lumen of the piston rod. In some embodiments, prior to using the syringe needle to perform a medical penetration, the syringe needle is positioned within the internal lumen without passing through the distal end of the piston rod or a seal attached to the distal end (e.g., plunger seal 3 in FIG. 12). Thus, in some embodiments, the pushing shaft (e.g., including or connected to an elongated needle seat or base) may be configured to be resiliently coupled to the piston rod (e.g., by spring 5 in FIG. 12), with a distal portion of the piston rod coupled to the seal such that the seal can be configured as a floating seal.

[0221] In some embodiments, the piston rod (e.g., push rod 15 in FIG. 12 ) is configured to receive and / or accommodate a syringe needle (e.g., syringe needle 6 in FIG. 12 ) or at least a portion thereof. In some embodiments, the piston rod is hollow. In some embodiments, the piston rod includes an internal lumen configured to receive and / or accommodate a syringe needle or at least a portion thereof. The internal lumen of the piston rod may, but is not limited to, be configured to receive and / or accommodate a flowable composition (e.g., a pharmaceutical composition). In some embodiments, the internal lumen of the piston rod contains a gas (e.g., air) and accommodates the syringe needle, but does not contain a liquid such as a drug solution. In some embodiments, the piston rod can be used to aspirate the flowable composition. In some embodiments, the piston rod can be pulled by a handle (e.g., handle 21 in FIG. 12 ) to aspirate the flowable composition into a syringe (e.g., syringe 1 in FIG. 12 ). In some embodiments, the piston rod can be used to inject the flowable composition. In some embodiments, the piston rod is driven by a pushing shaft (e.g., by spring 5 in FIG. 12 ), and the syringe needle inside the piston rod can pass through a seal at the distal end of the piston rod (e.g., plunger seal 3 in FIG. 12 ). In some embodiments, a needle body opening is present between the proximal and distal ends of the syringe needle, and when the needle body opening is distal to the seal, the flowable composition inside the syringe can contact the needle body opening. In some embodiments, the needle body passage connects the needle body opening to the needle distal opening such that a pressure differential between the needle body opening (e.g., when inside the syringe and in contact with the flowable composition) and the needle distal opening can drive the flowable composition through the needle body passage, thereby injecting the flowable composition (through the needle distal opening) into an apparent or potential tissue void, cavity, or blood vessel.

[0222] In some embodiments, a portion of the piston rod (e.g., push rod 15 in FIG. 12 ) is configured to mate with a guide tube (e.g., guide tube 16 in FIG. 12 ). In some embodiments, the guide tube is a tube mounted inside the housing. In some embodiments, the guide tube is mounted inside another tube within the housing. In some embodiments, a portion of the piston rod is slidably joined to an inner surface of the guide tube such that the piston rod is movable axially along the guide tube. In some embodiments, a portion of the push shaft is configured to mate with the guide tube. In some embodiments, a portion of the push shaft is slidably joined to an inner surface of the guide tube such that the push shaft can move axially to move the syringe needle relative to the guide tube. In some embodiments, the guide tube may include a structure on its inner surface (e.g., one or more axial ridges or grooves) that slidably joins with a corresponding structure (e.g., one or more axial grooves or ridges) on the outer surface of the push shaft and / or the piston rod. The corresponding structure (e.g., axial ridges and grooves) allows sliding movement of the push shaft and / or piston rod in the axial direction while maintaining positional stability and / or minimizing movement of the syringe needle in other directions (e.g., radially). In some embodiments, the proximal portion of the piston rod includes a protrusion (e.g., one or more annular ridges) that interfaces with the inner surface of the guide tube. Thus, in some embodiments, the piston rod can be considered a floating structure because it is slidably interfaced with the inner surface of the guide tube and is movable relative to the axial direction of the guide tube due to the interface between the piston rod and the spring. In some embodiments, the guide tube is fixed relative to the housing.

[0223] In some embodiments, a distal portion of the piston rod (e.g., push rod 15 in FIG. 12 ) is configured to mate with a seal (e.g., plunger seal 3 in FIG. 12 ). In some embodiments, the piston rod is configured to slidably mate with an interior surface of a syringe (e.g., syringe 1 in FIG. 12 ). In some embodiments, the seal is a floating seal that slidably and sealingly mates with an interior surface of the syringe. In some embodiments, the seal separates a proximal lumen and a distal lumen formed by a syringe barrel of the syringe, the distal lumen of the syringe being configured to aspirate and / or store the flowable composition. In some embodiments, the seal, together with the syringe barrel of the syringe, forms a lumen configured to aspirate and / or store the flowable composition. In some embodiments, the seal is at a distal end of the piston rod that is inserted into the syringe.

[0224] In some embodiments, a syringe (e.g., syringe 1 in FIG. 12 ) is configured to mate with a housing. In some embodiments, a proximal portion of the syringe is fixedly or removably joined to the housing. In some embodiments, a distal portion of the syringe is fixedly or removably joined to a distal seal (e.g., sealing tip 8 in FIG. 12 ). In some embodiments, an internal lumen of the syringe is configured to aspirate and / or store a flowable composition, such as a pharmaceutical composition. In some embodiments, the internal lumen configured to contain the flowable composition is distal to a floating seal (e.g., a plunger seal) and proximal to a distal seal (or sealing tip), and is formed by sealing joints between the syringe and the floating seal and between the syringe and the distal seal. In some embodiments, the distal seal is sealingly joined to a distal end of the syringe. In some instances, the distal seal may be pressed against the distal end of the syringe to form the sealing joint. 16A-16C, and the distal seal may have a flat, spherical, or conical distal portion. The distal seal may have a distal portion with a flat, convex, spherical, concave, or any other suitable distal surface shape.

[0225] In some examples, the distal seal may include a proximal portion that is inserted into the syringe to form a sealing joint with the inner surface of the syringe. In some examples, the portion of the distal seal and the inner surface of the syringe may include corresponding structures that interface with each other (e.g., protrusions such as threads and ridges (e.g., annular ridges), and recesses such as grooves (e.g., annular grooves)). For example, the portion of the distal seal may include threads on its outer surface that interface with threads on the inner surface of the distal portion of the syringe. In some examples, the distal seal may include a portion that interfaces with the outer surface of the syringe. In some examples, the portion of the distal seal and the outer surface of the syringe may include corresponding structures that interface with each other (e.g., protrusions such as threads and ridges, and recesses such as grooves). For example, the portion of the distal seal may include threads on its inner surface that interface with threads on the outer surface of the distal portion of the syringe.

[0226] In some examples, the distal seal may include a proximal portion that is joined to a cap (e.g., cap 23 shown in FIG. 12). In some examples, the interior surface of the cap and the exterior surface of the syringe may include corresponding structure (e.g., protrusions such as threads and ridges (e.g., annular ridges) and recesses such as grooves (e.g., annular grooves)) that join together, for example, by a threaded engagement. In some examples, the cap joins to the distal seal at annular groove 24 and presses the distal seal against the distal opening of the syringe barrel to form a sealing joint.

[0227] In some embodiments, the devices disclosed herein include a stopper, such as limiter 18 in FIG. 12 . In some embodiments, the stopper can be used to limit the maximum length of axial movement of the push shaft, for example, to achieve accurate injection. In some embodiments, the stopper can be used to limit rotational and / or radial movement of the push shaft, for example, to prevent or minimize deviation of the push shaft (and the needle seat and syringe needle connected thereto) from the central axis of the assembled device. In some embodiments, the stopper can be bonded to the guide tube. In some embodiments, the stopper can be bonded to a proximal end that is fixedly or removably bonded to the guide tube. In some embodiments, the guide tube can be used to guide the movement of the push shaft and piston rod, for example, by corresponding structure on the member, to achieve precision in the axial movement of the push shaft and piston rod and precision in the movement of the syringe needle. In some embodiments, during transportation and storage of the assembled device, and during use of the device for medical penetration, the device prevents or minimizes rotation and / or displacement (e.g., deviation from a central axis) of the pusher shaft, piston rod, needle seat or base, and / or syringe needle through a combination of features (e.g., a stopper and guide tube).

[0228] In some embodiments, a device disclosed herein includes an adapter, such as adapter 20 of FIG. 12. In some embodiments, the adapter may include a distal end including multiple distal petals and / or a proximal end including multiple proximal petals. In some embodiments, the adapter may include an adapter needle. In some embodiments, the adapter can be used to transfer a flowable composition from a container (e.g., a vial) to a syringe of a device disclosed herein. In some embodiments, a syringe can be inserted into the proximal end of the adapter. For example, a distal seal (e.g., sealing tip 8 of FIG. 12) can be inserted into the adapter, where the adapter needle contacts and passes through the distal seal to establish fluid communication with the internal lumen of the syringe distal to the floating seal. Fluid communication allows for the passage of gas, liquid, or a mixture thereof. In some embodiments, the adapter needle can be inserted into a container (e.g., a vial) containing a flowable composition (e.g., a drug solution), establishing fluid communication between the internal lumen of the syringe and the interior of the container, e.g., by using the adapter needle to pierce the seal of the container. In some embodiments, a handle (e.g., handle 21 in FIG. 12 ) configured to mate with a proximal portion of the piston rod can be used to push and / or pull the piston rod axially relative to the syringe. For example, the handle can be pulled proximally to aspirate the flowable composition from the container through the adapter needle and into the internal lumen of the syringe. In another example, the handle can be pushed distally to expel gas and / or liquid through the adapter needle. For example, the handle may be pulled proximally to aspirate liquid (e.g., drug solution) into the syringe along with any undesired gas (e.g., air), then the assembly including the syringe and adapter may be positioned so that the adapter needle points upward (e.g., vertical), and the handle is pushed distally (e.g., in an upward direction) to expel the undesired gas through the adapter needle, thereby leaving the flowable composition within the syringe.

[0229] In some examples, the syringe of the device disclosed herein may be pre-filled with a flowable substance or composition. In some embodiments, the syringe (e.g., syringe 1 shown in FIG. 12) may be installed in one or more parts. In some embodiments, the container (e.g., syringe unit) may include a cylindrical wall sealingly joined to a fixed seal (fixed to the container at the distal end of the container and allowing passage of a needle) and a floating seal (movable within the container and allowing passage of a needle), and the space enclosed by the cylindrical wall, fixed seal, and floating seal may be pre-filled with a flowable substance or composition. In some embodiments, the device or system may include a first syringe unit, and the container may be a second syringe unit configured to join to the distal end of the first syringe unit. Before or after filling the container (e.g., syringe unit) with the flowable substance or composition, the container (e.g., syringe unit) may be inserted into or attached to the body of the device (e.g., first syringe unit). In some embodiments, a floating seal in the container (e.g., syringe unit) can contact the distal end of the piston rod, thereby establishing a joint between the piston rod and the floating seal that transfers force from the spring to the floating seal. A static seal at the distal end of the container (e.g., syringe unit) can contact a contact element at the distal end of the device, and the contact element can be the distal seal of the syringe. In some embodiments, the static seal of the container (e.g., syringe unit) also functions as the distal seal and / or contact element of the syringe. In some embodiments, the container (e.g., syringe unit) can be configured to be at least partially inserted into a syringe barrel. In some embodiments, the static seal sealingly joins the container (e.g., syringe unit), which in turn joins to the inner wall of the syringe barrel. In some embodiments, the static seal sealingly joins to the container (e.g., syringe unit) and the inner wall of the syringe barrel.The joint between the container (e.g., syringe unit) and the syringe barrel and the joint between the fixed seal and the container wall may include any suitable joint, such as an insert, a threaded, a non-threaded, a clamped joint, a capped joint, or any combination thereof.

[0230] In some embodiments, the devices disclosed herein provide precise control of the syringe needle as it is advanced through one or more tissues and are particularly useful for entering visible or potential tissue voids, cavities, or vessels, such as the potential space between two adjacent tissues with different densities. In some embodiments, the devices disclosed herein provide precise entry into the epidural space while reducing or minimizing the risk of underpenetration and / or overshoot (e.g., needle insertion too deep). In some instances, the axial movement of the syringe needle is controllable and can achieve micrometer precision when advancing within tissue. In some instances, the axial movement of the syringe needle within tissue can be set within a length of between about 0 and about 4.0 mm (e.g., between about 0 and about 0.5 mm, between about 0 and about 1.0 mm, between about 0 and about 1.5 mm, between about 0 and about 2.0 mm, or between about 0 and about 2.5 mm). In some embodiments, the devices disclosed herein include a syringe needle (e.g., 6 shown in FIG. 12 ) having dimensions and configurations disclosed herein, e.g., the syringe needle has a bevel angle between about 0 degrees and about 40 degrees, particularly between about 5 degrees and about 30 degrees, e.g., between about 15 degrees and about 25 degrees. In some embodiments, the volume of flowable composition delivered (e.g., by injection) using the devices disclosed herein can be selected according to a particular subject's condition and can be adjusted as conditions change. In some embodiments, energy stored in an energy storage member (e.g., a spring) is automatically released to propel a floating seal (e.g., via piston rod 15 in FIG. 12 ), thereby expelling a volume of the flowable composition into an apparent or potential tissue void, cavity, or vessel. In view of the combination of various features disclosed herein, the devices and methods disclosed herein can achieve precise, safe, and controllable delivery of a drug to a target tissue (e.g., an apparent or potential tissue void, cavity, or vessel).

[0231] In some embodiments, a device or system disclosed herein includes a cannula (e.g., a microcannula), a microneedle, and a manipulation module (e.g., including a handle or knob configured to control advancement or retraction of the microneedle and advancement or retraction of the flexible cannula). In some embodiments, the cannula includes a distal tip that may include a sharp tip, a stylet, a bevel, or a blunt tip. In some embodiments, the cannula includes a flexible body. In some embodiments, the manipulation module is configured to control the placement and delivery of the cannula to achieve minimally invasive surgery. In some embodiments, the microneedle has a curved tip and is configured to be housed within the cannula. In some embodiments, the microneedle is configured to be advanced and / or retracted through an internal lumen of the cannula. In some embodiments, a proximal end of the cannula is configured to mate with a distal connector of the manipulation module. In some embodiments, the manipulation module includes one or more elements configured to mate with the microneedle to control movement of the microneedle within the internal lumen of the cannula. In some embodiments, the distal connector of the operational module is configured to mate to one or more syringes via one or more adapters. In some embodiments, each syringe is connected to an adapter connected to the operational module. In some embodiments, the one or more syringes may contain one or more compositions, such as a flowable material, a viscoelastic material, or an infusion solution, and may control delivery of the compositions through the microneedles.

[0232] In some embodiments, the linear member (e.g., a cannula) is a thin, flexible, hollow tube with a smooth, rounded tip at its distal end, the opposing proximal end of which may have a hub (e.g., a plastic hub) that can be attached to a syringe. In some embodiments, the cannula includes a sharp distal tip. In some embodiments, the cannula includes a blunt distal tip. In some embodiments, the distal end of the cannula opens a pathway between structures within tissue, thereby assisting the anatomical structure while reducing tissue damage. In some embodiments, the cannula may include an opening at its distal end, for example, an opening at the blunt tip of the cannula. In some embodiments, the cannula may include a side opening in a sidewall of the cannula, but may or may not include an opening at the distal end.

[0233] In some embodiments, the device or system includes a hollow needle having a proximal end, wherein the needle is slidable relative to the cannula. In some embodiments, the device or system includes an actuation member connected to the proximal end of the hollow needle for translating the hollow needle. In some embodiments, the hollow needle is configured to translate relative to the cannula, thereby driving a distal portion of the needle along an exit axis that is oriented obliquely relative to a longitudinal axis of the cannula.

[0234] In some embodiments, the device or system includes a fluid source in fluid communication with a proximal end of a hollow needle. In some embodiments, the needle includes a sharp distal tip. In some embodiments, the sharp distal tip of the needle includes a first bevel, a second bevel, and an optional third bevel, wherein the first bevel, the second bevel, and the optional third bevel are oriented at an angle relative to one another. In some embodiments, the outlet axis is oriented at an angle between about 5° and about 30° relative to a longitudinal axis of the cannula. In some embodiments, the outlet axis is oriented at an angle between about 7° and about 9° relative to a longitudinal axis of the cannula. In some embodiments, the cannula includes a beveled distal end, wherein the beveled distal end has an angle between about 10° and about 30°. In some embodiments, the cannula defines a plurality of lumens extending longitudinally through the length of the cannula, at least one of the lumens being configured to slidably receive a needle. -6 N / mm~12×10 -6 In some embodiments, the cannula has a bending stiffness of between 2.0×10 -6 N / mm~8.0×10 -6 In some embodiments, the cannula has a bending stiffness of between about 1.0×10 N / mm. -6 N / mm, approximately 1.5 x 10 -6 N / mm, approx. 2.0 x 10 -6 N / mm, approximately 2.2 x 10 -6 N / mm, approximately 2.4 x 10 -6 N / mm, approximately 2.6 x 10 -6 N / mm, approximately 2.8 x 10 -6 N / mm, approx. 3.0 x 10 -6 N / mm, approximately 3.2 x 10 -6 N / mm, approximately 3.4 x 10 -6 N / mm, approximately 3.6 x 10 -6 N / mm, approximately 3.8 x 10 -6 N / mm, approx. 4.0 x 10 -6 N / mm, approximately 4.2 x 10 -6 N / mm, approximately 4.4 x 10 -6 N / mm, approximately 4.6 x 10-6 N / mm, approximately 4.8 x 10 -6 N / mm, approx. 5.0 x 10 -6 N / mm, approximately 5.2 x 10 -6 N / mm, approximately 5.4 x 10 -6 N / mm, approximately 5.6 x 10 -6 N / mm, approximately 5.8 x 10 -6 N / mm, approx. 6.0 x 10 -6 N / mm, approximately 6.2 x 10 -6 N / mm, approximately 6.4 x 10 -6 N / mm, approximately 6.6 x 10 -6 N / mm, approximately 6.8 x 10 -6 N / mm, approx. 7.0 x 10 -6 N / mm, approximately 7.2 x 10 -6 N / mm, approximately 7.4 x 10 -6 N / mm, approximately 7.6 x 10 -6 N / mm, approximately 7.8 x 10 -6 N / mm, approx. 8.0 x 10 -6 N / mm, approximately 8.5 x 10 -6 N / mm, approx. 9.0 x 10 -6 N / mm, approximately 9.5 x 10 -6 N / mm, approximately 10.0 x 10 -6 N / mm, approximately 10.5 x 10 -6 N / mm, approx. 11.0 x 10 -6 N / mm or approximately 11.5 x 10 -6 It has a bending stiffness of N / mm.

[0235] In some embodiments, the present disclosure provides methods of using a device or system that includes a cannula and a hollow needle that is movable relative to the cannula.

[0236] The exemplary embodiments and optionally specific implementations of the present disclosure are described in detail above in combination with the drawings. However, the present disclosure is not limited to the details described in the above embodiments. Simple modifications can be applied to the embodiments of the present disclosure, and all of these modifications are within the scope of the present disclosure.

[0237] It should be understood that any suitable injection device or system, including but not limited to those described herein in conjunction with the drawings, can be used in the methods of epidural injection disclosed herein or in combination with any of the catheter guide structures described herein to position a catheter within the epidural space. For example, the injection device or system shown in FIG. 12A can be used. In some embodiments, the injection device or system includes a syringe barrel including a proximal end and a distal end, a floating seal within the syringe barrel, a puncture member at the distal end of the syringe barrel, such as a needle, that is not attached to the floating seal, and an actuation member configured to resiliently engage the floating seal via an energy storage member (e.g., a spring) and / or another suitable resilient member. In some embodiments, the puncture member includes a distal end opening configured to form fluid communication with a lumen within the syringe barrel that contains the flowable composition. In some embodiments, the injection device or system further includes a stopper in the syringe barrel between the floating seal and the distal end of the syringe barrel. As shown in step 1 of FIG. 12A , the injection device or system is in an initial state, where the distal end opening of the puncture member has not yet penetrated the target tissue and the distance between the actuating member and the floating seal is x1. In step 2 of FIG. 12A , the distal end opening of the puncture member has already penetrated the relatively dense tissue, where the distance between the actuating member and the floating seal remains the same (x1). In step 3 of FIG. 12A , when the energy storage member is compressed by reducing the distance between the actuating member and the floating seal from x1 to x2, the distal end opening of the puncture member is maintained within the relatively dense tissue (e.g., ligament tissue). In this way, the energy storage member applies and maintains a force on the floating seal. The flowable composition passes through the distal opening of the puncture member, and pressure is then applied to the relatively dense tissue. Due to tissue density, the relatively dense tissue exerts back pressure on the distal opening of the puncture member, thereby preventing the flowable composition from discharging into the tissue.In step 4 of FIG. 12A , the puncture member is advanced distally into relatively less dense tissue, e.g., an apparent or potential tissue void, cavity, or vessel (e.g., the epidural space). In some embodiments, due to the decreased tissue density, the backpressure at the distal opening of the puncture member is less than the pressure of the flowable composition, thereby enabling the release of the flowable composition into the relatively less dense tissue, e.g., an apparent or potential tissue void, cavity, or vessel. As shown in step 5 of FIG. 12A , when the flowable composition exits the distal end opening of the puncture member, energy in the energy storage member is released, thereby increasing the distance between the actuation member and the floating seal from x2 to x3. Distal movement of the floating seal in the syringe barrel may be blocked by a stopper, for example, to control the volume of flowable composition delivered into the relatively less dense tissue.

[0238] Another example is shown in step 1 of FIG. 12B , in which the medical puncture device is in an initial state, where the distal end opening of the puncture member has not yet penetrated the target tissue. In step 2 of FIG. 12B , the energy storage member is compressed while the distal end opening of the puncture member is maintained outside the tissue, and the floating seal is not advanced distally to expel the flowable composition from the distal end opening. In step 3 of FIG. 12B , the distal end opening of the puncture member has already penetrated relatively dense tissue (e.g., ligament tissue). The energy storage member applies and maintains a force on the floating seal. The flowable composition passes through the distal opening of the puncture member, and pressure is then applied to the relatively dense tissue. Due to tissue density, the relatively dense tissue exerts back pressure on the distal opening of the puncture member, thereby preventing the flowable composition from expelling into the tissue. In step 4 of FIG. 12B , the distal end opening of the puncture member begins to enter the relatively non-dense tissue, such as an apparent or potential tissue void, cavity, or vessel (e.g., the epidural space), while the energy storage member is maintained compressed. In step 5 of FIG. 12B , as the tissue density decreases, the backpressure at the distal end opening of the puncture member becomes less than the pressure of the flowable composition, thereby allowing the flowable composition to be released into the relatively non-dense tissue. As the flowable composition exits the distal end opening of the puncture member, the energy in the energy storage member is released. In some embodiments, distal movement of the floating seal in the syringe barrel may be blocked by a stopper to block the flow of the flowable composition. In this manner, the volume of the flowable composition delivered into the relatively non-dense tissue can be controlled. As shown in step 6 of FIG. 12B , the force applied to the actuation member may be released.

[0239] Another example is shown in Figure 12C. In some embodiments, an injection device or system includes a syringe barrel including a proximal end and a distal end, a floating seal within the syringe barrel, a puncture member, such as a needle, at the distal end of the syringe barrel and not attached to the floating seal, and an energy storage member configured to resiliently bond to the floating seal and the proximal end of the syringe barrel. In some embodiments, the injection device or system further includes a stopper in the syringe barrel between the floating seal and the distal end of the syringe barrel. In some embodiments, the medical puncture device includes a contact member. In step 1 of Figure 12C, the medical puncture device is in an initial state, in which the distal end opening of the puncture member is within a contact element that prevents the flowable composition from exiting the distal end opening. The energy storage member applies a force to the floating seal, and pressure is then applied to the contact member through the flowable composition and the distal opening of the puncture member. Due to the density of the contact member, the backpressure at the distal opening of the puncture member prevents the flowable composition from leaking out of the syringe barrel. In step 2 of FIG. 12C, the distal end opening of the puncture member has already entered relatively dense tissue (e.g., ligament tissue), and the backpressure of the relatively dense tissue at the distal end opening prevents the flowable composition from leaking into the tissue. In step 3 of FIG. 12C, the distal end opening of the puncture member begins to enter relatively less dense tissue, such as an apparent or potential tissue void, cavity, or vessel (e.g., the epidural space). In step 4 of FIG. 12C, due to the decreased tissue density, the backpressure at the distal opening of the puncture member becomes less than the pressure of the flowable composition, thereby allowing the release of the flowable composition into the relatively less dense tissue. As the flowable composition exits the distal end opening of the puncture member, the energy in the energy storage member is released. In some embodiments, distal movement of the floating seal in the syringe barrel may be blocked by a stopper to block the flow of the flowable composition, thus controlling the volume of the flowable composition delivered into relatively non-dense tissue.

[0240] FIG. 13 illustrates epidural anesthesia. An epidural needle (e.g., a stylet) can be inserted through the skin and subcutaneous tissue, the supraspinous and interspinous ligaments, and into the ligamentum flavum. As the needle is advanced, the epidural space is identified by a loss of resistance. The syringe can then be removed, and the epidural catheter can be advanced through the needle and into the epidural space. The needle can be removed from the catheter, leaving a portion of the catheter (e.g., 4 cm to 6 cm) within the epidural space.

[0241] In some embodiments, a method of using the injection system or device provided in FIGS. 14A-14B and 15 for epidural injection, wherein the injection system or device includes a syringe barrel 1 extending from a proximal end to a distal end; a first hollow needle 6 extending from the proximal end to a distal end including an end opening, the needle distal end being connected to the distal end of the syringe barrel; a floating seal 3 positioned inside the syringe barrel, forming a lumen between the floating seal and the distal end of the syringe barrel and including a hollow passage aligned with the first hollow needle; and a push shaft 2 extending from the proximal end to the distal end. the push shaft 2 having a hollow passage extending therethrough, wherein a distal end of the push shaft is proximal to and in contact with the floating seal, and the hollow passage of the push shaft is aligned with the hollow passage of the floating seal and the first hollow needle to form a central hollow passage extending from the proximal end of the push shaft to a distal opening of the first hollow needle; a proximal seal 8a at the proximal end of the central hollow passage; and an actuation unit including an actuation member 2a (e.g., a control knob) and an energy storage member 5 (e.g., a spring), wherein the actuation member 2a is resiliently joinable with the push shaft 2 by the energy storage member 5. In some embodiments, the injection system or device further includes a puncture unit 6′ capable of puncturing the proximal seal 8a and opening the central hollow passage. In some embodiments, the injection device or system further includes a needle guide structure 43 having a hollow passage. In some embodiments, the injection device or system further includes a catheter guide channel 12b through which the catheter 11 is inserted into the central hollow channel and ultimately into the epidural space.

[0242] In some embodiments, FIG. 15 illustrates the operation of an injection system or device (e.g., as shown in FIGS. 14A-14B ) used to inject a flowable composition into the epidural space and / or place an implant (e.g., a catheter) in the epidural space. In step 1 of FIG. 15 , the injection system or device is in an initial state, in which the distal end opening of the first hollow needle 6 has not yet entered the target tissue, and the energy storage member 5 is in its resting state. In step 2 of FIG. 15 , the distal end opening of the first hollow needle 6 has already reached dense tissue (e.g., the ligamentum flavum), and the energy storage member 5 (e.g., a spring) is compressed by moving the control knob 2 a, and the pressure from the dense tissue (e.g., the ligamentum flavum) balances the pushing force from the energy storage member 5, so that the floating seal 3 is not pushed distally. In step 3 of FIG. 15 , the distal end opening of the first hollow needle 6 has already reached relatively less dense tissue (e.g., the epidural space). In some embodiments, the pressure at the distal end opening of the first hollow needle 6 decreases and becomes smaller than the pushing force from the energy storage member 5, thus allowing the floating seal 3 to move distally in the absence of any manual movement of the push shaft. When a flowable substance can be injected and / or an implant (e.g., a catheter) can be attached, such automatic movement of the floating seal 3 provides a clear visual indication that the distal end opening of the first hollow needle 6 has already reached the epidural space. In step 4 of FIG. 15 , the distal end opening of the first hollow needle 6 has already reached the epidural space, and the puncture unit 6′ is advanced distally to puncture the proximal seal 8a, thereby forming a hollow passage from the proximal end of the needle guide structure 43 to the distal end opening of the first hollow needle 6.

[0243] In some embodiments, the guide structure 43 may include a side port 44, such that when the guide structure 43 is advanced distally, the side port aligns with a catheter guide structure (e.g., 12b in Figures 14B and 15) having a hollow passage, and a catheter is inserted through the hollow passage of the catheter guide structure, through the side port, into the hollow needle guide passage within the guide structure 43, into the central hollow passage within the push shaft 2, into the hollow puncture needle 6, and finally into the epidural space.

[0244] In step 5 of FIG. 15 , a second syringe 50 having a hollow needle is inserted sequentially through the needle guide structure 43, the hollow passage in the puncture unit 6′, the punctured proximal seal 8a, the hollow passage in the push shaft 2, the hollow passage in the floating seal 3, and the first hollow needle 6, and finally passes through the distal end opening of the first hollow needle 6 to be punctured into the epidural space. The fluid substance (e.g., a drug component) contained in the second syringe 50 may then be injected into the epidural space through the needle of the second syringe. In some embodiments, injecting a fluid substance is necessary or desirable, and thus a step such as step 5 of FIG. 15 is performed. In some embodiments, injecting a fluid substance is not necessary or desirable, and thus a step such as step 5 of FIG. 15 is omitted. In some embodiments, as shown in step 6 of FIG. 15 , after puncturing the proximal seal 8a and, optionally, injecting a fluid substance using the second syringe 50, the catheter 11 is propelled into the central hollow passage and finally passed through the distal end opening of the first hollow needle 6 to be positioned in the epidural space. In some embodiments, the distal propulsion of the catheter 11 is controlled by the catheter insertion unit 42. In some embodiments, the catheter insertion unit is a pair of gears between which the catheter 11 is positioned. In some embodiments, the distal propulsion of the catheter 11 is achieved by moving the gears. In some embodiments, the distal end of the catheter 11 passes through the catheter stabilizing structure 12a, the catheter guide passage 12b, a portion of the needle guide structure 43, the punctured proximal seal 8a, the hollow passage of the push shaft 2, the hollow passage of the floating seal 3, and the first hollow needle 6, in that order. In this way, the distal end of the catheter is positioned in the epidural space, and a drug can be continuously delivered to the epidural space from the distal end of the catheter, as needed. Once the catheter is inserted into the target site, the injection system or device can be removed, leaving the catheter inserted at the target site.

[0245] In some embodiments, FIG. 15 illustrates the operation of an injection system or device (e.g., as shown in FIGS. 14A-14B) used to inject a flowable composition into the epidural space and / or place an implant (e.g., a catheter) within the epidural space.

[0246] In some embodiments, Figure 18 illustrates the operation of an accumulator device (e.g., as shown in Figures 16A-16B or 17) used to inject a flowable composition into the epidural space and / or place an implant (e.g., a catheter) within the epidural space. In step 1 of Figure 18, the accumulator device is in an initial state by connecting a needle (e.g., 5 in Figure 17) to the device, where the needle includes a needle tip (e.g., 18 in Figure 17), a needle lumen (e.g., 6 in Figure 17), and a needle hub (e.g., 14 in Figure 17). In some embodiments, the integrated device includes: i) a syringe barrel (e.g., 1 in FIG. 17 ), the syringe barrel extending from a proximal end to a distal end, the distal end of the syringe barrel including a needle seat (e.g., 4 in FIG. 17 ) configured to connect to a needle hub, and the needle seat including a passageway (e.g., 7 in FIG. 17 ) configured to be in fluid communication with the needle lumen; ii) a gasket seal (e.g., 3 in FIG. 17 ), the gasket seal and an inner wall of the syringe barrel forming a fluid-tight seal, the gasket seal adjacent the distal end of the syringe barrel, the gasket seal including a through-hole (e.g., 9 in FIG. 17 ) along the axis of the syringe barrel, the through-hole aligning with the passageway in the needle seat; and iii) a push-pull device. a push shaft (e.g., 2 in FIG. 17 ) extending from a proximal end to a distal end, the distal end of the push shaft joining the gasket seal and including a central passage (e.g., 10 in FIG. 17 ) having a distal end aligned with the through-hole of the gasket seal, and a valve (e.g., 11 in FIG. 17 ) aligned with the proximal end of the central passage; iv) a spring (e.g., 12 in FIG. 17 ) having a distal end joined to a portion of the push shaft and a proximal end joined to a structure within or on the syringe barrel (e.g., a baffle) configured to compress the spring; and v) a catheter (e.g., 16 in FIG. 17 ) configured to be inserted through the valve and enter the central passage.In this initial state, the distal tip (e.g., 18 in FIG. 17) of the needle (e.g., 5 in FIG. 17) has not yet penetrated the target tissue, and the elastic element (e.g., spring 12 in FIG. 17) therein is in its rest state.

[0247] In step 2 of Figure 18, the push shaft is actuated proximally, thereby compressing the spring and forming a gas-containing flowable composition lumen (e.g., 8 in Figure 17) between the gasket seal and the distal end of the syringe barrel. In step 2 of Figure 18, the push shaft is locked to maintain the compressed state of the spring and maintain the position of the gasket seal in the syringe barrel.

[0248] In step 3 of Figure 18, when the user does not need to grip the push shaft to maintain the spring in a compressed state, the needle tip is advanced within the subject's body toward a location within the subject's ligamentum flavum. In step 3 of Figure 18, when the needle tip is within the ligamentum flavum, the push shaft is unlocked. When the distal tip of the needle (e.g., 18 in Figure 17) reaches the subject's ligamentum flavum (or other dense tissue), pressure from the dense tissue balances the pushing force from the compressed spring, so that the push shaft or gasket seal is not advanced distally.

[0249] In step 4 of Figure 18, the needle tip is advanced through the ligamentum flavum and into the epidural space of the subject, thereby allowing the compressed spring to decompress and displacing the gasket seal distally to connect the central passageway with the passageway in the needle seat. When the distal tip of the needle (e.g., 18 in Figure 17) reaches the epidural space (or less dense tissue), the pressure at the distal tip drops and becomes less than the pushing force from the compressed state of the spring, thus allowing distal movement of the push shaft or gasket seal in the absence of any manual movement of the push shaft. If a flowable substance can be injected and / or an implant (e.g., a catheter) can be attached, this automatic movement of the push shaft or gasket seal provides a clear visual indication that the distal tip of the needle has already reached the epidural space.

[0250] 18, an anesthetic agent is injected into the needle lumen through a side port of the needle, thereby injecting the anesthetic agent into the epidural space of the subject. In some embodiments, the anesthetic agent is delivered into the needle lumen by a second syringe through a side port of the needle.

[0251] Optionally, in step 6 of Figure 18, a second syringe for injecting an anesthetic agent is disconnected from the side port of the needle, thereby emptying the needle lumen for subsequent insertion of a catheter from the collection device. A hollow passage is formed from the proximal tip of the needle (e.g., 18 of Figure 17), through the needle lumen (e.g., 6 of Figure 17), the passage in the needle seat (e.g., 7 of Figure 17), the through-hole in the gasket seal (e.g., 9 of Figure 17), and the central passage (e.g., 10 of Figure 17) to the valve.

[0252] In step 7 of FIG. 18 , a catheter is inserted through the valve, central passage, through-hole, passage, and needle lumen, thereby positioning the distal portion of the catheter in the epidural space. In some embodiments, the integrated device includes a catheter guide passage (e.g., 13 in FIG. 17 ). In some embodiments, the catheter guide passage further includes a side port (e.g., 19 in FIG. 17 ) configured to align with the catheter guide passage. In some embodiments, the catheter is inserted sequentially through the catheter stabilizing structure (e.g., 17 in FIG. 17 ), the side port, the catheter guide passage, the valve, the central passage, the gasket seal passage, the needle seat passage, the needle lumen, and the distal tip of the needle, and finally enters the epidural space. In some embodiments, distal advancement of the catheter (e.g., 16 in FIG. 17 ) is controlled by a catheter insertion unit (e.g., 42 in FIG. 17 ). In some embodiments, the catheter insertion unit is a pair of gears with the catheter positioned between the two gears. In some embodiments, distal advancement of the catheter is achieved by moving the gears.

[0253] In step 7 of Figure 18, the needle is disconnected from the needle seat to remove the catheter from the device, while the distal portion of the catheter remains in the epidural space. In this way, the distal end of the catheter is positioned in the epidural space, and drugs can be continuously delivered to the epidural space from the distal end of the catheter as needed.

[0254] In some embodiments, the catheter is used for epidural anesthesia by continuous infusion or intermittent bolus, optionally manually delivered intermittent bolus (MIB) and programmed intermittent bolus (PIB). In some embodiments, the catheter is used for surgical epidural anesthesia and / or postoperative analgesia.

[0255] It should be noted that the technical features described in the above embodiments can be combined in any reasonable manner unless they are contradictory, and in order to avoid unnecessary repetition, possible combinations are not separately described in the embodiments.

[0256] Furthermore, different specific implementations of the embodiments of the present disclosure can be freely combined, and as long as these combinations do not contradict the spirit of the present disclosure, these combinations should be considered as part of the present disclosure. [Brief explanation of the drawings]

[0257] The drawings illustrate some embodiments of the features and advantages of the present disclosure. These embodiments are not intended to limit the scope of the appended claims in any way. [Figure 1A] Schematic diagrams of different stages of operating an exemplary medical puncture device are shown, for example, during epidural anesthesia and / or injection into the epidural space 14. [Figure 1B] Schematic diagrams of different stages of operating an exemplary medical puncture device are shown, for example, during epidural anesthesia and / or injection into the epidural space 14. [Figure 1C]Schematic diagrams of different stages of operating an exemplary medical puncture device are shown, for example, during epidural anesthesia and / or injection into the epidural space 14. [Figure 1D] Schematic diagrams of different stages of operating an exemplary medical puncture device are shown, for example, during epidural anesthesia and / or injection into the epidural space 14. [Figure 1E] Schematic diagrams of different stages of operating an exemplary medical puncture device are shown, for example, during epidural anesthesia and / or injection into the epidural space 14. [Figure 1F] Steps for operating an exemplary medical puncture device that does not have a contact member (e.g., 1b shown in Figures 1A-1E), of which a distal seal (e.g., 8 shown in Figures 1A-1E) can directly contact tissue, are shown. [Figure 2A] Schematic diagrams of different stages of operating an exemplary medical puncture device are shown, for example, during epidural anesthesia and / or injection into the epidural space 14. [Figure 2B] Schematic diagrams of different stages of operating an exemplary medical puncture device are shown, for example, during epidural anesthesia and / or injection into the epidural space 14. [Figure 2C] Schematic diagrams of different stages of operating an exemplary medical puncture device are shown, for example, during epidural anesthesia and / or injection into the epidural space 14. [Figure 2D] Schematic diagrams of different stages of operating an exemplary medical puncture device are shown, for example, during epidural anesthesia and / or injection into the epidural space 14. [Figure 2E] Schematic diagrams of different stages of operating an exemplary medical puncture device are shown, for example, during epidural anesthesia and / or injection into the epidural space 14. [Figure 2F] 2A-2E show schematic diagrams of different stages of operating an exemplary medical puncture device, e.g., during epidural anesthesia and / or injection into the epidural space 14. Steps for operating an exemplary medical puncture device without a contact member (e.g., 1b shown in FIGS. 2A-2E), of which a distal seal (e.g., 8 shown in FIGS. 2A-2E) can be in direct contact with tissue, are shown. [Figure 2G]1 shows a schematic diagram of different stages of operating an exemplary medical puncture device, for example during epidural anesthesia and / or injection into the epidural space 14. The steps of operating an exemplary medical puncture device are shown, which includes an additional actuating member 2′ that is joined to a floating seal 3 by another spring 4′, while the actuating member 2 is joined to the floating seal 3 by a spring 4. [Figure 3A] 1 is a topographical view of an exemplary medical puncture device, which includes a floating seal 3 and one or more needle body openings (6b or 6b1, 6b2 and / or 6b3) and a needle distal opening 6a. [Figure 3B] 1 is a topographical view of an exemplary medical puncture device, which includes a floating seal 3 and one or more needle body openings (6b or 6b1, 6b2 and / or 6b3) and a needle distal opening 6a. [Figure 3C] 1 is a topographical view of an exemplary medical puncture device, which includes a floating seal 3 and one or more needle body openings (6b or 6b1, 6b2 and / or 6b3) and a needle distal opening 6a. [Figure 3D] 1 is a topographical view of an exemplary medical puncture device, which includes a floating seal 3 and one or more needle body openings (6b or 6b1, 6b2 and / or 6b3) and a needle distal opening 6a. [Figure 3E] 1 is a topographical view of an exemplary medical puncture device, which includes a floating seal 3 and one or more needle body openings (6b or 6b1, 6b2 and / or 6b3) and a needle distal opening 6a. [Figure 3F] 1 is a topographical view of an exemplary medical puncture device, which includes a floating seal 3 and one or more needle body openings (6b or 6b1, 6b2 and / or 6b3) and a needle distal opening 6a. [Figure 4A] 1 is a top view of an exemplary medical puncture device, the medical puncture device including a floating seal 3 and a needle body opening 6b. [Figure 4B]1 is a top view of an exemplary medical puncture device, the medical puncture device including a floating seal 3 and a needle body opening 6b. [Figure 4C] 1 is a top view of an exemplary medical puncture device, the medical puncture device including a floating seal 3 and a needle body opening 6b. [Figure 5A] 1 is a topographical view of an exemplary medical puncture device, which includes floating seals 3a and 3b and one or more needle body openings (6b or 6b1 and / or 6b2). [Figure 5B] 1 is a topographical view of an exemplary medical puncture device, which includes floating seals 3a and 3b and one or more needle body openings (6b or 6b1 and / or 6b2). [Figure 5C] 1 is a topographical view of an exemplary medical puncture device, which includes floating seals 3a and 3b and one or more needle body openings (6b or 6b1 and / or 6b2). [Figure 5D] 1 is a topographical view of an exemplary medical puncture device, which includes floating seals 3a and 3b and one or more needle body openings (6b or 6b1 and / or 6b2). [Figure 5E] 1 is a topographical view of an exemplary medical puncture device, which includes floating seals 3a and 3b and one or more needle body openings (6b or 6b1 and / or 6b2). [Figure 5F] 1 is a topographical view of an exemplary medical puncture device, which includes floating seals 3a and 3b and one or more needle body openings (6b or 6b1 and / or 6b2). [Figure 6] 1 shows a top view of an exemplary medical puncture device, which includes a through angled guiding groove 3a and a check valve 9. FIG. [Figure 7]1 shows a top view of an exemplary medical puncture device, which includes a through angled guiding groove 3a and a check valve 9. FIG. [Figure 8] 1 shows a top view of an exemplary medical lancing device, which includes a non-through angled guiding groove 3a. [Figure 9] 1 shows a top view of an exemplary medical puncture device, which includes an angled guide needle hole 6c and a check valve 9. FIG. [Figure 10] 1 shows a top view of an exemplary medical puncture device, which includes an angled guide needle hole 6c and a needle hole plug 10. FIG. [Figure 11] 1 shows a schematic diagram of implanting a catheter 11 into the epidural space 14 using an exemplary medical device assembly including a central guide groove 2c. The reference numerals and exemplary corresponding structures in the drawings provided below are merely illustrative and should not be considered limiting. 1—syringe barrel, 1a—axial stopper, 1b—circular contact element, 2—pressure element, 2c—central guide groove, 3—floating seal, 3a—angled guide groove, 4—elastic sheath, 5—spring, 6—hollow puncture needle, 6a—needle distal opening, 6b—needle body opening, 6c—angled guide needle hole, 7—flowable composition lumen, 8—distal seal, 9—check valve, 10—needle hole plug, 11—catheter, 12—auxiliary guide needle, 13—dense tissue (e.g., ligamentum flavum), 14—potential or apparent tissue void, cavity, or vessel (e.g., epidural space). [Figure 12A] 1A-1D show schematic diagrams of different stages of operating an exemplary medical lancing device. [Figure 12B] 1A-1D show schematic diagrams of different stages of operating an exemplary medical lancing device. [Figure 12C] 1A-1D show schematic diagrams of different stages of operating an exemplary medical lancing device. [Figure 13] An example of epidural injection (e.g., epidural anesthesia) is shown. [Figure 14A]1A and 1B show a schematic and external view of an exemplary injection system. [Figure 14B] 1A and 1B show a schematic and an internal view of an exemplary injection system. [Figure 15-1] 1 shows a schematic diagram of the different stages of operating an exemplary injection system. The reference numerals in the drawings and the exemplary corresponding structures provided below are merely illustrative, see e.g., Figures 14A-14B and 15, and should not be considered limiting. 1 - syringe barrel, 2 - push shaft, 2a - control knob, 3 - floating seal, 5 - spring, 6 - hollow needle structure, 6' - puncture unit (for puncturing the proximal seal), 8a - proximal seal, 11 - catheter, 12a - stabilizing structure, 12b - catheter guide passage, 40 - main housing, 41 - handle, 42 - rotating wheel of catheter insertion unit, 43 - needle guide structure, 44 - side port, 50 - syringe for drug injection. [Figure 15-2] Continued from Figure 15-1. [Figure 16A] 1A and 1B show a schematic diagram and an external view of an exemplary integrated device, respectively; [Figure 16B] 1A and 1B show a schematic diagram of an exemplary integrated device and an internal view of an exemplary integrated injection system. [Figure 17] 1 shows a structural diagram of an exemplary integrated device. The reference numerals in the drawings and the exemplary corresponding structures provided below are merely for illustration, see, for example, Figures 16 and 17, and should not be considered limiting. 1 - syringe barrel, 2 - push shaft, 3 - gasket seal, 4 - needle seat, 5 - needle, 6 - needle lumen, 7 - passageway, 8 - flowable composition lumen, 9 - through-hole, 10 - central passageway, 11 - valve, 12 - elastic element, 13 - catheter guide passageway, 14 - needle hub, 15 - needle side port, 16 - catheter, 17 - stabilizing structure, 18 - distal tip, 19 - side port, 20 - central chamber, 21 -, 40 - housing, 41 - handle, 42 - rotating wheel of catheter insertion unit, 43 - catheter storage mechanism. [Figure 18-1] 1A-1D show schematic diagrams of different stages of operating an exemplary integrated device. [Figure 18-2] Continuation of Figure 18-1.

Claims

1. 1. An apparatus comprising: a) a syringe barrel extending from a proximal end to a distal end, wherein the distal end of the syringe barrel includes a needle seat configured to be connected to a needle including a needle lumen, and wherein the needle seat includes a passage configured to be in fluid communication with the needle lumen; b) a gasket seal, the gasket seal and an interior wall of the syringe barrel forming a fluid-tight seal, wherein a flowable composition lumen is formed between the gasket seal and the distal end of the syringe barrel, and wherein the gasket seal includes a through hole configured to align with the passageway in the needle seat; c) a push shaft, the push shaft extending from a proximal end to a distal end, the distal end of the push shaft joining the gasket seal, and the push shaft a central passage including a distal end that aligns with the through-hole of the gasket seal; and a push shaft including a valve aligned with the proximal end of the central passage; d) a resilient element configured to actuate the push shaft to move the gasket seal distally along the axis of the syringe barrel; and e) a catheter configured for insertion through the valve and into the central passage; Device.

2. the needle is an epidural needle; 10. The apparatus of claim 1.

3. The needle is a Tuohy epidural needle, a Hustead epidural needle, a Crawford epidural needle, or a Weiss epidural needle.

3. The apparatus of claim 2.

4. The needle has a specified size between about 17 G and about 22 G (ISO-9626). An apparatus according to any one of claims 1 to 3.

5. The needle has a specified size of 17 G to 18 G (ISO-9626). An apparatus according to any one of claims 1 to 4.

6. The needle has a specified size of 19 G to 20 G (ISO-9626). An apparatus according to any one of claims 1 to 4.

7. the needle length is between about 2.5 inches and about 6 inches, and optionally the needle length is between about 3 inches and about 3.5 inches; An apparatus according to any one of claims 1 to 6.

8. The needle includes a straight or beveled distal tip. An apparatus according to any one of claims 1 to 7.

9. the needle includes a curved distal tip; An apparatus according to any one of claims 1 to 7.

10. the needle includes a distal tip having a blunt bevel; An apparatus according to any one of claims 1 to 9.

11. the needle includes a side port; An apparatus according to any one of claims 1 to 10.

12. the side port of the needle is configured to allow injection of an anesthetic agent through the needle lumen; 12. The apparatus of claim 11.

13. the gasket seal is configured to allow the catheter to be advanced distally through the through-hole, optionally wherein the through-hole is along the axis of the syringe barrel; An apparatus according to any one of claims 1 to 12.

14. the gasket seal is configured to allow or prevent proximal retraction of the catheter through the through-hole; An apparatus according to any one of claims 1 to 13.

15. the through-hole is configured to close or remain open when the catheter or the central passage is not inserted into the gasket seal; An apparatus according to any one of claims 1 to 14.

16. the through-hole is configured to allow the catheter or the central passageway to pass through the gasket seal.

16. Apparatus according to any one of claims 1 to 15.

17. a distal end of the central passageway passing through or adjacent the through-hole in the gasket seal; 17. Apparatus according to any one of claims 1 to 16.

18. a distal end of the central passageway extending distally beyond the gasket seal, or wherein the distal end of the central passageway is flush with the distal end of the through-hole, or wherein the distal end of the central passageway is flush with the proximal end of the through-hole; 18. Apparatus according to any one of claims 1 to 17.

19. the valve is at the proximal end of the central passage; 19. Apparatus according to any one of claims 1 to 18.

20. the push shaft further includes a central chamber in fluid communication with the central passage, at least a portion of the central chamber being between the valve and the proximal end of the central passage; 20. Apparatus according to any one of claims 1 to 19.

21. the valve is configured to allow unidirectional passage of the catheter.

21. Apparatus according to any one of claims 1 to 20.

22. The push shaft includes a catheter guide passage, and the valve is positioned at the distal end of the catheter guide passage.

22. Apparatus according to any one of claims 1 to 21.

23. the valve is at the distal end of the catheter guide passage; 23. The apparatus of claim 22.

24. the push shaft includes a side port configured to allow the catheter to pass through the side port and enter the catheter guide passage; 24. Apparatus according to claim 22 or claim 23.

25. the push shaft includes a locking mechanism configured to maintain the position of the gasket seal in the syringe barrel and the compressed or expanded state of the elastic element.

25. Apparatus according to any one of claims 1 to 24.

26. The elastic element comprises a spring, a rubber band, a bungee cord, a memory foam, an airbag, or a combination thereof.

26. Apparatus according to any one of claims 1 to 25.

27. a distal end of the elastic element is attached to a portion of the push shaft or the gasket seal, and a proximal end of the elastic element is attached to a portion of the syringe barrel; 27. Apparatus according to any one of claims 1 to 26.

28. the elastic element is configured to be compressed, and wherein decompression of the compressed elastic element applies a force to actuate the push shaft or the gasket seal, moving the gasket seal distally along the axis of the syringe barrel.

28. The apparatus of claim 27.

29. a distal end of the elastic element is attached to a portion of the syringe barrel, and a proximal end of the elastic element is attached to a portion of the push shaft or the gasket seal; 27. Apparatus according to any one of claims 1 to 26.

30. the elastic element is configured to be expanded, wherein contraction of the expanded elastic element applies a force to actuate the push shaft or the gasket seal, moving the gasket seal distally along the axis of the syringe barrel.

30. The apparatus of claim 29.

31. The catheter has a specified size of between about 19 G and about 20 G (ISO-9626).

31. Apparatus according to any one of claims 1 to 30.

32. a housing that accommodates at least a portion of the syringe barrel, at least a portion of the push shaft, and at least a portion of the catheter; 32. Apparatus according to any one of claims 1 to 31.

33. a catheter storage mechanism and a catheter actuation mechanism; 33. Apparatus according to any one of claims 1 to 32.

34. At least a portion of the catheter is inserted through the valve.

34. Apparatus according to any one of claims 1 to 33.

35. At least a portion of the catheter is inserted into the central passage.

35. Apparatus according to any one of claims 1 to 34.

36. At least a portion of the catheter passes through the through hole in the gasket seal.

36. Apparatus according to any one of claims 1 to 35.

37. At least a portion of the catheter passes through the passageway of the needle seat.

37. Apparatus according to any one of claims 1 to 36.

38. At least a portion of the catheter is inserted into the needle lumen.

38. Apparatus according to any one of claims 1 to 37.

39. the catheter includes a distal end configured to form a coil; 39. Apparatus according to any one of claims 1 to 38.

40. 1. An apparatus comprising: a) a syringe barrel extending from a proximal end to a distal end, the distal end of the syringe barrel including a needle seat connected to a needle including a needle lumen, the needle seat including a passage in fluid communication with the needle lumen; b) a gasket seal, the gasket seal and an inner wall of the syringe barrel forming a fluid-tight seal, the gasket seal adjacent the distal end of the syringe barrel, the gasket seal including a through hole that aligns with the passage in the needle seat; c) a push shaft, the push shaft extending from a proximal end to a distal end, the distal end of the push shaft joining the gasket seal, and the push shaft a central passage including a distal end that aligns with the through-hole of the gasket seal; and a push shaft including a valve aligned with the proximal end of the central passage; d) a spring, the distal end of the spring being attached to a portion of the push shaft and the proximal end of the spring being attached to a structure within or on the syringe barrel (e.g., a baffle), the spring being configured to be compressed, and decompression of the compressed spring actuating the push shaft or the gasket seal to move the gasket seal distally along the axis of the syringe barrel; e) a catheter configured to be inserted through the valve and enter the central passage; f) a housing, the housing accommodating at least a portion of the syringe barrel, at least a portion of the push shaft, and at least a portion of the catheter; Device.

41. 1. An apparatus comprising: a) a syringe barrel extending from a proximal end to a distal end, the distal end of the syringe barrel including a needle seat connected to a needle including a needle lumen, the needle seat including a passage in fluid communication with the needle lumen; b) a gasket seal, wherein the gasket seal and an interior wall of the syringe barrel form a fluid-tight seal, wherein a flowable composition lumen is formed between the gasket seal and the distal end of the syringe barrel, and wherein the gasket seal includes a through hole that aligns with the passageway in the needle seat; c) a push shaft, the push shaft extending from a proximal end to a distal end, the distal end of the push shaft joining the gasket seal, and the push shaft a central passage including a distal end that aligns with the through-hole of the gasket seal; and a push shaft including a valve aligned with the proximal end of the central passage; d) a spring, the distal end of which is attached to a portion of the push shaft and the proximal end of which is attached to a structure (e.g., a baffle) within or on the syringe barrel, the spring being compressed, and decompression of the compressed spring actuating the push shaft or the gasket seal to move the gasket seal distally along the axis of the syringe barrel; e) a catheter configured to be inserted through the valve and enter the central passage; f) a housing, the housing accommodating at least a portion of the syringe barrel, at least a portion of the push shaft, and at least a portion of the catheter; Device.

42. the flowable composition lumen contains a gas, optionally wherein the gas is air; 42. The apparatus of claim 41.

43. the flowable composition lumen is free of liquid; 43. Apparatus according to claim 41 or claim 42.

44. 1. An apparatus comprising: a) a syringe barrel extending from a proximal end to a distal end, the distal end of the syringe barrel including a needle seat connected to a needle including a needle lumen, the needle seat including a passage in fluid communication with the needle lumen; b) a gasket seal, said gasket seal and an inner wall of said syringe barrel forming a fluid-tight seal, said gasket seal including a through hole aligned with said passage in said needle seat; c) a push shaft, the push shaft extending from a proximal end to a distal end, the distal end of the push shaft joining the gasket seal, and the push shaft a central passage including a distal end that aligns with the through-hole of the gasket seal; and a push shaft including a valve aligned with the proximal end of the central passage; d) a spring, the distal end of which is connected to a portion of the push shaft and the proximal end of which is connected to a structure (e.g., a baffle) within the syringe barrel or on the syringe, the spring applying a force to the push shaft or the gasket seal, causing the gasket seal to abut the distal end of the syringe barrel and connecting the central passage with the passage in the needle seat; e) a catheter configured to be inserted through the valve and enter the central passage; f) a housing, the housing accommodating at least a portion of the syringe barrel, at least a portion of the push shaft, and at least a portion of the catheter; Device.

45. 1. An apparatus comprising: a) a syringe barrel extending from a proximal end to a distal end, the distal end of the syringe barrel including a needle seat connected to a needle including a needle lumen, the needle seat including a passage in fluid communication with the needle lumen; b) a gasket seal, said gasket seal and an inner wall of said syringe barrel forming a fluid-tight seal, said gasket seal including a through hole aligned with said passage in said needle seat; c) a push shaft, the push shaft extending from a proximal end to a distal end, the distal end of the push shaft joining the gasket seal, and the push shaft a central passage including a distal end aligned with the through hole of the gasket seal; a valve positioned at the proximal end of the central passage; a push shaft including a catheter guide passage, wherein the valve is aligned with a distal end of the catheter guide passage; d) a spring, the distal end of which is connected to a portion of the push shaft and the proximal end of which is connected to a structure (e.g., a baffle) within the syringe barrel or on the syringe, the spring applying a force to the push shaft or the gasket seal, causing the gasket seal to be adjacent to the distal end of the syringe barrel and connecting the central passage to the passage in the needle seat; e) a catheter, a portion of the catheter being within the catheter guide channel; f) a housing, the housing accommodating at least a portion of the syringe barrel, at least a portion of the push shaft, and at least a portion of the catheter; Device.

46. The distal end of the catheter is within the catheter guide passage of the push shaft.

46. ​​The apparatus of claim 45.

47. The distal end of the catheter is inserted through the valve of the push shaft.

46. ​​The apparatus of claim 45.

48. the distal end of the catheter is within the central passage of the push shaft or the through-hole of the gasket seal; 46. ​​The apparatus of claim 45.

49. the distal end of the catheter is within the passage of the needle seat; 46. ​​The apparatus of claim 45.

50. The distal end of the catheter is within the needle lumen of the needle.

46. ​​The apparatus of claim 45.

51. 1. A method for accessing the epidural space of a subject, comprising: a) connecting the needle to the device; wherein the needle includes a needle tip, a needle lumen, and a needle hub, and the device includes: i) a syringe barrel extending from a proximal end to a distal end, wherein the distal end of the syringe barrel includes a needle seat configured to be connected to a needle, and wherein the needle seat includes a passage configured to be in fluid communication with the needle lumen; ii) a gasket seal, the gasket seal and an inner wall of the syringe barrel forming a fluid-tight seal, the gasket seal adjacent the distal end of the syringe barrel, the gasket seal including a through hole along the axis of the syringe barrel, the through hole aligning with the passage in the needle seat; iii) a push shaft, the push shaft extending from a proximal end to a distal end, the distal end of the push shaft joining the gasket seal, and the push shaft comprising: a central passage including a distal end that aligns with the through-hole of the gasket seal; and a push shaft including a valve aligned with the proximal end of the central passage; iv) a spring, wherein a distal end of the spring is attached to a portion of the push shaft and a proximal end of the spring is attached to a structure within or on the syringe barrel (e.g., a baffle), wherein the spring is configured to be compressed; v) a catheter configured for insertion through the valve and into the central passage; b) actuating the push shaft proximally, thereby compressing the spring and forming a flowable composition lumen containing gas between the gasket seal and the distal end of the syringe barrel; method.

52. c) locking the push shaft to maintain the compression of the spring and the position of the gasket seal on the syringe barrel; 52. The method of claim 51.

53. d) advancing the needle tip within the subject's body toward a location within the subject's ligamentum flavum without the user having to grip the push shaft to maintain the spring in the compressed state.

53. The method of claim 52.

54. e) unlocking the push shaft when the needle tip is within the ligamentum flavum; 54. The method of claim 53.

55. f) advancing the needle tip through the ligamentum flavum and into the epidural space of the subject, thereby allowing the compressed spring to decompress and displacing the gasket seal distally to connect the central passage with the passage in the needle seat; 55. The method of claim 54.

56. g1) injecting an anesthetic agent into the needle lumen through a side port of the needle, thereby injecting an anesthetic agent into the epidural space of the subject; and / or g2) inserting a second needle through the side port of the needle, entering the needle lumen, and passing through the distal opening of the needle, thereby positioning the distal end of the second needle within the subject's subarachnoid space; injecting an anesthetic agent into the subarachnoid space through the second needle; and withdrawing the second needle from the subarachnoid space after injecting the anesthetic agent.

56. The method of claim 55.

57. h) inserting the catheter through the valve, the central passage, the through-hole, the passage, and the needle lumen, thereby positioning a distal portion of the catheter within the epidural space; 57. The method of claim 56.

58. i) disconnecting the needle from the needle seat to remove the catheter from the device, while retaining the distal portion of the catheter within the epidural space; 58. The method of claim 57.

59. using said catheter for epidural anesthesia by continuous infusion or intermittent bolus, optionally manually delivered intermittent bolus (MIB) and programmed intermittent bolus (PIB); 59. The method of any one of claims 51 to 58.

60. The catheter is used for surgical epidural anesthesia and / or postoperative analgesia.

60. The method of any one of claims 51 to 59.

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