Precise controllable injection of intercostal nerve block

Abstract

An injection system comprising: a syringe (1) extending from a proximal end to a distal end; a push shaft (2b) extending from a proximal end to a distal end, wherein the distal end of the push shaft (2b) is located inside the syringe (1); a drive unit comprising a drive member, an energy storage member and a floating seal (3), where the floating seal (3) is located inside the syringe (1), forming a seal between the floating seal and the syringe (1) and forming a chamber between the floating seal (3) and the distal end of the syringe (1), and where the floating seal (3) is resiliently engageable with the drive member via the energy storage member; and a needle (6) extending from the proximal end to the distal end and comprising an end opening; wherein the distal end of the push shaft (2b) is located at the proximal end of the floating seal (3); wherein the flowable composition is located in a chamber formed between the floating seal (3) and the distal end of the syringe (1); wherein the proximal end of the needle (6): a) is connected to the distal end of the syringe (1), or b) is connected to the distal end of the push shaft (2b), where the needle (6) further comprises a needle body opening located between the needle proximal end and the needle distal end, where the needle body opening is located proximal to the needle distal end opening, and a needle body channel connecting the needle distal end opening and the needle body opening.

Description

Cross - reference to related applications

[0001] This application claims priority to International Application No. PCT / CN2022 / 131456, filed on November 11, 2022, the entire content of which is incorporated herein by reference. Technical field

[0002] The present invention belongs to the technical field of anesthetic medical devices, and particularly relates to a drug delivery and injection device for intercostal nerve block under thoracoscopy. Background art

[0003] Intercostal nerve block (ICNB) is used to treat various acute and chronic pain conditions affecting the chest and upper abdomen (including pain after breast and chest wall surgery). With the increasing popularity of minimally invasive surgical techniques such as thoracoscopy, thoracic surgeons are performing an increasing number of intercostal nerve (ICN) block procedures under direct vision of the thoracoscope.

[0004] Currently, thoracoscopy - assisted ICNB is usually performed by injecting a needle close to the ICN to ensure its blocking effect, and the flexible needle is clamped by a forceps. During puncture, the puncture depth of the needle needs to be manually controlled, and medical staff need to rely on their experience to judge whether the needle reaches the target position (such as the intercostal space) in the extrapleural space (EPS). If the injection needle is mispositioned, this procedure may result in a weakened or ineffective ICN block, and / or even cause unnecessary damage to important surrounding organs and large blood vessels in the ICN or thoracic cavity (such as the heart, aorta, vena cava, azygos vein). Once punctured, these organs or tissues may cause massive bleeding, posing a significant risk to the patient's surgery and health. Therefore, there is an urgent need for improved medical puncture devices and methods that can achieve precise multiple injections in the EPS, thereby achieving safe, precise, and efficient ICNB. This disclosure is dedicated to solving this need and other needs. Summary

[0005] To address at least one defect or deficiency in existing devices and methods, in some aspects, the present disclosure provides a method for precisely injecting a drug into the EPS using a medical puncture / injection / syringe device, component, or system to achieve ICNB. The puncture / injection / syringe device, component, or system of the present disclosure is particularly suitable for achieving precise control of the puncture depth and needle insertion, as well as stable and quantitative multiple injections.

[0006] In some aspects, the present invention provides a method for performing ICNB through a pressure-sensitive injection system that can accurately locate target tissue spaces, cavities, or interstices, and the tip of the needle remains hidden until it reaches the target site. The disclosed puncture / injection / syringe device, assembly, or system also allows the user to externally monitor the insertion of the needle tip, enabling precise reaching of the target site (such as the EPS or intercostal space) and avoiding over-insertion or damage to surrounding tissues (such as blood vessels and / or nerves). In some embodiments, the disclosed puncture / injection / syringe device, assembly, or system employs an integrated structure with a controllable pressure-sensing syringe that can automatically deliver a measured dose of medication. In some embodiments, the disclosed puncture / injection / syringe device, assembly, or system has a flexible head for facilitating accurate positioning and easy close contact with the thoracic membrane (such as the parietal pleura).

[0007] In one aspect, the present disclosure provides a method for performing intercostal nerve block on a subject in need thereof, the method comprising: 1) providing an injection system comprising: a syringe barrel extending from a proximal end to a distal end; a plunger shaft extending from a proximal end to a distal end, wherein the distal end of the plunger shaft is located within the syringe barrel; a drive unit comprising a drive member, a storage member, and a floating seal, wherein the floating seal is located within the syringe barrel, forms a seal between the floating seal and the syringe barrel, and forms a chamber between the floating seal and the distal end of the syringe barrel, and wherein the floating seal is elastically engageable with the drive member via the storage member; and a needle extending from a proximal end to a distal end and comprising an end opening; wherein the distal end of the plunger shaft is located proximal to the floating seal; wherein a flowable composition is located within the chamber formed between the floating seal and the distal end of the syringe barrel; wherein the proximal end of the needle: a) is connected to the distal end of the syringe barrel, or b) is connected to the distal end of the plunger shaft, wherein the needle further comprises a needle body opening located between the proximal end and the distal end of the needle, wherein the needle body opening is proximal to the needle distal end opening, and a needle body channel connecting the needle distal end opening and the needle body opening; 2) controlling the drive member to compress the storage member without moving the floating seal; 3) advancing the distal end of the needle into a first target site within the intercostal space of the subject; and 4) continuing to advance the distal end of the needle until the distal end of the needle penetrates the parietal pleura of the subject and enters the extrapleural space, thereby allowing the storage member to release energy and driving the floating seal to move distally, whereby the flowable composition flows through the needle end opening into the extrapleural space.

[0008] In another aspect, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment as disclosed herein, wherein the injection system further includes a contact member and an elastic element, wherein the contact member is located at the distal end of the syringe barrel, the distal end of the needle, and the distal end of the elastic element, and wherein the contact member is configured to elastically engage with the distal end of the syringe barrel through the elastic element.

[0009] In yet another aspect, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment as disclosed herein, wherein the injection system further includes a syringe handle, and wherein the syringe handle is connected to the syringe barrel.

[0010] In yet another aspect, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment as disclosed herein, wherein the proximal end of the needle is connected to the distal end of the push shaft, wherein the needle further includes a needle body opening located between the proximal end of the needle and the distal end of the needle, wherein the needle body opening is proximal to the distal opening of the needle, and includes a needle body channel connecting the distal opening of the needle and the needle body opening; and wherein the injection system further includes a distal seal, wherein the distal seal is located within the syringe barrel and at the distal end of the syringe barrel. In some embodiments, the step of advancing the distal end of the needle toward the intercostal space of the subject includes: applying a force to the push shaft to overcome the resistance, causing the needle to move distally toward the parietal pleura of the subject and penetrate the parietal pleura of the subject without discharging the flowable composition.

[0011] In another aspect, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment as disclosed herein, wherein the proximal end of the needle is connected to the distal end of the syringe barrel; and wherein the step of advancing the distal end of the needle toward the intercostal space of the subject includes: controlling the syringe handle to compress the elastic element, thereby causing the distal end of the needle to advance toward the parietal pleura of the subject and penetrate the parietal pleura without discharging the flowable composition.

[0012] In another aspect, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment as disclosed herein, wherein the drive member is a pressing element configured to engage with a control knob. In some embodiments, the pressing element is cylindrical. In some embodiments, the step of controlling the drive member to compress the energy storage member without moving the floating seal includes: rotating the control knob to drive the pressing element, thereby applying a force to the energy storage member and compressing the energy storage member.

[0013] In yet another aspect, the present disclosure provides a method of performing an intercostal nerve block on a subject in need thereof as disclosed herein, which further comprises step 2a): after step 1) and before step 2), or after step 2) and before step 3), positioning the distal end of the syringe barrel towards a first target site within the intercostal space; wherein the contact member directly contacts the superficial tissue of the first target site. In some embodiments, step 2a) is after step 1) and before step 2).

[0014] In another aspect, the present disclosure provides a method of performing an intercostal nerve block on a subject in need thereof as disclosed herein, which further comprises step 5): withdrawing the needle from the first target site.

[0015] In another aspect, the present disclosure provides a method of performing an intercostal nerve block on a subject in need thereof as disclosed herein, which further comprises step 6): moving the injection system near a second target site, and then sequentially performing steps 2a')-2)-3')-4)-5'), wherein step 2a') comprises: positioning the distal end of the syringe barrel towards the second target site within the intercostal space, wherein the contact member directly contacts the superficial tissue of the second target site; wherein step 3') comprises: advancing the distal end of the needle towards the second target site within the intercostal space of the subject; and wherein step 5') comprises: withdrawing the needle from the second target site.

[0016] In another aspect, the present disclosure provides a method of performing an intercostal nerve block on a subject in need thereof as disclosed herein, which further comprises step 7): moving the injection system near a third target site, and then sequentially performing steps 2a'')-2)-3'')-4)-5''), wherein step 2a'') comprises: positioning the distal end of the syringe barrel towards the third target site within the intercostal space, wherein the contact member directly contacts the superficial tissue of the third target site; wherein step 3'') comprises: advancing the distal end of the needle towards the third target site within the intercostal space of the subject; and wherein step 5'') comprises: withdrawing the needle from the third target site.

[0017] In another aspect, the present disclosure provides a method of performing an intercostal nerve block on a subject in need thereof as disclosed herein, which further comprises step 8): moving the injection system near the next target site, and then sequentially performing steps 2a''')-2)-3''')-4)-5'''), wherein step 2a''') comprises: positioning the distal end of the syringe barrel towards the next target site within the intercostal space, wherein the contact member directly contacts the superficial tissue of the next target site; Step 3”’) includes: advancing the distal end of the needle into the next target site within the intercostal space of the subject; and Step 5”’) includes: withdrawing the needle from the next target site.

[0018] In another aspect, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment, wherein the energy storage member includes a spring and / or an elastic sheath.

[0019] In another aspect, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment, wherein the elastic element includes a spring and / or an elastic sheath.

[0020] In another aspect, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment, comprising: 1) Providing an injection system, comprising: a syringe barrel extending from a proximal end to a distal end and defining a chamber extending from the proximal end to the distal end; a push rod extending from the proximal end to the distal end and forming a seal between the distal end of the push rod and the syringe barrel; a floating seal disposed within the chamber near the distal end of the syringe barrel and forming a seal between the floating seal and the distal end of the syringe barrel; and a needle extending from the proximal end to the distal end and including an end opening; wherein the flowable composition is located in: a) the chamber between the distal end of the push rod and the floating seal, wherein the proximal end of the needle is connected to the floating seal; or b) the chamber between the floating seal and the distal end of the syringe barrel, wherein the proximal end of the needle is connected to the distal end of the push rod, and wherein the needle further includes: a needle body opening located between the proximal end and the distal end of the needle, wherein the needle body opening is proximal to the distal end opening of the needle; and a needle body channel connecting the distal end opening of the needle to the needle body opening; 2) Advancing the distal end of the needle into the intercostal space of the subject; and 3) Continuing to advance the distal end of the needle until the distal end of the needle penetrates the parietal pleura of the subject and enters the extrapleural space, thereby allowing the flowable composition to flow from the chamber through the end opening of the needle into the extrapleural space.

[0021] In another aspect, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment, wherein the step of advancing the distal end of the needle into the intercostal space of the subject includes: applying a force to the push rod to overcome the resistance and move the needle distally into the intercostal space of the subject without discharging the flowable composition into the parietal pleura or the extrapleural space.

[0022] In another aspect, the present disclosure provides a method of performing an intercostal nerve block on a subject in need thereof, wherein the flowable composition is located within a chamber between a floating seal and a distal end of a syringe barrel, and wherein the needle further comprises: a needle body opening located between a proximal end of the needle and a distal end of the needle, wherein the needle body opening is proximal to the distal opening of the needle; and a needle body channel connecting the distal opening of the needle and the needle body opening; wherein the proximal end of the needle is connected to the distal end of a push rod by a needle hub, wherein the needle hub and the floating seal are configured to elastically engage with each other, and wherein the needle hub is configured to advance the needle distally when a force is applied to the push rod. In some embodiments, prior to advancing the distal end of the needle, both the needle body opening and the distal opening of the needle are proximal to the floating seal. In some embodiments, the method of performing an intercostal nerve block on a subject in need thereof as disclosed herein comprises the step of advancing the distal end of the needle, wherein the needle body opening is proximal to the floating seal, wherein the distal opening of the needle is distal to the floating seal and within a chamber containing the flowable composition, and wherein the flowable composition is prevented from exiting through the distal opening of the needle. In some embodiments, the method of performing an intercostal nerve block on a subject in need thereof as disclosed herein comprises the step of advancing the distal end of the needle, wherein both the needle body opening and the distal opening of the needle are distal to the floating seal and within a chamber containing the flowable composition, and wherein the flowable composition is prevented from exiting through the distal opening of the needle. In some embodiments, the method of performing an intercostal nerve block on a subject in need thereof as disclosed herein comprises the step of advancing the distal end of the needle, wherein the needle body opening is distal to the floating seal and within a chamber containing the flowable composition, wherein the distal opening of the needle contacts tissue of the intercostal space of the subject, and wherein the flowable composition is prevented from exiting through the distal opening of the needle.

[0023] In another aspect, the present disclosure provides a method of performing an intercostal nerve block on a subject in need thereof, wherein the flowable composition is located within a chamber between a floating seal and a distal end of a syringe barrel, and wherein the needle further comprises: a needle body opening located between a proximal end of the needle and a distal end of the needle, wherein the needle body opening is proximal to the distal opening of the needle, and a needle body channel connecting the distal opening of the needle and the needle body opening; wherein the proximal end of the needle is connected to the distal end of a push rod by a needle hub, wherein the needle hub and the floating seal are configured to elastically engage with each other, and wherein the needle hub is configured to advance the needle distally when a force is applied to the push rod. In some embodiments, the method of performing an intercostal nerve block on a subject in need thereof as disclosed herein comprises the step of further advancing the distal end of the needle until the distal end of the needle penetrates the parietal pleura of the subject and enters the extrapleural space, wherein the needle body opening is within a chamber containing the flowable composition, wherein the distal opening of the needle is within the extrapleural space of the subject, and wherein the floating seal moves distally without further advancing the needle, thereby allowing the flowable composition to flow into the extrapleural space through the needle body opening, the needle body channel, and the distal opening.

[0024] In another aspect, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment, wherein the flowable composition is located within a chamber between the distal end of the push shaft and the floating seal, and wherein the proximal end of the needle is connected to the floating seal; the method includes the step of further advancing the distal end of the needle until it penetrates the parietal pleura of the subject and enters the extrapleural space, wherein the distal end of the needle extends through the parietal pleura of the subject's forehead and into the extrapleural space, thereby allowing the floating seal to move distally under resistance without further advancing the needle, thereby discharging the flowable composition through the needle tip opening into the extrapleural space.

[0025] In another aspect, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment, wherein the injection system further includes a syringe handle, and wherein the syringe handle is connected to the syringe barrel.

[0026] In another aspect, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment, wherein the injection system further includes a distal seal, and wherein the distal seal is located within the syringe barrel and at the distal end of the syringe barrel.

[0027] In another aspect, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment, wherein the injection system further includes a contact member and an elastic element, wherein the contact member is located at the distal end of the syringe barrel, the distal end of the needle, and the distal end of the elastic element; and wherein the contact member is configured to elastically engage with the distal end of the syringe barrel through the elastic element. In some embodiments, the method of performing an intercostal nerve block on a subject in need of treatment as disclosed herein further includes step 2a): after step 1) and before step 2), positioning the distal end of the syringe barrel towards the target site within the intercostal space, wherein the contact member directly contacts the surface tissue of the target site.

[0028] In another aspect, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment, wherein the method is performed under thoracoscopy.

[0029] In another aspect, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment, wherein the subject suffers from pain due to traumatic injury, cancer, and / or surgery in their abdominal or thoracic region.

[0030] In another aspect, the present disclosure provides a method for performing an intercostal nerve block on a subject in need of treatment, wherein the flowable composition comprises one or more anesthetics for intercostal nerve block, and optionally one or more additives. In some embodiments, the one or more anesthetics are selected from ropivacaine, dibucaine, bupivacaine, etidocaine, tetracaine, procaine, chloroprocaine, prilocaine, mepivacaine, lidocaine, xylocaine, and mixtures thereof. In some embodiments, the additive is epinephrine.

[0031] In another aspect, the present disclosure provides an injection system comprising: a syringe barrel extending from a proximal end to a distal end; a plunger shaft extending from a proximal end to a distal end, wherein the distal end of the plunger shaft is located within the syringe barrel; a drive unit comprising a drive member, a energy storage member, and a floating seal, wherein the floating seal is located within the syringe barrel, forms a seal between the floating seal and the syringe barrel, and forms a chamber between the floating seal and the distal end of the syringe barrel, and wherein the floating seal is elastically engageable with the drive member via the energy storage member; and a needle extending from a proximal end to a distal end and comprising an end opening; wherein the distal end of the plunger shaft is located proximal to the floating seal; wherein the flowable composition is located within the chamber formed between the floating seal and the distal end of the syringe barrel; wherein the proximal end of the needle: a) is connected to the distal end of the syringe barrel, or, b) is connected to the distal end of the plunger shaft, wherein the needle further comprises a needle body opening located between the proximal end and the distal end of the needle, wherein the needle body opening is proximal to the distal opening of the needle, and a needle body channel connecting the distal opening of the needle to the needle body opening.

[0032] In another aspect, the present disclosure provides the injection system as disclosed herein, which further comprises a contact member and an elastic element, wherein the contact member is located at the distal end of the syringe barrel, the distal end of the needle, and the distal end of the elastic element; and wherein the contact member is configured to be elastically engaged with the distal end of the syringe barrel via the elastic element.

[0033] In another aspect, the present disclosure provides the injection system as disclosed herein, which further comprises a syringe handle, wherein the syringe handle is connected to the syringe barrel.

[0034] In another aspect, the present disclosure provides the injection system as disclosed herein, wherein the proximal end of the needle is connected to the distal end of the plunger shaft, wherein the needle further comprises a needle body opening located between the proximal end and the distal end of the needle, wherein the needle body opening is proximal to the distal opening of the needle; and a needle body channel connecting the distal opening of the needle to the needle body opening, wherein the injection system further comprises a distal seal, and wherein the distal seal is located within the syringe barrel and at the distal end of the syringe barrel.

[0035] In another aspect, the present disclosure provides an injection system as disclosed herein, wherein the energy storage member includes a spring and / or an elastic sheath.

[0036] In another aspect, the present disclosure provides an injection system as disclosed herein, wherein the elastic element includes a spring and / or an elastic sheath.

[0037] In another aspect, the present disclosure provides an injection system as disclosed herein, wherein the needle is a hollow piercing needle.

[0038] In another aspect, the present disclosure provides an injection system as disclosed herein, wherein the contact member is a soft buffer.

[0039] In another aspect, the present disclosure provides an injection system as disclosed herein, wherein the drive member presses an element configured to engage with a control knob. In some embodiments, the push rod is configured to pass through and optionally engage with a cylindrical pressing element. In some embodiments, the pressing element is cylindrical.

[0040] In another aspect, the present disclosure provides an injection system as disclosed herein, wherein the chamber formed between the floating seal and the distal end of the syringe barrel is a flowable composition chamber.

[0041] In another aspect, the present disclosure provides an injection system comprising: A syringe barrel extending from a proximal end to a distal end; A push rod extending from a proximal end to a distal end, wherein the distal end of the push rod is located within the syringe barrel; A drive unit including a drive member, a spring, and a floating seal, wherein the floating seal is located within the syringe barrel, forms a seal between the floating seal and the syringe barrel, and forms a flowable composition chamber between the floating seal and the distal end of the syringe barrel, wherein the floating seal can be elastically engaged with the drive member through the spring, and wherein the drive member is a cylindrical pressing element configured to engage with a control knob; A needle extending from a proximal end to a distal end and including an end opening, wherein the proximal end of the needle is connected to the distal end of the syringe barrel, and wherein the needle is a hollow piercing needle; A buffer and an elastic element, wherein the buffer is located at the distal end of the syringe barrel, the distal end of the needle, and the distal end of the elastic element; and wherein the buffer is configured to be elastically engaged with the distal end of the syringe barrel through the elastic element, wherein the elastic element is a spring; and A syringe handle located at the proximal end of the syringe barrel; Wherein the distal end of the push rod is located proximal to the floating seal, and wherein the push rod is configured to pass through and optionally engage with the cylindrical pressing element.

[0042] In another aspect, the present disclosure provides an injection system comprising: A syringe barrel extending from a proximal end to a distal end; A push shaft extending from a proximal end to a distal end, wherein the distal end of the push shaft is located within the syringe barrel; A drive unit, which includes a drive member, a spring, and a floating seal, wherein the floating seal is located within the syringe barrel, a seal is formed between the floating seal and the syringe barrel, and a flowable composition chamber is formed between the floating seal and the distal end of the syringe barrel, wherein the floating seal can be elastically engaged with the drive member through the spring, and wherein the drive member is a cylindrical pressing element configured to engage with a control knob; A needle extending from a proximal end to a distal end and including an end opening, wherein the proximal end of the needle is connected to the distal end of the push shaft, wherein the needle further includes a needle body opening located between the proximal end and the distal end of the needle, wherein the needle body opening is proximal to the needle distal end opening, and a needle body channel connecting the needle distal end opening and the needle body opening; A distal seal located within the syringe barrel and at the distal end of the syringe barrel; A buffer member and an elastic element, wherein the buffer member is located at the distal end of the syringe barrel, the distal end of the needle, and the distal end of the elastic element; and wherein the buffer member is configured to be elastically engaged with the distal end of the syringe barrel through the elastic element, wherein the elastic element is a spring; and A syringe handle located at the proximal end of the syringe barrel; Wherein the distal end of the push shaft is proximal to the floating seal, and wherein the push shaft is configured to pass through and optionally engage with the cylindrical pressing element. Brief Introduction of the Drawings

[0043] The drawings illustrate the features of the present disclosure and the advantages of certain embodiments. These embodiments are not intended to limit the scope of the appended claims in any way.

[0044] Figure 1A - 1E Schematic diagrams showing different operating stages of an exemplary medical puncture device, for example, during puncture and injection into the extrapleural space or the intercostal space 14. Figure 1F Shows the steps of operating an exemplary medical puncture device in the absence of a contact member (e.g., Figure 1A - 1E as shown in 1b), wherein the distal seal (e.g., Figure 1A - 1E as shown in 8) can directly contact the tissue.

[0045] Figure 2A - 2F Schematic diagrams showing different operating stages of an exemplary medical puncture device, for example, during puncture and injection into the extrapleural space or the intercostal space 14. Figure 2F Shows the steps of operating an exemplary medical puncture device in the absence of a contact member (e.g., Figure 2A - 2E as shown in 1b), wherein the distal seal (e.g., Figure 2A - 2E as shown in 8) can directly contact the tissue. Figure 2GShows the steps of operating an exemplary medical puncture device, which includes an additional pressing element 2' that engages a floating seal 3 via another spring 4', while the pressing element 2 engages the floating seal 3 via a spring 4.

[0046] Figure 3A - 3F Is a partial structural diagram 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.

[0047] Figure 4A - 4C Is a partial structural diagram of an exemplary medical puncture device, which includes a floating seal 3 and a needle body opening 6b.

[0048] Figure 5A - 5F Is a partial structural diagram 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).

[0049] Figure 6 Shows a partial structural diagram of an exemplary medical puncture device, which includes a through inclined guide groove 3a' and a one-way valve 9.

[0050] Figure 7 Shows a partial structural diagram of an exemplary medical puncture device, which includes a through inclined guide groove 3a' and a one-way valve 9.

[0051] Figure 8 Shows a partial structural diagram of an exemplary medical puncture device, which includes a non-through inclined guide groove 3a'.

[0052] Figure 9 Shows a partial structural diagram of an exemplary medical puncture device, which includes an inclined guide needle hole 6c and a one-way valve 9.

[0053] Figure 10 Shows a partial structural diagram of an exemplary medical puncture device, which includes an inclined guide needle hole 6c and a needle hole plug 10.

[0054] Figure 11A - 11B Shows a schematic diagram of implanting a catheter 11 into an extrapleural space or an intercostal space 14 using an exemplary medical device assembly including a central guide groove 2c. Figure 11A Shows a contact member 1b in contact with tissue, while Figure 11B Shows a distal seal 8 in contact with tissue, without an intermediate contact member.

[0055] The following provides reference numerals and exemplary corresponding structures for illustrative purposes only. For example, refer to Figure 1A - 1E To Figure 11A - 11B, and should not be considered restrictive: 1 - syringe; 1a - axial limiter; 1b - annular contact element; 2b - push shaft; 2c - central guide groove; 3 - floating seal; 4 - elastic sheath; 5 - spring; 6 - hollow puncture needle; 6a - needle distal opening; 6b - needle body opening; 6c - inclined guide needle hole; 7 - flowable composition chamber; 8 - distal seal; 9 - one - way valve; 10 - needle hole plug; 11 - catheter; 12 - auxiliary guide needle; 13 - dense tissue (e.g., parietal pleura or muscle); 14 - extrapleural space or intercostal space.

[0056] Figure 12A - 12C Schematic diagrams showing different operating stages of an exemplary medical puncture device.

[0057] Figure 13A - 13B Schematic diagrams showing the appearance and structure of an exemplary injection system or medical puncture device, e.g., during puncture and injection of a drug into the extrapleural space (EPS) or intercostal space of a subject in need of treatment. Figure 13A Schematic diagram showing the appearance of an exemplary injection system or medical puncture device. Figure 13B Schematic diagram showing the structure of the exemplary injection system or medical puncture device, which includes a syringe 1 extending from proximal to distal; a push shaft 2b extending from proximal to distal, wherein the distal end of the push shaft 2b is located inside the syringe 1; a drive unit including a pressing element 2, a spring 5, and a floating seal 3, wherein the floating seal 3 is located inside the syringe 1, forms a seal between the floating seal 3 and the syringe 1, and forms a flowable composition chamber 7 between the floating seal 3 and the distal end of the syringe 1, wherein the floating seal 3 can be elastically engaged with the pressing element 2 through the spring 5, and wherein the pressing element 2 is configured to engage with a control knob 2b; a hollow puncture needle 6 extending from proximal to distal, which includes an end opening, a needle body opening located between the proximal end and the distal end of the needle, wherein the needle body opening is proximal to the needle distal opening, and a needle body channel connecting the needle distal opening and the needle body opening, wherein the proximal end of the needle 6 is connected to the distal end of the push shaft 2b; a distal seal 8 located inside the syringe 1 and at the distal end of the syringe 1; a contact element 25 and an elastic element 26, wherein the contact element 25 is configured to elastically engage with the distal end of the syringe 1 through the elastic element 26; and a syringe handle 41; wherein the contact element 25 can directly contact the tissue.

[0058] Figure 14 Schematic diagrams showing different operating steps of an exemplary injection system or medical puncture device.

[0059] Figure 15A - 15B Schematic diagrams showing the appearance and structure of an exemplary injection system or medical puncture device, e.g., during puncture and injection of a drug into the extrapleural space (EPS) or intercostal space of a subject in need of treatment. Figure 15AThe appearance view of the exemplary injection system or medical puncture device is shown. Figure 15B The structural view of the exemplary injection system or medical puncture device is shown, which includes an injection barrel 1 extending from the proximal end to the distal end; a push shaft 2b extending from the proximal end to the distal end, wherein the distal end of the push shaft 2b is located inside the injection barrel 1; a drive unit, which includes a pressing element 2, a spring 5 and a floating seal 3, wherein the floating seal 3 is located inside the injection barrel 1, forms a seal between the floating seal 3 and the injection barrel 1, and forms a flowable composition chamber 7 between the floating seal 3 and the distal end of the injection barrel 1, wherein the floating seal 3 can be elastically engaged with the pressing element 2 through the spring 5, and wherein the pressing element 2 is configured to engage with a control knob 2a; a hollow puncture needle 6 extending from the proximal end to the distal end and including an end opening, wherein the proximal end of the needle 6 is connected to the distal end of the injection barrel 1; a contact element 25 and an elastic element 26, wherein the contact element 25 is configured to be elastically engaged with the distal end of the injection barrel 1 through the elastic element 26; and a syringe handle 41; wherein the contact element 25 can directly contact the tissue.

[0060] Figure 16 The schematic views of different operation stages of the exemplary injection system or medical puncture device are shown.

[0061] The following provides reference numerals and exemplary corresponding structures for illustrative purposes only. For example, referring to FIG. 13- Figure 16 and should not be considered restrictive: 1 - injection barrel; 2 - pressing element; 2a - control knob; 2b - push shaft; 3 - floating seal; 5 - spring; 6 - hollow puncture needle; 7 - flowable composition chamber; 8 - distal seal; 25 - contact element; 26 - elastic element; 40 - main housing; 41 - syringe handle.

[0062] Figure 17 The schematic views of different operation stages of a syringe equipped with a contact member and a pressing unit are shown.

[0063] The following provides reference numerals and exemplary corresponding structures for illustrative purposes only. For example, referring to Figure 17 and should not be considered restrictive: 1 - injection barrel; 2b - push shaft; 3 - floating seal; 25 - contact member; A - high-density tissue; B - low-density tissue.

[0064] Figure 18A - 18H The schematic views of an exemplary contact member, a second elastic element and a connecting member as part of an additional device are shown.

[0065] The following provides reference numerals and exemplary corresponding structures for illustrative purposes only. For example, referring to FIG. 18 of Figure 18A - 18H, and should not be considered restrictive: 1 - syringe barrel; 6 - hollow puncture needle (the distal opening of the needle and the opening of the needle body are not shown); 25 - contact member; 25a - the first part of the contact member; 25b - the second part of the contact member; 26 - second elastic element; 27 - connecting member.

[0066] Figure 19A - 19B Schematic diagram showing an exemplary pressing element as part of an additional device.

[0067] The following provides reference numerals and exemplary corresponding structures only for illustrative purposes. For example, referring to FIG. 19 Figure 19A - 19B , and should not be considered restrictive: 1 - syringe barrel; 2b - push rod; 30 - pressing unit; 31 - first elastic element; 32 - limiter or locking element.

[0068] The following provides reference numerals and exemplary corresponding structures only for illustrative purposes and should not be considered restrictive: 1 - syringe barrel; 1a - axial limiter; 1b - annular contact element; 2 - pressing element; 2’ - additional pressing element; 2a - control knob; 2b - push rod; 2c - central guiding groove; 3 - floating seal; 3a - first floating seal; 3b - second floating seal; 3a’ - inclined guiding groove; 4 - elastic sheath; 4’ - spring; 5 - spring; 6 - hollow puncture needle; 6a - distal opening of the needle; 6b, 6b1, 6b2 - openings of the needle body; 6c - inclined guiding needle hole; 7 - cavity for the flowable composition; 8 - distal seal; 9 - one - way valve; 10 - needle hole plug; 11 - catheter; 12 - auxiliary guiding needle; 13 - dense tissue (e.g., parietal pleura or muscle); 14 - extrapleural space (EPS) or intercostal space; 25 - contact member; 25a - the first part of the contact member; The second part of the 25b - contact member; 26 - Elastic element; 27 - Connecting member (e.g., the connecting member in the pressing unit); 30 - Pressing unit; 31 - First elastic element (e.g., the first elastic element in the pressing unit); 32 - Limiter or locking element (e.g., the limiter or locking element in the pressing unit); 40 – Main housing; 41 - Syringe handle. Detailed description

[0069] The following is a detailed description of some embodiments of the present disclosure. It should be understood that the specific embodiments described herein are intended to illustrate and explain the embodiments of the present disclosure and should not be considered restrictive.

[0070] It should be noted that when there is no conflict, the embodiments of the present disclosure and the features of the embodiments can be combined in any appropriate manner.

[0071] In some embodiments, the positional descriptions such as "front", "back", "forward", "backward", "distal", and "proximal" are based on the perspective of the operator of the medical puncture device or the medical device component. That is, when the operator is using the medical puncture device or the medical device component, the direction away from the operator and relatively far from the operator is the forward direction, and the direction pointing to the operator and relatively close to the operator is the backward direction.

[0072] As used herein, the terms "proximal" and "distal" respectively refer to the directions closer to and farther from the operator (e.g., surgeon, physician, nurse, technician, etc.) who inserts the medical device into the patient's body, where the tip (distal end) of the device is first inserted into the patient's body. Thus, for example, the end of the needle (e.g., microneedle) described herein that is first inserted into the patient's body is the distal end, and the opposite end of the needle (e.g., the end of the medical device manipulated by the operator) is the proximal end of the needle.

[0073] As used herein, unless the context clearly dictates otherwise, the singular forms "a", "an", and "the" include plural referents. For example, "a" or "an" means "at least one" or "one or more". Similarly, the term "member" is intended to mean a single member or a combination of members, and the term "material" is intended to mean one or more materials or a combination thereof.

[0074] As used herein, the terms "about" or "approximately" refer to the conventional error range of the corresponding value known to those skilled in the art. The "about" values or parameters mentioned herein include (and describe) embodiments involving the value or parameter itself. For example, "about" can refer to within 1 or greater standard deviations according to the practice in the relevant art. Alternatively, "about" can refer to a range of up to 20%, up to 10%, up to 5%, or up to 1% of a given value.

[0075] Throughout this disclosure, various aspects are presented in range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as a rigid limitation on the scope of the disclosure. Accordingly, the description of a range should be considered to specifically disclose all possible sub-ranges as well as the individual numerical values within that range. For example, in the case of providing a range of values, it should be understood that each intermediate value between the upper and lower limits of that range, as well as any other stated or intermediate value within the range, is encompassed within the disclosure. The upper and lower limits of these smaller ranges can be independently included in the smaller ranges and are also encompassed within the disclosure, subject to any specific exclusions within the stated range. Where the stated range includes one or both of the limiting values, those ranges excluding one or both of the included limiting values are also included in the disclosure. This applies regardless of how broad the range is.

[0076] As used in the claims, the use of ordinal numbers such as "first," "second," "third," etc. to modify the claim elements themselves does not mean that one claim element is prior to, ahead of, or chronologically before another claim element or the chronological order of performing the acts of a method, but is merely used as a label to distinguish one claim element having a certain name from another element having the same name (but using an ordinal number) to distinguish the claim elements. Similarly, the use of a), b), etc. or i), ii), etc. themselves does not imply any priority, precedence, or order of the steps in the claims. Similarly, the use of these terms in the specification does not imply any required priority, precedence, or order.

[0077] As used herein, the terms "puncturing member" and "punctured member" are used interchangeably and refer to an article configured to puncture a tissue layer and deliver a substance to a target tissue layer, such as a needle or a microneedle.

[0078] As used herein, the terms "drug container" and "drug-containing chamber" are used interchangeably and refer to an article (such as a syringe) configured to hold a volume of a substance (such as a drug or medicine).

[0079] As used herein, the term "intercostal space" refers to the anatomical space between two adjacent ribs. Since there are twelve ribs on each side, there are eleven intercostal spaces, each of which is numbered according to the rib above it. An intercostal space includes the external intercostal muscle, the internal intercostal muscle, and the innermost intercostal muscle arranged in three layers, as well as the intercostal neurovascular bundle composed of the intercostal vein, artery, and nerve, which is located between the internal intercostal muscle and the innermost intercostal muscle.

[0080] As used herein, the term "extrapleural space" or its abbreviation "EPS" refers to the anatomical area between the inner surface of the rib and the parietal pleura. The EPS may contain adipose tissue (such as extrapleural fat), loose connective tissue, lymph nodes, blood vessels, endothoracic fascia, and muscle tissue (such as the innermost intercostal muscle).

[0081] As used herein, the terms "intercostal groove" and "costal groove" are used interchangeably and refer to the groove structure on the inner surface of the lower edge of the rib for accommodating the intercostal neurovascular bundle composed of the intercostal blood vessels and nerves.

[0082] All publications mentioned in this application (including patent documents, scientific articles, and databases) are incorporated herein by reference in their entirety for all purposes to the same extent as if each individual publication were incorporated by reference separately. If the definitions set forth herein are contrary to or otherwise inconsistent with the definitions set forth in the patents, applications, published applications, and other publications incorporated herein by reference, the definitions set forth herein shall control.

[0083] The section headings used herein are for organizational purposes only and should not be construed as limiting the subject matter described. I. Review

[0084] Pain was once regarded as the fifth vital sign of the human body after respiration, pulse, blood pressure, and body temperature, and is receiving increasing attention due to its impact on physical and mental health and quality of life (Clara Scher et al. 2018). Traditional thoracic surgery is an invasive surgery that causes large incisions and severe postoperative pain. Compared with traditional thoracic surgery, video-assisted thoracic surgery has the advantages of shorter operation time, less intraoperative bleeding, and faster postoperative recovery, resulting in smaller incisions, fewer complications, and being more conducive to postoperative adjuvant treatment (Tianci Chai et al. 2019). However, most patients still experience varying degrees of pain after video-assisted thoracic surgery.

[0085] Pain after thoracic surgery can make patients reluctant to cough, expectorate, or take deep breaths, which may lead to postoperative respiratory dysfunction and trigger complications such as hypoxemia, hypercapnia, pulmonary infection, atelectasis, and arrhythmia, thereby affecting postoperative recovery, prolonging hospital stay, and increasing hospitalization costs. Therefore, postoperative analgesia is a necessary treatment measure.

[0086] The traditional postoperative analgesia method after thoracic surgery is thoracic epidural block. However, its application is limited due to the risk of spinal cord injury. Paravertebral block and percutaneous intercostal nerve block are also used for postoperative analgesia. They require percutaneous puncture under ultrasound guidance to inject local anesthetic into the paravertebral space or the lower edge of the rib to relieve pain. However, they also have limitations in clinical application. For example, they require a high level of professional technical skills for positioning; they need to be operated or guided by an experienced anesthesiologist, and at the same time, bedside ultrasound equipment is required, which increases the human and material costs; and the incidence of complications is relatively high, such as iatrogenic pneumothorax, hematoma, inaccurate analgesic effect, and even severe local anesthetic toxicity reactions.

[0087] ICNB can be used to treat various acute and chronic pain conditions affecting the chest and upper abdomen (including pain after breast and chest wall surgery). The ICNs innervate most of the skin and muscle tissues of the chest and abdominal wall (Anthony M.-H. Ho, et al. 2022). Each ICN originates from the spinal nerve root at the same vertebral level as the rib it accompanies. Once it leaves the intervertebral foramen, the ICN lies between the parietal pleura and the innermost intercostal muscle. Within a few centimeters, the nerve penetrates between the internal intercostal muscle and the innermost intercostal muscle and remains in this position until it terminates at the anterior chest wall or abdomen (Caleb S. Baxter et al. 2022, Mario G Santamarina, et al. 2017).

[0088] With the widespread application of minimally invasive surgical techniques such as thoracoscopy, the operation of performing ICN block under direct vision by medical practitioners (such as thoracic surgeons) has gradually increased. Thoracoscopy-assisted ICNB is usually carried out by using a forceps (such as an oval forceps) to hold a flexible injection needle, puncturing the parietal pleura and then reaching the target injection site. Aspiration is usually required before injection to avoid misinjection of the drug into the blood vessel, and then multiple ICNBs can be performed in sequence (Andres Obeso 2018). If bleeding occurs during the puncture process, it is usually necessary to stop the bleeding by electrocoagulation or gauze compression, and then re-puncture and inject.

[0089] Implementing ICNB under thoracoscopy requires extremely high operational skills from medical practitioners and often involves collaboration among several people. During puncture, a flexible needle is clamped with a surgical forceps. After finding the blocking point, the operator needs to adjust the position of the needle, pierce the pleura, and then manually push the syringe to administer the drug. Repeat these procedures at other sites for injection until the blocking process is completed. Therefore, the puncture depth of the needle needs to be manually controlled, and medical practitioners must rely on experience to judge whether the needle has reached the target site (such as the intercostal groove) within the EPS. If the injection needle is not accurately positioned, this procedure may lead to a weakened or ineffective ICN block, and / or even cause unnecessary damage to important surrounding organs and large blood vessels within the ICN or the thoracic cavity (such as the heart, aorta, vena cava, azygos vein). Once punctured, these organs or tissues may cause massive bleeding, posing a significant risk to the patient's surgery and health. Therefore, there is a great clinical need and practical significance in providing an improved injection device and method that can accurately inject EPS at multiple target sites, thereby achieving safe, accurate, and efficient ICNB. This disclosure is dedicated to addressing this need and other needs.

[0090] To address the problems of the prior art (such as those described above), this disclosure provides a syringe or injection device, kit, assembly, or system and its method of use, which has at least the following advantages in achieving ICNB: 1) It can accurately locate and inject drugs into the EPS at one or more target sites, obtaining an improved blocking effect; 2) The needle remains hidden until it reaches the puncture site, minimizing potential damage to surrounding tissues (such as important organs and blood vessels); 3) It can have an integrated structure, equipped with a controllable pressure-sensing syringe, enabling quantitative and automatic drug administration; 4) It has a flexible head, which allows for accurate positioning and easy and tight contact with the thoracic membrane (such as the parietal pleura); and 5) The provided injection device or system can easily enter through a surgical incision or trocar, enabling convenient and rapid injection of drugs (such as analgesic drugs). This invention significantly reduces the surgical risk and operational difficulty, simplifies the operation process of ICNB and pain management, and improves efficiency.

[0091] In some embodiments, this disclosure provides a method for performing intercostal nerve block on a subject in need of treatment, which includes: 1) Providing an injection system, which includes: a syringe barrel extending from proximal to distal; a push rod extending from proximal to distal, wherein the distal end of the push rod is located within the syringe barrel; a drive unit, which includes a drive member, an energy storage member, and a floating seal, wherein the floating seal is located within the syringe barrel, forms a seal between the floating seal and the syringe barrel, and forms a chamber between the floating seal and the distal end of the syringe barrel, and wherein the floating seal can be elastically engaged with the drive member through the energy storage member; and a needle extending from proximal to distal and including an end opening; wherein the distal end of the push rod is located proximal to the floating seal; wherein the flowable composition is located within a chamber formed between the floating seal and the distal end of the syringe barrel; wherein the proximal end of the needle: a) is connected to the distal end of the syringe barrel; or b) is connected to the distal end of the push rod, wherein the needle further includes a needle body opening located between the proximal end and the distal end of the needle, wherein the needle body opening is proximal to the distal opening of the needle, and a needle body channel connecting the distal opening of the needle and the needle body opening; 2) controlling the drive member to compress the energy storage member without moving the floating seal; 3) advancing the distal end of the needle toward a first target site within the intercostal space of the subject; and 4) continuing to advance the distal end of the needle until the distal end of the needle penetrates the parietal pleura of the subject and enters the extrapleural space, thereby allowing the energy storage member to release energy, causing the floating seal to move distally, whereby the flowable composition flows through the needle tip opening into the extrapleural space.

[0092] In some embodiments, the present disclosure provides a method of performing an intercostal nerve block on a subject in need thereof as disclosed herein, wherein the injection system further includes a contact member and an elastic element, wherein the contact member is located at the distal end of the syringe barrel, the distal end of the needle, and the distal end of the elastic element; and wherein the contact member is configured to elastically engage with the distal end of the syringe barrel through the elastic element.

[0093] In some embodiments, the present disclosure provides a method of performing an intercostal nerve block on a subject in need thereof as disclosed herein, wherein the injection system further includes a syringe handle, wherein the syringe handle is connected to the syringe barrel.

[0094] In some embodiments, the present disclosure provides a method of performing an intercostal nerve block on a subject in need thereof as disclosed herein, wherein the proximal end of the needle is connected to the distal end of the push rod; wherein the needle further includes a needle body opening located between the proximal end and the distal end of the needle, wherein the needle body opening is proximal to the distal opening of the needle, and a needle body channel connecting the distal opening of the needle and the needle body opening; and wherein the injection system further includes a distal seal, wherein the distal seal is located within the syringe barrel and at the distal end of the syringe barrel. In some embodiments, the step of advancing the distal end of the needle toward the intercostal space of the subject includes: applying a force to the push rod to overcome the resistance, causing the needle to move distally toward the parietal pleura of the subject and penetrate the parietal pleura of the subject without discharging the flowable composition.

[0095] In some embodiments, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment, wherein the proximal end of the needle is connected to the distal end of the syringe barrel; and wherein the step of advancing the distal end of the needle toward the intercostal space of the subject comprises: controlling the syringe handle to compress an elastic element, thereby moving the distal end of the needle toward the parietal pleura of the subject and piercing the parietal pleura of the subject without expelling the flowable composition.

[0096] In some embodiments, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment, wherein the drive member is a pressing element configured to engage a control knob. In some embodiments, the pressing element is cylindrical. In some embodiments, the step of controlling the drive member to compress the energy storage member without moving the floating seal comprises: rotating the control knob to drive the pressing element, thereby applying a force to the energy storage member to compress the energy storage member.

[0097] In some embodiments, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment, which further comprises step 2a): after step 1) and before step 2), or after step 2) and before step 3), positioning the distal end of the syringe barrel toward a first target site within the intercostal space; wherein the contact member is in direct contact with the superficial tissue of the first target site. In some embodiments, step 2a) is performed after step 1) and before step 2).

[0098] In some embodiments, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment, which further comprises step 5): withdrawing the needle from the first target site.

[0099] In some embodiments, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment, which further comprises step 6): moving the injection system near a second target site, and then sequentially performing steps 2a')-2)-3')-4)-5'), wherein step 2a') comprises: positioning the distal end of the syringe barrel toward a second target site within the intercostal space, wherein the contact member is in direct contact with the superficial tissue of the second target site; wherein step 3') comprises: advancing the distal end of the needle toward the second target site within the intercostal space of the subject; and wherein step 5') comprises: withdrawing the needle from the second target site.

[0100] In some embodiments, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment, which further comprises step 7): moving the injection system near a third target site, and then sequentially performing steps 2a'')-2)-3'')-4)-5''), Step 2a”) includes: positioning the distal end of the syringe barrel towards a third target site within the intercostal space, wherein the contact member is in direct contact with the superficial tissue of the third target site; Step 3”) includes: advancing the distal end of the needle towards a third target site within the intercostal space of the subject; and Step 5”) includes: withdrawing the needle from the third target site.

[0101] In some embodiments, the present disclosure provides a method for performing an intercostal nerve block on a subject in need of treatment as disclosed herein, further comprising step 8): moving the injection system near the next target site, and then sequentially performing steps 2a”’)-2)-3”’)-4)-5”’), wherein step 2a”’) includes: positioning the distal end of the syringe barrel towards the next target site within the intercostal space, wherein the contact member is in direct contact with the superficial tissue of the target site; wherein step 3”’) includes: advancing the distal end of the needle towards the next target site within the intercostal space of the subject; and wherein step 5”’) includes: withdrawing the needle from the next target site.

[0102] In some embodiments, the present disclosure provides a method for performing an intercostal nerve block on a subject in need of treatment, comprising: 1) Providing an injection system, comprising: a syringe barrel extending from a proximal end to a distal end and forming a chamber extending from the proximal end to the distal end; a push rod extending from the proximal end to the distal end and forming a seal between the distal end of the push rod and the syringe barrel; a floating seal disposed within the chamber near the distal end of the syringe barrel and forming a seal between the floating seal and the distal end of the syringe barrel; and a needle extending from the proximal end to the distal end and including an end opening; wherein the flowable composition is located in: a) the chamber between the distal end of the push rod and the floating seal, wherein the proximal end of the needle is connected to the floating seal, or b) the chamber between the floating seal and the distal end of the syringe barrel, wherein the proximal end of the needle is connected to the distal end of the push rod, and wherein the needle further comprises: a needle body opening located between the proximal end and the distal end of the needle, wherein the needle body opening is proximal to the distal opening of the needle, and a needle body channel connecting the distal opening of the needle and the needle body opening; 2) Advancing the distal end of the needle towards the intercostal space of the subject; and 3) Continuing to advance the distal end of the needle until the distal end of the needle penetrates the parietal pleura of the subject into the extrapleural space, thereby allowing the flowable composition to flow from the chamber through the end opening of the needle into the extrapleural space.

[0103] In some embodiments, the present disclosure provides a method of performing an intercostal nerve block on a subject in need thereof as disclosed herein, wherein the step of advancing the distal end of the needle towards the intercostal space of the subject comprises: applying a force to the push shaft to overcome the resistance, thereby causing the needle to move distally and enter the intercostal space of the subject without discharging the flowable composition into the parietal pleura or the extrapleural space.

[0104] In some embodiments, the present disclosure provides a method of performing an intercostal nerve block on a subject in need thereof as disclosed herein, wherein the flowable composition is located in a chamber between the floating seal and the distal end of the syringe barrel, and wherein the needle further comprises: a needle body opening located between the proximal end and the distal end of the needle, wherein the needle body opening is proximal to the distal opening of the needle, and a needle body channel connecting the distal opening of the needle to the needle body opening; wherein the proximal end of the needle is connected to the distal end of the push shaft through a needle hub, wherein the needle hub and the floating seal are configured to elastically engage with each other, and wherein the needle hub is arranged to cause the needle to advance distally when a force is applied to the push shaft. In some embodiments, prior to the step of advancing the distal end of the needle, both the needle body opening and the needle tip opening are proximal to the floating seal. In some embodiments, the method of performing an intercostal nerve block on a subject in need thereof as disclosed herein comprises the step of advancing the distal end of the needle, wherein the needle body opening is proximal to the floating seal, wherein the needle tip opening is distal to the floating seal and is located in a chamber containing the flowable composition, and wherein the discharge of the flowable composition from the needle tip opening is prevented. In some embodiments, the method of performing an intercostal nerve block on a subject in need thereof as disclosed herein comprises the step of advancing the distal end of the needle, wherein both the needle body opening and the needle tip opening are distal to the floating seal and are located in a chamber containing the flowable composition, and wherein the discharge of the flowable composition from the needle tip opening is prevented. In some embodiments, the method of performing an intercostal nerve block on a subject in need thereof as disclosed herein comprises the step of advancing the distal end of the needle, wherein the needle body opening is distal to the floating seal and is located in a chamber containing the flowable composition, wherein the needle tip opening contacts the intercostal space tissue of the subject, and wherein the discharge of the flowable composition from the needle tip opening is prevented.

[0105] In some embodiments, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment, wherein a flowable composition is located in a chamber between a floating seal and a distal end of a syringe barrel, and wherein the needle further comprises: a needle body opening between a proximal end of the needle and a distal end of the needle, wherein the needle body opening is proximal to the distal opening of the needle, and a needle body channel connecting the distal opening of the needle and the needle body opening; wherein the proximal end of the needle is connected to the distal end of a push rod by a needle hub, wherein the needle hub and the floating seal are configured to elastically engage with each other, and wherein the needle hub is configured to advance the needle distally when a force is applied to the push rod. In some embodiments, the method of performing an intercostal nerve block on a subject in need of treatment as disclosed herein includes the step of continuing to advance the distal end of the needle until the distal end of the needle penetrates the parietal pleura of the subject and enters the extrapleural space, wherein the needle body opening is in the chamber containing the flowable composition, wherein the end opening of the needle is in the extrapleural space of the subject, and wherein the floating seal moves distally while the needle is not further advanced, thereby allowing the flowable composition to flow into the extrapleural space through the needle body opening, the needle body channel, and the end opening of the needle.

[0106] In some embodiments, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment, wherein a flowable composition is located in a chamber between the distal end of a push rod and a floating seal, wherein the proximal end of the needle is connected to the floating seal, and the method includes the step of continuing to advance the distal end of the needle until the distal end of the needle penetrates the parietal pleura of the subject and enters the extrapleural space, wherein the distal end of the needle penetrates the parietal pleura of the subject and enters the extrapleural space, such that the floating seal is resisted and moves distally while the needle is not further advanced, thereby discharging the flowable composition through the end opening of the needle into the extrapleural space.

[0107] In some embodiments, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment, wherein the injection system further comprises a syringe handle, and wherein the syringe handle is connected to the syringe barrel.

[0108] In some embodiments, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment, wherein the injection system further comprises a distal seal, and wherein the distal seal is located within the syringe barrel and at the distal end of the syringe barrel.

[0109] In some embodiments, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment as disclosed herein, wherein the injection system further comprises a contact member and an elastic element, wherein the contact member is located at the distal end of the syringe barrel, the distal end of the needle, and the distal end of the elastic element; and wherein the contact member is configured to elastically engage with the distal end of the syringe barrel through the elastic element. In some embodiments, the method of performing an intercostal nerve block on a subject in need of treatment as disclosed herein further comprises step 2a): after step 1) and before step 2), positioning the distal end of the syringe barrel towards the target site within the intercostal space, wherein the contact member is in direct contact with the superficial tissue of the target site.

[0110] In some embodiments, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment as disclosed herein, wherein the method is performed under thoracoscopy.

[0111] In some embodiments, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment as disclosed herein, wherein the subject suffers from pain due to traumatic injury, cancer, and / or surgery in their abdominal or thoracic region.

[0112] In some embodiments, the present disclosure provides a method of performing an intercostal nerve block on a subject in need of treatment as disclosed herein, wherein the flowable composition comprises one or more anesthetics for intercostal nerve block, and optionally one or more additives. In some embodiments, the one or more anesthetics are selected from ropivacaine, dibucaine, bupivacaine, etidocaine, tetracaine, procaine, chloroprocaine, prilocaine, mepivacaine, lidocaine, xylocaine, bupivacaine, levobupivacaine, marcaine, naropin, sensorcaine, or any combination thereof. In some embodiments, the flowable composition further comprises one or more additives. In some embodiments, the additive is epinephrine. In some embodiments, the additives include analgesics known in the art, for example, including but not limited to: α-2 agonists (including but not limited to clonidine, dexmedetomidine, dexamethasone, and tizanidine); opioids (including but not limited to oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, morphine, codeine, methadone, tramadol, and buprenorphine); non-steroidal anti-inflammatory drugs (NSAIDs) (including but not limited to COX-1 inhibitors, COX-2 inhibitors, COX-1+2 inhibitors, ketorolac, diclofenac, parecoxib, and ibuprofen).

[0113] In some embodiments, the present disclosure provides an injection system comprising: a syringe barrel extending from a proximal end to a distal end; a plunger shaft extending from a proximal end to a distal end, wherein the distal end of the plunger shaft is located within the syringe barrel; a drive unit comprising a drive member, a energy storage member, and a floating seal, wherein the floating seal is located within the syringe barrel, forming a seal between the floating seal and the syringe barrel and forming a chamber between the floating seal and the distal end of the syringe barrel; and wherein the floating seal is elastically engageable with the drive member via the energy storage member; and a needle extending from a proximal end to a distal end and including an end opening. wherein the distal end of the plunger shaft is located proximal to the floating seal, wherein a flowable composition is located within the chamber formed between the floating seal and the distal end of the syringe barrel; wherein the proximal end of the needle is connected to the distal end of the syringe barrel.

[0114] In some embodiments, the present disclosure provides an injection system comprising: a syringe barrel extending from a proximal end to a distal end; a plunger shaft extending from a proximal end to a distal end, wherein the distal end of the plunger shaft is located within the syringe barrel; a drive unit comprising a drive member, a energy storage member, and a floating seal, wherein the floating seal is located within the syringe barrel, forming a seal between the floating seal and the syringe barrel and forming a chamber between the floating seal and the distal end of the syringe barrel, and wherein the floating seal is elastically engageable with the drive member via the energy storage member; and a needle extending from a proximal end to a distal end and including an end opening. wherein the distal end of the plunger shaft is located proximal to the floating seal; wherein a flowable composition is located within the chamber formed between the floating seal and the distal end of the syringe barrel; wherein the proximal end of the needle is connected to the distal end of the plunger shaft, wherein the needle further comprises a needle body opening located between the proximal end and the distal end of the needle, wherein the needle body opening is proximal to the needle distal end opening, and a needle body channel connecting the needle distal end opening and the needle body opening. In some embodiments, the injection system further comprises a distal seal, wherein the distal seal is located within the syringe barrel and at the distal end of the syringe barrel.

[0115] In some embodiments, the present disclosure provides the injection system as disclosed herein, further comprising a contact member and an elastic element, wherein the contact member is located at the distal end of the syringe barrel, the distal end of the needle, and the distal end of the elastic element; wherein the contact member is configured to be elastically engaged with the distal end of the syringe barrel via the elastic element.

[0116] In some embodiments, the present disclosure provides the injection system as disclosed herein, further comprising a syringe handle, wherein the syringe handle is connected to the syringe barrel.

[0117] In some embodiments, the present disclosure provides an injection system as disclosed herein, wherein the drive member is a pressing element configured to engage with a control knob. In some embodiments, the push rod is configured to pass through and optionally engage with a cylindrical pressing element. In some embodiments, the pressing element is cylindrical.

[0118] In some embodiments, the present disclosure provides an injection system as disclosed herein, wherein the chamber formed between the floating seal and the distal end of the syringe barrel is a chamber for the flowable composition.

[0119] In some embodiments, the present disclosure provides an injection system comprising: A syringe barrel extending from a proximal end to a distal end; A push rod extending from a proximal end to a distal end, wherein the distal end of the push rod is located within the syringe barrel; A drive unit including a drive member, a spring, and a floating seal, wherein the floating seal is located within the syringe barrel, forms a seal between the floating seal and the syringe barrel, and forms a chamber for the flowable composition between the floating seal and the distal end of the syringe barrel, wherein the floating seal is elastically engageable with the drive member through the spring, and wherein the drive member is a cylindrical pressing element configured to engage with a control knob; A needle extending from a proximal end to a distal end and including an end opening, wherein the proximal end of the needle is connected to the distal end of the syringe barrel, and wherein the needle is a hollow piercing needle; A buffer and an elastic element, wherein the buffer is located at the distal end of the syringe barrel, the distal end of the needle, and the distal end of the elastic element; and wherein the buffer is configured to be elastically engaged with the distal end of the syringe barrel through the elastic element, wherein the elastic element is a spring; and A syringe handle located at the proximal end of the syringe barrel; Wherein the distal end of the push rod is located proximal to the floating seal, and wherein the push rod is configured to pass through and optionally engage with the cylindrical pressing element.

[0120] In some embodiments, the present disclosure provides an injection system comprising: A syringe barrel extending from a proximal end to a distal end; A push rod extending from a proximal end to a distal end, wherein the distal end of the push rod is located within the syringe barrel; A drive unit including a drive member, a spring, and a floating seal, wherein the floating seal is located within the syringe barrel, forms a seal between the floating seal and the syringe barrel, and forms a chamber for the flowable composition between the floating seal and the distal end of the syringe barrel, wherein the floating seal is elastically engageable with the drive member through the spring, and wherein the drive member is a cylindrical pressing element configured to engage with a control knob; A needle extending from a proximal end to a distal end and including an end opening, wherein the proximal end of the needle is connected to the distal end of a push shaft, wherein the needle further includes a needle body opening located between the proximal end and the distal end of the needle, wherein the needle body opening is proximal to the distal opening of the needle, and a needle body channel connecting the distal opening of the needle and the needle body opening; A distal seal located within the syringe barrel and at the distal end of the syringe barrel; A buffer member and an elastic member, wherein the buffer member is located at the distal end of the syringe barrel, the distal end of the needle, and the distal end of the elastic member, and wherein the buffer member is configured to be elastically engaged with the distal end of the syringe barrel through the elastic member, wherein the elastic member is a spring; and A syringe handle located at the proximal end of the syringe barrel; wherein the distal end of the push shaft is proximal to the floating seal, and wherein the push shaft is configured to pass through and optionally engage a cylindrical pressing element.

[0121] Other features and advantages of the present disclosure will be described in detail in the following description.

[0122] Some embodiments of the present disclosure will be described in conjunction with the accompanying drawings. II. Systems and Devices

[0123] In some embodiments, systems and devices are described herein for assisting in the insertion of a piercing member (such as a needle or microneedle) into the intercostal space and / or assisting in the injection of a drug into an EPS target site to achieve ICNB. In some embodiments, systems and devices are described herein for controlling the depth of insertion of a piercing member (such as a microneedle) into the intercostal space in order to deliver an anesthetic agent to a site near the intercostal nerve in, for example, the EPS.

[0124] In some embodiments, an injection system or device is provided herein that includes: a syringe barrel extending from a proximal end to a distal end and forming a chamber extending from the proximal end to the distal end; a push shaft extending from the proximal end to the distal end and forming a seal between the distal end of the push shaft and the syringe barrel; a floating seal disposed within the chamber near the distal end of the syringe barrel and forming a seal between the floating seal and the distal end of the syringe barrel; and a needle extending from the proximal end to the distal end and including an end opening for allowing a flowable composition (such as an anesthetic solution) to flow out of the chamber through the distal end of the syringe barrel via the needle; wherein the flowable composition is located within the chamber between the distal end of the push shaft and the floating seal, and wherein the proximal end of the needle is connected to the floating seal.

[0125] In some embodiments, the injection systems disclosed herein further include a contact member and an optional elastic element, wherein the contact member is located distally of the distal end of the syringe barrel and the distal end of the needle. In some embodiments, the contact member is configured to elastically engage with the distal end of the syringe barrel via the elastic element. In some embodiments, the contact member is in direct contact with the surface tissue of the target site. In some embodiments, the contact member and the elastic element engage with each other to provide an elastic buffer for the force applied to the needle, thereby preventing the needle from penetrating too deeply.

[0126] In some embodiments, provided herein is an injection system or device comprising: a syringe barrel extending from a proximal end to a distal end and defining a chamber extending from the proximal end to the distal end; a push rod extending from the proximal end to the distal end and forming a seal between the distal end of the push rod and the syringe barrel; a floating seal disposed within the chamber near the distal end of the syringe barrel and forming a seal between the floating seal and the distal end of the syringe barrel; and a needle extending from the proximal end to the distal end and including an end opening for allowing a flowable composition (such as anesthetic solution) to flow out of the chamber through the distal end of the syringe barrel via the needle, wherein the flowable composition is located within the chamber between the floating seal and the distal end of the syringe barrel, wherein the proximal end of the needle is connected to the distal end of the push rod, and wherein the needle further includes: a needle body opening located between the proximal end and the distal end of the needle, wherein the needle body opening is proximal to the needle distal opening, and a needle body channel connecting the needle distal opening and the needle body opening.

[0127] In some embodiments, the injection system or device comprises: a syringe barrel including a proximal end and a distal end; a floating seal disposed within the syringe barrel; a needle seat located proximal to the floating seal (e.g., the needle seat is closer to the operator while the floating seal is closer to the subject), and the floating seal and the needle seat are configured to elastically engage with each other. In some embodiments, the system further includes a needle including a proximal end and a distal end of the needle, and the proximal end of the needle engages with the needle seat. In any of the embodiments herein, the proximal end of the needle may be fixed to the needle seat or detachably connected to (such as inserted into) the needle seat. In any of the embodiments herein, the needle may include: (i) a needle distal opening; (ii) a needle body opening located between the proximal end and the distal end of the needle; and (iii) a needle body channel connecting the needle distal opening and the needle body opening. In any of the embodiments herein, the needle body opening may be proximal to the needle end opening. In any of the embodiments herein, the needle seat may be configured to advance the needle distally towards the floating seal (e.g., when the distal end of the needle is close to the floating seal), through the floating seal (e.g., when the distal end of the needle enters or pierces the floating seal) and / or through the distal end of the syringe barrel.

[0128] In some embodiments, the present disclosure provides an injection system or device that includes: a syringe barrel extending from a proximal end to a distal end; a plunger shaft extending from a proximal end to a distal end, wherein the distal end of the plunger shaft is located within the syringe barrel; a drive unit that includes a drive member, a energy storage member, and a floating seal, wherein the floating seal is located within the syringe barrel, forms a seal between the floating seal and the syringe barrel, and forms a chamber between the floating seal and the distal end of the syringe barrel, and wherein the floating seal is elastically engageable with the drive member through the energy storage member; and a needle extending from a proximal end to a distal end and including an end opening; wherein the distal end of the plunger shaft is located proximal to the floating seal; wherein a flowable composition is located within the chamber formed between the floating seal and the distal end of the syringe barrel; wherein the proximal end of the needle: a) is connected to the distal end of the syringe barrel; or b) is connected to the distal end of the plunger shaft, wherein the needle further includes a needle body opening located between the proximal end of the needle and the distal end of the needle, wherein the needle body opening is proximal to the distal opening of the needle, and a needle body channel connecting the distal opening of the needle and the needle body opening.

[0129] In some embodiments, the injection system or device disclosed herein includes: a syringe barrel extending from a proximal end to a distal end; a plunger shaft extending from a proximal end to a distal end, wherein the distal end of the plunger shaft is located within the syringe barrel; a drive unit that includes a drive member, a energy storage member, and a floating seal, wherein the floating seal is located within the syringe barrel, forms a seal between the floating seal and the syringe barrel, and forms a chamber between the floating seal and the distal end of the syringe barrel, and wherein the floating seal is elastically engageable with the drive member through the energy storage member; and a needle extending from a proximal end to a distal end and including an end opening; wherein the distal end of the plunger shaft is located proximal to the floating seal; wherein a flowable composition is located within the chamber formed between the floating seal and the distal end of the syringe barrel; wherein the proximal end of the needle is connected to the distal end of the syringe barrel.

[0130] In some embodiments, the injection system or device disclosed herein includes: a syringe barrel extending from a proximal end to a distal end; a plunger shaft extending from a proximal end to a distal end, wherein the distal end of the plunger shaft is located within the syringe barrel; a drive unit including a drive member, an energy storage member, and a floating seal, wherein the floating seal is located within the syringe barrel, forms a seal between the floating seal and the syringe barrel, and forms a chamber between the floating seal and the distal end of the syringe barrel, and wherein the floating seal is elastically engageable with the drive member via the energy storage member; and a needle extending from a proximal end to a distal end and including an end opening; wherein the distal end of the plunger shaft is located proximal to the floating seal; wherein the flowable composition is located within the chamber between the floating seal and the distal end of the syringe barrel; wherein the proximal end of the needle is connected to the distal end of the plunger shaft, wherein the needle further includes a needle body opening located between the proximal end and the distal end of the needle, wherein the needle body opening is proximal to the needle distal opening, and a needle body channel connecting the needle distal opening and the needle body opening. In some embodiments, the injection system or device further includes a distal seal, and wherein the distal seal is located within the syringe barrel and at the distal end of the syringe barrel.

[0131] In some embodiments, the chamber formed between the floating seal and the distal end of the syringe barrel disclosed herein is a flowable composition chamber.

[0132] In some embodiments, the energy storage member of the injection system or device disclosed herein includes a spring and / or an elastic sheath.

[0133] In some embodiments, the drive member of the injection system or device disclosed herein is a push element configured to engage with a control knob. In some embodiments, the plunger shaft is configured to pass through and optionally engage with the push element. In some embodiments, the push element is cylindrical.

[0134] In some embodiments, the injection system or device disclosed herein further includes a contact member and an elastic element, wherein the contact member is located at the distal end of the syringe barrel, the distal end of the needle, and the distal end of the elastic element; and wherein the contact member is configured to elastically engage with the distal end of the syringe barrel via the elastic element. In some embodiments, the contact member includes a soft cushioning member. In some embodiments, the elastic element includes a spring and / or an elastic sheath.

[0135] In some embodiments, the injection system or device disclosed herein further includes a syringe handle, wherein the syringe handle is connected to the syringe barrel.

[0136] In any of the embodiments disclosed herein, the needle can be a hollow piercing needle.

[0137] In some embodiments, the injection systems or devices disclosed herein include: a syringe barrel extending from a proximal end to a distal end; a plunger shaft extending from a proximal end to a distal end, wherein the distal end of the plunger shaft is located within the syringe barrel; a drive unit including a drive member, a spring, and a floating seal, wherein the floating seal is located within the syringe barrel, forms a seal between the floating seal and the syringe barrel, and forms a flowable composition chamber between the floating seal and the distal end of the syringe barrel, wherein the floating seal is elastically engageable with the drive member via the spring, and wherein the drive member is a cylindrical pressing element configured to engage with a control knob; a needle extending from a proximal end to a distal end and including an end opening, wherein the proximal end of the needle is connected to the distal end of the syringe barrel, and wherein the needle is a hollow piercing needle; a buffer and an elastic element, wherein the buffer is located at the distal end of the syringe barrel, the distal end of the needle, and the distal end of the elastic element; and wherein the buffer is configured to be elastically engaged with the distal end of the syringe barrel via the elastic element, wherein the elastic element is a spring; and a syringe handle located at the proximal end of the syringe barrel; wherein the distal end of the plunger shaft is located proximal to the floating seal, and wherein the plunger shaft is configured to pass through and optionally engage with the cylindrical pressing element.

[0138] In some embodiments, the injection systems or devices disclosed herein include: a syringe barrel extending from a proximal end to a distal end; a plunger shaft extending from a proximal end to a distal end, wherein the distal end of the plunger shaft is located within the syringe barrel; a drive unit including a drive member, a spring, and a floating seal, wherein the floating seal is located within the syringe barrel, forms a seal between the floating seal and the syringe barrel, and forms a flowable composition chamber between the floating seal and the distal end of the syringe barrel, wherein the floating seal is elastically engageable with the drive member via the spring, and wherein the drive member is a cylindrical pressing element configured to engage with a control knob; a needle extending from a proximal end to a distal end and including an end opening, wherein the proximal end of the needle is connected to the distal end of the plunger shaft, wherein the needle further includes a needle body opening located between the proximal end of the needle and the distal end of the needle, wherein the needle body opening is proximal to the distal opening of the needle, and a needle body channel connecting the distal opening of the needle and the needle body opening; a distal seal located within the syringe barrel and at the distal end of the syringe barrel; a buffer and an elastic element, wherein the buffer is located at the distal end of the syringe barrel, the distal end of the needle, and the distal end of the elastic element; and wherein the buffer is configured to be elastically engaged with the distal end of the syringe barrel via the elastic element, wherein the elastic element is a spring; and a syringe handle located at the proximal end of the syringe barrel; wherein the distal end of the plunger shaft is located proximal to the floating seal, and wherein the plunger shaft is configured to pass through and optionally engage with the cylindrical pressing element.

[0139] In any of the embodiments disclosed herein, a proximal chamber and a distal chamber may be provided on different sides of a floating seal within a syringe barrel. In some embodiments, the distal chamber contains a flowable composition (such as a drug, a pharmaceutical product, and / or a pharmaceutically acceptable carrier or excipient, such as saline), while the proximal chamber does not contain a non-gaseous flowable composition. The proximal chamber may be pre-filled with a gas, such as sterilized air, and / or be capable of communicating with the external environment (such as the atmosphere) when the needle is advanced and / or passed through the syringe barrel.

[0140] In some embodiments, the needle included in the embodiments described herein has a bevel, which facilitates the needle to puncture tissue (such as an intercostal space or a space near the intercostal nerve) while minimizing collateral damage. In some embodiments, the needle disclosed herein may define a narrow chamber (for example, a gauge size greater than or equal to 27-gauge, 28-gauge, 29-gauge, 30-gauge, 32-gauge, 34-gauge, 36-gauge, etc.) for performing ICNB while minimizing the needle tract diameter caused by needle insertion. In some embodiments, the chamber and bevel aspect ratio of the needle described herein is the same as or different from that of the standard 22-gauge to 25-gauge needles commonly used for ICNB.

[0141] In some embodiments, the injection system or device disclosed herein includes or is configured to be connected to a drug container containing a drug (such as a gel, etc.). The drug container may be at least partially constituted by a syringe barrel.

[0142] In some embodiments, the needle is connected to the distal end of the drug container (for example, the needle is located at the distal end of the syringe), such as described in 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, US10,555,833, and US10,517,756, which are hereby incorporated by reference for all purposes. In some embodiments, prior to use, the needle is neither exposed at the distal end of the syringe barrel nor directly engaged with the distal end of the syringe barrel. In some embodiments, the needle is at least partially located within the syringe barrel. In some embodiments, the present disclosure uses a needle connected to a floating seal within the syringe barrel. In some embodiments, the needle is connected to the distal end of a push rod within the syringe barrel.

[0143] In some embodiments, the proximal end of the needle is directly connected to the floating seal. In other embodiments, the proximal end of the needle is connected to the distal end of the push shaft through a needle hub, and the injection system disclosed herein further includes an energy storage member (e.g., one or more springs) configured to engage the needle hub with the floating seal. In some embodiments, the distal portion of the energy storage member is configured to be located within the syringe barrel and directly or indirectly engage the floating seal. In some embodiments, the energy storage member is configured to generate a force on the proximal portion of the floating seal. In some embodiments, when the distal tip of the needle is located within an apparent or potential tissue void, chamber, or space, the force is sufficient to cause the floating seal to move within the syringe barrel, thereby delivering at least a portion of the substance from the drug container (e.g., a flowable composition chamber) through the needle. Additionally, when the distal tip of the needle is located within tissue adjacent (e.g., above or below) an apparent or potential tissue void, chamber, or space (e.g., an EPS or intercostal groove), the force is not sufficient to cause the floating seal to move within the syringe barrel. In some embodiments, the apparent or potential tissue void, chamber, or EPS has a first density, and the adjacent tissue has a second density higher than the first density. In some embodiments, the apparent or potential tissue void, chamber, or space generates a first back pressure, and the adjacent tissue generates a second back pressure higher than the first back pressure.

[0144] In some embodiments, the needle is connected to the floating seal. In some embodiments, the proximal end of the needle is directly connected to the floating seal. In other embodiments, the proximal end of the needle is connected to a push shaft within the syringe barrel, where the push shaft is separately provided and located 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 located distal to the floating seal or may pass through the floating seal, but the proximal end of the needle remains distal to the floating seal and is not fixedly connected to the floating seal.

[0145] In some embodiments, a drug container (e.g., containing a liquid) is provided between a proximal seal and a distal seal (each of which is movable within the syringe barrel), such as described in US2020 / 0069883, which is hereby incorporated by reference for all purposes. In those devices, a force applied proximal to the proximal seal is transmitted through the liquid to the distal seal connected to the needle.

[0146] In some embodiments of the present disclosure, a drug container (e.g., a flowable composition chamber) is provided between the floating seal and the distal end of the syringe barrel (wherein the distal end does not move relative to the syringe barrel). In some embodiments, the distal end of the syringe barrel includes a distal seal, and a flowable composition chamber is provided between the floating seal and the distal seal. In some embodiments, since the needle hub is elastically connected to the floating seal (and thus to the flowable composition), this elastic connection can help the operator apply an appropriate force and buffer the impact of the force. In addition, the operator can keep the needle hub stationary relative to the syringe barrel and observe the movement of the floating seal to evaluate the depth of needle insertion. Once fluid communication is established between the flowable composition and an apparent or potential tissue void, chamber, or space (e.g., EPS or intercostal groove), and the pressure in the flowable composition is greater than the pressure in the apparent or potential tissue void, chamber, or space (e.g., EPS or intercostal groove), the floating seal can move when the flowable composition enters the tissue (e.g., EPS or intercostal space) without the needle and needle hub moving. Thus, accurate needle placement and stable injection can be achieved, and the probability of the needle being inserted too deeply can be effectively reduced or eliminated.

[0147] In some embodiments that can be combined with any of the above or below embodiments, the devices disclosed herein are provided and / or packaged in the form of an integrated device that includes components that engage with each other. In some embodiments, the devices disclosed herein do not require the operator to assemble one or more components before use. In some embodiments, the devices disclosed herein include a pre-filled drug container (e.g., a flowable composition chamber) that contains a flowable composition, such as a drug in the form of a liquid, solution, suspension, emulsion, gel, oil, and / or ointment, etc.

[0148] The flowable composition includes a liquid (e.g., a solution, suspension, etc.) or a semi-solid composition (e.g., a gel) that is easy to manipulate and injectable near a target tissue (e.g., the intercostal nerve). "Flowable" encompasses formulations ranging from low viscosity or aqueous consistency to high viscosity, such as viscoelastic or pasty materials. In various embodiments, the flowability of the flowable composition enables it to conform to the irregularities, crevices, fissures, and / or voids of the tissue site. In some embodiments, the flowable composition comprises one or more pharmaceuticals or drugs. In some embodiments, the flowable composition comprises one or more anesthetics for ICNB. Exemplary anesthetics include those known in the art. For example, they include, but are not limited to, ropivacaine, dibucaine, bupivacaine, etidocaine, tetracaine, procaine, chloroprocaine, prilocaine, mepivacaine, lidocaine, xylocaine, bupivacaine, levobupivacaine, marcaine, naropin, sensorcaine, or any combination thereof. In some embodiments, the flowable composition comprises one or more anesthetics for ICNB and one or more additives. In some embodiments, the additive includes epinephrine. In some embodiments, the additive includes analgesics known in the art, e.g., including but not limited to α-2 agonists (including but not limited to clonidine, dexmedetomidine, dexamethasone, and tizanidine); opioids (including but not limited to oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, morphine, codeine, methadone, tramadol, and buprenorphine); and non-steroidal anti-inflammatory drugs (NSAIDs) (including but not limited to COX-1 inhibitors, COX-2 inhibitors, COX-1+2 inhibitors, ketorolac, diclofenac, parecoxib, and ibuprofen).

[0149] In some embodiments that can be combined with any of the embodiments described herein, one or more components of the system or device disclosed herein can be configured to assemble with each other. For example, the system or device can include one or more syringes.

[0150] In some embodiments, the system or device may include two or more units, such as a first syringe unit, which includes: a first barrel; a needle hub located within the first barrel; and a needle including a needle proximal end and a needle distal end that engages the needle hub. In some embodiments, the system or device may include a second syringe unit configured to engage the distal end of the first syringe unit, including: a second barrel, and a floating seal located within the second barrel, the floating seal being configured to elastically engage the needle hub when the first and second syringe units are engaged. In some embodiments, the system or device may include a third syringe unit configured to engage the distal end of the second syringe unit, including a third barrel containing a flowable composition (such as an anesthetic solution), and the needle hub may be configured to advance the needle to place the needle proximal end and / or the needle distal end within the flowable composition. In any of the embodiments herein, the system or device may include one or more syringe units, optionally including a fourth syringe unit configured to engage the distal end of the third syringe unit.

[0151] In some embodiments, the system or device may include a first syringe unit, which includes: a first barrel; a needle hub and a floating seal located within the first barrel and elastically engaging each other, wherein the needle hub is located proximal to the floating seal; and a needle including a needle proximal end and a needle distal end that engages the needle hub, the needle including: (i) a needle distal opening, (ii) a needle body opening located between the needle proximal end and the needle distal end, wherein the needle body opening is proximal to the needle distal opening, and (iii) a needle body channel 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 engage the distal end of the first syringe unit, including a second barrel containing a flowable composition (such as an anesthetic solution), and the needle hub may be configured to advance the needle to place the needle proximal end and / or the needle distal end within the flowable composition. In any of the embodiments herein, the device may include one or more syringe units, optionally including a third syringe unit configured to engage the distal end of the second syringe unit.

[0152] In some embodiments, the device or system may include a first syringe unit, comprising: a first barrel; a needle seat located within the first barrel; and a needle including a proximal end of the needle engaged with the needle seat and a distal end of the needle, the needle including: (i) a distal opening of the needle, (ii) a body opening of the needle located between the proximal end and the distal end of the needle, wherein the body opening is proximal to the distal opening of the needle, and (iii) a body channel connecting the distal opening of the needle and the body opening of the needle. In some embodiments, the system or device may further include a second syringe unit configured to connect to the distal end of the first syringe unit, comprising: a second barrel; a floating seal located within the second barrel, the floating seal configured to elastically engage with the needle seat when the first and second syringe units are engaged; and a flowable composition (such as anesthetic solution), and the needle seat may be configured to advance the needle to place the proximal end and / or the distal end of the needle within the flowable composition. In any of the embodiments herein, the device may include one or more syringe units, optionally including a third syringe unit configured to engage with the distal end of the second syringe unit.

[0153] In some embodiments, the present disclosure provides a medical puncture device, comprising: a barrel, wherein the barrel includes a distal end and a proximal open end; a push shaft extending from the proximal end to the distal end and forming a seal between the distal end of the push shaft and the barrel; and a floating seal, wherein the floating seal is located within the barrel and is elastically engageable with the push shaft; a hollow puncture needle connected to the push shaft, wherein the hollow puncture needle includes a distal opening of the needle and a body opening of the needle, and wherein the body opening of the needle is proximal to the floating seal (the distal opening of the needle may be proximal to the floating seal, for example, the entire length of the needle is proximal to the floating seal; or, the needle may pass through the floating seal such that the distal opening of the needle is distal to the floating seal); and a chamber for a flowable composition (such as anesthetic solution) formed by the distal end of the barrel, the barrel chamber wall (e.g., a portion of the barrel), and the floating seal. In some embodiments, the distal end of the barrel does not include a distal seal. In some embodiments, the distal end of the barrel is connected to a distal seal located within the barrel.

[0154] In some embodiments, the medical puncturing device is configured such that the hollow puncturing needle can be advanced forward by pressing the push shaft. In some embodiments, the hollow puncturing needle punctures a floating seal and the distal end of the syringe barrel in sequence, thereby connecting the flowable composition cavity, the needle body opening, and the needle distal opening. In some embodiments, the hollow puncturing needle is pre-inserted into the floating seal. For example, the needle distal opening may be located within the floating seal and blocked by the floating seal, and the needle can be advanced through the flowable composition cavity to pierce the end of the syringe barrel. In some embodiments, the hollow puncturing needle pre-passes through the floating seal. In some embodiments, the distal end of the syringe barrel does not include a distal seal. In some embodiments, the distal end of the syringe barrel is connected to a distal seal located within the syringe barrel. For example, the needle distal opening may be located within the flowable composition cavity, while the needle body opening is located proximal to the floating seal or within the floating seal (e.g., as Figure 3E shown, the needle body opening may be blocked by the floating seal), and then the needle can be advanced to pierce the distal end of the syringe barrel. In some embodiments, the hollow puncturing needle pre-passes through the floating seal and is located at or passes through the distal end of the syringe barrel. For example, the needle distal opening may be located within the distal seal at the distal end of the syringe barrel (e.g., the needle distal opening may be blocked by the distal seal), or at the distal end of the distal seal and / or the distal end of the syringe barrel, while the needle body opening is located proximal to the floating seal (e.g., as Figure 3D , 6b1 shown), within the floating seal (e.g., as Figure 3D , 6b2 shown, the needle body opening may be blocked by the floating seal), or within the flowable composition cavity (e.g., as Figure 3D , 6b3 shown), and then the needle can be advanced through the distal end of the syringe barrel and the needle distal opening can be exposed to puncture tissue.

[0155] In some embodiments that can be combined with any of the embodiments herein, the present disclosure provides an injection system or a medical puncturing device that further includes a contact member extending from a proximal end to a distal end, wherein the contact member can be assembled to a needle seat connected to the distal end of the syringe barrel, or can be assembled to the distal end of the syringe barrel, wherein the distal end of the contact member is located at the distal end of the needle distal opening and the distal end of the syringe barrel, and wherein the distal end of the contact member can be in direct contact with the surface tissue (e.g., parietal pleura) of the target site. In some embodiments, the contact member can provide a buffering effect to reduce the risk of the needle being inserted too deeply. In some embodiments, the proximal end of the contact member is in direct contact with the needle seat. In some embodiments, as Figure 18A shown, after assembling the contact element 25 to a conventional syringe, the proximal end of the contact member is in direct contact with the distal end of the syringe barrel 1. In some embodiments, after assembling the contact member to a conventional syringe, the proximal end of the contact member is in direct contact with the needle seat. In some embodiments, as Figure 18AAs shown, after the contact member is assembled to a conventional syringe, the proximal end of the contact member is in direct contact with the needle hub or syringe barrel, and the contact element 25 is made of one or more materials with a low elastic modulus (e.g., Young's modulus). In some embodiments, the Young's modulus of the contact member is from about 0.001 GPa to about 10 GPa.

[0156] In some embodiments, the injection system or medical puncture device disclosed herein further includes the contact member described herein and a second elastic element (e.g., Figure 18C - 18E 26 in), wherein after the contact member is assembled to the distal end of the syringe barrel or the needle hub connected to the distal end of the syringe barrel, the second elastic element elastically connects the proximal end of the contact member to the distal end of the syringe barrel or the needle hub. In some of the above embodiments, as Figure 18B shown, the contact element 25 has a high elastic modulus (e.g., Young's modulus) and is elastically engaged with the distal end of the needle hub or syringe barrel through the second elastic element 26. In some embodiments, the Young's modulus of the contact element is greater than 10 GPa. In some embodiments, the elastic modulus of the contact element is greater than the elastic modulus of the second elastic element. In some embodiments, the contact member includes a first portion and a second portion, wherein the first portion is located distal to the second portion. In some embodiments, the first portion and the second portion have different elasticities. In some embodiments, the elasticity of the first portion is greater than the elasticity of the second portion. In some embodiments, the elasticity of the first portion is less than the elasticity of the second portion. In some embodiments, as Figure 18D shown, the contact member 25 includes a first portion 25a and a second portion 25b, wherein the elasticity of the first portion 25a is greater than the elasticity of the second portion 25b, the first portion 25a is located distal to the second portion 25b, and the proximal end of the second portion 25b is connected to the needle hub or syringe barrel through the second elastic element 26.

[0157] In some embodiments, the injection system or medical puncture device disclosed herein further includes the contact member described herein and a connecting member (e.g., Figure 18F 27 in), wherein after the contact member is assembled to the distal end of the needle, the connecting member connects the proximal end of the contact member to the needle hub or the distal end of the syringe barrel, and wherein the elasticity of the connecting member is less than that of the contact member. In some of the above embodiments, the contact member has a low elastic modulus. In some embodiments, the Young's modulus of the contact member is from about 0.001 GPa to about 10 GPa. In some embodiments, the connecting member has a high elastic modulus. In some embodiments, the Young's modulus of the connecting member is greater than 10 GPa.

[0158] In some embodiments, the contact member is in the form of a sheath or sleeve surrounding the needle. In some embodiments, the contact member is an elastic sheath or sleeve surrounding the needle (e.g., Figure 18Ain 25). In some embodiments, the contact member is in the form of a block (e.g., Figure 18B in 25). In some embodiments, the contact member is in the form of a block and the distal end of the needle can pierce the block. In some embodiments, the contact member is an elastic block, and the distal end of the contact member has a surface shape adapted to the surface tissue of the target injection site. For example, the distal end of the contact member may have a specific pattern (e.g., Figure 18G ). As another example, the distal end of the contact member may be inclined (e.g., Figure 18H ). In some embodiments, the second elastic element is in the form of a spring (e.g., Figure 18B and Figure 18D in 26). In some embodiments, the second elastic element is in the form of a sheath or cannula surrounding the needle (e.g., Figure 18C and Figure 18E in 26). In some embodiments, the second elastic element is an elastic sheath surrounding the needle. In some embodiments, the connecting member is in the form of a sheath or cannula surrounding the needle (e.g., Figure 18F in 27).

[0159] In some embodiments, the injection system or medical puncture device provided herein includes: a syringe barrel extending from a proximal end to a distal end and forming a chamber extending from the proximal end to the distal end; a plunger shaft extending from the proximal end to the distal end and forming a seal between the distal end of the plunger shaft and the syringe barrel; a floating seal disposed in the chamber near the distal end of the syringe barrel and forming a seal between the floating seal and the distal end of the syringe barrel; and a needle extending from the proximal end to the distal end and including an end opening; wherein the flowable composition is located in the chamber between the distal end of the plunger shaft and the floating seal, wherein the proximal end of the needle is connected to the floating seal; a contact member extending from the proximal end to the distal end; and a pressing element including a first elastic element; wherein the distal end of the contact member is located distal to the distal opening of the needle, and the distal end of the contact member can be in direct contact with the surface tissue of the target injection site; and wherein the pressing element elastically engages the plunger shaft and the syringe barrel through the first elastic element.

[0160] In some of the foregoing embodiments, the contact member can be any contact member described herein. In some embodiments, the injection device or medical puncture device may further include a second elastic element, wherein the second elastic element can be any second elastic element described herein. In some embodiments, the injection device or medical puncture device may further include a connecting member, wherein the connecting member can be any connecting member described herein.

[0161] In some of the foregoing embodiments, the pressing element elastically engages the plunger shaft and the syringe barrel through the first elastic element. In some embodiments, the first elastic element is in the form of a spring (e.g., Figure 19A and 19B31) in. In some embodiments, the first elastic element may apply a force to the push shaft and push the push shaft towards the distal end. In some embodiments, the pressing element may restrict the movement of the syringe barrel of a conventional syringe, particularly the movement towards the distal end. In some embodiments, the pressing element has a pair of limiters (e.g., Figure 19A 32) or a locking element (e.g., Figure 19B 33) in. After the pressing element is assembled to the syringe, the limiter or the locking element may prevent the syringe barrel from moving distally.

[0162] Optionally, the medical puncture device has a state in which the flowable composition chamber, 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 located proximal to the floating seal, and the needle distal opening is located distal to the floating seal and within the flowable composition chamber. In the fluid communication state, the needle and / or the floating seal may move. For example, the floating seal may move under the elastic resilience force between it and the push shaft, such that the floating seal seals or blocks the needle body opening, thereby preventing or terminating the discharge of the flowable composition from the needle body opening and / or the needle distal opening.

[0163] Optionally, in the fluid communication state, when the floating seal moves forward and contacts the distal end of the syringe barrel, the floating seal may seal the needle body opening, thereby preventing or terminating the discharge of the flowable composition from the needle body opening and / or the needle distal opening. In some embodiments, the device or system of the present disclosure further includes a distal seal located within the syringe barrel and at the distal end of the syringe barrel. In some embodiments, when the floating seal moves forward and contacts the distal seal at the distal end of the syringe barrel, the floating seal may seal the needle body opening, thereby preventing or terminating the discharge of the flowable composition from the needle body opening and / or the needle distal opening.

[0164] Optionally, in some embodiments that can be combined with any of the above or below embodiments, a limiter (e.g., an axial limiter) may be provided distal to the floating seal within the syringe chamber. In some embodiments, the limiter may be used to restrict the forward movement of the floating seal.

[0165] In some embodiments, the injection system or medical puncture device disclosed herein has a fluid communication state in which the flowable composition chamber is connected to the needle body opening and the needle distal opening. When the medical puncture device is in the fluid communication state, the needle body opening may be located distal to the limiter (e.g., as Figure 2D shown), and the floating seal may move forward due to its elastic engagement with the push shaft.

[0166] Optionally, the injection system or medical puncture device disclosed herein includes a manual control element that is connected to the floating seal and extends outside the syringe barrel.

[0167] Optionally, the injection system or medical puncture device disclosed herein includes a pre-puncture state, a superficial tissue puncture state, and a fluid communication state after a hollow puncture needle penetrates the distal closed end of the syringe barrel. In the pre-puncture state, the superficial tissue puncture state, and the fluid communication state, the length ranges of the hollow puncture needle extending from the distal closed end of the syringe barrel may respectively correspond to a pre-puncture length range, a superficial tissue puncture length range, and a fluid communication length range, where: when the length of the hollow puncture needle extending from the distal closed end of the syringe barrel is within the pre-puncture length range, the needle body opening remains above the flowable composition chamber (e.g., the needle body opening may be located proximal to the floating seal and within the floating seal); and / or when the length of the hollow puncture needle extending from 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 chamber; and / or when the length of the hollow puncture needle extending from 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 chamber.

[0168] Optionally, an axially extending annular contact element is formed at the distal closed end of the syringe barrel, where the difference between the upper and lower limits of the pre-puncture length range is equal to the axial length of the annular contact element.

[0169] Optionally, the elastic movement unit includes an elastic sheath covering the outside of the hollow puncture needle. When the needle body opening is located proximal to the floating seal, the elastic sheath can seal the needle body opening.

[0170] In some embodiments, the injection system or medical puncture device disclosed herein includes a catheter guiding structure that can place a catheter into a target site (e.g., in an EPS) to achieve continuous ICNB. In some embodiments, the catheter guiding structure is used to thread a catheter into the chamber of the hollow puncture needle (e.g., the needle body channel connected to the distal opening of the needle and / or the needle body opening).

[0171] Optionally, the catheter guiding structure includes an inclined guiding groove formed on the floating seal and extending towards the hollow puncture needle at an angle.

[0172] Optionally, the inclined guiding groove is arranged to penetrate the floating seal from front to back. In some embodiments, the catheter guiding structure further includes a one-way valve embedded in the inclined guiding groove and capable of opening and closing, and / or a guiding groove plug inserted into the inclined guiding groove.

[0173] Optionally, the inclined guiding groove is provided on the upper surface of the floating seal and is a non-penetrating groove.

[0174] Optionally, the needle body opening is formed as an inclined opening that opens obliquely backward.

[0175] Optionally, the catheter guiding structure includes an inclined guiding needle hole formed in the wall of the hollow puncture needle body, which opens obliquely backward. In some embodiments, the medical puncture device has a fluid communication state, in which the flowable composition cavity is connected to the needle body opening and the needle distal opening. In the fluid communication state, the inclined guiding needle hole is located proximal to the floating seal.

[0176] Optionally, the catheter guiding structure further includes a one-way valve embedded in the inclined guiding needle hole and capable of opening and closing, or a guiding groove plug inserted into the inclined guiding needle hole.

[0177] Optionally, the catheter guiding structure includes a pierceable central guiding groove formed at the center of the proximal surface of the pressing element. In some embodiments, a needle proximal opening is formed on the hollow puncture needle, and the needle proximal opening is arranged to be axially aligned with the central guiding groove.

[0178] Optionally, the injection device or medical puncture device disclosed herein includes a separately manufactured and formed puncture control module and a fluid storage module, wherein: the puncture control module includes a first syringe unit, an elastic moving unit disposed within the first syringe unit, and a hollow puncture needle; the fluid storage module includes a second syringe unit, a flowable composition cavity formed within the barrel of the second syringe unit, and a module packaging member that is removably packaged proximal to the second syringe unit; and a detachable connection structure is formed between the first syringe unit and the second syringe unit.

[0179] In another aspect, the present disclosure provides a medical device assembly. In some embodiments, the medical device assembly includes a catheter and a medical puncture device having a catheter guiding structure.

[0180] Optionally, the medical device assembly further includes a hollow auxiliary guiding needle that is used in combination with the catheter guiding structure. In some embodiments, when the hollow auxiliary guiding needle is connected to the catheter guiding structure, the catheter can sequentially pass through the needle body channel of the auxiliary guiding needle and the catheter guiding structure, and penetrate into the needle body channel of the hollow puncture needle.

[0181] In some embodiments, when using the injection system or medical puncture device of the present disclosure, the user can first apply pressure to the push shaft to drive the hollow puncture needle connected to the floating seal towards the intercostal space of the subject. When the distal opening of the hollow puncture needle reaches an apparent or potential tissue void, chamber system, and space (such as the EPS or intercostal groove), the flowable composition (such as anesthetic solution) will no longer be restricted from discharging from the distal opening of the needle, and the resistance (e.g., the resistance between the floating seal and the syringe barrel) is sufficient to maintain the current position of the distal end of the needle while allowing the flowable composition to be injected into the tissue void (such as the intercostal groove). In some embodiments, the pressure of the flowable composition in the flowable composition chamber can become higher than the pressure in the apparent or potential tissue void, chamber, or space.

[0182] In some embodiments, when using the injection system or medical puncture device of the present disclosure, the user can first apply pressure to the push shaft to drive the hollow puncture needle to sequentially pass through the floating seal and the distal closed end of the syringe barrel. When the distal opening of the needle reaches an apparent or potential tissue void, chamber system, and space, the body opening of the needle is already located in the flowable composition chamber, and the floating seal has formed an elastic engagement with the push shaft. In some embodiments, the pressure of the flowable composition in the flowable composition chamber can become higher than the pressure in the apparent or potential tissue void, chamber, or space. At this time, the flowable composition in the flowable composition chamber can flow into the apparent or potential tissue void, chamber, or space through the body opening and the distal opening of the needle. During the injection process, by only maintaining the position of the push shaft, under the elastic engagement of the floating seal and the push shaft, the flowable composition in the flowable composition chamber can flow into the body opening of the needle (and then through the body channel and out of the distal opening of the needle), thereby realizing the injection, puncture, and / or dilation of the apparent or potential tissue void, chamber, or space. In addition, the medical device assembly described in the present disclosure can realize the implantation of a catheter and other medical devices through the medical puncture device (such as through the catheter guiding structure and the needle body lumen described herein).

[0183] In some embodiments, before the hollow puncture needle penetrates an apparent or potential tissue void, chamber, or space, the external pressure at the distal opening of the needle is higher than the pressure of the flowable composition in the flowable composition chamber, so the flowable composition cannot flow out of the distal opening of the needle. Therefore, by observing whether the floating seal moves forward due to the elastic engagement with the push shaft, it can be determined whether the hollow puncture needle has penetrated an apparent or potential tissue void, chamber, or space, thereby reminding the operator of the current puncture depth to ensure accurate puncture. Since the injection is controlled by the change in the fluid pressure in the flowable composition chamber, during the injection process, it is not necessary for the operator to manually apply thrust or force, thereby preventing fluctuations in the flow rate and achieving stable injection. III. Medical Puncture Method

[0184] In some aspects, provided herein is a method for performing an intercostal nerve block on a subject in need of treatment, which includes: 1) Providing an injection system, which includes: a syringe barrel extending from a proximal end to a distal end and forming a chamber extending from the proximal end to the distal end; a plunger shaft extending from the proximal end to the distal end and forming a seal between the distal end of the plunger shaft and the syringe barrel; a floating seal disposed within the chamber near the distal end of the syringe barrel and forming a seal between the floating seal and the distal end of the syringe barrel; and a needle extending from the proximal end to the distal end and including an end opening; Wherein the flowable composition is located at: a) within the chamber between the distal end of the plunger shaft and the floating seal, wherein the proximal end of the needle is connected to the floating seal; or b) within the chamber between the floating seal and the distal end of the syringe barrel, wherein the proximal end of the needle is connected to the distal end of the plunger shaft; and wherein the needle further includes: a needle body opening located between the proximal end and the distal end of the needle, wherein the needle body opening is proximal to the distal opening of the needle; and a needle body channel connecting the distal opening of the needle and the needle body opening; 2) Advancing the distal end of the needle towards the intercostal space of the subject; and 3) Continuing to advance the distal end of the needle until the distal end of the needle penetrates the parietal pleura of the subject and enters the extrapleural space, thereby allowing the flowable composition to flow from the chamber through the end opening of the needle into the extrapleural space.

[0185] In some embodiments, provided herein is a method for performing an intercostal nerve block on a subject in need of treatment, which includes: 1) Providing an injection system, which includes: a syringe barrel extending from a proximal end to a distal end; a plunger shaft extending from the proximal end to the distal end, wherein the distal end of the plunger shaft is located within the syringe barrel; a drive unit including a drive member, an energy storage member, and a floating seal, wherein the floating seal is located within the syringe barrel, forms a seal between the floating seal and the syringe barrel, and forms a chamber between the floating seal and the distal end of the syringe barrel, and wherein the floating seal is elastically engageable with the drive member through the energy storage member; and a needle extending from the proximal end to the distal end and including an end opening; Wherein the distal end of the plunger shaft is proximal to the floating seal; Wherein the flowable composition is located within the chamber formed between the floating seal and the distal end of the syringe barrel; Wherein the proximal end of the needle: a) is connected to the distal end of the syringe barrel; or b) is connected to the distal end of the plunger shaft, wherein the needle further includes a needle body opening located between the proximal end and the distal end of the needle, wherein the needle body opening is proximal to the distal opening of the needle, and a needle body channel connecting the distal opening of the needle and the main body opening of the needle; 2) Controlling the drive member to compress the energy storage member without moving the floating seal; 3) Advance the distal end of the needle towards a first target site within the intercostal space of the subject; 4) Continue to advance the distal end of the needle until the distal end of the needle penetrates the parietal pleura of the subject and enters the extrapleural space, thereby allowing the energy storage member to release energy, causing the floating seal to move distally, whereby the flowable composition flows through the needle tip opening into the extrapleural space.

[0186] In some embodiments (which may be combined with any of the injection systems and / or devices described above and below and may include any of the procedures and steps described above and below), provided herein is a method for performing an intercostal nerve block on a subject in need of treatment. In some embodiments (which may be combined with any of the injection systems and / or devices described above and below and may include any of the procedures and steps described above and below), provided herein is a method for delivering a flowable composition (such as an anesthetic solution) near the intercostal nerve of a subject in need of treatment. In some embodiments (which may be combined with any of the injection systems and / or devices described above and below and may include any of the procedures and steps described above and below), provided herein is a method for delivering a flowable composition to the intercostal space of a subject in need of treatment. In some embodiments (which may be combined with any of the injection systems and / or devices described above and below and may include any of the procedures and steps described above and below), provided herein is a method for delivering a flowable composition to the extrapleural space (EPS) of a subject in need of treatment. In some embodiments (which may be combined with any of the injection systems and / or devices described above and below and may include any of the procedures and steps described above and below), provided herein is a method for delivering a flowable composition to the intercostal groove of a subject in need of treatment.

[0187] In some embodiments, provided herein is a method comprising advancing the distal end of a needle towards the intercostal space of a subject, which includes applying a force to a push shaft to overcome resistance, causing the needle to move distally and enter the intercostal space of the subject without discharging the flowable composition into the parietal pleura or EPS.

[0188] In some embodiments, the injection system is configured to cause the needle to move forward by applying a force to the push shaft. In some embodiments, the proximal end of the needle is connected to a floating seal, and the step of advancing the distal end of the needle towards the intercostal space of the subject includes: applying a force to the push shaft, which force is transmitted through the flowable composition to the floating seal connected to the needle. In some embodiments, the proximal end of the needle is connected to the distal end of the push shaft through a needle hub, wherein the needle hub and the floating seal are configured to elastically engage with each other, and wherein the needle hub is configured to cause the needle to advance distally when a force is applied to the push shaft.

[0189] In some embodiments, the proximal end of the needle is connected to a floating seal and pierces the distal closed end of the syringe when advancing toward the intercostal space. In some embodiments, the proximal end of the needle is connected to a floating seal and, prior to advancement, the distal end of the needle is distal to the distal end of the syringe.

[0190] In some embodiments, the proximal end of the needle is connected to the distal end of the push shaft through a needle hub, where the needle hub and the floating seal are configured to elastically engage with each other, and the needle sequentially pierces the floating seal and the distal closed end of the syringe (or a distal seal located within the syringe and distal to the distal end of the syringe and then pierces the syringe closed end), thereby connecting the flowable composition chamber, the needle body opening, and the distal needle opening. In some embodiments, the needle is pre-inserted into the floating seal. For example, the distal needle opening can be located within the floating seal and blocked by the floating seal, and the needle can be advanced through the flowable composition chamber to pierce the distal closed end of the syringe (or first pierce the distal end disclosed herein and then pierce the distal closed end of the syringe). In some embodiments, the hollow piercing needle is pre-passed through the floating seal. For example, the distal needle opening can be located within the flowable composition chamber, while the needle body opening is located at the proximal end of the floating seal or within the floating seal (e.g., as Figure 3E shown, the needle body opening can be blocked by the floating seal), and then the needle can be advanced forward to pierce the distal closed end of the syringe (or first pierce the distal end disclosed herein and then pierce the distal closed end of the syringe). In some embodiments, the needle is pre-passed through the floating seal and inserted through or into the distal closed end of the syringe. For example, the distal needle opening can be located within the distal seal of the distal closed end of the syringe (e.g., the distal needle opening can be blocked by the distal seal), or distal to the distal seal and / or the distal closed end of the syringe, while the needle body opening is located at the proximal end of the floating seal (e.g., as Figure 3D , 6b1 shown), within the floating seal (e.g., as Figure 3D , 6b2 shown, the needle body opening can be blocked by the floating seal), or within the flowable composition chamber (e.g., as Figure 3D , 6b3 shown), and then the needle can be advanced through the distal closed end of the syringe to expose the distal needle opening for tissue puncture.

[0191] In some embodiments, provided herein is a method that includes advancing the needle distally and inserting it into the intercostal space of a subject without expelling the flowable composition (e.g., anesthetic solution). In some embodiments, the injection system is configured such that when the needle is moved distally and inserted into the intercostal space of a subject, no fluid is discharged into the parietal pleura or EPS.

[0192] In some embodiments, the needle is connected to a floating seal. When the distal end of the needle is advanced towards the intercostal space of the subject, the tissue in contact with the needle (such as the parietal pleura) restricts the outflow of the flowable composition from the distal opening of the needle, so that the flowable composition provided in the chamber cannot leave the chamber from the distal end of the needle. In some embodiments, the step of advancing the distal end of the needle towards the intercostal space of the subject includes: advancing the push shaft, the floating seal, and the distal end of the needle together towards the intercostal space of the subject, so that the volume of the flowable composition chamber remains substantially unchanged.

[0193] In some embodiments, when the proximal end of the needle is connected to the distal end of the push shaft through a needle hub, and the needle hub and the floating seal are configured to elastically engage with each other, and when the distal end of the needle is advanced towards the intercostal space of the subject, the body opening of the needle is located at the proximal end of the floating seal, and the end opening of the needle is located at the distal end of the floating seal and within the chamber containing the flowable composition, wherein the discharge of the flowable composition from the end opening of the needle is prevented. In some embodiments, when the distal end of the needle is advanced towards the intercostal space of the subject, both the body opening and the end opening of the needle are located at the distal end of the floating seal and within the chamber containing the flowable composition, wherein the discharge of the flowable composition from the end opening of the needle is prevented. In some embodiments, when the distal end of the needle is advanced towards the intercostal space of the subject, the body opening of the needle is located at the distal end of the floating seal and within the chamber containing the flowable composition, and the end opening of the needle contacts the surface tissue of the target site in the intercostal space of the subject, wherein due to the pressure of the surface tissue of the target site (such as the parietal pleura), the discharge of the flowable composition from the end opening of the needle is prevented. Optionally, the medical puncture device includes a state in which the flowable composition chamber, the body opening of the needle, and the distal opening of the needle are in fluid communication. For example, in the fluid communication state, the body opening of the needle can be located at the proximal end of the floating seal, while the distal opening of the needle is located at the distal end of the floating seal and within the flowable composition chamber. In the fluid communication state, the needle and / or the floating seal can move. For example, the floating seal can move under the action of the elastic restoring force between it and the pressing element, so that the floating seal seals or plugs the body opening of the needle, thereby preventing or terminating the discharge of the flowable composition (such as anesthetic solution) from the body opening of the needle and / or the distal opening of the needle. Optionally, in the fluid communication state, when the floating seal moves forward and contacts the distal closed end of the syringe barrel, the floating seal can seal the body opening of the needle, thereby preventing or terminating the discharge of the flowable composition (such as anesthetic solution) from the body opening of the needle and / or the distal opening of the needle.

[0194] In some embodiments, a method is provided herein, which includes continuing to advance the distal end of the needle until the distal end of the needle penetrates the parietal pleura of the subject and enters the EPS, thereby allowing the flowable composition to flow into the EPS through the end opening of the needle. In some embodiments, the injection system is configured such that when the distal end of the needle penetrates the parietal pleura of the subject and enters the EPS, the flowable composition is discharged.

[0195] In some embodiments, the injection system is configured such that a flowable composition is located within a chamber between the distal end of the push rod and the floating seal, and the proximal end of the needle is connected to the floating seal. When the distal end of the needle penetrates the parietal pleura of the subject and enters the EPS, the floating seal moves distally under resistance without actively advancing the needle, thereby allowing the flowable composition to be discharged into the EPS through the end opening of the needle.

[0196] In some embodiments, the injection system is configured such that the body opening of the needle is located within a chamber containing a flowable composition, the end opening of the needle penetrates the parietal pleura of the subject and enters the EPS, and the floating seal moves distally without further advancing the needle, thereby allowing the flowable composition to flow into the EPS through the body opening of the needle, the body channel of the needle, and the end opening of the needle.

[0197] In some embodiments, the present invention provides a method for performing an intercostal nerve block on a subject in need of treatment, which includes: 1) Providing an injection system, which includes: a syringe extending from a proximal end to a distal end; a push rod extending from a proximal end to a distal end, wherein the distal end of the push rod is located within the syringe; a drive unit, which includes a drive member, an energy storage member, and a floating seal, wherein the floating seal is located within the syringe, forms a seal between the floating seal and the syringe, and forms a chamber between the floating seal and the distal end of the syringe, and wherein the floating seal can be elastically engaged with the drive member through the energy storage member; and a needle extending from a proximal end to a distal end and including an end opening; wherein the distal end of the push rod is located proximal to the floating seal; wherein the flowable composition is located within the chamber formed between the floating seal and the distal end of the syringe; wherein the proximal end of the needle: a) is connected to the distal end of the syringe; or b) is connected to the distal end of the push rod, wherein the needle further includes a body opening located between the proximal end and the distal end of the needle, wherein the body opening is proximal to the distal opening of the needle, and a body channel connecting the distal opening of the needle and the body opening; 2) Controlling the drive member to compress the energy storage member without moving the floating seal; 3) Advancing the distal end of the needle towards a first target site within the intercostal space of the subject; and 4) Continuing to advance the distal end of the needle until the distal end of the needle penetrates the parietal pleura of the subject and enters the extrapleural space, thereby allowing the energy storage member to release energy, causing the floating seal to move distally, thereby allowing the flowable composition to flow into the extrapleural space through the end opening of the needle.

[0198] In some embodiments, a method of performing an intercostal nerve block as disclosed herein, wherein the injection system further comprises a contact member and an elastic element, wherein the contact member is located at the distal end of the syringe barrel, the distal end of the needle, and the distal end of the elastic element; and wherein the contact member is configured to elastically engage with the distal end of the syringe barrel through the elastic element. In some embodiments, the elastic element comprises a spring and / or an elastic sheath. In some embodiments, the energy storage member comprises a spring and / or an elastic sheath. In some embodiments, the injection system further comprises a syringe handle, wherein the syringe handle is connected to the syringe barrel. In some embodiments, the step of advancing the distal end of the needle towards the intercostal space of the subject comprises: controlling the syringe handle to compress the elastic element, thereby advancing the distal end of the needle towards and piercing the parietal pleura of the subject without discharging the flowable composition.

[0199] In some embodiments, a method of performing an intercostal nerve block as disclosed herein, wherein the injection system further comprises a contact member and an elastic element, wherein the contact member is located at the distal end of the syringe barrel, the distal end of the needle, and the distal end of the elastic element; and wherein the contact member elastically engages with the distal end of the syringe barrel through the elastic element. In some embodiments, the elastic element comprises a spring and / or an elastic sheath.

[0200] In some embodiments, a method of performing an intercostal nerve block as disclosed herein, wherein the injection system further comprises a syringe handle, wherein the syringe handle is connected to the syringe barrel.

[0201] In some embodiments, the present invention provides a method of performing an intercostal nerve block on a subject in need of treatment, comprising: 1) Providing an injection system, comprising: a syringe barrel extending from a proximal end to a distal end; a push rod extending from a proximal end to a distal end, wherein the distal end of the push rod is located within the syringe barrel; a drive unit comprising a drive member, an energy storage member, and a floating seal, wherein the floating seal is located within the syringe barrel, forms a seal between the floating seal and the syringe barrel, and forms a chamber between the floating seal and the distal end of the syringe barrel, and wherein the floating seal is elastically engageable with the drive member through the energy storage member; and a needle extending from a proximal end to a distal end and comprising an end opening; wherein the distal end of the push rod is located proximal to the floating seal; wherein the flowable composition is located within the chamber formed between the floating seal and the distal end of the syringe barrel; and wherein the proximal end of the needle is connected to the distal end of the syringe barrel; 2) Controlling the drive member to compress the energy storage member without moving the floating seal; 3) Advancing the distal end of the needle towards a first target site within the intercostal space of the subject; and 4) Advance the distal end of the needle further until the distal end of the needle penetrates the parietal pleura of the subject and enters the extrapleural space, thereby allowing the energy storage member to release energy, causing the floating seal to move distally, thereby allowing the flowable composition to flow into the extrapleural space through the end opening of the needle.

[0202] In some embodiments, the method of performing an intercostal nerve block as disclosed herein, wherein the injection system further comprises a contact member and an elastic element, wherein the contact member is located at the distal end of the syringe barrel, the distal end of the needle, and the distal end of the elastic element; and wherein the contact member is configured to elastically engage with the distal end of the syringe barrel through the elastic element. In some embodiments, the elastic element comprises a spring and / or an elastic sheath. In some embodiments, the energy storage member comprises a spring and / or an elastic sheath. In some embodiments, the injection system further comprises a syringe handle, wherein the syringe handle is connected to the syringe barrel. In some embodiments, the injection system further comprises a distal seal, and the distal seal is located within the syringe barrel and at the distal end of the syringe barrel. In some embodiments, the step of advancing the distal end of the needle towards the intercostal space of the subject comprises: applying a force to the push shaft to overcome the resistance, causing the needle to move distally, advancing it towards the parietal pleura of the subject and piercing it without expelling the flowable composition.

[0203] In some embodiments, the present invention provides a method of performing an intercostal nerve block on a subject in need of treatment, which comprises: 1) Providing an injection system, which comprises: a syringe barrel extending from a proximal end to a distal end; a push shaft extending from a proximal end to a distal end, wherein the distal end of the push shaft is located within the syringe barrel; a drive unit, which comprises a drive member, an energy storage member, and a floating seal, wherein the floating seal is located within the syringe barrel, forms a seal between the floating seal and the syringe barrel, and forms a chamber between the floating seal and the distal end of the syringe barrel, and wherein the floating seal can be elastically engaged with the drive member through the energy storage member; and a needle extending from a proximal end to a distal end and comprising an end opening; wherein the distal end of the push shaft is located proximal to the floating seal; wherein the flowable composition is located within the chamber formed between the floating seal and the distal end of the syringe barrel; wherein the proximal end of the needle is connected to the distal end of the push shaft, wherein the needle further comprises a needle body opening located between the proximal end of the needle and the distal end of the needle, wherein the needle body opening is proximal to the distal opening of the needle, and a needle body channel connecting the distal opening of the needle and the needle body opening; 2) Controlling the drive member to compress the energy storage member without moving the floating seal; 3) Advancing the distal end of the needle towards a first target site within the intercostal space of the subject; and 4) Advance the distal end of the needle further until the distal end of the needle penetrates the parietal pleura of the subject and enters the extrapleural space, thereby allowing the energy storage member to release energy, causing the floating seal to move distally, whereby the flowable composition flows into the extrapleural space through the end opening of the needle.

[0204] In some embodiments, the method of performing an intercostal nerve block disclosed herein, wherein the injection system further comprises a contact member and an elastic element, wherein the contact member is located at the distal end of the syringe barrel, the distal end of the needle, and the distal end of the elastic element; and wherein the contact member is configured to elastically engage the distal end of the syringe barrel through the elastic element. In some embodiments, the elastic element comprises a spring and / or an elastic sheath. In some embodiments, the energy storage member comprises a spring and / or an elastic sheath. In some embodiments, the method of performing an intercostal nerve block disclosed herein, wherein the injection system further comprises a distal seal, and wherein the distal seal is located within the syringe barrel and at the distal end of the syringe barrel. In some embodiments, the step of advancing the distal end of the needle toward the intercostal space of the subject comprises: applying a force to the push shaft to overcome the resistance, causing the needle to move distally toward the parietal pleura of the subject and penetrate it without discharging the flowable composition.

[0205] In some embodiments, the drive member disclosed herein is a pressing element configured to engage with a control knob. In some embodiments, the pressing element is cylindrical. In some embodiments, the step of controlling the drive member to compress the energy storage member without moving the floating seal comprises: rotating the control knob to drive the pressing element, thereby applying a force to the energy storage member and compressing the energy storage member.

[0206] In some embodiments, the method of performing an intercostal nerve block on a subject in need of treatment further comprises step 2a): after step 1) and before step 2), or after step 2) and before step 3), positioning the distal end of the syringe barrel toward a first target site within the intercostal space; wherein the contact member is in direct contact with the superficial tissue of the first target site. In some embodiments, step 2a) is performed after step 1) and before step 2). In some embodiments, the method of performing an intercostal nerve block on a subject in need of treatment further comprises step 5): withdrawing the needle from the first target site.

[0207] In some embodiments, the method of performing an intercostal nerve block disclosed herein further comprises step 6): moving the injection system near a second target site, and then sequentially performing steps 2a)-2)-3’)-4)-5’), wherein step 2a’) comprises: positioning the distal end of the syringe barrel toward a second target site within the intercostal space, wherein the contact member is in direct contact with the superficial tissue of the second target site; where step 3') includes: advancing the distal end of the needle into the second target site within the intercostal space of the subject; and where step 5') includes: withdrawing the needle from the second target site.

[0208] In some embodiments, the method for performing an intercostal nerve block disclosed herein further includes step 7): moving the injection system near a third target site and then sequentially performing steps 2a")-2)-3")-4)-5"), where step 2a") includes: orienting the distal end of the syringe barrel towards the third target site within the intercostal space, wherein the contact member is in direct contact with the superficial tissue of the third target site; where step 3") includes: advancing the distal end of the needle into the third target site within the intercostal space of the subject; and where step 5") includes: withdrawing the needle from the third target site.

[0209] In some embodiments, the method for performing an intercostal nerve block disclosed herein further includes step 8): moving the injection system near the next target site and then sequentially performing steps 2a"')-2)-3"')-4)-5"'), where step 2a"') includes: orienting the distal end of the syringe barrel towards the next target site within the intercostal space, wherein the contact member is in direct contact with the superficial tissue of the next target site; where step 3"') includes: advancing the distal end of the needle into the next target site within the intercostal space of the subject; and where step 5"') includes: withdrawing the needle from the next target site.

[0210] In some embodiments, the method for performing an intercostal nerve block on a subject in need of treatment includes: step 1): providing as shown in FIG. 13 and Figure 14The exemplary injection system or medical puncture device shown; Step 2): Position the injection system or medical puncture device so that the contact member 25 contacts the surface tissue of the first target site within the intercostal space, and control the pressing element 2 (e.g., by rotating the control knob 2a to drive the pressing element 2) to compress the spring 5 without moving the floating seal 3; Step 3): By applying a force to the push shaft 2b, advance the distal end of the needle 6 towards the first target site within the intercostal space without discharging the flowable composition from the flowable composition chamber 7, and continue to advance the distal end of the needle 6 until the distal end of the needle penetrates the parietal pleura of the subject and enters the extrapleural space, thereby allowing the spring 5 to release energy and causing the floating seal 3 to move distally, so that the flowable composition automatically flows into the extrapleural space through the end opening of the needle 6; and Step 4): Withdraw the needle 6 from the first target site, then move to the next target site as needed, and repeat the above steps 1)-4) one or more rounds until all target injection points have been injected with the flowable composition (e.g., anesthetic solution for ICNB), and optionally remove the injection system or medical puncture device from the subject.

[0211] In some embodiments, the method of performing an intercostal nerve block on a subject in need of treatment disclosed herein includes: Step 1): Provide an exemplary injection system or medical puncture device as shown in FIGS. 15 and Figure 16 The exemplary injection system or medical puncture device shown; Step 2): Position the injection system or medical puncture device so that the contact member 25 contacts the surface tissue of the first target site within the intercostal space, and control the pressing element 2 (e.g., by rotating the control knob 2a to drive the pressing element 2) to compress the spring 5 without moving the floating seal 3; Step 3): By controlling the syringe handle 41 to compress the elastic element 26, advance the distal end of the needle 6 towards the first target site within the intercostal space, thereby advancing the distal end of the needle 6 to pierce the contact element 25 and penetrate the parietal pleura of the subject without discharging the flowable composition from the flowable composition chamber 7, and continue to advance the distal end of the needle until the distal end of the needle penetrates the parietal pleura of the subject and enters the extrapleural space, thereby allowing the spring 5 to release energy and causing the floating seal 3 to move distally, whereby the flowable composition automatically flows into the extrapleural space through the end opening of the needle; and Step 4): Withdraw the needle 6 from the first target site, then move to the next target site as needed, and repeat the above steps one or more rounds until all target injection points have been injected with the flowable composition (e.g., anesthetic solution for ICNB), and optionally remove the injection system or medical puncture device from the subject.

[0212] In some embodiments, the methods of performing an intercostal nerve block on a subject in need of treatment, the methods of delivering a flowable composition in the vicinity of the intercostal nerves of a subject in need of treatment, or the methods of delivering a flowable composition to the intercostal space / EPS / intercostal groove of a subject in need of treatment disclosed herein are performed under thoracoscopy.

[0213] In some embodiments, the subjects disclosed herein suffer from pain due to traumatic injury, cancer, and / or surgery in their abdominal or chest regions.

[0214] In some embodiments, the flowable composition disclosed herein comprises one or more anesthetics for intercostal nerve block, and optionally one or more additives. In some embodiments, the one or more anesthetics are anesthetics known in the art. In some embodiments, the one or more anesthetics include ropivacaine, dibucaine, bupivacaine, etidocaine, tetracaine, procaine, chloroprocaine, prilocaine, mepivacaine, lidocaine, xylocaine, bupivacaine, levobupivacaine, marcaine, naropin, sensorcaine, or any combination thereof. In some embodiments, the additive includes epinephrine. In some embodiments, the additive includes analgesics known in the art, for example, including but not limited to α-2 agonists (including but not limited to clonidine, dexmedetomidine, dexamethasone, and tizanidine); opioids (including but not limited to oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, morphine, codeine, methadone, tramadol, and buprenorphine); and non-steroidal anti-inflammatory drugs (NSAIDs) (including but not limited to COX-1 inhibitors, COX-2 inhibitors, COX-1+2 inhibitors, ketorolac, diclofenac, parecoxib, and ibuprofen).

[0215] Optionally, the methods of performing an intercostal nerve block on a subject in need of treatment disclosed herein include providing an injection system that is further configured to have a limiter, such as an axial limiter, disposed distally of the floating seal within the syringe chamber. In some embodiments, the limiter can be used to restrict the forward movement of the floating seal. In some embodiments, the injection system has a fluid communication state in which the flowable composition chamber is connected to the needle body opening and the needle distal opening. When the medical puncture device is in the fluid communication state, the needle body opening can be located distally of the limiter (e.g., as Figure 2D shown), and the floating seal can move forward due to its elastic engagement with the pressing element. Optionally, the injection system includes a manual control element that is connected to the floating seal and extends outside the syringe barrel.

[0216] Optionally, the method for performing an intercostal nerve block on a subject in need of treatment as disclosed herein includes providing an injection system having a pre-puncture state, a superficial tissue puncture state, and a post-puncture fluid communication state after a needle punctures the distal closed end of a syringe barrel. In the pre-puncture state, the superficial tissue puncture state, and the fluid communication state, the length range of the hollow puncture needle extending from the distal closed end of the syringe barrel can respectively correspond to a pre-puncture length range, a superficial tissue puncture length range, and a fluid communication length range, wherein: when the length of the hollow puncture needle extending from the distal closed end of the syringe barrel is within the pre-puncture length range, the needle body opening remains above the cavity of the flowable composition (for example, the needle body opening can be located proximal to the floating seal and within it); and / or when the length of the hollow puncture needle extending from 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 cavity of the flowable composition; and / or when the length of the hollow puncture needle extending from the distal closed end of the syringe barrel is within the fluid communication length range, the needle body opening is located within the cavity of the flowable composition.

[0217] Optionally, an axially extending annular contact element is formed at the distal closed end of the syringe barrel, wherein the difference between the upper and lower limits of the pre-puncture length range is equal to the axial length of the annular contact element.

[0218] Optionally, the elastic movement unit includes an elastic sheath covering the outside of the hollow puncture needle. When the needle body opening is located proximal to the floating seal, the elastic sheath can seal the needle body opening.

[0219] In some embodiments, the present disclosure provides a method for delivering a flowable composition near the intercostal nerve of a subject in need of treatment. In some embodiments, the present disclosure provides a method for delivering a flowable composition into the intercostal space of a subject in need of treatment. In some embodiments, the present disclosure provides a method for delivering a flowable composition to the EPS of a subject in need of treatment. In some embodiments, the present disclosure provides a method for delivering a flowable composition to the intercostal groove of a subject in need of treatment. In some embodiments, the present disclosure provides a method for performing an intercostal nerve block on a subject in need of treatment by delivering one or more anesthetics into the intercostal space. In some embodiments, one or more anesthetics are pre-loaded into the cavity of the flowable composition of the injection system or device described herein. After the tip of the injection device or system penetrates the parietal pleura of the subject and enters the EPS, one or more anesthetics are automatically injected into the EPS. More details of the device, system, and method are disclosed below.

[0220] In some embodiments, as shown in FIGS. 1-11B, the present disclosure provides a method for performing an intercostal nerve block using a medical puncturing or penetrating device, the device including a syringe barrel 1, a driving unit (e.g., an elastic moving unit for pushing the needle), a hollow puncturing needle 6, and a flowable composition chamber 7. In some embodiments, the syringe barrel 1 includes a distal closed end and a proximal open end. In some embodiments, the syringe barrel 1 can be designed to have two open ends axially, and the distal sealing can be achieved by installing a distal seal 8 at the distal opening of the syringe barrel 1. In some embodiments, the distal seal 8 can be made of a material that can be punctured by the hollow puncturing needle 6, such as rubber or the like.

[0221] In some embodiments, the driving unit (e.g., the elastic moving unit) disclosed herein includes a pressing element 2 and a floating seal 3, wherein the floating seal 3 is sealingly engaged with the inner wall of the syringe barrel and is configured to move axially, e.g., move towards the distal or proximal end of the syringe barrel. In some embodiments, the pressing element 2 or a part thereof is located outside the proximal opening of the syringe barrel so that the operator can manually press the pressing element or a part thereof. In some embodiments, the floating seal 3 is elastically engaged with the pressing element 2, and when pressure is applied to the pressing element 2, the floating seal 3 can move forward or backward relative to the pressing element. In some embodiments, the floating seal 3 is configured to move towards the distal end of the syringe barrel. In some embodiments, the floating seal 3 is configured to move towards the proximal end of the syringe barrel. In some embodiments, the position of the pressing element relative to the syringe barrel remains stationary, and the floating seal 3 is configured to move forward (e.g., in the distal direction) due to the elastic restoring force generated by the elastic engagement with the pressing element.

[0222] In some embodiments, the hollow puncturing needle 6 is fixedly connected to the pressing element 2. When no pressure is applied to the pressing element 2, the hollow puncturing needle 6 remains proximal to the floating seal 3 and the two do not contact. In some embodiments, the hollow puncturing needle 6 itself includes a needle distal opening 6a and a needle body opening 6b. In some embodiments, the needle distal opening 6a and the needle body opening 6b are connected through the needle lumen or the needle body channel of the hollow puncturing needle 6.

[0223] In some embodiments, the flowable composition chamber 7 is used for storing, e.g., liquid drugs. In some embodiments, the flowable composition chamber is enclosed by the distal closed end of the syringe barrel, the chamber wall of the syringe barrel, and the floating seal 3; that is, the flowable composition chamber occupies the distal portion of the syringe barrel chamber. In some embodiments, since the floating seal 3 can move axially, the flowable composition chamber 7 is configured to have a variable volume, and thus the fluid pressure within the flowable composition chamber 7 may change due to the axial movement of the floating seal 3.

[0224] In some embodiments, provided herein is a method of performing an intercostal nerve block using the medical puncturing device or injection system disclosed herein, which includes applying pressure to the pressing element 2, thereby pushing the hollow puncturing needle 6 in the distal direction, successively through the floating seal 3 (e.g., by puncturing the floating seal or piercing an existing hole or slit in the floating seal) and the distal closed end of the syringe barrel (e.g., by puncturing the distal closed end or piercing an existing hole or slit in the distal closed end). The existing hole or slit may penetrate the floating seal, e.g., from the proximal surface of the floating seal to the distal surface of the floating seal, thereby forming a through hole in the floating seal. The existing hole or slit may not penetrate the entire floating seal, and the advancement of the distal end of the needle through the floating seal may include advancement by any suitable combination of passing through the existing hole or slit and puncturing a portion of the floating seal. For example, the distal end of the needle may first be advanced through the existing hole or slit in the proximal surface, then puncture the floating seal and exit from the distal surface of the floating seal, and vice versa. In some embodiments, the hollow puncturing needle 6 pierces an apparent or potential tissue void, chamber, or space (e.g., the intercostal space or EPS), thereby placing the distal opening 6a of the needle in the apparent or potential tissue void, chamber, or space (e.g., the intercostal space or EPS). In some embodiments, the body opening 6b of the needle is located within the flowable composition chamber 7, and the floating seal 3 is elastically engaged with the pressing element 2. In some embodiments, the fluid pressure within the flowable composition chamber 7 is higher than the pressure within the apparent or potential tissue void, chamber, or space (e.g., the intercostal space or EPS).

[0225] At this time, the flowable composition within the flowable composition chamber 7 can flow through the body opening 6b and the distal opening 6a of the needle and into the apparent or potential tissue void, chamber, or space (e.g., the intercostal space or the extrapleural space). In some embodiments, during the injection process, the user can simply maintain the pressure on the pressing element 2, e.g., without further increasing the pressure. Under the action of the elastic engagement between the floating seal 3 and the pressing element 2, the flowable composition (e.g., one or more anesthetics) within the flowable composition chamber 7 can enter the body opening 6b of the needle and pass through the needle body channel, thereby enabling injection, penetration, and / or dilation of the apparent or potential tissue void, chamber, or space.

[0226] In some embodiments, when the hollow puncture needle 6 enters the parietal pleura but does not penetrate through the parietal pleura, the external pressure on the distal opening 6a of the needle is higher than the fluid pressure within the flowable composition chamber 7. For example, because the distal opening of the needle is in a tissue (such as the parietal pleura) that is denser, harder, and / or less deformable than an apparent or potential tissue void, chamber, or space (such as EPS). Therefore, the flowable composition within the flowable composition chamber cannot be discharged from the distal opening 6a of the needle and enter the denser tissue. For example, when the hollow puncture needle 6 has penetrated the parietal pleura 13 but has not penetrated through the parietal pleura and entered the EPS 14, the flowable composition will not be discharged from the distal opening 6a of the needle regardless of whether the body opening 6b of the needle is in fluid communication with the flowable composition chamber 7. This is because a relatively high external pressure is applied on the distal opening 6a of the needle. When the external pressure is higher than the fluid pressure within the flowable composition chamber 7, the dense tissue (such as the parietal pleura) in close contact with the distal opening of the needle actually acts as a plug to prevent the flowable composition from flowing out.

[0227] In some embodiments, by observing whether the floating seal 3 moves forward due to elastic engagement when the pressing element 2 is held stationary under pressure, the operator can determine whether the hollow puncture needle 6 has penetrated an apparent or potential tissue void, chamber, or space (such as EPS), thereby informing the operator of the current needle depth and / or the position of the distal opening of the needle and ensuring accurate placement of the needle. In some embodiments, since the injection process is controlled by the change in fluid pressure within the flowable composition chamber 7, during the injection process, there is no need to manually apply a force transmitted via a relatively rigid medium (such as a solid or a liquid) to push the tip of the needle and accurately place it into an apparent or potential tissue void, chamber, or space (such as EPS). Instead, due to the elastic engagement between the pressing element 2 and the floating seal 3, a sudden force applied on the pressing element 2 can be buffered, allowing for a more controllable and stable movement of the floating seal. In some embodiments, by using the device disclosed herein, fluctuations in the flow rate can be prevented or reduced, and a stable injection can be achieved.

[0228] In some embodiments, when the hollow puncture needle 6 penetrates the distal closed end of the syringe barrel, the medical puncture device can be in at least three states: a pre-puncture state, a superficial tissue puncture state, and a fluid communication state.

[0229] In some embodiments, in the pre-puncture state, the length of the hollow puncture needle 6 extending from the distal closed end of the syringe barrel ranges within a pre-puncture length range. Within this range, the hollow puncture needle 6 has not yet started to puncture the organism or its tissue.

[0230] In some embodiments, the systems or devices of the present disclosure include a flowable composition chamber pre-filled with a flowable composition. In some embodiments, the needle has passed through the floating seal prior to use of the system or device. In some embodiments, prior to use of the system or device, the needle has passed through the floating seal and the distal end of the syringe barrel, e.g., a distal seal for sealing the distal end of the syringe barrel.

[0231] In some embodiments, e.g., prior to or during use of the system or device, the distal opening 6a of the needle may be outside the flowable composition chamber, while the body opening 6b of the needle may be proximal to the floating seal (e.g., as shown in Figure 3C , 6b1) or within the floating seal (e.g., as shown in Figure 3C , 6b2). Due to the viscosity of the composition, the flowable composition can be prevented from discharging from the distal opening of the needle until the distal opening of the needle reaches the target tissue, e.g., an apparent or potential tissue void, chamber, or space.

[0232] In some embodiments, e.g., prior to or during use of the system or device, the distal opening 6a of the needle may be within the distal seal at the distal closed end of the syringe barrel (e.g., the distal opening of the needle may be blocked by the distal seal), while the body opening 6b of the needle may be proximal to the floating seal (e.g., as shown in Figure 3D , 6b1), within the floating seal (e.g., as shown in Figure 3D , 6b2), or within the flowable composition chamber (e.g., as shown in Figure 3D , 6b3). The flowable composition can be prevented from discharging from the distal opening and the body opening of the needle.

[0233] In some embodiments, e.g., prior to or during use of the system or device, the distal opening 6a of the needle may be within the flowable composition chamber, while the body opening 6b of the needle may be within the floating seal (e.g., as shown in Figure 3E , 6b1) or within the flowable composition chamber (e.g., as shown in Figure 3E , 6b2). The flowable composition can be prevented from discharging from the body opening of the needle.

[0234] In some embodiments, e.g., prior to or during use of the system or device, the distal opening 6a of the needle may be within the floating seal, while the body opening 6b of the needle may be proximal to the floating seal (e.g., as shown in Figure 3F , 6b). The flowable composition can be prevented from discharging from the body opening of the needle.

[0235] In some embodiments, in the state of piercing the surface tissue, the length range of the hollow puncture needle 6 extending from the distal closed end of the syringe is the surface tissue piercing length range. Within this range, the distal end of the hollow puncture needle 6 has entered the surface tissue (such as the parietal pleura), but has not entered the obvious or potential tissue voids, chambers or spaces (such as EPS14). In some embodiments, due to the relatively dense surface tissue (such as the parietal pleura), the external pressure on the distal opening 6a of the needle is higher than the fluid pressure in the flowable composition chamber 7. Therefore, regardless of whether the body opening 6b of the needle is connected to the flowable composition chamber 7, the flowable composition will not enter the body opening 6b of the needle and / or discharge from the distal opening 6a of the needle.

[0236] In some embodiments, in the fluid communication state, the length range of the hollow puncture needle 6 extending from the distal closed end of the syringe is the fluid communication length range. Within this range, the distal end of the hollow puncture needle 6 has penetrated into the obvious or potential tissue voids, chambers or spaces. In some embodiments, the device can be designed such that in the fluid communication state, the fluid pressure in the flowable composition chamber 7 is higher than the pressure in the obvious or potential tissue voids, chambers or spaces (such as EPS). In some embodiments, in the fluid communication state, the body opening 6b of the needle is already located within the flowable composition chamber 7, and due to the pressure difference between the inside (such as within the obvious or potential tissue voids, chambers or spaces) and the outside (such as within the flowable composition chamber 7), the flowable composition within the chamber 7 can flow through the body opening 6b, the body channel, and then through the distal opening 6a of the needle into the obvious or potential tissue voids, chambers or spaces (such as EPS).

[0237] In some embodiments, since the floating seal 3 is elastically engaged with the pressing element 2 (for example, due to the pressure in the flowable composition chamber being higher than the back pressure at the distal opening of the needle in the EPS or intercostal space), the floating seal 3 moves distally until the floating seal seals the body opening 6b of the needle (for example, as Figure 4A - 4B shown). In some embodiments, the axial dimension of the body opening of the needle is not greater than the thickness of the floating seal. In some embodiments, the body opening of the needle can be completely sealed or blocked by the floating seal, at which time the flowable composition no longer discharges from the distal opening 6a of the needle and enters the tissue void. In some embodiments, when the floating seal blocks the body opening of the needle, only a portion of the total volume of the flowable composition discharges from the distal opening 6a of the needle (for example, as Figure 4A shown). In some embodiments, when the floating seal blocks the body opening of the needle, the total volume of the flowable composition in the chamber has discharged from the distal opening 6a of the needle (for example, as Figure 4B shown).

[0238] In some embodiments, when the needle body opening can be located within the distal seal or the subject's tissue, the flowable composition stops discharging from the distal opening 6a of the needle (e.g., as Figure 4C shown). In some embodiments, the distance between the distal opening 6a of the needle and the needle body opening 6b can be kept constant. In some embodiments, the distance between the distal opening 6a of the needle and the needle body opening 6b can vary. For example, a needle with a suitable distance between the distal opening 6a of the needle and the needle body opening 6b can be selected based on the known or estimated tissue depth to be reached. In some embodiments, the stopper 1a is disposed in the syringe chamber and can be used to limit the forward movement of the floating seal 3 to achieve precise injection, e.g., injecting a predetermined volume.

[0239] 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 operations, e.g., as Figure 6 - 11B shown.

[0240] In some embodiments, provided herein is a method of performing an intercostal nerve block, which includes using a system or device including two or more floating seals disclosed herein. For example, as Figure 5A shown, a first chamber is formed between the floating seal 3b and the distal seal of the syringe barrel, and a second chamber is formed between the floating seal 3a and the floating seal 3b. In some embodiments, the first chamber and the second chamber contain the same flowable composition. In some embodiments, the first chamber and the second chamber contain different flowable compositions. In some embodiments, the first chamber and the second chamber contain the same drug (e.g., anesthetic) in the same or different flowable carriers or excipients. In some embodiments, the first chamber and the second chamber contain different drugs (e.g., different anesthetics) in the same or different flowable carriers or excipients. In some embodiments, the first chamber contains a drug and the second chamber contains a pharmaceutically acceptable carrier or excipient, such as saline, and vice versa.

[0241] In some embodiments, the flowable compositions in the first and second chambers can be sequentially delivered to an apparent or potential tissue space, chamber, or cavity (e.g., the intercostal space or EPS). In some embodiments, the flowable compositions in the first and second chambers can be mixed in an apparent or potential tissue space, chamber, or cavity (e.g., the intercostal space or EPS). In some embodiments, the flowable composition in the first chamber enters an apparent or potential tissue space, chamber, or cavity (e.g., the intercostal space or EPS) to reach and / or expand the tissue space, chamber, or cavity (e.g., the intercostal space or EPS). Subsequently, the flowable composition containing the drug in the second chamber can enter the apparent or potential tissue space, chamber, or cavity (e.g., the intercostal space or EPS). For example, as Figure 5A shown, when the distal opening 6a of the needle is in the intercostal space or EPS and the body opening 6b of the needle is in the first chamber (between the floating seal 3b and the distal seal of the syringe barrel), the flowable composition in the first chamber is delivered to the intercostal space or EPS. In Figure 5B , when the floating seal 3b moves distally and the body opening 6b of the needle contacts the second chamber (between the floating seal 3a and the floating seal 3b), the distal opening 6a of the needle can remain stationary in the intercostal space or EPS. In this way, the flowable composition in the second chamber begins to be delivered to the intercostal space or EPS until a certain volume is delivered and / or the floating seal 3a (or the floating seals 3a and 3b together) blocks the body opening 6b of the needle, as Figure 5C shown. In some embodiments, a set (e.g., predetermined) volume of the flowable composition in the first chamber and / or a set (e.g., predetermined) volume of the flowable composition in the second chamber can be delivered to the intercostal space or EPS. In some embodiments, the dimension of the body opening 6b of the needle along the needle axis is greater than the thickness of the floating seal 3b, such that 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 seals 3b and 3a) can be sequentially and continuously delivered to the intercostal space or EPS through the distal opening of the needle. In some embodiments, the dimension of the body opening 6b of the needle along the needle axis is not greater than the sum of the thicknesses of the floating seals 3a and 3b. In some embodiments, the dimension of the body opening 6b of the needle along the needle axis is greater than the thickness of the floating seal 3b and less than the sum of the thicknesses of the floating seals 3a and 3b. In some embodiments, the systems or devices disclosed herein include one or more additional floating seals (e.g., a third floating seal 3c) located proximal to the floating seal 3a, distal to the floating seal 3b, and / or between the 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.

[0242] 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 Figure 5D shown, when the distal needle opening 6a is in an apparent or potential tissue void, chamber, or space (e.g., an intercostal space or EPS), and the needle body opening 6b1 is in a first chamber (between the floating seal 3b and the distal seal of the syringe barrel) and the needle body opening 6b2 is blocked by the floating seal 3b, the flowable composition in the first chamber is delivered to the tissue (e.g., an intercostal space or EPS). In Figure 5E , when the floating seal 3b moves distally to block the needle body opening 6b1, thereby allowing the needle body opening 6b2 to contact a second chamber (between the floating seal 3a and the floating seal 3b), the distal needle opening 6a can remain stationary in an apparent or potential tissue void, chamber, or space (e.g., an intercostal space or EPS). In this way, the flowable composition in the second chamber begins to be delivered to the tissue (e.g., an intercostal space or EPS) until a certain volume is delivered and / or the floating seal 3a (or the floating seals 3a and 3b together) blocks the needle body opening 6b2 (and / or the needle body opening 6b1), as Figure 5F shown. In some embodiments, a set (e.g., predetermined) volume of the flowable composition in the first chamber and / or a set (e.g., predetermined) volume of the flowable composition in the second chamber can be delivered to an apparent or potential tissue void, chamber, or space (e.g., an intercostal space or EPS). In some embodiments, the distance along the needle axis between the needle body opening 6b1 and the needle body opening 6b2 is greater than the thickness of the floating seal 3b, such that a first flowable composition (between the floating seal 3b and the distal seal of the syringe barrel) and a second flowable composition (between the floating seal 3b and the floating seal 3a) can be sequentially and continuously delivered to an apparent or potential tissue void, chamber, or space (e.g., an intercostal space or EPS) through the distal needle opening. In some embodiments, the distance along the needle axis between the needle body opening 6b1 and the needle body opening 6b2 is not greater than the sum of the thicknesses of the floating seals 3a and 3b. In some embodiments, the distance along the needle axis between the needle body opening 6b1 and the needle body opening 6b2 is greater than the thickness of the floating seal 3b and less than the sum of the thicknesses of the floating seals 3a and 3b. In some embodiments, the systems or devices disclosed herein include one or more additional needle body openings (e.g., a third needle body opening 6b3) located proximal to the needle body opening 6b2, distal to the needle body opening 6b1, and / or between the needle body openings 6b1 and 6b2, 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.

[0243] In some embodiments, provided herein is a method of performing an intercostal nerve block, which includes using any of the injection systems or devices described herein, wherein the injection systems and devices are capable of controlling the termination of the injection process.

[0244] In some embodiments, when the injection device or system used in the method of performing an intercostal nerve block disclosed herein is in a fluid communication state, the floating seal 3 moves forward due to elastic engagement with the pressing member 2 until it seals the needle body opening 6b. Once the needle body opening 6b is sealed, the injection process terminates. In some embodiments, the axial position of the needle body opening 6b within the flowable composition chamber 7 limits the maximum injection volume of the injection device or system. In some embodiments, when the needle body opening 6b is blocked or sealed by the floating seal 3, the floating seal 3 has not yet contacted the wall of the distal closed end of the syringe barrel. In some embodiments, the flowable composition chamber 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.

[0245] In some embodiments, when it is desired to empty the flowable composition chamber 7, the floating seal 3 can be designed to seal the needle body opening 6b when the floating seal contacts the wall of the distal closed end of the syringe barrel. In some embodiments, the needle body opening 6b is located at the distal end of the flowable composition chamber 7. In some embodiments, the floating seal 3 contacts the wall of 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 of the distal closed end of the syringe barrel. In some embodiments, the flowable composition chamber 7 is emptied, and there is no or almost no flowable composition between the floating seal 3 and the wall of the distal closed end of the syringe barrel.

[0246] In some embodiments, as the flowable composition within the flowable composition chamber 7 gradually enters an apparent or potential tissue void, chamber, or space (e.g., the intercostal space or EPS), a state may occur where the fluid pressure within the flowable composition chamber 7 balances with the pressure within the apparent or potential tissue void, chamber, or space (e.g., the intercostal space or EPS). At this time, due to the balance of forces, the floating seal 3 no longer moves. To continue injection and / or empty the flowable composition chamber 7, an additional force needs to be applied to the floating seal 3 to move it forward towards the distal closed end of the syringe barrel.

[0247] For example, as Figure 2A - 2EAs shown, one, two or more axially extending sliding grooves (not shown) may be provided on the body wall of the syringe barrel 1. A slider matching the sliding groove may be provided on the pressing element 2 (for example, the slider may include a part of the pressing element 2 extending outside the syringe barrel 1), so as to increase the upper limit of the moving distance or stroke of the pressing element 2, because the movement is no longer limited by the proximal end of the pressing element 2. When the floating seal 3 can no longer move due to the balance of forces (for example, the balance between the pressure in the flowable composition chamber 7 and the pressure in the apparent or potential tissue voids, chambers or gaps), a greater pressure can be applied to the slider of the pressing element 2 to drive the pressing element 2 to advance distally, which in turn can increase the elastic restoring force between the floating seal 3 and the pressing element 2, thereby breaking the balance of forces and causing the floating seal 3 to move forward towards the distal end of the syringe barrel. In this way, more flowable composition is discharged from the flowable composition chamber 7, and in some embodiments, the flowable composition chamber 7 is emptied.

[0248] In some embodiments, other driving structures may be used to further move the floating seal 3 until it contacts the wall of the closed end at the distal end of the syringe barrel. Some exemplary driving structures are described below.

[0249] In some embodiments, axially extending sliding grooves may be provided on the peripheral wall of the syringe barrel 1 and at the proximal end of the floating seal 3. In some embodiments, the manual control part may include a pressing element 2' (which may be in the form of a slider) that slidably cooperates with the sliding groove on the peripheral wall of the syringe barrel. In some embodiments, a part of the pressing element (such as a slider) 2' extends outside the syringe barrel through the sliding groove, which facilitates the operation by the user. In some embodiments, the floating seal 3 and the pressing element (such as a slider) 2' are elastically connected. For example, as Figure 2G shown in step 1, the floating seal 3 and the pressing element (such as a slider) 2' may be joined to each other by an elastic member (such as a spring) 4', while the floating seal 3 and the pressing element (such as a slider) 2 may be joined to each other by an elastic member (such as a spring) 4. In some embodiments, the pressing element 2 may include a rod configured to be inserted into the space between the parts of the pressing element 2' so that the pressing elements 2 and 2' do not interfere with each other. In some embodiments, the elastic members (such as springs) 4 and the elastic members (such as springs) 4' may function independently without interfering with each other. In some embodiments, the spring 4 is smaller than the spring 4', for example, the average diameter of the spring 4 may be smaller than the average diameter of the spring 4'. In some embodiments, the elastic member 4' is nested inside the elastic member 4. In Figure 2G step 2, a force may be applied to the pressing element 2 to move the needle distally while keeping the position of the floating seal 3 unchanged. In some embodiments, as Figure 2GAs shown in Step 3, a force can be applied to the pressing element 2' to move it distally along the axial direction of the sliding groove on the peripheral wall of the syringe barrel. In this way, the elastic member (such as a spring) 4' between the floating seal 3 and the pressing element (such as a slider) 2' can be elastically compressed. In some embodiments, when the position of the pressing element (such as a slider) 2' remains unchanged, under the action of the elastic force, the floating seal 3 can break the force balance and continue to move distally until the volume of the discharged flowable composition reaches the target volume. In some embodiments, as Figure 2G shown in Step 4, the pressing element (such as a slider) 2' can move distally to further move the floating seal 3 distally, thereby discharging the flowable composition from the needle.

[0250] In some embodiments, the injection system or device includes an element configured to enable an operator to manually control the movement of the floating seal 3 with one hand or both hands. In some embodiments, the manual control element can be moved using one or more fingers, for example, one finger of the same hand holding the syringe barrel. In some embodiments, the manual control element is fixed to the floating seal 3 and partially extends outside the syringe barrel. In some embodiments, when the volume of the flowable composition injected into a visible or potential tissue space, chamber, or gap (such as the intercostal space or EPS) does not reach the target volume and the floating seal 3 no longer moves due to the force balance, the operator can further drive the floating seal 3 to move forward by moving the part of the manual control element extending outside the syringe barrel until the volume of the discharged flowable composition reaches the target volume. In some embodiments, using the manual control element helps to empty the flowable composition chamber 7. These embodiments are not limited to the case where it is necessary to empty the flowable composition chamber 7.

[0251] In some embodiments, the injection device or system can achieve precise delivery (such as by injection) of a predetermined volume of the flowable composition and / or be capable of controlling the volume to be delivered. In some embodiments, the predetermined volume is the volume preset before delivery. In some embodiments, the predetermined volume is one of a plurality of volumes that the operator can select during the delivery process, and the delivered volume can be different from the preset volume. In some embodiments, as Figure 1A - 1F 、 Figure 2A - 2F shown in and FIG. 11, an axial limiter 1a is provided in the syringe cavity and at the distal end of the floating seal 3 to limit the forward movement of the floating seal 3. In some embodiments, when the medical puncture device is in a fluid communication state, the needle body opening 6b can be located at the distal end of the axial limiter 1a, and the floating seal 3 can move forward due to elastic engagement with the pressing element 2.

[0252] In some embodiments, the floating seal 3 moves to a position restricted by the axial limiter 1a. In some embodiments, when the floating seal 3 moves to a position restricted by the axial limiter 1a, the pressure within the flowable composition chamber 7 remains no lower than the pressure within the apparent or potential tissue voids, chambers, or spaces. In some embodiments, the floating seal 3 can be pushed forward to the position restricted by the axial limiter 1a by the elastic restoring force between the floating seal 3 and the pressing element 2, without relying on an additional drive structure or force to move the floating seal 3 to the position restricted by the axial limiter 1a.

[0253] In some embodiments, before the floating seal 3 moves to the position restricted by the axial limiter 1a due to the elastic restoring force between it and the pressing member 2, the pressure within the flowable composition chamber 7 has become equal to the pressure within the apparent or potential tissue voids, chambers, or spaces (i.e., due to the balance of forces, the floating seal 3 no longer moves before it reaches the axial limiter 1a). At this time, solely relying on the elastic restoring force between the floating seal 3 and the pressing element 2, the floating seal 3 will not be pushed forward to the position restricted by the axial limiter 1a. Therefore, in some embodiments, one or more additional drive structures or mechanisms can be employed to further push the floating seal 3 forward. For example, the additional drive structure or mechanism can include the manual control elements described herein (e.g., as Figure 2A - 2E shown). In some embodiments, the axial limiter 1a provides a mechanism for achieving a set volume of fluid injection.

[0254] In some embodiments, provided herein is a method of performing an intercostal nerve block, which includes using any of the injection systems and devices described herein, wherein in some embodiments, the injection system and device are capable of automatically controlling the timing of puncture and injection.

[0255] In some embodiments, when the injection device or system is in the pre-puncture state, i.e., when the length of the hollow puncture needle 6 extending from the distal closed end of the syringe is within the pre-puncture length range (or when the hollow puncture needle 6 has penetrated the distal closed end of the syringe but has not yet started to puncture the living body or its tissue), the needle body opening 6b is held above the flowable composition chamber 7 (e.g., at its proximal end). When provided in this manner, early leakage from the distal opening 6a of the needle can be prevented, and the reliability of the medical puncture device can be improved.

[0256] In some embodiments, corresponding structures may be provided on the device to prevent early leakage before the hollow puncture needle 6 punctures the tissue and / or before the distal opening 6a of the needle reaches an apparent or potential tissue void, chamber, or space (e.g., the intercostal space or EPS). For example, an axially extending annular contact element 1b may be formed at the distal closed end of the syringe barrel. In some embodiments, the axial length of the annular contact element 1b is set to be the same as 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 the pre-puncture length of the needle when the hollow puncture needle 6 pierces the distal closed end of the syringe barrel and when it starts to puncture the living body or tissue). In this setting, as long as the distal end of the hollow puncture needle 6 remains within the axial length range of the annular contact element 1b, no early leakage will occur at the distal opening 6a of the needle. During puncture, the annular contact element 1b may first contact the surface of the living body or tissue to stabilize the medical puncture device, and then, pressure may be applied to the pressing element 2 to start the puncture operation.

[0257] In some embodiments, when the medical puncture device is in the state of superficial tissue puncture, that is, when the length of the hollow puncture needle 6 extending from the distal closed 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 pierced the superficial tissue and is extending towards the parietal pleura but has not entered the EPS), the needle body opening 6b is at least partially connected to the flowable composition chamber 7. In some embodiments, before the distal end of the hollow puncture needle 6 pierces an apparent or potential tissue void, chamber, or space (e.g., the extrapleural space), a fluid communication is established between the flowable composition chamber 7, the distal opening 6a of the needle, and the needle body opening 6b. In some embodiments, the flowable composition in the chamber 7 may enter the needle body channel of the hollow puncture needle 6 in advance (via the needle body opening 6b), thereby removing at least a part of the air that may be present in the needle body channel, and thus reducing the amount of air entering the apparent or potential tissue void, chamber, or space (e.g., EPS).

[0258] In some embodiments, when the distal end of the hollow puncture needle 6 starts to pierce the superficial tissue, the needle body opening 6b starts to be connected to the flowable composition chamber 7. In some embodiments, when the distal end of the hollow puncture needle 6 pierces an apparent or potential tissue void, chamber, or space (e.g., EPS), the needle body channel of the hollow puncture needle 6 has been filled with the flowable composition, thereby eliminating or reducing the possibility of air entering the apparent or potential tissue void, chamber, or space (e.g., EPS).

[0259] In some embodiments, when the injection system or device is in a fluid communication state, i.e., when the length that the hollow puncture needle 6 extends 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 space, chamber or gap), the needle body opening 6b is already located within the flowable composition chamber 7, thereby achieving the maximum flow rate at the needle body opening 6b, thus increasing the injection speed.

[0260] In some embodiments, provided herein is a method for performing an intercostal nerve block, which includes using any injection system or device described herein, wherein in some embodiments, the injection system or device is capable of preventing fluid from flowing back and / or overflowing reversely through the needle body opening 6b.

[0261] In some embodiments, when the distal needle opening 6a is connected to the flowable composition chamber 7 while the needle body opening 6b is still located proximal to the floating seal 3, there is a risk of fluid flowing back and / or overflowing reversely through the needle body opening 6b. In some embodiments, when the distal opening 6a is within an apparent or potential tissue space, chamber or gap (such as the intercostal space or EPS) while the needle body opening 6b is still located proximal to the floating seal 3, there is a risk of fluid flowing back and / or overflowing reversely through the needle body opening 6b. In some embodiments, an elastic sheath 4 covering the outside of the hollow puncture needle 6 can be provided within the drive unit (such as an elastic moving unit), for example, between the needle hub and the floating seal 3. In some embodiments, when the needle body opening 6b is located proximal to the floating seal 3 (for example, when the needle body opening 6b is not yet connected to the flowable composition chamber 7), the elastic sheath 4 can maintain the sealing of the needle body opening 6b, thereby effectively avoiding the reverse flow and / or reverse overflow of the flowable composition, preventing contamination of the area near the floating seal 3, reducing fluid loss, and improving the reliability of the product.

[0262] In some embodiments, the resilient sheath 4 is not used to seal the needle body opening 6b, but rather simply serves as an elastic engagement part between the floating seal 3 and the pressing element 2. In some embodiments, by moving the pressing element 2 forward, the resilient sheath 4 between the floating seal 3 and the pressing element 2 can be compressed, thereby forming an elastic restoring force between the floating seal 3 and the pressing element 2, which in turn can drive the floating seal 3 to move forward. In some embodiments, the elastic engagement part between the floating seal 3 and the pressing element 2 can include or be a spring 5 that is connected to the floating seal 3 and the pressing element 2 at its two axial ends respectively. This connection at one or both ends of the spring can be direct or indirect. This connection at one or both ends of the spring can be releasable or non - releasable. The spring, floating seal, and pressing element can be manufactured separately and then assembled together in any suitable order. Alternatively, any two or more of the spring, floating seal, and pressing element can be integral, such as being manufactured as a single unit. The spring 5 and the resilient sheath 4 can be used separately or in combination.

[0263] In some embodiments, the elastic engagement between the floating seal 3 and the pressing element 2 can be achieved by other methods than providing one or more elastic engagement parts. For example, the floating seal 3 and the pressing element 2 can be provided as an integral integrated drive unit (such as an elastic movement unit).

[0264] In some embodiments, devices and methods for implanting into apparent or potential tissue voids, chamber systems, and spaces (such as the intercostal space or EPS) using the medical puncture device disclosed herein are provided. In some embodiments, the methods disclosed herein include using a catheter guiding structure to guide a catheter 11 into the needle body channel of the hollow puncture needle 6 in order to place it into a target site (such as EPS) for performing continuous ICNB. In some embodiments, a catheter guiding structure is provided in the medical puncture device disclosed herein.

[0265] In some embodiments, as Figure 6 - 8 shown, the catheter guiding structure includes an inclined guiding groove 3a' that is provided in or engages with the floating seal 3 and extends at an angle towards the hollow puncture needle 6. In some embodiments, when the flowable composition chamber 7, the needle body opening 6b, and the needle distal opening 6a are connected, the flowable composition can enter and expand the apparent or potential tissue void, chamber, or space. In some embodiments, the catheter 11 can be implanted into the expanded apparent or potential tissue void, chamber, or space through the inclined guiding groove 3a', the needle body opening 6b, the needle body channel of the hollow puncture needle 6, and the needle distal opening 6a.

[0266] It should be noted that the inclined guiding groove 3a' can be provided as a groove penetrating the floating seal 3 in the proximal / distal direction, or as a non-penetrating groove formed on the proximal surface of the floating seal 3.

[0267] In some embodiments, the inclined guiding groove 3a' is a penetrating groove. In some embodiments, the catheter guiding structure further includes a valve 9 disposed in or engaged with the inclined guiding groove 3a', and the valve can be a one-way valve configured to open and close. In some embodiments, the valve includes a plurality of valve flaps configured to open or close the valve. In some embodiments, in the absence of an external force, the one-way valve 9 is closed and prevents the flowable composition in the flowable composition chamber 7 from leaking through the valve. In some embodiments, in the presence of an opening force, the plurality of valve flaps of the valve can be opened, so that the catheter 11 can penetrate into the needle body opening 6b through the opened valve. In some embodiments, the catheter guiding structure further includes a guiding groove plug configured to be removably inserted into the inclined guiding groove 3a', and when the catheter 11 needs to be implanted, the guiding groove plug can be pulled out.

[0268] In some embodiments, the inclined guiding groove 3a' is a non-penetrating groove. In some embodiments, the inclined guiding groove is directly punctured by the catheter 11 to be implanted. In some embodiments, the inclined guiding groove is punctured by a puncturing member other than the catheter, and the catheter 11 can enter the needle body opening 6b through the punctured opening.

[0269] In some embodiments, in order to match the guiding direction of the inclined guiding groove 3a', the needle body opening 6b can be provided in the form of an inclined opening that obliquely opens backward, so that the needle body opening 6b can be aligned with the inclined guiding groove 3a', thereby precisely guiding the catheter 11 through the inclined guiding groove and into the needle body opening.

[0270] In some embodiments, such as Figure 9 and Figure 10 shown, the catheter guiding structure includes an inclined guiding needle hole 6c formed or provided on the body wall of the hollow puncturing needle 6 and obliquely opening backward. In some embodiments, for example, when the medical puncturing device is in a fluid communication state, the inclined guiding needle hole 6c is held at the proximal end of the floating seal 3. In some embodiments, the catheter 11 can penetrate into the needle body channel of the hollow puncturing needle 6 through the inclined guiding needle hole 6c. In some embodiments, the catheter 11 can be implanted into an apparent or potential tissue void, chamber or space (or an apparent or potential tissue void, chamber or space expanded with a flowable composition) through the needle distal opening 6a.

[0271] In some embodiments, the catheter guiding structure may further include a valve 9 disposed within or engaged with the angled guide needle bore 6c. The valve may be a one-way valve configured to open and close. In some embodiments, the valve includes a plurality of flaps configured to open or close the valve. In some embodiments, in the absence of an external force, the one-way valve 9 is closed, preventing the flowable composition within the flowable composition chamber 7 from leaking through the valve. In some embodiments, in the presence of an opening force, the plurality of flaps of the valve may be opened, enabling the catheter 11 to penetrate through the opened valve and the angled guide needle bore 6c into the needle body channel (which may be connected to or separated from the needle body channel connecting the needle body opening 6b and the needle distal opening 6a). In some embodiments, the catheter guiding 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 may be removed to initiate the implantation operation of the catheter 11. In some embodiments, the guide needle bore 6c is connected to the needle distal opening 6a. The needle body channel connecting the needle distal opening 6a and the needle body opening 6b may be the same as or separate from the needle body channel connecting the needle distal opening 6a and the guide needle bore 6c. In some embodiments, the guide needle bore 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 channel connecting the needle body opening 6b to the needle distal end may be completely separated from the needle body channel connecting the guide needle bore 6c to the needle distal end. The needle body channel connecting the needle body opening 6b to the needle distal end may at least partially overlap or be in fluid communication with the needle body channel connecting the guide needle bore 6c to the needle distal end.

[0272] In some embodiments, such as shown in FIG. 11, the catheter guiding structure includes a central guide groove 2c formed or disposed on the proximal surface of the pressing element 2. In some embodiments, the central guide groove 2c includes a hole, or a hole may be formed at the center of the proximal surface of the pressing element 2. In some embodiments, the central guide groove 2c may be punctured to provide a hole. In some embodiments, a needle proximal opening is provided on the hollow puncture needle 6 and is axially aligned with the central guide groove 2c. In some embodiments, when it is necessary to implant the catheter 11, the central guide groove 2c may be punctured, and the catheter 11 may penetrate through the opening of the punctured central guide groove 2c and the needle proximal opening of the hollow puncture needle 6 into the needle body channel (which may be connected to or separated from the needle body channel connecting the needle body opening 6b and the needle distal opening 6a). In some embodiments, the catheter 11 may be implanted into an apparent or potential tissue void, chamber, or space (or an apparent or potential tissue void, chamber, or space expanded by a flowable composition) through the needle distal opening (such as the needle distal opening 6a or a different needle distal opening).

[0273] In some embodiments, provided herein is a method of performing an intercostal nerve block, which includes using a kit that includes components configured to be assembled to form any of the injection systems or devices disclosed herein.

[0274] In some embodiments, a kit for assembling an injection system or device includes a puncture control module and a flowable composition storage module (e.g., a fluid storage module). In some embodiments, the puncture control module and the flowable composition storage module are manufactured and / or provided independently. In some embodiments, the puncture control module includes a first syringe unit, and a drive unit (e.g., an elastically movable unit) and a hollow puncture needle 6 disposed within the syringe barrel of the first syringe unit. Based on the embodiments disclosed herein, it can be seen that the puncture control module may further include other parts or components, 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 chamber 7 formed within the syringe barrel of the second syringe unit, and a module packaging 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 form a syringe barrel 1 after being connected to each other. Based on the embodiments disclosed herein, it can be seen that the fluid storage module may further include other parts, such as a distal seal 8.

[0275] In some embodiments, the puncture control module and the fluid storage module can be separately manufactured, assembled, and / or packaged and then assembled with each other (and optionally with other modules, components, and / or parts) into the medical puncture device disclosed herein. In some embodiments, the module packaging member is used to seal the proximal end of the flowable composition chamber 7. In some embodiments, the module packaging assembly can be removed when the puncture control module and the fluid storage module are assembled.

[0276] In some embodiments, provided herein is a method of performing an intercostal nerve block, which includes using a medical device assembly and a system including the assembly. As Figure 7 shown in and FIG. 11, in some embodiments, the medical device assembly includes a catheter 11 and a medical puncture device including a catheter guiding structure disclosed herein. In some embodiments, the catheter 11 can be implanted into an apparent or potential tissue space, chamber, or cavity through the medical puncture device. The medical device assembly described herein can have all the technical effects provided by the medical puncture device.

[0277] In some embodiments, the medical device component includes a hollow auxiliary guiding needle 12, which is used in combination with a catheter guiding structure. In some embodiments, the diameter of the needle body channel of the auxiliary guiding needle 12 is large enough to accommodate the catheter 11 and allow the catheter to penetrate. In some embodiments, during the operation of implanting the catheter, the auxiliary guiding needle 12 is connected to the catheter guiding structure, so that the catheter 11 can sequentially pass through the needle body channel of the auxiliary guiding needle 12, the catheter guiding structure, the needle body channel of the hollow puncture needle 6, and then enter the apparent or potential tissue space, chamber or gap (e.g., intercostal space or EPS) through the distal opening 6a of the needle. In some embodiments, before implanting the catheter, the apparent or potential tissue space, chamber or gap (e.g., intercostal space or EPS) is expanded with a flowable composition using the medical puncture device disclosed herein. In some embodiments, the catheter is implanted when the apparent or potential tissue space, chamber or gap (e.g., intercostal space or EPS) is expanded with a flowable composition using the medical puncture device disclosed herein. In some embodiments, the catheter is implanted before the apparent or potential tissue space, chamber or gap (e.g., intercostal space or EPS) is expanded with a flowable composition using the medical puncture device disclosed herein.

[0278] In some embodiments, as Figure 7 shown, the catheter guiding structure includes a through inclined guiding groove 3a' and a one-way valve 9, and the one-way valve 9 is embedded in the inclined guiding groove 3a' and can be opened and closed. In some embodiments, the needle body opening 6b is provided in the form of a backwardly inclined opening. In some embodiments, when implanting the catheter 11, the auxiliary guiding needle 12 is used to open the one-way valve 9 so that the auxiliary guiding needle can be positioned within the inclined guiding groove 3a'. In some embodiments, the distal end of the auxiliary guiding needle 12 is advanced into the needle body opening 6b, and the catheter 11 can be advanced to sequentially pass through the needle body channel of the auxiliary guiding needle 12, the needle body channel of the hollow puncture needle 6, and the distal opening of the needle 6a, and then implanted into the apparent or potential tissue space, chamber or gap (e.g., intercostal space or EPS).

[0279] In some embodiments, as shown in FIG. 11, the catheter guiding structure includes a central guiding groove 2c. In some embodiments, a needle proximal opening is formed on the hollow puncture needle 6, and it is axially aligned with the central guiding groove 2c. In some embodiments, when implanting the catheter 11, the auxiliary guiding needle 12 can puncture the central guiding groove 2c so that the auxiliary guiding needle 12 is axially aligned with the proximal opening of the hollow puncture needle 6. In some embodiments, the catheter 11 passes through the needle body channel of the auxiliary guiding needle 12 and the proximal opening of the hollow puncture needle 6 in sequence, penetrates into the needle body channel of the hollow puncture needle 6, and then is implanted into the apparent or potential tissue space, chamber or gap (e.g., intercostal space or EPS) through the distal opening of the needle (e.g., the distal opening 6a of the needle).

[0280] In some embodiments, the pressing element (e.g., Figure 13B or Figure 15B the pressing element 2 therein) includes a threaded portion configured to threadedly engage with a control knob (e.g., Figure 13B or Figure 15B the control knob 2a therein). For example, the control knob may include internal helical threads configured to mate with the threaded portion of the pressing element. In some embodiments, the control knob may rotate about a central axis and, through the threaded engagement, rotation of the control knob can drive the pressing element to translate axially. In some embodiments, the pressing element moves relative to a housing (e.g., Figure 13B or Figure 15B the main housing 40 therein) along a helical path having a rotational component and a translational component axially. In some embodiments, depending on whether the control knob is rotated clockwise or counterclockwise, the translation of the pressing element can be in the distal direction (e.g., toward the subject) or in the proximal direction (e.g., toward the operator). In some examples, clockwise rotation of the control knob causes the pressing element to advance in the distal direction, while counterclockwise rotation of the control knob causes the pressing element to retract in the proximal direction. In other examples, counterclockwise rotation of the control knob causes the pressing element to advance in the distal direction, while clockwise rotation of the control knob causes the pressing element to retract in the proximal direction.

[0281] In some embodiments, the pressing element is connected to the syringe needle such that axial movement of the pressing element causes and / or permits movement of the syringe needle. In some embodiments, the pressing element and the syringe needle are directly connected. In some embodiments, the pressing element and the syringe needle are indirectly connected. In some embodiments, the pressing element and the syringe needle are elastically connected. In some embodiments, the pressing element and the syringe needle elastically engage with each other. In some embodiments, the pressing element and the syringe needle are connected by an elastic connection. In some embodiments, the pressing element and the syringe needle are fixedly or detachably connected. In some embodiments, the pressing element and the syringe needle are fixedly or detachably engaged with each other. In some embodiments, the pressing element and the syringe needle are connected by a fixed connection. In some embodiments, the connection between the pressing element and the syringe needle is strong enough such that the pressing element can drive the syringe needle forward or backward. In some embodiments, the syringe needle is disposed on a needle seat or base (which is part of the pressing element), or is directly or indirectly connected to the pressing element. In some embodiments, the needle seat or base is axially elongated and has a cross-sectional area smaller than the cross-sectional area of the portion of the pressing element that is directly adjacent to the needle seat or base. In some embodiments, the needle seat or base is fixedly connected to the pressing element. In some embodiments, the needle seat or base is integral with the pressing element. In some embodiments, the pressing element and the syringe needle are connected by a needle seat or base that is at least axially strong enough such that the pressing element can move distally or proximally axially, thereby advancing or retracting the syringe needle relative to the outer housing or casing.

[0282] In some embodiments, the pressing element (e.g., Figure 13B or Figure 15B the pressing element 2 therein) and the push rod are connected by an elastic element or part (such as a spring). In some embodiments, the elastic element or part is directly or indirectly connected to the pressing element and / or the needle seat or base, or a part thereof. For example, a part of the elastic element or part (such as the proximal end) can directly or indirectly engage with a part of the pressing element or the needle seat or base. The elastic element or part can be fixedly or detachably engaged with the proximal portion of the needle seat or base. In some embodiments, the elastic element or part is directly or indirectly connected to the piston rod. For example, a part of the elastic element or part (such as the distal end) can directly or indirectly engage with a part of the piston rod (such as the proximal end). In some embodiments, the elastic element or part is fixedly or detachably connected to the piston rod. In some embodiments, the pressing element can be pushed distally relative to the housing so as to apply a force to the elastic element or part (such as a spring), and thereby apply a force to the piston rod, while the injection needle is advanced distally by the pressing element.

[0283] In some embodiments, the needle hub or base or a portion thereof is axially elongated to provide a space between a portion of the push shaft and the piston rod, the space configured to receive one or more resilient elements or parts. In embodiments using multiple resilient elements or parts, any two or more of the resilient elements or parts may be arranged in series or in parallel. Each resilient element or part may be in the form of a flexible sheath or tube, a spring, an O-ring, an elongated rod or strip, or any combination thereof. The resilient element or part may be arranged parallel to the needle hub or base and / or allow the needle hub or base to pass therethrough. For example, the elongated needle hub or base may pass through the coils of a spring, where the proximal end of the spring engages the proximal portion of the elongated needle hub or base and the distal end of the spring engages the proximal portion of the piston rod. The distal portion of the elongated needle hub or base may be inserted into the chamber of the push shaft, and all or a portion of the injection needle may be received in the chamber of the push shaft. In some embodiments, prior to medical puncture using the injection needle, the injection needle is located within the inner lumen and does not pass through the distal end of the push shaft or a seal attached thereto. Thus, in some embodiments, the pressing element (e.g., including or connected to the elongated needle hub or base) may be configured to elastically engage the push shaft, and the distal portion of the push shaft engages the seal such that the seal may be configured as a floating seal.

[0284] In some embodiments, provided herein is a method of performing an intercostal nerve block that includes using any of the injection systems or devices described herein. In some embodiments, the injection systems and devices are capable of achieving precise control as the injection needle is advanced through the parietal pleura, particularly suitable for accessing the EPS or intercostal groove. In some embodiments, the devices disclosed herein are capable of precisely accessing the EPS and / or intercostal groove while reducing or minimizing the risk of under-puncture and / or over-puncture, e.g., the needle penetrates too deeply and damages surrounding tissues such as blood vessels and / or nerves. In some embodiments, as the injection needle is advanced within the EPS or intercostal space, its axial movement can be controlled and achieved with micron-level precision. In some embodiments, the axial movement distance of the injection needle within the tissue can be set to any distance that meets the requirement for the tip of the injection needle to penetrate from the parietal pleura into the EPS or intercostal space. In some examples, the axial movement distance of the injection needle within the tissue can be set within a length range of about 0 to about 3.0 mm, e.g., about 0 to about 0.2 mm, about 0 to about 0.5 mm, about 0 to about 0.8 mm, about 0 to about 1.0 mm, about 0 to about 1.2 mm, about 0 to about 1.5 mm, about 0 to about 1.8 mm, or about 0 to about 2.0 mm. In some embodiments, the devices disclosed herein include an injection needle having the dimensions and configurations disclosed herein, e.g., the bevel angle of the injection needle is between about 0 degrees and about 40 degrees, particularly between about 5 degrees and about 30 degrees, such as between about 15 degrees and about 25 degrees. In some embodiments, the volume of the flowable composition (e.g., anesthetic solution) delivered (e.g., by injection) using the devices disclosed herein can be selected according to the condition of the specific subject and can be adjusted according to changes in the condition. In some embodiments, the energy stored in a storage member (e.g., a spring) is automatically released to advance a floating seal, thereby discharging a certain volume of the flowable composition into an apparent or potential tissue void, cavity, or space (e.g., the intercostal space or EPS). Given the combination of the various features disclosed herein, the devices and methods disclosed herein are capable of achieving precise, safe, and controllable delivery of an agent (e.g., an anesthetic) to a target tissue of a subject, such as the intercostal space or EPS.

[0285] In some embodiments, a flowable composition (such as an anesthetic solution) can be injected into the intercostal space or EPS through the injection needle of the injection device disclosed herein, thereby injecting the flowable composition near the intercostal nerve to be blocked. In some examples, the distal tip of the injection needle inserts and penetrates through the superficial tissue of the target site and is advanced through the parietal pleura into the EPS.

[0286] In some embodiments, after the distal end of the injection needle reaches the EPS, a composition such as an anesthetic can be delivered into the EPS. In some examples, a composition such as an anesthetic can be delivered through one or more openings of the injection needle.

[0287] It should be understood that any suitable medical puncture device, including but not limited to those described herein in conjunction with the accompanying drawings, can be used in the method of performing an intercostal nerve block disclosed herein. For example, the medical puncture device shown in Figure 12A can be used. In some embodiments, the medical puncture device includes a syringe having a proximal end and a distal end; a floating seal located within the syringe; a puncturing member, such as a needle, located at the distal end of the syringe, wherein the puncturing member is not connected to the floating seal; and a driving member configured to elastically engage with the floating seal through an energy storage member (such as a spring, etc. and / or other suitable elastic members). In some embodiments, the puncturing member includes a distal opening configured to form fluid communication with a chamber within the syringe containing a flowable composition. In some embodiments, the medical puncture device further includes a stopper located within the syringe, between the floating seal and the distal end of the syringe. As shown in step 1 of Figure 12A , the medical puncture device is in an initial state, wherein the distal opening of the puncturing member has not entered the tissue of the subject, and the distance between the driving member and the floating seal is x1. In Figure 12A , step 2, the distal opening of the puncturing member has entered relatively dense tissue (such as the parietal pleura or muscle), wherein the distance between the driving member and the floating seal remains the same (x1). In Figure 12A , step 3, the distal opening of the puncturing member remains in relatively dense tissue, at which time the energy storage member is compressed, for example, by reducing the distance between the driving member and the floating seal from x1 to x2. In this way, the energy storage member exerts a force on the floating seal and maintains this force. Through the flowable composition and the distal opening of the puncturing member, pressure is exerted on the relatively dense tissue (such as the parietal pleura or muscle). Due to the tissue density, the relatively dense tissue (such as the parietal pleura or muscle) exerts a back pressure on the distal opening of the puncturing member, thereby preventing the flowable composition from draining into the tissue. In Figure 12A , step 4, the puncturing member is advanced distally into low-density tissue, such as an apparent or potential tissue void, chamber, or space (such as an intercostal space or EPS). In some embodiments, due to the decrease in tissue density, the back pressure on the distal opening of the puncturing member is less than the pressure of the flowable composition, thereby allowing the flowable composition to be released into the low-density tissue, such as an apparent or potential tissue void, chamber, or space (such as an intercostal space or EPS). As the flowable composition is discharged from the distal opening of the puncturing member, the energy in the energy storage member is released, thereby increasing the distance between the driving member and the floating seal from x2 to x3, as shown in Figure 12A , step 5. The distal movement of the floating seal within the syringe can be stopped by the stopper, for example, in order to control the volume of the flowable composition delivered to the low-density tissue (such as an intercostal space or EPS).

[0288] Another example is as follows Figure 12B as shown in step 1, where the medical piercing device is in an initial state, and the distal opening of the piercing member has not yet entered the tissue of the subject. In Figure 12B step 2, the energy storage member can be compressed while the distal opening of the piercing member remains outside the tissue, and the floating seal is not advanced distally to discharge the flowable composition from the distal opening. In Figure 12B step 3, the distal opening of the piercing member has entered relatively dense tissue (such as the parietal pleura or muscle). The energy storage member exerts a force on the floating seal and maintains this force. Through the flowable composition and the distal opening of the piercing member, pressure is exerted on the high-density tissue (such as the parietal pleura or muscle). Due to the tissue density, the high-density tissue (such as the parietal pleura or muscle) exerts a back pressure on the distal opening of the piercing member, thereby preventing the flowable composition from being discharged into the tissue. In Figure 12B step 4, the distal opening of the piercing member begins to enter low-density tissue (such as EPS), such as an apparent or potential tissue void, chamber or space (such as EPS), while the energy storage member remains in a compressed state. In Figure 12B step 5, due to the decrease in tissue density, the back pressure on the distal opening of the piercing member is less than the pressure of the flowable composition, thereby allowing the flowable composition to be released into the low-density tissue (such as EPS). As the flowable composition is discharged from the distal opening of the piercing member, the energy in the energy storage member is released. In some embodiments, the distal movement of the floating seal within the syringe barrel can be stopped by a stopper to stop the flow of the flowable composition. In this way, the volume of the flowable composition delivered to the low-density tissue (such as EPS) can be controlled. As Figure 12B shown in step 6, the force applied to the drive member can be released.

[0289] Another example is shown in Figure 12C . In some embodiments, the medical piercing device includes a syringe barrel having a proximal end and a distal end; a floating seal located within the syringe barrel; a piercing member, such as a needle, located at the distal end of the syringe barrel, where the piercing member is not connected to the floating seal; and an energy storage member configured to elastically engage the floating seal and the proximal end of the syringe barrel. In some embodiments, the medical piercing device further includes a stopper located within the syringe barrel between the floating seal and the distal end of the syringe barrel. In some embodiments, the medical piercing device includes a contact member. In Figure 12C step 1, the medical piercing device is in an initial state, where the distal opening of the piercing member is within the contact member, preventing the flowable composition from being discharged from the distal opening. The energy storage member exerts a force on the floating seal, and through the flowable composition and the distal opening of the piercing member, pressure is exerted on the contact member. Due to the density of the contact member, the back pressure on the distal opening of the piercing member prevents the flowable composition from leaking from the syringe barrel. In Figure 12CIn step 2, the distal opening of the piercing member has entered the high-density tissue (such as the parietal pleura or muscle), and the back pressure of the high-density tissue on the distal opening prevents the flowable composition from leaking into the high-density tissue (such as the parietal pleura or muscle). In Figure 12C In step 3, the distal opening of the piercing member begins to enter the low-density tissue, such as an apparent or potential tissue space, chamber or gap (such as EPS). In Figure 12C In step 4, due to the decrease in tissue density, the back pressure on the distal opening of the piercing member is less than the pressure of the flowable composition, thereby allowing the flowable composition to be released into the low-density tissue (such as EPS). As the flowable composition is discharged from the distal opening of the piercing member, the energy in the energy storage member is released. In some embodiments, the distal movement of the floating seal within the syringe barrel can be stopped by a stopper, thereby stopping the flow of the flowable composition. Thus, the volume of the flowable composition delivered to the low-density tissue can be controlled.

[0290] Another example is Figure 17 as shown. As Figure 17 shown in steps a-c, an additional device is attached to a conventional syringe, and the flowable composition is drawn into the chamber. As Figure 17 shown in steps d and e, the syringe with the additional device is in an initial state, where the distal opening of the needle is located within the contact member, preventing the flowable composition from being discharged from the distal opening. The first elastic element applies a force to the push shaft, which in turn applies a pressure to the contact member through the flowable composition and the distal opening of the needle. Due to the density of the contact member 25, the back pressure on the distal opening of the needle prevents the flowable composition from leaking from the syringe barrel. In Figure 17 In steps f and g, the distal opening of the needle has entered the high-density tissue A (such as the parietal pleura), and the back pressure of the high-density tissue on the distal opening prevents the flowable composition from leaking into the tissue. At the same time, the contact member, the optional second elastic element and the optional connecting member can increase the resistance to the distal advancement of the needle, thereby reducing the risk of the needle being inserted too deeply. In Figure 17 In step h, the distal opening of the needle begins to enter the low-density tissue B, such as an apparent or potential tissue space, chamber or gap (such as EPS). In Figure 17 In step i, due to the decrease in tissue density, the back pressure on the distal opening of the needle is less than the pressure of the flowable composition, thereby allowing the flowable composition to be released into the low-density tissue (such as EPS). The energy stored in the first elastic element is released, pushing the push shaft to move distally, while the contact member prevents the floating seal 3 from moving distally. Therefore, the flowable composition is discharged from the distal opening of the piercing member. In some embodiments, the distal movement of the push shaft within the syringe barrel can be stopped by a stopper, thereby stopping the flow of the flowable composition. Thus, the volume of the flowable composition delivered to the low-density tissue can be controlled.

[0291] In some embodiments, a method of performing an intercostal nerve block as disclosed herein, a method of delivering a flowable composition near an intercostal nerve, or a method of delivering a flowable composition into the intercostal space / EPS / intercostal groove of a subject in need of treatment includes: injecting the flowable composition (such as an anesthetic solution) as a single injection at a target site, or performing multiple injections at different target sites.

[0292] Exemplary embodiments and optional implementations of the present disclosure have been described in detail above in connection with the accompanying drawings. However, the present disclosure is not limited to the details described in the above embodiments. Simple variations can be made to the embodiments of the present disclosure, and all such variations are within the scope of the present disclosure.

[0293] It should be noted that the embodiments described herein can be implemented alone or in any suitable combination. Each technical feature described in the above embodiments can be combined in any reasonable manner when there is no conflict. To avoid unnecessary repetition, possible combinations are not separately described in the embodiments.

[0294] In addition, different implementations of the embodiments of the present disclosure can be freely combined. As long as they do not violate the idea of the present disclosure, they should also be regarded as part of the present disclosure.

[0295] References Andres Obeso. 2018. Selective thoracoscopic intercostal block through a transbronchial aspiration needle: an alternative analgesic tool for pain control after video-assisted thoracic surgery. Pulm Resp Med Int J. 1(1):6–7. Anthony M.-H. Ho, et al. 2022. Intercostal Nerve Block–Landmarks and Nerve Stimulator Technique. NYSO RA. Caleb S. Baxter, Abhishek Singh, Fayez A. Ajib, and Brian M. Fitzgerald 2022. Intercostal Nerve Block. Treasure Island(FL): StatPearls Publishing. Clara Scher, Lauren Meador, Janet H. Van Cleave, and M. Carrington Reid. 2018. Moving beyond pain as the fifth vital sign and patient satisfaction scores to improve pain care in the 21st Century. Pain Manag Nurs. 19(2):125–129. Mario G Santamarina, Ignacio Beddings, Guillermo V Lermanda Holmgren, Hector Opazo Sanchez, and Mariano M Volpacchio 2017. Multidetector CT for Evaluation of the Extrapleural Space. Radiographics 37(5):1352 - 1370. Tianci Chai, Yuhan Lin, Mingqiang Kang, and Jiangbo Lin. 2019. Thoracotomy versus video - assisted thoracoscopic resection of lung cancer. Medicine (Baltimore). 98(10):e14646.

Claims

1. A method of performing an intercostal nerve block on a subject in need of treatment, comprising: 1) providing an injection system, comprising: a syringe barrel extending from a proximal end to a distal end; a plunger shaft extending from a proximal end to a distal end, wherein the distal end of the plunger shaft is located within the syringe barrel; a drive unit comprising a drive member, a storage member, and a floating seal, wherein the floating seal is located within the syringe barrel, forms a seal between the floating seal and the syringe barrel, and forms a chamber between the floating seal and the distal end of the syringe barrel, and wherein the floating seal is elastically engageable with the drive member via the storage member; and a needle extending from a proximal end to a distal end and comprising an end opening; wherein the distal end of the plunger shaft is located proximal to the floating seal; wherein a flowable composition is located within the chamber formed between the floating seal and the distal end of the syringe barrel; wherein the proximal end of the needle: a) is connected to the distal end of the syringe barrel, or b) is connected to the distal end of the plunger shaft, wherein the needle further comprises a needle body opening located between the proximal end and the distal end of the needle, wherein the needle body opening is proximal to the needle distal end opening, and a needle body channel connecting the needle distal end opening and the needle body opening; 2) controlling the drive member to compress the storage member without moving the floating seal; 3) advancing the distal end of the needle towards a first target site within the intercostal space of the subject; and 4) continuing to advance the distal end of the needle until the distal end of the needle penetrates the parietal pleura of the subject and enters the extrapleural space, thereby allowing the storage member to release energy, causing the floating seal to move distally, and causing the flowable composition to flow through the end opening of the needle into the extrapleural space.

2. The method according to claim 1, wherein the injection system further comprises a contact member and an elastic element, wherein the contact member is located at the distal end of the syringe barrel, the distal end of the needle, and the distal end of the elastic element; and wherein the contact member is configured to be elastically engaged with the distal end of the syringe barrel via the elastic element.

3. The method according to claim 1 or 2, wherein the injection system further comprises a syringe handle, wherein the syringe handle is connected to the syringe barrel.

4. The method according to any one of the preceding claims, wherein the injection system of 1)-b) further comprises a distal seal, and wherein the distal seal is located within the syringe barrel and at the distal end of the syringe barrel.

5. The method according to any one of the preceding claims, wherein advancing the distal end of the needle towards the intercostal space of the subject as described in 1)-b) comprises: Applying a force to the plunger shaft to overcome the resistance, causing the needle to move distally towards and enter the parietal pleura of the subject without discharging the flowable composition.

6. The method according to claim 3, wherein 1)-a) advancing the distal end of the needle towards the intercostal space of the subject comprises: Controlling the syringe handle to compress the elastic element, thereby advancing the distal end of the needle towards and into the parietal pleura of the subject without discharging the flowable composition.

7. The method according to any one of the preceding claims, wherein the drive member is a pressing element configured to engage with a control knob.

8. The method according to claim 7, wherein the pressing element is cylindrical.

9. The method according to claim 7 or 8, wherein said controlling the drive member to compress the energy storage member without moving the floating seal includes: Rotating the control knob to drive the pressing element, thereby applying a force to the storage member and compressing the storage member.

10. The method according to any one of claims 2-9, further comprising step 2a): after step 1) and before step 2), or after step 2) and before step 3), positioning the distal end of the syringe barrel towards the first target site within the intercostal space, wherein the contact member is in direct contact with the surface tissue of the first target site.

11. The method according to claim 10, wherein step 2a) is carried out after step 1) and before step 2).

12. The method according to any one of the preceding claims, further comprising step 5): withdrawing the needle from the first target site.

13. The method according to claim 12, further comprising step 6): moving the injection system near a second target site, and then successively performing steps 2a') - 2) - 3') - 4) - 5'), Among which, step 2a') includes: positioning the distal end of the syringe barrel towards the second target site within the intercostal space, wherein the contact member is in direct contact with the superficial tissue of the second target site; wherein step 3') comprises: advancing the distal end of the needle towards the second target site within the intercostal space of the subject; and wherein step 5') comprises: withdrawing the needle from the second target site.

14. The method according to claim 13, further comprising step 7): moving the injection system near a third target site, and then successively performing steps 2a'') - 2) - 3'') - 4) - 5''), where step 2a”) includes: positioning the distal end of the syringe barrel towards the third target site within the intercostal space, wherein the contact member is in direct contact with the superficial tissue of the third target site; wherein step 3'') comprises: advancing the distal end of the needle towards the third target site within the intercostal space of the subject; and wherein step 5'') comprises: withdrawing the needle from the third target site.

15. The method according to claim 14, further comprising step 8): moving the injection system near the next target site, and then successively performing steps 2a''') - 2) - 3''') - 4) - 5'''), where step 2a”’) includes: positioning the distal end of the syringe barrel towards the next target site within the intercostal space, wherein the contact member is in direct contact with the superficial tissue of the next target site; wherein step 3''') comprises: advancing the distal end of the needle towards the next target site within the intercostal space of the subject; and wherein step 5''') comprises; withdrawing the needle from the next target site.

16. The method according to any one of the preceding claims, wherein the energy storage member comprises a spring and / or an elastic sheath.

17. The method according to any one of claims 2 - 16, wherein the elastic element comprises a spring and / or an elastic sheath.

18. A method for performing intercostal nerve block on a subject in need of treatment, comprising: 1) providing an injection system, comprising: a syringe barrel extending from a proximal end to a distal end and forming a chamber extending from the proximal end to the distal end; a push rod extending from the proximal end to the distal end and forming a seal between the distal end of the push rod and the syringe barrel; a floating seal disposed within the chamber near the distal end of the syringe barrel and forming a seal between the floating seal and the distal end of the syringe barrel; and a needle extending from the proximal end to the distal end and including an end opening; wherein the flowable composition is located in: a) the chamber between the distal end of the push rod and the floating seal, wherein the proximal end of the needle is connected to the floating seal; or b) the chamber between the floating seal and the distal end of the syringe barrel, wherein the proximal end of the needle is connected to the distal end of the push rod; wherein the needle further comprises: a needle body opening located between the proximal end and the distal end of the needle, wherein the needle body opening is proximal to the needle distal end opening; and a needle body channel connecting the needle distal end opening and the needle body opening; 2) Advance the distal end of the needle towards the intercostal space of the subject; and 3) Continue to advance the distal end of the needle until the distal end of the needle penetrates the parietal pleura of the subject and enters the extrapleural space, thereby allowing the flowable composition to flow from the chamber through the end opening of the needle into the extrapleural space.

19. The method according to claim 18, wherein advancing the distal end of the needle towards the intercostal space of the subject comprises: Apply a force to the push shaft to overcome the resistance, causing the needle to move distally and enter the intercostal space of the subject without discharging the flowable composition into the parietal pleura or the extrapleural space.

20. The method according to claim 18 or 19, wherein the proximal end of the needle of 1)-b) is connected to the distal end of the push shaft through a needle hub, wherein the needle hub and the floating seal are configured to elastically engage with each other, and wherein the needle hub is configured to advance the needle distally when a force is applied to the push shaft.

21. The method according to any one of claims 18-20, wherein before advancing the distal end of the needle, both the body opening and the distal opening of the needle of 1)-b) are proximal to the floating seal.

22. The method according to any one of claims 18-21, which includes advancing the distal end of the needle, wherein the body opening of the needle of 1)-b) is proximal to the floating seal, wherein the end opening of the needle is distal to the floating seal and is located in the chamber containing the flowable composition, and wherein the flowable composition is prevented from discharging from the end opening of the needle.

23. The method according to any one of claims 18-21, which includes advancing the distal end of the needle, wherein both the body opening and the end opening of the needle of 1)-b) are distal to the floating seal and are located in the chamber containing the flowable composition, and wherein the flowable composition is prevented from discharging from the end opening of the needle.

24. The method according to any one of claims 18-21, which includes advancing the distal end of the needle, wherein the body opening of the needle of 1)-b) is distal to the floating seal and is located in the chamber containing the flowable composition, wherein the end opening of the needle contacts the tissue in the intercostal space of the subject, and wherein the flowable composition is prevented from discharging from the end opening of the needle.

25. The method according to any one of claims 18-22, which includes continuing to advance the distal end of the needle until the distal end of the needle penetrates the parietal pleura of the subject and enters the extrapleural space, wherein the body opening of the needle of 1)-b) is located in the chamber containing the flowable composition, wherein the end opening of the needle is located in the extrapleural space of the subject, and wherein, without further advancing the needle, the floating seal is moved distally, thereby allowing the flowable composition to flow through the body opening, the body channel, and the end opening of the needle into the extrapleural space.

26. The method according to claim 18 or 19, which includes continuing to advance the distal end of the needle until the distal end of the needle penetrates the parietal pleura of the subject and enters the extrapleural space, wherein the flowable composition of 1)-a) is located in the chamber between the distal end of the push shaft and the floating seal, and wherein the proximal end of the needle is connected to the floating seal; and wherein the distal end of the needle penetrates the parietal pleura of the subject and enters the extrapleural space, thereby allowing the floating seal to overcome the resistance and move distally without further advancing the needle, thereby discharging the flowable composition into the extrapleural space through the end opening of the needle.

27. The method according to any one of claims 18 - 26, wherein the injection system further comprises a syringe handle, and wherein the syringe handle is connected to the syringe barrel.

28. The method according to any one of claims 18 - 27, wherein the injection system further comprises a distal seal, and wherein the distal seal is located within the syringe barrel and at the distal end of the syringe barrel.

29. The method according to any one of claims 18 - 28, wherein the injection system further comprises a contact member and an elastic element, wherein the contact member is located at the distal end of the syringe barrel, the distal end of the needle, and the distal end of the elastic element; and wherein the contact member is configured to elastically engage with the distal end of the syringe barrel via the elastic element.

30. The method according to claim 29, further comprising step 2a): after step 1) and before step 2), positioning the distal end of the syringe barrel towards the target site within the intercostal space, wherein the contact member is in direct contact with the superficial tissue of the target site.

31. The method according to any one of the preceding claims, wherein the method is performed under thoracoscopy.

32. The method according to any one of the preceding claims, wherein the subject suffers from pain due to traumatic injury, cancer, and / or surgery in their abdominal or thoracic region.

33. The method according to any one of the preceding claims, wherein the flowable composition comprises one or more anesthetics for intercostal nerve block, and optionally one or more additives.

34. The method according to claim 33, wherein the one or more anesthetics are selected from ropivacaine, dibucaine, bupivacaine, etidocaine, tetracaine, procaine, chloroprocaine, prilocaine, mepivacaine, lidocaine, xylocaine, and mixtures thereof.

35. The method according to claim 33 or 34, wherein the additive is epinephrine.

36. An injection system, comprising: A syringe barrel extending from proximal to distal; A push rod extending from proximal to distal, wherein the distal end of the push rod is located within the syringe barrel; A drive unit, which includes a drive member, an energy storage member, and a floating seal, wherein the floating seal is located within the syringe barrel, forms a seal between the floating seal and the syringe barrel, and forms a chamber between the floating seal and the distal end of the syringe barrel, and wherein the floating seal can be elastically engaged with the drive member via the energy storage member; and a needle extending from proximal to distal and including an end opening; wherein the distal end of the push rod is located proximal to the floating seal; wherein the flowable composition is located within the chamber formed between the floating seal and the distal end of the syringe barrel; wherein the proximal end of the needle: a) is connected to the distal end of the syringe barrel, or b) is connected to the distal end of the push rod, wherein the needle further includes a needle body opening located between the proximal end of the needle and the distal end of the needle, wherein the needle body opening is proximal to the distal opening of the needle, and a needle body channel connecting the distal opening of the needle and the needle body opening.

37. The injection system according to claim 36, wherein the injection system further comprises a contact member and an elastic element, wherein the contact member is located at the distal end of the syringe barrel, the distal end of the needle, and the distal end of the elastic element; and wherein the contact member is configured to elastically engage with the distal end of the syringe barrel via the elastic element.

38. The injection system according to claim 36 or 37, wherein the injection system further comprises a syringe handle, and the syringe handle is connected to the syringe barrel.

39. The injection system according to any one of claims 36 - 38, wherein the injection system of 1) - b) further comprises a distal seal, and the distal seal is located within the syringe barrel and at the distal end of the syringe barrel.

40. The injection system according to any one of claims 36 - 39, wherein the energy storage member comprises a spring and / or an elastic sheath.

41. The injection system according to any one of claims 37 - 39, wherein the elastic element comprises a spring and / or an elastic sheath.

42. The injection system according to any one of claims 36 - 41, wherein the needle is a hollow puncture needle.

43. The injection system according to any one of claims 37 - 42, wherein the contact member is a soft buffer.

44. The injection system according to any one of claims 36 - 43, wherein the drive member is a pressing element configured to engage with a control knob.

45. The injection system according to claim 44, wherein the pressing element is cylindrical.

46. The injection system according to claim 44 or 45, wherein the push rod is configured to pass through the cylindrical pressing element and optionally engage with the cylindrical pressing element.

47. The injection system according to any one of claims 36 - 46, wherein the chamber formed between the floating seal and the distal end of the syringe barrel is a flowable composition chamber.

48. An injection system, comprising: A syringe barrel extending from a proximal end to a distal end; A push rod extending from a proximal end to a distal end, wherein the distal end of the push rod is located within the syringe barrel; A drive unit comprising a drive member, a spring, and a floating seal, wherein the floating seal is located within the syringe barrel, forms a seal between the floating seal and the syringe barrel, and forms a flowable composition chamber between the floating seal and the distal end of the syringe barrel, wherein the floating seal can be elastically engaged with the drive member through the spring, and wherein the drive member is a cylindrical pressing element configured to engage with a control knob; A needle extending from a proximal end to a distal end and having an end opening, wherein the proximal end of the needle is connected to the distal end of the syringe barrel, and wherein the needle is a hollow puncture needle; A buffer and an elastic element, wherein the buffer is located at the distal end of the syringe barrel, the distal end of the needle, and the distal end of the elastic element; and wherein the buffer is configured to be elastically engaged with the distal end of the syringe barrel through the elastic element, and the elastic element is a spring; And A syringe handle located at the proximal end of the syringe barrel; Wherein the distal end of the push rod is located proximal to the floating seal, and wherein the push rod is configured to pass through the cylindrical pressing element and optionally engage with the cylindrical pressing element.

49. An injection system, comprising: A syringe barrel extending from a proximal end to a distal end; A push rod extending from a proximal end to a distal end, wherein the distal end of the push rod is located within the syringe barrel; A drive unit, which includes a drive member, a spring, and a floating seal, wherein the floating seal is located within the syringe barrel, forms a seal between the floating seal and the syringe barrel, and forms a cavity for the flowable composition between the floating seal and the distal end of the syringe barrel, wherein the floating seal is elastically engageable with the drive member via the spring, and wherein the drive member is a cylindrical pressing element configured to engage with a control knob; A needle extending from a proximal end to a distal end and including an end opening, wherein the proximal end of the needle is connected to the distal end of a push rod, wherein the needle further includes a needle body opening located between the proximal end and the distal end of the needle, wherein the needle body opening is proximal to the distal opening of the needle, and a needle body channel connecting the distal opening of the needle and the needle body opening; A distal seal located within the syringe barrel and at the distal end of the syringe barrel; A buffer and an elastic element, wherein the buffer is located at the distal end of the syringe barrel, the distal end of the needle, and the distal end of the elastic element; and wherein the buffer is configured to be elastically engaged with the distal end of the syringe barrel via the elastic element, and wherein the elastic element is a spring; and A syringe handle located at the proximal end of the syringe barrel; wherein the distal end of the push rod is proximal to the floating seal, and wherein the push rod is configured to pass through the cylindrical pressing element and optionally engage with the cylindrical pressing element.

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