Parallel path lancing device guide and method

Abstract

A guide device is provided to facilitate positioning of a puncture device (needle) at a defined position relative to an ultrasound probe. The guide device provides additional support for the needle tip near the injection site and maintains the selected path during injection. After injection, the additional support is automatically retracted for easy disposal along with the used syringe. The guide device minimizes contact of contaminated parts and allows for insertion, alignment, and removal of syringes for multiple different injections without removing the ultrasound probe from the patient. More particularly, the present invention relates to a lancing device guide comprising: an adapter configured for fixed attachment to an ultrasound probe; and a syringe holder assembly slidably mounted to the adapter and configured to receive a syringe therein, the syringe holder assembly configured to be slidable on the probe adapter in an axial direction relative to the ultrasound probe; the syringe holder assembly configured to selectively adjust the radial distance of a needle path of the syringe relative to the ultrasound probe; the adapter including a tip guide for selectively aligning the distal end of the needle with the radial distance of the path; and the syringe assembly configured to slide forward on the adapter to insert the needle into the patient over the tip guide when the ultrasound probe is inserted into the patient. The present invention further relates to a method of performing an injection, particularly using the lancing device guide of the present invention, and to a guide plate configured for use with the lancing device guide of the present invention.

Description

[Technical Field]

[0001] The present invention relates to a lancing device guide for use with a medical imaging diagnostic device, and more particularly to a device for guiding a lancing device to a reproducible position in a patient relative to a probe of a medical imaging diagnostic device. More particularly, the present invention relates to a lancing device guide comprising: an adapter configured to be fixedly attached to an ultrasound probe; and a syringe holder assembly slidably attached to the adapter and configured to receive a syringe therein, the syringe holder assembly configured to be slidable on the probe adapter in an axial direction relative to the ultrasound probe; the syringe holder assembly configured to selectively adjust the radial distance of a needle path of the syringe relative to the ultrasound probe; the adapter including a tip guide for selectively aligning the distal end of the needle with the radial distance of the path; and the syringe assembly configured to slide forward on the adapter to insert the needle into the patient beyond the tip guide when the ultrasound probe is inserted into the patient. The present invention also relates to a method of performing an injection, particularly using the lancing device guide of the present invention, and a guide plate configured for use with the lancing device guide of the present invention. Thus, a guide device is provided to facilitate placement of a puncture device (needle) at a defined location relative to an ultrasound probe. The guide device provides additional support for the needle tip near the needle injection site to maintain a selected path throughout the injection. After injection, the additional support is automatically retracted for easy disposal along with the used syringe. The guide device minimizes contact of contaminated parts and allows for insertion, alignment, and removal of syringes for multiple different injections without removing the ultrasound probe from the patient. [Background technology]

[0002] Diagnostic imaging devices, such as ultrasound probes, have revolutionized the way many important medical procedures are performed. These medical devices utilize imaging technology to explore and evaluate the condition of human tissues and / or organs. As a result, diagnostic and treatment protocols have been developed, allowing many highly successful and safe procedures to be performed with minimal disruption to the patient. For example, ultrasound probes have become an accepted method for exploring the internal cavities of humans and animals, such as the digestive and reproductive tracts, for routine examinations and to identify evidence of tumors or other tissue areas of concern.

[0003] A lancing device guide is necessary to enable accurate guidance of the lancing device when moving it within a subject's tissue. Most lancing devices, such as cannulae (hollow needles), used to penetrate tissue are designed with asymmetrical bevels and sharp edges, so that the incision and movement of the lancing device within the tissue does not only move the lancing device in the axial direction in which it is pushed. Frictional resistance that occurs unevenly along the bevel causes the needle to move in other directions as well. A lancing device guide that can correct for this movement is needed.

[0004] WO2021067734 discloses a device for use with an ultrasound probe to guide a puncture device. However, this device has the disadvantage that the tip of the puncture device (e.g., a needle or cannula) is not sufficiently stabilized to compensate for the forces resulting from moving an asymmetrically beveled needle through tissue, resulting in inaccurate movement of the puncture device within the subject. Furthermore, the puncture device may be accidentally pushed into the patient's lumen, resulting in contamination of the puncture device and damaging the patient's tissue. For example, if the device is contaminated by excrement in the rectal lumen and repeated guiding of the puncture device results in the puncture device coming into contact with the contaminated part, posing a risk of infection to the patient when the puncture device enters the patient's tissue. Such risks can only be avoided by replacing and / or cleaning (e.g., sterilizing) the device between repeated uses on the same patient.

[0005] EP 2170440 A2 discloses an injection device for use with a medical instrument to guide a puncture device. The device includes a guide tube to which the puncture device is attached so as to prevent it from moving freely as it penetrates and / or moves through a subject's tissue. However, when removing the puncture device from the puncture device guide, the puncture device must be pulled back through the guide tube, causing tissue and contaminants (e.g., fecal matter) adhering to the puncture device guide or the tip of the puncture device to accumulate within the guide tube. If the device is reused by pushing another puncture device along the guide tube, the accumulated material will adhere to the puncture device and be carried into the subject as it penetrates the subject's surface. This can cause infection and / or inflammation of the subject's tissue and must be avoided. Furthermore, the device may be accidentally pushed into the patient's lumen, thereby contaminating the device and damaging the patient's tissue. For example, if the device becomes contaminated by fecal matter in the rectal lumen, repeated guiding of the puncture device may cause the puncture device to come into contact with the contaminated area, increasing the risk of infection when the puncture device enters the patient's tissue. Such risks can only be avoided by replacing and / or cleaning (e.g., sterilizing) the device between repeated uses on the same patient. The use of the device of EP2170440A2 for repeated accurate injections can only be facilitated by cleaning the device or using a new device.

[0006] None of the above disclosures disclose a lancing device guide for accurately and safely repeatably guiding a lancing device for injection at a specific location on and / or within a patient.

[0007] The present invention has been made in light of the above-mentioned prior art. It is therefore an object of the present invention to provide a lancing device guide for use with medical imaging equipment, and more particularly, a device for accurately and repeatedly guiding a lancing device to a position on and / or within a patient relative to a probe of the medical imaging equipment. A further problem that the present invention aims to solve is to provide a lancing device guide for use with medical imaging equipment that enables accurate and safe repeatable guidance of a lancing device to a position on and / or within a patient relative to a medical imaging probe. A further problem that the present invention aims to solve is to provide a device that reduces, minimizes, or eliminates the risk of accidentally forcing the device into a patient's lumen. A further problem that the present invention aims to solve is to provide a device that reduces, minimizes, or eliminates the risk of contaminating the puncture / injection site, especially when the device is used repeatedly. A further problem that the present invention aims to solve is to provide a device that reduces, minimizes, or eliminates the need for cleaning (e.g., sterilization) or replacement of the device between repeated uses on the same patient.

[0008] That object is solved by the subject matter defined in the claims.

[0009] The present invention is advantageous over the prior art by reducing the risk of the puncturing device guide accidentally entering a lumen and thereby becoming contaminated and / or causing harm to the patient. Furthermore, the present invention is advantageous by guiding the puncturing device with greater precision. Furthermore, the puncturing device guide of the present invention has the advantage that it will not become contaminated (e.g., by bodily waste) when used with a puncturing device that itself becomes contaminated during use. Therefore, the puncturing device guide of the present invention does not need to be replaced or cleaned between repeated guiding of different puncturing devices when used with the same patient. Furthermore, the feature of contamination-free guiding of the puncturing device can be combined with high precision of movement of the puncturing device within the patient's tissue. Furthermore, the puncturing device guide is designed to be particularly useful for injecting needles and / or administering compositions and / or substances into an anal sphincter device for the prevention and / or treatment of anal incontinence. [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 is an isometric view of one embodiment of a needle guide device for use with an ultrasound probe, consistent with embodiments described herein. [Figure 2A] FIG. 2 is an assembly diagram showing the attachment of the probe and the probe adapter in FIG. 1. [Figure 2B] FIG. 2 is an isometric view showing the attachment of the probe and probe adapter of FIG. 1. [Figure 3] FIG. 2 is an isometric view of the syringe holder assembly of FIG. 1. [Figure 4A] 2 is a side view showing the attachment of the syringe holder assembly and the probe adapter of FIG. 1. FIG. [Figure 4B] FIG. 2 is a rear isometric view showing the attachment of the syringe holder assembly and probe adapter of FIG. 1. [Figure 5A] 2C is an isometric view showing the syringe holder assembly of FIG. 3 in an elevated configuration relative to the probe adapter of FIG. 2B. [Figure 5B] 2C is an isometric view showing the syringe holder assembly of FIG. 3 in a lowered configuration relative to the probe adapter of FIG. 2B. [Figure 6A] 2 is a side view showing a syringe engaged with the needle guide plate of FIG. 1. FIG. [Figure 6B] FIG. 2 is a rear isometric view showing a syringe engaged with the needle guide plate of FIG. 1. [Figure 7A] 5A is an isometric view showing the attachment of the syringe and needle guide plate of FIGS. 6A and 6B to the syringe holder assembly and probe adapter of FIG. 5A. FIG. [Figure 7B] 5A is an isometric view showing the attachment of the syringe and needle guide plate of FIGS. 6A and 6B to the syringe holder assembly and probe adapter of FIG. 5A. FIG. [Figure 7C] 5A is an isometric view showing the attachment of the syringe and needle guide plate of FIGS. 6A and 6B to the syringe holder assembly and probe adapter of FIG. 5A. FIG. [Figure 8A] FIG. 1 is an isometric view showing the position of the needle guide device and syringe during injection. [Figure 8B] FIG. 1 is an isometric view showing the position of the needle guide device and syringe during injection. [Figure 9A] FIG. 10 is an isometric view showing the needle guide device and syringe in a retracted position after injection. [Figure 9B] FIG. 10 is an isometric view showing the needle guide device and syringe in a retracted position after injection. [Figure 10A] 2 is an isometric view of the ejector body mechanism when ejecting a syringe from the needle guide device of FIG. 1. FIG. [Figure 10B] 2 is an isometric view of the ejector body mechanism when ejecting a syringe from the needle guide device of FIG. 1. FIG. [Figure 10C] 2 is an isometric view of the ejector body mechanism when ejecting a syringe from the needle guide device of FIG. 1. FIG. [Figure 11A] FIG. 10 is a side view illustrating the alignment of another embodiment of a needle guide plate and a probe adapter. [Figure 11B] FIG. 10 is a rear perspective view showing the alignment of another embodiment of a needle guide plate and a probe adapter. [Figure 11C] FIG. 11C is a side view showing engagement of the needle guide plate and probe adapter of FIGS. 11A and 11B. [Figure 11D] FIG. 11C is a rear perspective view showing engagement of the needle guide plate and probe adapter of FIGS. 11A and 11B. [Figure 12] FIG. 10 is a flow diagram of an exemplary process for performing an injection using a parallel path puncture device guide in accordance with embodiments described herein. [Figure 13] FIG. 10 is a flow diagram of an exemplary process for performing an injection using a parallel path puncture device guide in accordance with embodiments described herein. [Figure 14] FIG. 10 shows force measurements when a deflecting needle is attached to a syringe holder assembly with (w / ) or without (w / o) a guide. DETAILED DESCRIPTION OF THE INVENTION

[0011] (Terms and Definitions) The term "injection" as used herein preferably refers to a process consisting of introducing an injection device, such as a needle, into body tissue without initiating an evacuation process.

[0012] The term "syringe" generally refers to any fluid delivery device comprising a fluid reservoir (e.g., a syringe body having at least one chamber). The syringe body may be composed of one or more chambers, preferably cylindrical. Each chamber is preferably adapted to receive a syringe piston. Displacement of at least one syringe piston within the syringe body allows fluid to be expelled from the syringe body through an injection needle. A syringe may, for example, comprise a syringe body with a single syringe chamber, to which an injection needle can be connected and in which a syringe piston can be disposed. Alternatively, a syringe may comprise two or more chambers, to which an injection needle can be connected and in which a syringe piston is preferably disposed in each case. In a preferred embodiment of the present invention, the syringe is further used as an electromyography probe (EMG probe) for conducting electrical signals from the tissue into which the injection is performed.

[0013] The term "injection needle" or "needle" as used herein preferably refers to a device comprising an injection cannula (hollow injection needle) that can be attached to a syringe or inseparably attached to a syringe or a piston device having at least one syringe piston and at least one piston stem. The injection needle is preferably straight or curved. It can have asymmetric or symmetric bevels of different angles. The injection needle can be made from one or more materials, such as, but not limited to, stainless steel.

[0014] The term "administration" as used herein preferably consists of ejecting an injection solution, preferably releasing a pharmaceutically active substance and / or composition, through an injection device into a specific site within the human body, particularly preferably within or adjacent to the musculature providing anal continuity (e.g., the anal sphincter tissue). The administration process can be, but is not limited to, static, i.e., the injection device remains in the position where it was delivered. Alternatively, the injection process can be dynamic, preferably, the injection device is retracted from the patient's tissue during administration of the substance. As used herein, the term "patient" can be used interchangeably with the term "subject," which preferably refers to a human, animal, or mammal.

[0015] As used herein, the term "comprising" should not be interpreted exclusively to mean "consisting of" (i.e., not excluding the presence of additional other substances). Rather, "comprising" means that optional additional substances may be present. The term "comprising" encompasses, as particularly contemplated embodiments within its scope, "consisting of" (i.e., excluding the presence of additional other substances) and "comprising but not consisting of" (i.e., requiring the presence of additional other substances), with the former being more preferred.

[0016] The terms "a," "an," and "the" are intended to be interpreted as including one or more items. Additionally, the term "based on" is intended to be interpreted as "based at least in part on," unless expressly stated otherwise. The term "and / or" is intended to be interpreted as including any and all combinations of one or more of the associated items. The term "exemplary" is used herein to mean "serving as an example." Any embodiment or implementation described as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments or implementations.

[0017] The use of ordinal numbers such as "first," "second," and "third" in the claims to modify claim elements does not, per se, imply any preference, priority, or ordering of one claim element over another, or the chronological order in which method actions are performed or instructions executed by an apparatus are performed, 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.

[0018] No element, act, or instruction used herein should be construed as critical or essential to the invention unless expressly described as such. Also, as used herein, the article "a" is intended to include one or more items.

[0019] Detailed Description of the Embodiments The following detailed description refers to the accompanying drawings, in which the same reference numbers in different drawings may identify the same or similar elements, and is not intended to limit the invention.

[0020] The embodiments described herein relate to a guide device for facilitating the placement of a lancing device (e.g., a needle) at a predetermined location relative to an ultrasound probe. As used herein, the term "guide device" can be used interchangeably with the terms "lancing device guide" or "lancing device guide." The guide devices described below include components that are adjustable at different predetermined distances from the ultrasound probe to provide multiple parallel paths relative to one another. Thus, these guide devices allow the needle path to be moved radially without changing its angle of orientation relative to the ultrasound probe. However, despite the improvement of providing different parallel paths, proper alignment of the needle tip at the injection point remains a challenge for those skilled in the art.

[0021] Consistent with embodiments described herein, the guide device provides additional support for the needle tip near the needle injection site to maintain the selected path through the injection. In some embodiments, the additional support can be automatically retracted for simple disposal with the used syringe after injection. The devices and methods described herein may enable syringe insertion and needle insertion, alignment, and removal for multiple different injections (e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, or more different injections) without removing the ultrasound probe from the patient. Preferably, the devices and methods described herein may enable needle insertion, alignment, and removal for 5 to 20, and more preferably 12, injections.

[0022] For example, in one embodiment, the ultrasound probe may be a transrectal ultrasound probe, which may be configured to facilitate guiding a hypodermic needle for administering a drug relative to the ultrasound probe. Consistent with embodiments described herein, the needle guide device may be adjustable between multiple parallel paths while maintaining the angular and axial relationship between the needle and the ultrasound probe. A needle guide is provided to selectively position the distal end of the needle on one of the parallel paths and maintain needle alignment throughout the injection procedure. According to one embodiment, the needle guide includes a combination of interacting features of a syringe holder assembly, an adapter or probe adapter (105), and a needle guide plate. The needle guide plate is positioned at the distal end of the probe adapter to stabilize the needle tip and ensure alignment with the axis of the syringe body.

[0023] Thus, the present invention provides a lancing device guide comprising: an adapter (105) configured to be fixedly attached to an ultrasonic probe (10); a syringe holder assembly (140) slidably attached to the adapter (105) and configured to receive a syringe (15) therein, the syringe holder assembly (140) configured to be slidable on the probe adapter (105) in an axial direction relative to the ultrasonic probe (10); the syringe holder assembly (140) configured to selectively adjust the radial distance of a path of a needle (25) of the syringe (15) relative to the ultrasonic probe (10); the adapter (105) including a tip guide (135, 1135) for selectively aligning the distal end of the needle (25) with the radial distance of the path; and when the ultrasonic probe (10) is inserted into a patient, the syringe assembly is configured to slide forward on the adapter to insert the needle into the patient over the tip guide. The distal guide (135, 1135) is preferably also useful for preventing the syringe holder from entering the lumen, especially when attached to an ultrasound transducer. More preferably, the distal guide (135, 1135) is useful for preventing the syringe holder from entering the rectal lumen.

[0024] In one embodiment of the present invention, syringe holder assembly 140 is configured to receive one or more syringes 15, preferably 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 syringes, and more preferably 12 syringes 15. In one embodiment of the present invention, syringe holder assembly 140 is configured to receive one or more injection needles 25, preferably 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 syringes, and more preferably 12 needles, with the number of needles being the same as, or preferably not the same as, the number of syringes 15 received by syringe holder assembly 140. If the number of needles is not the same as the number of syringes, the syringe preferably includes 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 adapters, each of which can secure a needle. Furthermore, the syringe is preferably configured so that, when all adapters are connected to a single needle, any fluid in the syringes can be simultaneously pushed or pulled through all of the needles, preferably to different locations on the same patient. Alternatively, multiple syringes, preferably 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 syringes, can be configured to be connected to only one needle. This allows fluids from different syringes to be simultaneously or sequentially pushed or pulled through a single needle, preferably to the same location on the same patient. Preferably, the number of syringes (15) that the syringe holder assembly (140) receives is 1 to 3, and the number of injection needles (25) that the syringe holder assembly (140) receives is 3 to 12, more preferably 6 to 12, and even more preferably 12. Preferably, the syringe holder assembly (140) is configured to receive one syringe (15) and 12 injection needles (25).

[0025] An example of such a puncture device guide according to the present invention is shown in FIG. 1. FIG. 1 is an isometric view of one embodiment of a needle guide device 100 for use with an intraluminal ultrasound probe 10 consistent with embodiments described herein. As shown, the needle guide device 100 includes a probe adapter 105 having a tip guide 135, a body member 110, a slide member 115, a cradle member 120, a syringe cartridge member 125, and a guide plate 130. The body member 110, slide member 115, cradle member 120, and syringe cartridge member 125 may collectively be referred to as a syringe holder assembly 140. Preferably, the tip guide 135 is designed to prevent the probe 10 from moving too deeply into the patient when the tip guide 135 contacts the patient. To prevent this, the tip guide 135 preferably has a rectangular or circular shape. Preferably, the tip guide 135 has a hole or holes or gaps or slots for the passage of one needle, or 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 needles. More preferably, the hole(s), slot, or gap in the tip guide is large enough to allow one or more needles to pass through the tip guide without touching it. This is important to avoid potential contamination of the tip guide. Preferably, such slots, gaps, or holes have a width of about 0 to about 10 mm, more preferably about 2 to about 8 mm, and more preferably about 3 to about 5 mm. Preferably, the tip guide is about 0.5 to about 5 cm by about 0.5 to about 5 cm, more preferably about 1 cm by about 1.5 cm, or alternatively, about 0.25 cm. 2 ~Approx. 25cm 2 The tip guide 135 has an area in the range of 0.1 mm to 0.2 mm. The inventors have found that the tip guide 135 is not only suitable for aligning the needle tip within the shaft of the ultrasound probe 10, but also prevents the device from accidentally entering a lumen, such as the rectum, during use of the device, which could lead to contamination of the device and / or harm to the patient. Thus, the tip guide 135 is particularly useful with the device of the present invention when used on a patient.

[0026] In the assembled configuration, prior to administration, a hypodermic syringe 15 having a needle 25 can be received within the needle guide device 100, as described below. During use, the syringe 15 is inserted into the syringe cartridge member 125, which is then inserted into the cradle member 120. The slide member 115 is moved to adjust the position of the body 110 and syringe 15 relative to the probe 10 so that the guide plate 130, having the distal end of the needle 25 therein, engages the tip guide 135 of the probe adapter 105. The probe 10 can be inserted into the patient's rectum, for example, no further than the tip guide 135. With the probe 10 positioned within the patient, the slide member 115 is further advanced, causing the needle 25 to inject into the patient. If the lancing device guide includes a guide plate 130, as described further below, with the probe 10 positioned within the patient, the slide member 115 is moved further forward until the main body 110 contacts the guide plate 130 and the needle 25 is injected into the patient. The inventors have found that when the syringe holder assembly 140 is attached to the ultrasound probe 10, the injection needle is injected into the patient about 2 to about 10 cm, more preferably about 3 to about 6 cm, and even more preferably about 5 cm, to reach the anal sphincter. Therefore, the distance between the distal end of the injection needle 25 and the tip guide 135, 1135 is preferably about 2 to about 10 cm, more preferably about 3 to about 6 cm, and even more preferably about 5 cm. In a preferred embodiment of the present invention, the lancing device guide further comprises a guide plate (130, 1130) including a hole (606) for receiving a needle (25) therein, a boss (608, 1108) configured to be received by the tip guide (135, 1135), and a coupling element (602) configured to removably attach the guide plate (130, 1130) to the tip guide (135, 1135). In a further preferred embodiment, the guide plate (130, 1130) further comprises a plurality of holes (606) at different radial distances, each of the plurality of holes (606) corresponding to one of the radial distances of the path of the needle (25).

[0027] In a preferred embodiment of the present invention, the lancing device guide is configured such that, in an assembled configuration, prior to administration, a hypodermic syringe 15 having a needle 25 can be received within the needle guide device 100, as described below. Preferably, it is further configured such that during use, the syringe 15 can be inserted into the syringe cartridge member 125 and then into the cradle member 120. The slide member 115 is preferably configured to be moved to adjust the position of the body 110 and syringe 15 relative to the probe 10 such that the tip guide 135, 1135 of the probe adapter, within which the distal end of the needle 25 resides, is engaged by the guide plate 130. The probe 10 is preferably configured to be inserted into the patient's rectum, for example, no further than the tip guide 135, 1135. With the probe 10 positioned within the patient, the slide member 115 is preferably configured to move further forward so that the body 110 contacts the guide plate 130 and the needle 25 can be injected into the patient. Preferably, the lancing device guide is configured to allow the needle to move through a hole(s), slot, or gap in the guide plate. The inventors have found that the use of a guide plate, such as that described herein and shown in FIG. 7, is particularly advantageous because it provides better needle stabilization, i.e., requires more force at the needle tip to cause bending or movement of the needle relative to the transducer axis (Example 1, Table 1). The inventors have also demonstrated that such a guide plate improves the accuracy of the needle as it moves through muscle tissue, allowing the needle tip to more accurately reach the target location (Example 2, Table 2). Therefore, the use of a guide plate 130 is preferably particularly advantageous for achieving the objectives of the present invention. Even more preferred is the use of a guide plate including one or more holes 606 for receiving the needle(s) 25 therein. Preferably, a guide plate including multiple holes 606 has about 2 to about 15 holes, more preferably about 2 to about 10 holes, and even more preferably about 2 to about 5 holes.More preferably, the guide plate 130 with one or more holes 606 includes a boss 608, 1108 configured to be received by the distal guide 135 of the adapter 105. More preferably, such a guide plate 130 includes a coupling element 602 configured to removably attach the guide plate 130 to the distal guide 135. More preferably, each of the plurality of holes 606 corresponds to a selected radial distance in the path of the needle 25. More preferably, the radial distance is selected to be about 0.1 to about 10 cm away from the probe 100, more preferably about 0.1 to about 5 cm, and even more preferably about 0.1 to about 2 cm away from the probe.

[0028] More preferably, the guide plate 130, 1130 includes a release hole 604 adjacent the coupling element (602), the release hole (604) configured to receive a tab (360) therein that releases the coupling element (602) from the tip guide (135, 1135). Preferably, the release hole 604 can receive the tab 360, preferably located on the syringe holder assembly 140. The release hole is configured such that, upon receiving the tab 360, the coupling element 602 is released from the tip guide 135. Preferably, release of the guide plate 140 by insertion of the tab 360 into the release hole 604 results in attachment of the guide plate 130 to the syringe holder assembly 140. Preferably, the lancing device guide and guide plate are configured to allow for easy replacement of the guide plate, particularly during use. Preferably, the lancing device guide and guide plate are configured so that a new guide plate is used for each injection, i.e., the guide plate is replaceable after each injection.

[0029] In a further preferred embodiment, the syringe holder assembly (140) further comprises a tab (360), which is inserted into the release hole (604) when the syringe holder assembly (140) slides forward on the adapter (105) to release the coupling element (602) and attach the guide plate (130, 1130) to the syringe holder assembly (140). Alternatively, in a preferred embodiment of the present invention, the tip guide 1135 further comprises one or more holes or slots (1107) at different radial distances, more preferably about 2 to about 15, more preferably about 2 to about 10, and even more preferably about 3 to about 5 slots 1107. Preferably, the radial distance is about 0.5 to about 5 cm, more preferably about 0.5 to about 2 cm, and even more preferably about 0.5 to about 1 cm. Preferably, the distance between the holes is about 0.1 to about 1 mm. The plurality of slots (1107) at different radial distances are preferably configured to receive bosses (1108) of the guide plate (1130). The tip guide 1135 is preferably configured to receive bosses 1108 of the guide plate 1130. More preferably, each of the plurality of slots 1107 corresponds to one of the radial distances of the needle path. Even more preferably, the radial distance is selected to be about 0.1 to about 10 cm away from the probe 10, even more preferably about 0.1 to about 5 cm, and even more preferably about 0.1 to about 2 cm away from the probe. An example of such a preferred embodiment is shown in Figures 11A to 11D.

[0030] In a further preferred embodiment of the present invention, the syringe holder assembly (140) is configured to slide rearward on the adapter (105) to retract the needle (25) from the patient and back over the tip guide (135, 1135), with the guide plates (130, 1130) remaining attached to the tabs as the syringe holder assembly (140) slides rearward.

[0031] Engagement of the guide plate 130 with the body 110 releases the guide plate 130 from the tip guide 135 and attaches it to the body 110. In particular, the guide plate 130, 1130 may be configured to be slidable onto the adapter together with the syringe holder assembly (140), for example, as shown in Figures 9A and 9B, after it is attached to the body 110 and released from the tip guide 135, 1135.

[0032] In one embodiment of the present invention, via cartridge member 125, syringe barrel 20 is housed within cradle member 120 for administering its contents during withdrawal from a patient. Preferably, retracting slide member 115 results in axial movement of needle 25 relative to probe 10 and adapter 105 by up to about 5 cm, more preferably by up to about 3 cm. Preferably, retracting slide member 115 results in axial movement of needle 25 relative to tip guide 135, 1135, thereby reducing the distance of the distal end of needle 25 relative to tip guide 135, 1135 by about 1 to about 10 cm, more preferably about 2 to about 6 cm, and even more preferably about 3 cm. The inventors have found that such a distance is particularly advantageous because it allows the suspension to be administered to the entire length of a muscle, preferably the external anal sphincter.

[0033] When the slide member 115 is fully pulled toward the proximal end of the cradle member 120 (FIG. In a configuration such as that of Patent Document 8B, the distance between the distal end of the needle 25 and the tip guide 135, 1135 is preferably about 0.1 cm to about 3 cm, more preferably about 1 cm to about 2 cm, and even more preferably about 1.5 cm. The inventors have found that such a remaining distance between the distal end of the needle and the guide of the prior application is particularly advantageous because, after administration of the suspension to the patient, the needle remains within the patient while the tip guide is in contact with the patient, thereby allowing a reasonable amount of time for the administered suspension to be fully immersed in the patient's tissue. This prevents the suspension from flowing back out of the body through the injection path when the injection needle is removed from the patient.

[0034] In another preferred embodiment of the present invention, syringe holder assembly 140 is configured to slide rearward on adapter 105 to retract needle 25 from the patient and back over tip guide 135. Preferably, with guide plate 130 now attached to body 110, slide member 115 is pulled rearward (e.g., away from tip guide 135), thereby withdrawing needle 25 from tip guide 135.

[0035] The syringe cartridge member 125 can then be released from the cradle member 120 and the used syringe 15 and guide plate 130 are simultaneously removed from the syringe cartridge member 125 .

[0036] In another embodiment of the present invention, syringe holder assembly 140 is configured to slide rearward.

[0037] 2A and 2B are assembled and isometric views, respectively, of the probe 10 and probe adapter 105 of FIG. 1. Consistent with embodiments described herein, the probe adapter 105 may include a generally tubular configuration sized and shaped to fit over the exterior of the ultrasound probe 10. The probe adapter 105 may be slid over the distal end of the probe 10 and held in place with a frictional / interference fit. The probe adapter 105 may be configured to receive and support the syringe holder assembly 140. As shown, the top of the adapter 105 includes a mounting rail 200 that engages with a clip element 315 protruding from the underside of the body member 110, as shown in FIG. 3A and described in detail below. In one embodiment, the mounting rail 200 includes oppositely facing ribs or protrusions 210 that together form a planar upper surface 215 for supporting the body member 110 thereon.

[0038] 2A and 2B, in one embodiment, the adapter 105 includes cutouts 217 to reduce the weight of the adapter 105 and to allow access to controls or ports located at various locations on the ultrasound probe 10. Consistent with embodiments described herein, the adapter 105 may be formed from a plastic or polymeric material and may be manufactured by any method, such as injection molding, extrusion, 3D printing, or the like.

[0039] The adapter 105 includes a tip guide 135 at its distal end. The tip guide 135 may project in a plane substantially perpendicular to the longitudinal axis of the probe 10 / probe adapter 105. As described further herein, the guide plate 130 may be removably clipped to the tip guide 135. The tip guide 135 may include a slot 207 through which the needle 25 may pass (e.g., during an injection procedure) in a selected parallel path (e.g., a selected radial distance of the needle 25 from the probe 10).

[0040] While the illustrated adapter 105 shows a particular configuration, it should be understood that different configurations may be implemented based on the configuration of the ultrasound probe with which the needle guidance device 100 is used. Additionally, although not depicted in the figures, in use, a sterile sheath or other covering may be placed on or over the ultrasound probe 10 prior to attachment of the ultrasound probe 10.

[0041] Figure 3 is an isometric view illustrating syringe holder assembly 140. As shown in Figure 3, body member 110 includes a generally frame-like structure having longitudinal sides 312 that receive and support slide member 115, cradle member 120, and syringe cartridge member 125. Syringe holder assembly 140 is further described in connection with subsequent figures.

[0042] 4A and 4B are side and rear isometric views, respectively, illustrating the attachment of the syringe holder assembly 140 to the probe adapter 105. As shown in FIGS. 3, 4A, and 4B, the body member 110 may further include a plurality of clip elements 315 on the bottom of both longitudinal sides 312. The clip elements 315 are spaced apart to engage with the mounting rails 200 on the adapter 105. In particular, each clip element 315 may include a barb or indentation configured to engage with a portion of the underside of the mounting rail to secure the syringe holder assembly 140 to the adapter 105 while allowing longitudinal positioning of the syringe holder assembly 140 relative to the ultrasound probe 10.

[0043] 4A and 4B, a downward force is applied to body member 110 during assembly, causing clip element 315 to engage an end portion of mounting rail 200. Continued downward force causes clip element 315 to expand outward, allowing barbs or recesses on clip element 315 to slide over and fully engage mounting rail 200. In other embodiments, clip element 315 may not include barbs, but rather may include non-angled inward protrusions. In such embodiments, body member 110 may be slid longitudinally over mounting rail 200 during assembly.

[0044] 3, 4A, and 4B, the longitudinal side 312 may include a plurality of routing adjustment channels 335 and routing selection apertures 340. In the illustrated embodiment, the body member 110 includes four opposing pairs of routing adjustment channels 335 and four opposing pairs of routing selection apertures 340. In other implementations, more or fewer routing adjustment channels 335 and / or routing selection apertures 340 may be used. Furthermore, although pairs of channels 335 and apertures 340 are described for corresponding longitudinal sides 312, in some implementations, the channel(s) 335 and / or aperture(s) 340 may be provided on only one side or on alternating sides (alternating left and right) of the body member 110.

[0045] Consistent with embodiments described herein, each of the path adjustment channels 335 forms a generally angled channel having a plurality of planar portions 337 and angled portions 339 corresponding to a plurality of possible path positions. In the illustrated embodiment, each path adjustment channel 335 includes four planar portions 337 and three angled portions 339 disposed between each planar portion 337. While not limited herein, in one embodiment, the vertical distance between the bottom of the first (e.g., lowest) planar portion 337 and the bottom of the fourth (e.g., highest) planar portion 337 is in the range of about 0 to about 10 centimeters (cm), more preferably about 0 to about 5 cm, and even more preferably about 0.5 to about 1.5 cm. In the same exemplary embodiment, the longitudinal distance between the center of the first planar portion 337 and the center of the fourth planar portion 337 is in the range of about 0 to about 15 cm, more preferably about 2 to about 15 cm, and even more preferably about 5 to about 12 cm. Each of the path adjustment channels 335 is configured to receive a corresponding selection pin 350 of the slide member 115 , thus limiting the movement of the slide member 115 to those positions defined by the path adjustment channels 335 .

[0046] The routing apertures 340 are spaced apart to correspond to the planar portions 337 of the routing adjustment channel 335. As described below, one of the routing apertures is configured to receive a corresponding portion of the slide member 115 to positively hold the slide member 115 in a position defined by one of the planar portions 337 and prevent inadvertent movement along the routing adjustment channel(s) 335 during use.

[0047] 3 , a portion of the cradle member 120 extends through an opening in the front of the body member 110 (e.g., between the longitudinal sides 312). More specifically, a tab 360 of the cradle member 120 extends beyond the front end of the body member 110 and is configured to engage the guide plate 130 in a manner described below. By sliding the slide member 115 relative to the body member 110, the selection pin 350 can be positioned at different planar portions 337 of the path adjustment channel 335. For example, the handle 370 of the slide member 115 may be pushed or pulled to reposition the selection pin 350, correspondingly changing the parallel path (e.g., the distance above the mounting rail 200) provided by the cradle member 120 and the tab 360.

[0048] 5A and 5B are isometric views showing syringe holder assembly 140 in elevated (e.g., highest) and lowered (e.g., lowest) parallel path configurations, respectively, relative to probe adapter 105. Syringe holder assembly 140 can position syringe 15 with needle 25 at any one of several distances from the ultrasound probe to provide an injection path parallel to the longitudinal axis of probe 10. As discussed above, the practitioner can select the parallel path for a particular application / patient.

[0049] 6A and 6B are side and rear isometric views showing a syringe 15 engaged with a needle guide plate 130. The syringe 15 may include a syringe barrel 20, a barrel flange 22, a needle 25, a plunger 30, and a plunger flange 32. The needle guide plate 130 may include a mounting clip 602 or other coupling element adjacent each release hole 604. The guide plate 130 may also include a set of tip height selection holes 606, a plate alignment boss 608, and a set of rail alignment grooves 610.

[0050] The number of tip height selection holes 606 can correspond to the number of different planar portions 337 that can be selected using the path adjustment channel 335 on the body member 110. Each tip height selection hole 606 is configured to guide the needle 25 on a particular parallel path. That is, the radial spacing (e.g., relative to the probe 10) between each of the tip height selection holes 606 can correspond to the radial spacing between the different planar portions 337 so as to ensure that the needle 25 follows a parallel path relative to the probe 10 when the needle 25 is inserted through a tip height selection hole 606 that corresponds to one of the planar portions 337. According to an embodiment, a practitioner can insert the needle 25 through a selected tip height selection hole 606 before inserting the syringe 15 into the syringe holder assembly 140.

[0051] 7A and 7B are isometric views illustrating the attachment of syringe 15 and needle guide plate 130 to syringe holder assembly 140 and probe adapter 105. As shown in FIG. 7A, syringe 15 and guide plate 130 may be simultaneously inserted into syringe holder assembly 140 with needle 25 extending through guide plate 130.

[0052] 7B, the syringe 15 can be inserted into the syringe cartridge member 125. When the syringe 15 is inserted into the syringe cartridge member 125, the tip of the needle 25 is positioned adjacent to the tip guide 135, with the guide plate 130 on the needle 25 between the body member 110 and the tip guide 135. When the syringe 15 is in the syringe cartridge member 125, the rail alignment groove 610 of the guide plate 130 can fit around the rail 200 of the probe adapter 105.

[0053] After the syringe 15 and guide plate 130 are attached to the syringe holder assembly 140, the guide plate 130 can be slid longitudinally forward (e.g., by a practitioner) along the needle 25 until the guide plate 130 engages the tip guide 135, as shown in FIGS. 1 and 7C . The plate alignment boss 608 can be configured to fit into the slot 207 of the tip guide 135. The plate alignment boss 608 can pass through the slot 207 of the tip guide 135 in a manner that prevents the needle 25 from contacting the tip guide 135 during insertion and retraction. According to an embodiment, the mounting clip 602 can be configured to clip onto the adapter 105 when the plate alignment boss 608 is inserted through the slot 207. More specifically, the clip 602 can be configured to mate with the opposing edge 209 of the tip guide 135 when the plate alignment boss 608 is inserted into the slot 207 of the tip guide 135.

[0054] 8A and 8B are isometric views showing the position of the needle guide device 100 and syringe 15 during an injection. With the probe 110 inserted into the patient, preferably until the tip guide 135 touches the patient's skin, the syringe holder assembly 140 can be pushed longitudinally forward along the mounting rail 200 from the orientation shown in FIGS. 1 and 7C to the orientation shown in FIG. 8A. The forward movement of the syringe holder assembly 140 causes the needle 25 to pass through the guide plate 130, over the tip guide 135, and into the patient, thereby achieving an injection depth of approximately 10 cm, more preferably approximately 7 cm, and even more preferably approximately 4 to 5 cm. When the syringe holder assembly 140 is fully moved forward, the tab 360 of the cradle member 120 is inserted into the release hole 604 of the guide plate 130. Upon passing through the holes 604, each of the tabs 360 is inserted between the edge 209 and the mounting clip 602, displacing (e.g., outward) the mounting clip 602 adjacent each of the release holes 604 and disengaging the mounting clip 602 from the end guide 135. While disengaging the clip 602 from the end guide 135, the insertion of the tab 360 into the release hole 604 also causes the tab 360 to retain / grip on the guide plate 130.

[0055] With the needle 25 inserted into the patient, the practitioner can apply opposing forces (e.g., squeeze) to the protrusion 365 and the syringe retraction support 367. As shown in FIG. 8B, the protrusion 365 can move longitudinally rearward toward the syringe retraction support 367. The force on the protrusion 365 pushes the barrel flange 22 back toward the plunger flange 32, retracting the barrel 20 and expelling its contents through the needle 25 as the needle 25 is withdrawn from the patient.

[0056] 9A and 9B are isometric views showing the retracted position of needle guide device 100 and syringe 15 after an injection. Upon completion of the injection, the practitioner can slide syringe holder assembly 140 longitudinally rearward on mounting rail 200 (e.g., while probe 10 remains in the patient). Guide plate 130 is retracted along with syringe holder assembly 140 due to engagement with tab 360.

[0057] After retracting syringe holder assembly 140 and guide plate 130, guide plate 130 can be pushed longitudinally forward to separate guide plate 130 from tab 360 and syringe holder assembly 140, as shown in FIG. 9B. For example, a practitioner can gently grasp the sides of guide plate 130 to deflect guide plate 130 and release tab 360 from release hole 604. According to an embodiment, guide plate 130 may remain stationary over the distal portion of needle 25.

[0058] 10A-10C are isometric views of the ejector body mechanism of the syringe cartridge member 125 during ejection of the syringe 15 from the needle guide device 100. As shown in FIGS. 10A and 10B, the ejection member 373 of the syringe cartridge member 125 may be raised (e.g., by a practitioner) to rotate the syringe cartridge member 125 and remove the syringe 15 from the cradle member 120. When the syringe cartridge member 125 is in the raised position, the practitioner has unimpeded access to the plunger flange 32 and / or barrel 20 of the syringe 15, and as shown in FIG. 10C, the syringe 15 and guide plate 130 can be grasped and removed from the syringe holder assembly 140 with the guide plate 130 still connected to the needle 25. In this manner, the syringe 15 and guide plate 130 can be removed and discarded without the practitioner coming into contact with contaminated portions of the syringe 15 or guide plate 130.

[0059] 11A-11D are isometric views illustrating another embodiment of a probe adapter and needle guide plate. Figures 11A and 11B are side and rear perspective views of a guide plate 1130 positioned over the needle 25 of a syringe 15, similar to the arrangement described above in connection with Figures 7A and 7B. Similar to the above description, the syringe 15 and guide plate 1130 combination may be simultaneously inserted into the syringe holder assembly 140, with the needle 25 extending through the guide plate 1130 and the distal end of the needle 25 adjacent the tip guide 1135 of the probe adapter 1105.

[0060] In contrast to the guide plate 130 described above, the guide plate 1130 may include only one hole 1106 configured to receive a needle 25. The tip guide 1135 includes two or more slots 1107 at different heights configured to receive plate alignment bosses 1108. Each of the slots 1107 may correspond to one of the selectable parallel paths described above, for example, in connection with FIG. 3. Thus, although only two slots 1107 are shown in FIGS. 11A-11D, in other embodiments, the tip guide 1135 may include more than two slots 1107.

[0061] 11C and 11D are side and rear perspective views of a guide plate 1130 attached to a tip guide 1135, similar to the arrangement described above in connection with FIGS. 1 and 7C. After the syringe 15 and guide plate 1130 are attached to the syringe holder assembly 140, the guide plate 1130 can be slid longitudinally forward (e.g., by a practitioner) along the needle 25 until the guide plate 1130 engages the tip guide 1135, as shown in FIGS. 11C and 11D. The plate alignment bosses 1108 may be configured to fit into selected slots 1107 in the tip guide 1135. According to one embodiment, selection of a particular parallel path for the syringe holder assembly 140 can align the needle 25 and guide plate 1130 with corresponding slots 1107 in the tip guide 1135.

[0062] According to one embodiment, the systems and methods described herein may be used to perform multiple injections in a radial pattern. After the first injection (e.g., as described above), the radial insertion distance of the syringe holder assembly 140 may be adjusted (e.g., as described above in connection with FIGS. 5A and 5B) as needed while the probe 10 remains in the patient. A new syringe 15 and guide plate 130 combination may be inserted into the syringe holder assembly 140 (as described in FIGS. 7A-7C), the probe 10 may be rotated to the patient's preferred orientation for the next injection, and subsequent injections may be performed using the process described above. Preferably, a new guide plate 130 is used for each new injection.

[0063] The present invention also provides a method of performing an injection, the method comprising the steps of: (a) attaching a probe adapter (140) to an ultrasound probe (10), the probe adapter (105) including a tip guide (135, 1135) at a distal end; (b) attaching a syringe holder assembly (140) to a probe adapter (140), the syringe holder assembly being longitudinally slidable relative to the probe adapter (140); (c) inserting the ultrasound probe (10) into the patient; (d) adjusting the syringe holder assembly (140) to provide a selected radial distance for the injection needle (25) from the ultrasound probe (10); (e) inserting the syringe (15) into the syringe holder assembly (140) and aligning the needle (25) with the tip guide (135, 1135); (f) sliding the syringe holder assembly (140) distally to push the needle past the tip guide (135, 1135) and into the patient; (g) sliding the syringe holder assembly (140) rearward to retract the needle (25) from the patient; and (h) Removing the syringe (15) from the syringe holder assembly (140).

[0064] Preferably, the step of inserting the syringe (15) into the syringe holder assembly (140) further includes the steps of: (i) providing a guide plate (130, 1130) having a boss (608, 1108) configured to be received by the tip guide (135, 1135) and a coupling element (602) configured to removably attach the guide plate (130, 1130) to the tip guide (135, 1135); (ii) inserting the injection needle (25) through the hole (606) in the guide plate (130, 1130); and (iii) inserting the syringe (15) into the syringe holder assembly (140) after inserting the injection needle (25) through the hole (606). Preferably, inserting the syringe 15 into the syringe holder assembly 140 further includes selecting a hole from a plurality of holes 1107 in the tip guide 1135, each hole corresponding to a different radial distance of the needle 25 from the ultrasonic probe 10. Preferably, inserting the syringe 15 into the syringe holder assembly 140 further includes sliding the guide plates 130, 1130 along the needle 25 until the guide plates 130, 1130 are attached to the tip guides 135, 1135. Preferably, the guide plates 130, 1130 are slid along the needle 25 until the guide plates 130, 1130 are attached to the tip guides 135, 1135. This may further include moving the guide plate (130, 1130) to engage the boss (608, 1108) with one of a plurality of slots in the tip guide (135, 1135), each of the plurality of slots corresponding to a different radial distance of the injection needle (25) from the ultrasonic probe (10).

[0065] Preferably, when the syringe holder assembly (140) is slid backward to retract the needle (25) from the patient, the injection needle (25) does not come into contact with the tip guides (135, 1135), particularly to avoid the possibility of contamination of the tip guides (135, 1135).

[0066] Preferably, when syringe holder assembly 140 is slid distally to push needle 25 past tip guides 135, 1135 and into the patient, syringe holder assembly 140 engages guide plates 130, 1130, releasing guide plates 130, 1130 from attachment to tip guides 135, 1135. More preferably, when syringe holder assembly 140 is slid rearward to retract needle 25 from the patient, syringe holder assembly 140 retracts guide plates 130, 1130 away from tip guides 135, 1135.

[0067] In a preferred embodiment of the method of the present invention, the method further includes the step of removing the guide plate (130, 1130) from the syringe holder assembly (135, 1135) by sliding the guide plate (130, 1130) distally along a portion of the injection needle (25).

[0068] Preferably, the step of removing the syringe (15) from the syringe holder assembly (140) of the method of the present invention further comprises removing the syringe (15) and the guide plate (130, 1130) while the injection needle (25) remains inserted through the guide plate (130, 1130).

[0069] Preferably, the method according to the invention is carried out by any lancing device according to the invention.Furthermore, preferably, the lancing device according to the invention is adapted to be used in the method according to the invention.

[0070] 12 is a flow diagram of an exemplary process for performing an injection using a parallel pathway lancing device guide, according to embodiments described herein. As shown in FIG. 12, process 1200 may include attaching a probe adapter to an ultrasound probe (block 1205) and attaching a syringe holder assembly to the probe adapter (block 1210). For example, as described above in connection with FIGS. 2A-4B, the probe adapter 105 may be secured to the probe 10, and the syringe holder assembly 140 may be clipped onto the rail 200 of the probe assembly 105.

[0071] Process 1200 may also include inserting the probe into the patient (block 1215) and adjusting the syringe holder assembly to a selected radial distance of the needle (block 1220). For example, as described above in connection with Figures 5A and 5B, the handle 370 of the slide member 115 may be pushed or pulled to change the position of the selection pin 350, which correspondingly changes the parallel path (e.g., radial distance above the mounting rail 200) that the cradle member 120 defines for the syringe 15.

[0072] Process 1200 may further include inserting a syringe into the syringe holder assembly and aligning the injection needle with the tip guide (block 1225). For example, according to one embodiment, block 1225 may include the steps of FIG. 13, described below. In a preferred embodiment of the present invention, the syringe inserted into the syringe holder contains a composition and / or substance. More preferably, the syringe contains a pharmaceutically active composition, such as a suspension of cells. In a preferred embodiment, the substance or composition is administered to the patient as the syringe (15) filled with the substance or composition slides back through the inserted syringe cartridge (125). Preferably, such substance or composition is intended to be administered into the patient by the pull of process 1200. 11A-11D, the practitioner can insert needle 25 through selected holes 1106 in guide plate 1130, insert syringe 15 into syringe holder assembly 140, and then attach guide plate 1130 to selected slots 1107 in tip guide 1135. In yet another embodiment, tip guide 1135 can include multiple holes corresponding to the parallel paths along which the syringe holder assembly is aligned, and needle 25 can be inserted through selected holes in tip guide 1135.

[0073] Process 1200 may further include sliding the syringe holder assembly distally to push the needle past the tip guide and into the patient (block 1230) and sliding the syringe holder assembly rearward to retract the needle from the patient (block 1235). For example, as described above in connection with FIGS. 8A-9B , with the probe 110 inserted into the patient, the syringe holder assembly 140 may be pushed longitudinally forward along the mounting rail 200. The forward movement of the syringe holder assembly 140 causes the needle 25 to pass through the guide plate 130, past the tip guide 135, and into the patient. With the needle 25 in the patient, the practitioner may depress the protrusion 365 and the syringe retraction support 367, causing the syringe 25 to expel or administer its contents through the needle 25. The protrusion 365 thereby preferably moves a predetermined distance toward the retraction support 367 to cause movement of the needle 25 relative to the transducer. Such length is preferably about 2 to about 10 cm, more preferably about 2 to about 5 cm, and even more preferably about 3 cm. After the injection is completed, the practitioner can slide syringe holder assembly 140 longitudinally rearward on mounting rail 200 while probe 10 remains in the patient.

[0074] The process 1200 may further include removing the syringe from the syringe holder assembly and discarding the syringe (block 1240). For example, as shown in FIGS. 10A and 10B, the syringe cartridge member 125 may be rotated to lift the syringe 15 from the cradle member 120. With the syringe cartridge member 125 in the lifted position, the practitioner may grasp the plunger flange 32 and / or barrel 20 of the syringe 15 to remove the syringe 15 from the syringe holder assembly 140 while the guide plate 130 remains connected to the needle 25, as shown in FIG. 10C. In this manner, the syringe 15 and guide plate 130 may be removed and discarded without the practitioner coming into contact with contaminated portions of the syringe 15 or guide plate 130.

[0075] Process 1200 may also include a process for determining whether an additional injection is needed (block 1245). If the patient does not need an additional injection (block 1245—No), process 1200 may include removing the ultrasound probe from the patient (block 1250). If the patient does need an additional injection (block 1245—Yes), process 1200 may return to process block 1220 and perform another injection using a new syringe and guide plate, if necessary.

[0076] 13, process block 1225 can include inserting the needle through a hole in the needle guide that corresponds to a selected radial distance of the injection needle (block 1305), inserting the syringe into the syringe holder assembly with the needle guide oriented over the needle shaft and the rail alignment groove resting on the mounting rail of the probe adapter (block 1310), and sliding the needle guide forward along the needle shaft to attach the needle guide to the probe adapter with the distal guide (block 1315). For example, before inserting the syringe 15 into the syringe holder assembly 140, the practitioner can insert the needle 25 through a selected hole 606 in the guide plate 130 so that the selected hole 606 corresponds to the parallel path to which the syringe holder assembly 140 is aligned. As described in relation to Figures 6A to 7C, with the guide plate 130 resting on the mounting rail 200, the practitioner can insert the syringe 15 into the syringe holder assembly 140 and slide the guide plate 130 forward to attach it to the tip guide 135 of the probe holder 105.

[0077] The embodiments described herein provide a guide device for facilitating placement of a lancing device (e.g., a needle) at a predetermined location relative to an ultrasound probe. Preferably, a substance or composition can be administered to a patient through the lancing device (e.g., a needle). The guide device provides additional support for the needle tip near the needle injection site to maintain a selected path during injection. After injection, the additional support is automatically retracted so that it can be discarded along with the used syringe. The guide device minimizes contact with contaminated parts and allows for insertion, alignment, and removal of syringes for multiple different injections without removing the ultrasound probe from the patient.

[0078] The description of the foregoing embodiments provides illustration and description, but is not intended to be exhaustive or to limit the invention to the precise form disclosed. Modifications and variations are possible in light of the above teachings or may be acquired from practice of the invention. For example, while a series of blocks is described with reference to FIG. 12, the order of the blocks may be changed in other embodiments. Moreover, non-dependent blocks may be performed in parallel.

[0079] In one embodiment of the present invention, the puncture device guide is suitable for medical use. Medical use herein refers to use consisting of preventing and / or treating a disease in a subject, preferably a human, animal, or mammal. Preferably, the medical use consists of preventing and / or treating urinary incontinence, anal incontinence, overactive bladder, underactive bladder, anal fistula, (chronic) inflammation, muscle pathology, neuropathology, and / or prostate malignancy. More preferably, the medical use refers to use for preventing and / or treating anal incontinence, more preferably urge fecal incontinence and / or passive fecal incontinence. To enable medical use of the device, such a device is preferably sterile at the time of use. Therefore, the device is preferably designed to be sterilizable before use. Preferably, such sterilization is performed using ethylene oxide, moist heat, dry heat, radiation, vaporized hydrogen peroxide, chlorine gas, vaporized peracetic acid, and / or nitrogen dioxide. Therefore, the device is preferably made of a sterilizable material, such as steel, ceramic, and / or plastic. More preferably, the device is made of a sterilizable material consisting of a plastic, more preferably a terpolymer, even more preferably an acrylonitrile-butadiene-styrene copolymer. It is also preferred that the material from which the device is made is biocompatible. As used herein, biocompatible preferably means meeting the specifications of ISO 10993-1:2018, more preferably meeting the specifications for contact with intact skin and / or intact mucosa as defined in ISO 10993-1:2018. Preferred device materials according to the present invention, which preferably meet the biocompatibility specifications, are selected from steel, ceramic, and / or plastic, more preferably from the terpolymer class, even more preferably from acrylonitrile-butadiene-styrene copolymers. It is also preferred to select the device material from any acrylonitrile-butadiene-styrene, such as Lustrian® 633 ABS (natural) (Bayer). It is also preferred that the device according to the present invention is sterilizable and biocompatible, and therefore particularly suitable for medical applications.Preferably, the lancing device guide according to the present invention is assembled from multiple parts or components, preferably 1 to 10 parts or components, more preferably 1 to 6 parts or components, and even more preferably 5 or 6 parts or components. Preferably, the lancing device guide according to the present invention is assembled from five different parts or components, preferably the adapter 105, the body member 110, the slide member 115, the cradle member 120, and the cartridge member 125. When the lancing device guide according to the present invention comprises a guide plate 130, 1130, it is assembled from six different parts or components, preferably the adapter 105, the body member 110, the slide member 115, the cradle member 120, the cartridge member 125, and the guide plate 130, 1130. These components are preferably each made from a single molded piece. Preferably, the number of molds required to manufacture the parts or components of the lancing device guide is equal to or less than the number of parts or components. Preferably, the number of molds required to manufacture the parts or components of the lancing device guide is 1 to 10, more preferably 1 to 6, and even more preferably 5 or 6. Preferably, 5 or 6 different molds are required to manufacture the components of the lancing device guide. More preferably, each of the 5 or 6 molds is designed to manufacture a respective one of the parts or components of the lancing device guide, including the adapter 105, the body member 110, the slide member 115, the cradle member 120, the cartridge member 125, and optionally, the guide plates 130, 1130. Also, preferably, one or more of the different components or parts are manufactured multiple times for use with a single patient, and preferably, one or more parts are replaced when multiple injections are performed in a single patient. Preferably, the guide plates 130, 1130 are manufactured multiple times so that a new guide plate 130, 1130 can be used after each injection. Preferably, the puncture device guide according to the present invention has a length of about 5 cm to about 30 cm, a width of about 1 cm to about 5 cm, and a height of about 1 cm to about 5 cm, so as to be suitable for medical use.Thus, in preferred embodiments of the present invention, the puncture device guide is (a) sterilizable, preferably by treatment with ethylene oxide, moist heat, dry heat, radiation, vaporized hydrogen peroxide, chlorine gas, vaporized peracetic acid, and / or nitrogen dioxide, and / or (b) biocompatible, preferably due to the choice of material selected from steel, ceramic, and / or plastic. More preferably, the device is made of a sterilizable plastic, more preferably a terpolymer, even more preferably an acrylonitrile-butadiene-styrene copolymer.

[0080] The present invention also provides a puncture device guide as described herein for use in a method for treating the human or animal body by surgery or therapy. In particular, the present invention provides a puncture device guide as described herein for use in a method for treating and / or preventing urinary incontinence, anal incontinence, overactive bladder, underactive bladder, anal fistula(s), anal fistula, (chronic) inflammation, muscle disease, neurological disease, and / or prostate malignancy. Preferably, in such methods, the pharmaceutically active substance and / or composition is administered to the site of injury or disease. Preferably, in such methods for treating and / or preventing urinary incontinence and / or anal incontinence, the pharmaceutically active substance and / or composition is administered to the anal sphincter tissue and / or urethral sphincter tissue. Preferably, in such methods for treating and / or preventing overactive bladder and / or underactive bladder, the pharmaceutically active substance and / or composition is administered to the bladder. Preferably, in such a method for treating and / or preventing anal fistula, the pharmaceutically active substance and / or composition is administered to the anal fistula. Preferably, in such a method for treating and / or preventing anal fistula, the pharmaceutically active substance and / or composition is administered into the anal fistula. Preferably, in such a method for treating and / or preventing prostate malignancy, the pharmaceutically active substance and / or composition is administered into the malignant prostate tissue. Preferably, in such a method for treating and / or preventing chronic inflammation, myopathy, or neuropathy, the pharmaceutically active substance and / or composition is administered to the site of inflammation, the site of myopathy, or the site of neuropathy, respectively. Preferably, the pharmaceutically active substance is selected from autologous and / or allogeneic cells. In one embodiment of the present invention, the puncture device guide is used for cell injection procedures, as already disclosed in EP2120976B1. Administration of cells to a given tissue or injury site is achieved by administering a therapeutically effective number of cells in solution or suspension, e.g., about 1 x 10 cells per 100 μl of infusion solution. 6 ~Approx. 6×10 6The injection solution preferably contains cells. The injection solution is preferably a physiologically acceptable medium, with or without autologous serum. Non-limiting examples of physiologically acceptable media include saline or an acid buffer. Preferably, the cells are administered to anal sphincter tissue as a treatment for anal incontinence to strengthen, improve, and / or repair the external and / or internal anal sphincter. Preferably, the cells are injected into or adjacent to the external and / or internal anal sphincter, survive, differentiate into mature muscle cells, and strengthen the sphincter and / or improve sphincter function. The viability and long-term survival of myogenic progenitor cells according to this embodiment have been previously demonstrated (Messner et al., 2021, Tuner et al., 2020). Preferably, a puncture device guide is used to prevent anal incontinence, and the administration of cells augments and / or strengthens existing incontinence devices. The feasibility of cell administration into muscle tissue for the treatment of fecal incontinence has already been demonstrated (Frudinger et al., 2018). The inventors have found that the puncture device guide of the present invention is particularly useful for preventing and / or treating anal incontinence because it is particularly accurate and safe for needle injection into anal sphincter tissue and / or cell administration into anal sphincter tissue. The improved accuracy as well as safety of the device of the present invention may lead to more effective disease prevention and / or treatment.

[0081] The present invention also provides a guide plate (130, 1130) as described herein, which preferably includes a hole (606) for receiving a needle (25) therein and a boss (608, 1108) configured to be received by a distal guide (135, 1135) of a lancing device guide according to the present invention. The guide plate (130, 1130) preferably further includes a coupling element (602) configured to removably attach the guide plate (130, 1130) to the distal guide (135, 1135) of a lancing device guide according to the present invention. Preferably, the guide plate (130, 1130) further includes a plurality of holes (606) at different radial distances, each of the plurality of holes (606) corresponding to one of the radial distances of the path of a needle (25) of a lancing device guide according to the present invention. The guide plate (130, 1130) may further include a release hole (604) adjacent to the coupling element (602), the release hole (604) being configured to receive a tab (360) therein that releases the coupling element (602) from the tip guide (135, 1135) of the puncture device guide according to the present invention.

[0082] Although the present invention has been described in detail above, it is expressly understood that modifications of the present invention will be apparent to those skilled in the relevant art without departing from the spirit of the invention. Various changes in form, design, or arrangement may be made to the present invention without departing from the scope of the invention. Different combinations exemplified above may be combined in a single embodiment. Therefore, the above description is to be considered illustrative rather than limiting, with the true scope of the invention being defined by the following claims.

[0083] The following examples are considered to be illustrative, but not limiting, of the present invention.

[0084] Example 1 - Measuring force by needle deflection

[0085] The syringe holder assembly according to Figure 7 was tested with and without the guide plate (130) attached to demonstrate the functional effectiveness of such a guide plate. A Terumo Agani 21Gx2´´ (0.8*50mm) Regular Bevel 11° needle (Ref. AN*2150R1) was used as the lancing device (25) of the assembly and attached to a 1 mL B-Braun Injekt®-F Tuberkulin syringe (REF: 9166017V) (130). The syringe and needle were attached to the syringe holder of Figure 7 with and without the guide plate (130) and attached to a BK8848 ultrasound probe. Next, a force transducer (F30 HSE Force Transducer Type 372, Serial no.: 97551) was attached to a Venier control Type 805 (Hugo Sachs Elektronik, HSE, Germany. Range: 0-20 mm, resolution: 0.5 mm / turn) and moved uniaxially. The force transducer was calibrated using a 10 mN calibration weight (HSE calibration weight, 1 cN = 10 mN = 1 Gram) to receive and verify the measured force. The force transducer was then connected to an amplifier (HSE TAM-A Transducer Amplifier Module Plugsys) attached to a personal computer running ACAD data acquisition software for Windows (HSE, Germany). The syringe holder assembly (with or without the guide plate) was then slid along the axis of the probe adapter (105) until the configuration shown in Figure 8A was reached. The tip of the needle was then placed on the hook of the force transducer, the ultrasound probe was secured, and the vernier control was rotated to move the needle axially from 0.5 mm to 1.5 mm in 0.5 mm steps. At each step, the force generated by the force transducer was recorded and used as an indicator of how securely the needle was attached within the assembly. Since more force was required to deflect the needle, a larger force was interpreted as greater stability. The measurement results are shown in Table 1 and Figure 14.It was found that higher forces were recorded with the syringe holder assembly with the guide plate when the needle tip was deflected 0.5 mm, 1.0 mm, and 1.5 mm compared to the syringe holder assembly without the guide plate. At a deflection of 2.0 mm, no difference could be determined due to the maximum force detectable by the system.

[0086] [Table 1]

[0087] Example 2 - Guide accuracy measurement in muscle tissue

[0088] To address the accuracy of guiding the lancing device through muscle tissue, different syringe holder assemblies (those corresponding to EP2170440A2 and the device according to Figure 7, either with or without the guide plate 130) were attached to a BK8848 ultrasound transducer covered with a transducer gel-filled latex cover. Each syringe holder assembly was then equipped with a BBraunn 1 ml syringe and a 21-gauge Lancet regular bevel needle. The BK8848 ultrasound transducer was attached to a BK FlexFocus ultrasound system to visualize the signal recorded by the transducer. The syringe holder assembly was placed in a water bath, and the needle was guided forward along the axis of the BK8848 force transducer until the tip reached the lateral detection window of the transducer. The needle tip visible on the ultrasound system for each syringe holder assembly was marked with an "x" to allow for later measurement of the accuracy of guiding the lancing device through tissue. The porcine muscle tissue was prepared by drilling holes with a scalpel to allow the BK8848 transducer to enter the holes, thereby simulating an intraluminal examination. Each syringe holder assembly was then used to guide a total of 12 needles into individual muscle tissue sites, each to a depth of up to 5 cm, allowing the needle to reach the transducer's sensor window. For each needle passing through the muscle tissue, the position of the needle tip as seen by the ultrasound system was marked, and the distance from the pre-set "x" position was measured in millimeters to understand the degree of needle deflection as it traveled through the muscle tissue. To compare the accuracy of each syringe holder assembly, the mean and standard deviation values of repeated measurements were calculated. As can be seen from Table 2, the syringe holder assembly of the present invention including the guide plate 130 led to the lowest needle deflection of 1.92±0.58 mm when compared to the equivalent device of EP2170440A2, which resulted in a deflection of 1.98±0.35 mm, and the syringe holder assembly of FIG. 7, which does not include the guide plate 130, which resulted in a needle deflection of 2.23±0.85 mm.

[0089] [Table 2]

[0090] References Frudinger, A., Marksteiner, R., Pfeifer, J., Margreiter, E., Paede, J., Thurner, M., 2018. Skeletal muscle-derived cell implantation for the treatment of sphincter-related faecal incontinence. Stem Cell Research & Therapy 9, 233. Messner, F., Thurner, M., Muller, J., Blumer, M., Hofmann, J., Marksteiner, R., Couillard-Despres, S., Troppmair, J., Ofner, D., Schneeberger, S., Hautz, T., 2021. Myogenic progenitor cell transplantation for muscle regeneration following hindlimb ischemia and reperfusion. Stem Cell Res Ther 12, 146. Thurner, M., Deutsch, M., Janke, K., Messner, F., Kreutzer, C., Beyl, S., Couillard-Despres, S., Hering, S., Troppmair, J., Marksteiner, R., 2020. Generation of myogenic progenitor cell-derived smooth muscle cells for sphincter regeneration. Stem Cell Res Ther 11, 233.

Claims

1. an adapter (105) configured to fixedly attach to the ultrasound probe (10); a syringe holder assembly (140) slidably mounted to the adapter (105) and configured to receive a syringe (15) therein; The syringe holder assembly (140) is configured to be slidable on the adapter (105) in an axial direction relative to the ultrasonic probe (10); The syringe holder assembly (140) is configured to selectively adjust the radial distance of a path of the needle (25) of the syringe (15) relative to the ultrasonic probe (10); The adapter (105) includes a tip guide (135, 1135) for selectively aligning the distal end of the needle (25) with the radial distance of the pathway; When the ultrasound probe (10) is inserted into a patient, the syringe holder assembly (140) is configured to slide forward on the adapter (105) to insert the needle (25) into the patient over the tip guide (135, 1135); a hole (606) for receiving said needle (25) therein; a boss (608, 1108) configured to be received by the tip guide (135, 1135); a coupling element (602) configured to removably attach a guide plate (130, 1130) to said tip guide (135, 1135); The lancing device guide further comprises a guide plate (130, 1130) including:

2. The puncture device guide of claim 1, wherein the guide plate (130, 1130) further comprises a plurality of holes (606) at different radial distances, each of the plurality of holes (606) corresponding to one of the radial distances of the path of the needle (25).

3. The puncture device guide of claim 1 or 2, wherein the tip guide (135, 1135) further comprises a plurality of slots (1107) of different radial distances configured to receive the bosses (608, 1108) of the guide plate (130, 1130), each of the plurality of slots (1107) corresponding to one of the radial distances of the path of the needle (25).

4. A puncture device guide as described in any one of claims 1 to 3, wherein the guide plate (130, 1130) further comprises a release hole (604) adjacent to the coupling element (602), the release hole (604) being configured to receive a tab (360) therein that releases the coupling element (602) from the tip guide (135, 1135).

5. 5. The puncture device guide of claim 4, wherein the syringe holder assembly (140) further comprises the tab (360), and the syringe holder assembly (140) slides forward on the adapter (105) so that the tab (360) is inserted into the release hole (604) to release the coupling element (602) and attach the guide plate (130) to the syringe holder assembly (140).

6. the syringe holder assembly (140) is configured to slide rearwardly on the adapter (105) to retract the needle (25) from the patient and back over the tip guide (135, 1135); The lancing device guide of claim 4 or 5, wherein the guide plate (130, 1130) remains attached to the tab (360) when the syringe holder assembly (140) slides rearward.

7. The puncture device guide of any one of claims 1 to 6, wherein the syringe holder assembly (140) is configured to slide rearward on the adapter (105) to retract the needle (25) from the patient and back over the tip guide (135, 1135).

8. The puncture device guide of any one of claims 1 to 7 configured for medical use to perform a method, the method comprising: Attaching an adapter (105) to the ultrasound probe (10), the adapter (105) including a tip guide (135, 1135) at a distal end; attaching a syringe holder assembly (140) to the adapter (105), the syringe holder assembly (140) being longitudinally slidable relative to the adapter (105); inserting the ultrasound probe (10) into a patient; adjusting the syringe holder assembly (140) to provide a selected radial distance for the needle (25) from the ultrasonic probe (10); providing a guide plate (130, 1130) having a boss (608, 1108) configured to be received by the tip guide (135, 1135), and a coupling element (602) configured to removably attach the guide plate (130, 1130) to the tip guide (135, 1135); inserting the needle (25) through the hole (606) in the guide plate (130, 1130); inserting the needle (25) through the hole (606) and then inserting the syringe (15) into the syringe holder assembly (140); sliding the guide plate (130, 1130) along the needle (25) until the guide plate (130, 1130) is attached to the tip guide (135, 1135), particularly by moving the guide plate (130, 1130) to engage the boss (608, 1108) with one of a plurality of slots (1107) in the tip guide (135, 1135), each of the plurality of slots (1107) corresponding to a different radial distance of the needle (25) from the ultrasonic probe (10), thereby aligning the needle (25) with the tip guide (135, 1135); sliding the syringe holder assembly (140) distally to push the needle (25) past the tip guide (135, 1135) and into the patient, wherein, in particular, the syringe holder assembly (140) engages the guide plate (130, 1130) and releases the guide plate (130, 1130) from attachment to the tip guide (135, 1135); sliding the syringe holder assembly (140) rearward to retract the needle (25) from the patient, wherein the needle (25) does not contact the tip guide (135, 1135), and in particular the syringe holder assembly (140) retracts the guide plate (130, 1130) away from the tip guide (135, 1135); and removing the syringe (15) and the guide plate (130) from the syringe holder assembly (140).

9. A puncture device guide according to any one of claims 1 to 8, wherein the puncture device guide is made of a sterilizable and / or biocompatible material selected from steel, ceramic and / or plastic.

10. The puncture device guide of claim 9, wherein the plastic is a terpolymer, in particular an acrylonitrile-butadiene-styrene copolymer.

11. 11. A puncture device guide according to any one of claims 1 to 10 for use in a method for the treatment of the human or animal body by surgery or therapy, in particular for the treatment and / or prevention of urinary incontinence, anal incontinence, overactive bladder, underactive bladder, anal fistula, inflammation, in particular chronic inflammation, muscle pathologies, neuropathologies and / or prostate malignancies, wherein a pharmaceutically active substance and / or composition is administered to the bladder, anal fistula, anal fistula, malignant prostate tissue, the site of inflammation, the site of manifestations of myopathy or the site of manifestations of neuropathies.

12. A puncture device guide described in any one of claims 1 to 10 for use in a method for treating and / or preventing urge fecal incontinence and / or passive fecal incontinence.

13. A guide plate (130, 1130), a hole (606) for receiving a needle (25) therein; a boss (608, 1108) configured to be received by the tip guide (135, 1135) of a lancing device guide according to any one of claims 1 to 12; A guide plate comprising: a coupling element (602) configured to removably attach the guide plate (130, 1130) of the lancing device guide of any one of claims 1 to 12 to the tip guide (135, 1135).

14. and / or - a plurality of holes (606) at different radial distances, each of said holes (606) corresponding to one of the radial distances of the path of the needle (25) of the puncture device guide according to any one of claims 1 to 12. A guide plate as described in claim 13, further comprising a release hole (604) adjacent to the coupling element (602), the release hole (604) being configured to receive a tab (360) therein that releases the coupling element (602) from the tip guide (135, 1135) of a puncture device guide as described in any one of claims 1 to 12.

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