GUIDE AND METHOD FOR PARALLEL PATH PUNCTURE DEVICE.

Abstract

A guide device is provided to facilitate the placement of a puncture device (a needle) in a defined position relative to an ultrasound probe. The guide device provides additional support to the needle tip near the needle's injection site to maintain a selected trajectory during injection. The additional support retracts automatically for easy removal with the used syringe after injection. The guide device minimizes contact with contaminated components and allows syringe insertion, alignment, and withdrawal for multiple different injections without removing the ultrasound probe from the patient. More particularly, this invention relates to a puncture device guide, comprising: an adapter configured to be permanently attached to an ultrasound probe;a syringe holder assembly configured to slide onto the adapter and receive a syringe thereon; wherein the syringe holder assembly is configured to slide onto the probe adapter in an axial direction relative to the ultrasound probe; wherein the syringe holder assembly is configured to allow selective adjustment of a radial distance for a syringe needle trajectory relative to the ultrasound probe; wherein the adapter includes a tip guide for selectively aligning a distal end of the needle with the radial distance for the trajectory;and wherein, when the ultrasound probe is introduced into a patient, the syringe assembly is configured to slide forward in the adapter to insert the needle beyond the tip guide into the patient. The present invention further relates to a method for performing an injection, in particular using a puncture device guide according to the present invention and a guide plate configured for use with a puncture device guide according to the present invention.

Description

GUIDE AND METHOD FOR PARALLEL TRAJECTORY PUNCTURE DEVICE FIELD OF INVENTION This invention relates to guidance devices for puncture devices for use with medical imaging instruments, and more particularly to devices for guiding puncture devices to repeatable locations in a patient in relation to a medical imaging instrument probe. More particularly, this invention relates to a puncture device guide,comprising: an adapter configured to be fixedly attached to an ultrasound probe; a syringe holder assembly configured to slide onto the adapter and receive a syringe therein; wherein the syringe holder assembly is configured to slide over the probe adapter in an axial direction relative to the ultrasound probe; wherein the syringe holder assembly is configured to allow selective adjustment of a radial distance for a syringe needle trajectory relative to the ultrasound probe; wherein the adapter includes a tip guide for selectively aligning a distal end of the needle with the radial distance for the trajectory; and wherein, when the ultrasound probe is inserted into a patient,The syringe assembly is configured to slide forward in the adapter to insert the needle beyond the tip guide into a patient. The present invention further relates to a method for performing an injection, in particular using a puncture device guide according to the present invention and a guide plate configured for use with a puncture device guide according to the present invention. Therefore,A guide device is provided to facilitate the placement of a puncture device (a needle) in a defined position relative to an ultrasound probe. The guide device provides additional support to the needle tip near the injection site to maintain a selected trajectory during injection. The additional support retracts automatically for easy removal with the used syringe after injection. The guide device minimizes contact with contaminated components and allows for syringe insertion, alignment, and withdrawal for multiple different injections without removing the ultrasound probe from the patient. QAPQ ίΠ / ΖΖηΖ / Β / ΥΙΛΙ Error! Unknown document property name. BACKGROUND OF THE INVENTION Imaging instruments, such as ultrasound probes, have revolutionized the way many important medical procedures are performed. These medical instruments use imaging techniques to explore and evaluate the condition of human tissues and / or organs. As a result, diagnostic and therapeutic protocols have been developed that allow many procedures to be performed safely and with great success, minimizing discomfort for patients. For example, ultrasound probes have become an accepted modality for exploring endocavitary structures, such as the digestive and reproductive tracts, in humans and animals for routine examinations, as well as for identifying evidence of tumors or other tissue regions of interest. Puncture device guides are necessary to allow for the precise guidance of a puncture device as it is moved within a subject's tissue. Since puncture devices such as cannulas (hollow needles) used to penetrate tissues are mostly designed with an asymmetrical bevel and sharp edges, the incision and movement of the puncture device within the tissue causes it to move not only along the axis of insertion. Frictional resistance that arises unevenly along the bevel causes the needle to move in other directions as well. Puncture device guides are required to compensate for this movement. WO2021067734 discloses a device for use with an ultrasound probe to guide puncture devices. However, this device has the disadvantage that the tip of a puncture device (e.g., the needle or cannula) is not sufficiently stabilized to compensate for the forces resulting from the movement of an asymmetrically beveled needle within tissue, and therefore may result in inaccurate movement of the puncture device within the subject. Furthermore, the device could be accidentally pushed into a patient's endocavity, leading to contamination of the device and possibly damage to the patient's tissue. If the device is contaminated, e.g., by feces from the rectal endocavity, and repeated guidance of a puncture device would cause the device to touch the contaminated area, the risk of infection exists when the device... QAPQ ίΠ / ZZΖηZ / Β / YΥΙΛΙ puncture penetrates the patient's tissues. This risk could only be avoided by replacing and / or cleaning (e.g., sterilizing) the device between repeated uses for the same patient. Document EP2170440A2 discloses an injection device for use with medical instruments and for guiding puncture devices. The device comprises a guide tube in which a puncture device is placed to prevent it from moving freely when penetrating and / or moving within a subject's tissue. However, when withdrawing the puncture device from the guide tube, the puncture device must be withdrawn through the guide tube, thereby depositing tissue and contaminated material (e.g., feces) adhering to the tip of the guide or the puncture device into the guide tube. Reusing the device by pushing another puncture device along the guide tube would cause the deposited material to adhere to the puncture device and be carried into the subject upon penetration of the subject's surface. This could cause infection and / or inflammation of the tissue in that subject and should be avoided.Furthermore, the device could be accidentally pushed into a patient's endocavity, leading to contamination of the device and potentially damaging the patient's tissue. If the device becomes contaminated, e.g., with feces from the rectal endocavity, repeated guidance of a puncture device would cause the puncture device to touch the contaminated area, increasing the risk of infection as the puncture device penetrates the patient's tissues. This risk could only be avoided by replacing and / or cleaning (e.g., sterilizing) the device between repeated uses for the same patient. Therefore, the use of the device in EP2170440A2 for repeated and accurate injections can only be facilitated by cleaning the device or using a new device. None of the disclosures mentioned above discloses a puncture device guide for the accurate, safe, and repeatable guidance of a puncture device to inject into specific locations on and / or in a patient. SUMMARY OF THE INVENTION The present invention has been developed taking into account the prior art described above. Therefore, the object of the present invention is to provide a puncture device guide for use with harvesting instruments. QRPQ iP / ZZΖ / B / YILI of medical imaging and more particularly devices for precisely and repeatedly guiding guide puncture devices to locations on and / or in a patient in relation to a medical imaging instrument probe. Another problem to be solved by the present invention is the provision of a puncture device guide for use with medical imaging instruments that allows repeatably precise and safe guidance of a puncture device to locations on and / or in a patient in relation to a medical imaging probe. Another problem to be solved by the present invention is the provision of such a device that reduces, minimizes, or eliminates the risk of accidentally pushing the device into a patient's endocavity.Another problem to be solved by the present invention is the provision of such a device that reduces, minimizes, or eliminates the risk of contaminating the puncture / injection site, particularly if the device is used repeatedly. Another problem to be solved by the present invention is the provision of such a device that reduces, minimizes, or eliminates the need to clean (e.g., sterilize) or replace the device between repeated uses for the same patient. The object is resolved with the material defined in the claims. The present invention is advantageous over the prior art because it reduces the risk of the puncture device guide accidentally entering the endocavitary cavity, becoming contaminated and / or harming the patient. Furthermore, the present invention is advantageous in guiding a puncture device with greater precision. In addition, the puncture device guide of the present invention has the advantage of not becoming contaminated (e.g., by feces) when used with a puncture device that itself becomes contaminated during use. Therefore, the puncture device guide of the present invention does not need to be replaced or cleaned between repeated guidance of different puncture devices when used on the same patient. Moreover, the characteristic of guiding puncture devices without contamination can be combined with high precision in the movement of the puncture device within the patient's tissue.Furthermore, the puncture device guide is designed to be especially useful for the injection of needles and / or the administration of compositions and / or substances into the anal sphincter apparatus for the prevention and / or treatment of anal incontinence. QAPQ ίΠ / ΖΖηΖ / Β / ΥΙΛΙ BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is an isometric view illustrating an embodiment of a needle guide device for use with an ultrasound probe, according to the embodiments described herein; Figures 2A and 2B are assembly and symmetric views, respectively, illustrating the connection of the probe and probe adapter of Figure 1; Figure 3 is an isometric view illustrating the syringe holder set in Figure 1; Figures 4A and 4B are side and rear isometric views illustrating the assembly of the syringe holder and probe adapter of Figure 1; Figures 5A and 5B are isometric views illustrating the syringe holder assembly of Figure 3 in raised and lowered configurations, respectively, relative to the probe adapter of Figure 2B; Figures 6A and 6B are side and rear isometric views illustrating a syringe attached to the needle guide plate of Figure 1. Figures 7A-7C are isometric views illustrating the joining of the syringe and needle guide plate of Figures 6A and 6B with the syringe holder assembly and probe adapter of Figure 5A; Figures 8A and 8B are isometric views that illustrate the positions of the needle guide device and syringe during an injection; Figures 9A and 9B are isometric views illustrating the retracted position of the needle guide device and syringe after an injection; Figures 10A-C are isometric illustrations of the ejector body mechanisms during syringe ejection from the needle guide device of Figure 1; Figures 11A and 11B are side and rear perspective views illustrating the alignment of another embodiment of a needle guide plate and probe adapter; Figures 11C and 11D are side and rear perspective views illustrating the coupling of the needle guide plate and probe adapter of Figures 11A and 11B; Figures 12 and 13 are flowcharts of an illustrative process for performing injections using a parallel path puncture device guide according to the implementations described herein; qapq Ln / zznz / e / γΐΛΐ and Figure 14 demonstrates the results of force measurements when deflector needles are attached to a syringe holder assembly with a guide (w / ) or without a guide (w / o). TERMS AND DEFINITIONS The term injection, as used herein, preferentially refers to a process comprising the introduction of an injection device, for example, a needle into body tissue without yet initiating an expulsion process. The term syringe generally refers to any fluid delivery device comprising a fluid reservoir (e.g., a syringe body with at least one chamber). The syringe body may comprise one or more chambers, which are preferably cylindrical. Each chamber is preferably adapted to receive a syringe piston. By displacement of the at least one syringe piston within the syringe body, the fluid can be expelled from the syringe body through the syringe needle. The injection syringe may comprise, for example, a syringe body with a single syringe chamber, to which the syringe needle is connected and in which a syringe piston is disposed. Alternatively, the syringe may comprise two or more chambers, to which the syringe needle is connected and in which, preferably, a syringe piston is disposed in each case.In a preferred embodiment of the present invention, the syringe is further used as an electromyography probe (EMG probe) to conduct electrical signals from the tissue where the injection takes place. The term syringe needle or needle, as used herein, preferably refers to devices comprising injection cannulas (hollow syringe needles) attachable to or inseparably connected to a syringe or a piston device with at least one syringe piston and at least one piston rod. The syringe needle is preferably straight or curved. It may have asymmetrical or symmetrical bevels of different angles. The syringe needle may be made of one or more materials, such as, for example, stainless steel. The term "administer," as used herein, preferably includes the expulsion of an injection solution that releases a preferably pharmaceutically active substance and / or composition through QAPQ iP / ZZΖ / B / YILI is an injection device in a specific location of the human body, in particular, preferably in or adjacent to the muscle tissue that provides anal continence (e.g., anal sphincter apparatus). The administration process may be, but is not limited to, static, i.e., the injection device remains in the position achieved. Alternatively, the injection process is dynamic, preferably in the sense that an injection device is withdrawn from a patient's tissue during the administration of the aforementioned substance. The term "patient," as used herein, may be interchangeable with the term "subject," which preferably refers to a human being, an animal, or a mammal. The term "comprising," as used herein, should not be interpreted as limited to the meaning of "consisting of" (i.e., excluding the presence of other additional matters). Rather, "comprising" implies that additional matter may optionally be present. The term "comprising" encompasses, in particular, conceived realizations within its scope that consist of (i.e., excluding the presence of other additional matters) and that comprise but do not consist of (i.e., require the presence of other additional matters), the former being preferred. The terms "a," "an," and "the" should be interpreted to include one or more elements. Furthermore, the expression "based on" should be interpreted as being based, at least in part, on, unless explicitly stated otherwise. The term "and / or" should be interpreted to include any and all combinations of one or more of the associated elements. The expression "illustrative" is used herein to mean that it serves as an example. Any embodiment or implementation described as illustrative should not necessarily be interpreted as preferred or advantageous over other embodiments or implementations. The use of ordinal terms such as first, second, third, etc., in claims to modify a claim element does not in itself connote any priority, precedence, or order of one claim element over another, the temporal order in which the actions of a method are performed, the temporal order in which the instructions executed by a device are performed, etc., but they are simply used as labels to distinguish a claim element with a particular name from another element with the same name (but for the use of the ordinal term) to distinguish the QRPQ ίΠ / ΖΖηΖ / Β / ΥΙΛΙ claim elements. No element, act, or instruction used in the description of this application should be construed as critical or essential to the invention unless explicitly described as such. Furthermore, as used herein, it is intended that Article 1(a) includes one or more elements. DETAILED DESCRIPTION OF THE ACHIEVEMENTS The following detailed description refers to the accompanying drawings. The same reference numbers on different drawings may identify identical or similar elements. Furthermore, the following detailed description does not limit the invention. The implementations described herein refer to guide devices for facilitating the placement of a puncture device (e.g., a needle) in a defined position relative to an ultrasound probe. The term "guide device," as used herein, may be used interchangeably with "puncture device guide" or "puncture device guide." The guide devices described below include components that are adjustable to provide a series of parallel paths at different defined distances from the ultrasound probe. These guide devices thus allow radial translation of the needle path without changing its orientation angle relative to the ultrasound probe.However, despite improvements in providing different parallel trajectories, proper alignment of the needle tip at the injection site remains a challenge for practitioners. According to the embodiments described herein, a guiding device provides additional support to the needle tip near the needle injection site to maintain a selected trajectory during injection. In some implementations, the additional support can be automatically retracted for easy removal with the used syringe after injection. The devices and methods described herein can permit the insertion, alignment, and withdrawal of syringes and syringe needles, respectively, 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 the need to withdraw the syringe. QRPQ iP / ZZΖ / B / YILI patient ultrasound probe. Preferably, the devices and methods described herein may permit the insertion, alignment and withdrawal of syringe needles for 5-20, more preferably 12 injections. For example, in one implementation, the ultrasound probe may be a transrectal ultrasound probe, and the guide device may be configured to facilitate the guidance of a hypodermic needle to deliver medication at a location relative to the ultrasound probe. According to the embodiments described herein, the needle guide device may be adjustable between a plurality of parallel paths while maintaining the angular orientation and axial relationship between the needle and the ultrasound probe. A needle guide is provided to selectively position a distal end of the needle in one of the parallel paths and to maintain needle alignment throughout an injection procedure. According to one implementation, the needle guide includes a combination of interacting features in a syringe holder assembly, a probe adapter (105), and a needle guide plate.The needle guide plate is placed at a distal end of the probe adapter to stabilize the needle tip and ensure it is aligned with the axis of the syringe body. Therefore, the present invention provides a puncture device guide, comprising: an adapter (105) configured to be permanently attached to an ultrasound probe (10); a set of syringe holders (140) configured to slide onto the adapter (105) and receive a syringe (15) thereon; wherein the syringe holder assembly (140) is configured to slide over the probe adapter (105) in an axial direction relative to the ultrasound probe (10); wherein the syringe holder assembly (140) is configured to allow selective adjustment of a radial distance for a needle path (25) of the syringe (15) with respect to the ultrasound probe (10); wherein the adapter (105) includes a tip guide (135, 1135) for selectively aligning a distal end of the needle (25) with the radial distance for the path; and wherein, when the ultrasound probe (10) is inserted into a patient, the syringe assembly is configured to slide forward in the adapter QRPQ iP / ZZΖ / B / YILI for inserting the needle beyond the tip guide in a patient. The tip guide (135, 1135) is preferably also useful for preventing the syringe holder from entering the endocavity, particularly when connected to an ultrasound transducer. More preferably, the tip guide (135, 1135) is useful for preventing the syringe holder from entering the rectal endocavity. In one embodiment of the present invention, the 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, more preferably 12 syringes (15). In one embodiment of the present invention, the syringe holder assembly (140) is configured to receive one or more syringe needles (25), preferably 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15, more preferably 12, wherein the number of syringe needles is the same as, or preferably not the same as, the number of syringes (15) received by the syringe holder assembly (140). If the number of syringe needles is not the same as the number of syringes, the syringe preferably comprises 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 adapters for attaching each of the syringe needles to it.On the other hand, the syringe is preferably configured so that if all adapters are connected to each of the syringe needles, any fluid in the syringe can be drawn or injected through all the syringe needles simultaneously and preferably at different locations in the same patient. Alternatively, multiple syringes, preferably 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15, can be configured to connect to a single syringe needle. This allows fluid from different syringes to be drawn or injected simultaneously or subsequently through one syringe needle, preferably at the same location in the same patient. Preferably, the number of syringes (15) received by the syringe holder set (140) is from 1 to 3 and the number of syringe needles (25) received by the syringe holder set (140) is from 3 to 12, more preferably from 6 to 12 and even more preferably 12.Preferably, the syringe holder assembly (140) is configured to receive one syringe (15) and 12 syringe needles (25). Figure 1 shows an example of such a needle guide device according to the present invention. Figure 1 is an isometric view illustrating an embodiment of a needle guide device 100 for use with an endocavity ultrasound probe 10, in accordance with the embodiments described in the QACQ iP / ZZΖ / B / YILI present document. As shown, the needle guide device 100 includes a probe adapter 105 with a tip guide 135, a body member 110, a sliding member 115, a frame member 120, a syringe cartridge member 125, and a guide plate 130. The body member 110, sliding member 115, frame member 120, and syringe cartridge member 125 may be collectively referred to as the syringe holder assembly 140. Preferably, the tip guide 135 is designed to prevent the probe 10 from moving deeper into a patient when the tip guide 135 contacts the patient. To prevent this, the tip guide 135 is preferably rectangular or circular in shape. Preferably, the 135 tip guide has one or more holes or a gap or slot to allow 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 point guide are large enough to allow one or more needles to pass through without touching the point guide. This is important to prevent possible contamination of the point guide. Preferably, such a slot, gap, or hole has a width of approximately 0 to approximately 10 mm, more preferably from approximately 2 to approximately 8 mm, and more preferably from approximately 3 to approximately 5 mm. Preferably, the point guide has a size in the range of approximately 0.5 to approximately 5 cm x approximately 0.5 to approximately 5 cm, more preferably approximately 1 cm x approximately 1.5 cm, or alternatively, an area of ​​approximately 0.25 cm² to approximately 25 cm².The inventors found that a 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 endocavitary spaces such as the rectum during use. If a device were to accidentally enter an endocavitary space, this could lead to contamination of the device and / or harm to the patient. Therefore, the tip guide 135 is particularly useful for the device of the present invention when used on a patient. In an assembled configuration and prior to administration, a 15-gauge hypodermic syringe with a 25-gauge needle can be received inside the 100-gauge needle guide device as described below. During use, the 15-gauge syringe is inserted ORCO iP / ZZΖ / B / YILI into the syringe cartridge member 125, which is then inserted into the frame member 120. The sliding member 115 is moved to adjust the position of the body 110 and the syringe 15 relative to the probe 10, so that the guide plate 130, with the distal end of the needle 25 inside, engages with the tip guide 135 of the probe adapter 105. The probe 10 can then be inserted into the patient's rectum, for example, no further than the tip guide 135. With the probe 10 in place, the sliding member 115 is moved forward and the needle 25 is injected into the patient. If the puncture device guide comprises a guide plate 130 as described below, with the probe 10 placed inside the patient, the sliding member 115 is moved further forward so that the body 110 comes into contact with the guide plate 130 and the needle 25 is injected into the patient.The inventors discovered that the syringe needle must be injected into a patient from approximately 2 to approximately 10 cm, more preferably from approximately 3 to approximately 6 cm, more preferably approximately 5 cm to reach the anal sphincter muscle when the syringe holder assembly 140 is attached to an ultrasound probe 10. Therefore, the distance between the distal end of the syringe needle 25 and the tip guide 135, 1135 is preferably from approximately 2 to approximately 10 cm, more preferably from approximately 3 to approximately 6 cm, more preferably approximately 5 cm.In a preferred embodiment of the present invention, the puncture device guide further comprises a guide plate (130, 1130), the guide plate including: a hole (606) for receiving the needle (25) through it, a projection (608, 1108) configured to be received by the tip guide (135, 1135), and a coupling element (602) configured to detachably connect the guide plate (130, 1130) to the tip guide (135, 1135). In a further preferred embodiment, the guide plate (130, 1130) further comprises multiple holes (606) at different radial distances, wherein each of the multiple holes (606) corresponds to one of the radial distances for the path of the needle (25). In a preferred embodiment of the present invention, the needle guide device is configured such that, in the assembled configuration and prior to administration, a hypodermic syringe 15 with a needle 25 can be received within the needle guide device 100 as described below. Preferably, it is configured such that during use, the QAPQ iP / ZZΖ / B / YILI syringe 15 can be inserted into the syringe cartridge member 125, which can then be inserted into the frame member 120. The sliding member 115 is preferably configured to move to adjust the position of the body 110 and the syringe 15 with respect to the probe 10, so that the tip guide 135, 1135 of the probe adapter engages with the guide plate 130, with the distal end of the needle 25 inside. 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 placed inside the patient, the sliding member 115 is preferably configured to move further forward so that the body 110 comes into contact with the guide plate 130 and the needle 25 can be injected into the patient.Preferably, the puncture device guide is configured so that the needle can move through the hole(s), slot, or gap in the guide plate. The inventors found that using a guide plate as described herein and, for example, shown in Figure 7, is particularly advantageous because the needle is better stabilized; that is, more force is required at the needle tip to cause bending or movement of the needle about the transducer axis (Example 1, Table 1). Additionally, the inventors were able to demonstrate that such a guide plate improves the accuracy of a needle as it moves through muscle tissue, allowing for more precise targeting of the intended needle tip (Example 2, Table 2). Therefore, using a guide plate 130 is preferred and particularly advantageous for achieving the object of the present invention.It is also preferred to use a guide plate that includes one or more holes 606 for receiving the needle(s) 25 through them. Preferably, the guide plate that includes multiple holes 606 comprises from approximately 2 to approximately 15 holes, more preferably from approximately 2 to approximately 10 holes, and even more preferably from approximately 2 to approximately 5 holes. It is further preferred that the guide plate that comprises one or more holes 606 contains a projection 608, 1108 configured to be received by the tip guide 135 of the adapter 105. More preferably, said guide plate 130 contains a coupling element 602 configured to detachably join the guide plate 130 to the tip guide 135. More preferably, the multiple holes 606 each correspond to selected radial distances for the path of the needle 25.More preferably, said radial distances qrpq Ln / zznz / e / γΐΛΐ are selected so that they are approximately 0.1 and approximately 10 cm away from probe 10, even more preferably from approximately 0.1 to approximately 5 cm and even more preferably from approximately 0.1 to approximately 2 cm away from the probe. More preferably, said guide plate 130, 1130 comprises a release hole 604 adjacent to the coupling element (602), wherein the release hole (604) is configured to receive a tab (360) therein that releases the coupling element (602) from the tip guide (135, 1135). The release hole 604 is preferably capable of receiving a tab 360 located preferably in the syringe holder assembly 140. This release hole is configured so that when it receives a tab 360, the coupling element 602 is released from the tip guide 135. Preferably, the release of the guide plate 140, by inserting a tab 360 into the release hole 604, leads to the attachment of the guide plate 130 to the syringe holder assembly 140. Preferably, the puncture device guide and the guide plate are configured so that the guide plate can be easily changed, particularly during use.Preferably, the puncture device guide and guide plate are configured so that a new guide plate is used for each injection, i.e., the guide plate can be changed after each injection. In a further preferred embodiment, the syringe holder assembly (140) further comprises the tab (360), wherein, if the syringe holder assembly (140) is slid forward in the adapter (105), the tab is inserted into the release hole (604) to release the coupling element (602) and engage the guide plate (130, 1130) with 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), more preferably from approximately 2 to approximately 15, more preferably from approximately 2 to approximately 10, and still more preferably from approximately 3 to approximately 5 slots 1107 at different radial distances.Preferably, the radial distances are from approximately 0.5 to approximately 5 cm, more preferably from approximately 0.5 to approximately 2 cm, and even more preferably from approximately 0.5 to approximately 1 cm. Preferably, the distance between the multiple holes is from approximately 0.1 to approximately 1 mm. The multiple grooves (1107) at different radial distances are preferably configured to receive the projection (1108) of the guide plate (1130). The tip guide 1135 is preferably configured to receive the projection 1108 of the guide plate 1130. More preferably, each of the multiple grooves 1107 corresponds to one of the radial distances for the needle path.More preferably, these radial distances are selected to be approximately 0.1 and approximately 10 cm from probe 10, even more preferably from approximately 0.1 to approximately 5 cm, and still more preferably from approximately 0.1 to approximately 2 cm from the probe. An example of such a preferred embodiment is shown in Figures 11A-11D. In a further preferred embodiment of the present invention, the syringe holder assembly (140) is configured to slide backward into the adapter (105) to retract the needle (25) from the patient and back past the tip guide (135, 1135), wherein, when the syringe assembly (140) slides backward, the guide plate (130, 1130) is held attached to the tabs. The coupling of the body 110 with the guide plate 130 causes the guide plate 130 to be released from the tip guide 135 and joined to the body 110. In particular, the guide plate 130, 1130 can be configured so that after joining to the body 110 and being released from the tip guide 135, 1135, it is able to slide over the adapter together with the syringe holder assembly (140), as shown, e.g., in Figures 9A and 9B. In one embodiment of the present invention, the syringe barrel 20 is retracted into the frame member 120 via the cartridge member 125 to deliver its contents during patient extraction. Preferably, pulling the sliding member 115 results in an axial movement of the needle 25 relative to the probe 10 and the adapter 105 of up to approximately 5 cm, more preferably up to approximately 3 cm. Preferably, pulling the sliding member 115 results in an axial movement of the needle 25 relative to the tip guide 135, thereby reducing the distance from the distal end of the needle 25 to the tip guide 135 to between approximately 1 and approximately 10 cm, more preferably between approximately 2 and approximately 6 cm, and even more preferably to approximately 3 cm. qrpq Ln / zznz / e / YiAi The inventors found this to be especially advantageous since, over such a distance, a suspension can be administered to the entire length of a muscle, preferably the external anal sphincter muscle. When the sliding member 115 is pulled fully toward the proximal end of the frame member 120 (configuration as in Figure 8B), the distance between the distal end of the needle 25 and the tip guide 135 is preferably from approximately 0.1 cm to approximately 3 cm, more preferably from approximately 1 cm to approximately 2 cm, and even more preferably approximately 1.5 cm. The inventors found that this remaining distance between the distal end of the needle and the tip guide is particularly advantageous because, after the administration of a suspension to a patient, the needle remains in the patient when the tip guide is in contact with the patient, thus allowing a reasonable amount of time to pass until the administered suspension is completely absorbed by the patient's tissues.This prevents the suspension from flowing back through the injection channel out of the patient's body when the needle is withdrawn from the patient. In another preferred embodiment of the present invention, the syringe holder assembly 140 is configured to slide backward in the adapter 105 to retract the needle 25 from the patient and back past the tip guide. Preferably, with the guide plate 130 now attached to the body 110, the sliding element 115 is pulled back (e.g., away from the tip guide 135), which removes the needle 25 from the tip guide 135. The syringe cartridge member 125 can then be released from the frame member 120 and the used syringe 15 and guide plate 130 are simultaneously removed from the syringe cartridge member 125. In another embodiment of the present invention, the syringe holder assembly 140 is configured to slide backwards. Figures 2A and 2B are overall and isometric views, respectively, of probe 10 and probe adapter 105 of Figure 1. According to the embodiments described herein, probe adapter 105 may include a generally tubular configuration sized and shaped to fit an outer surface of the ultrasound probe 10. Probe adapter 105 may slide over a distal end of probe 10 and be held in place by a friction / interference fit. The probe adapter 105 can be configured to receive and support the syringe holder assembly 140. As shown, an upper portion of the adapter 105 includes joining rails 200 that engage with corresponding clamping elements 315 that protrude from a lower surface of the body member 110, as shown in Figure 3A and described in detail below.In one implementation, the joining rails 200 include oppositely oriented ribs or projections 210 that together form a flat top surface 215 to support the body member 110 upon them. As shown in Figures 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 in various locations on the ultrasound probe 10. According to the embodiments described herein, the adapter 105 may be formed from a plastic or polymeric material and may be manufactured in any suitable manner, such as injection molding, extrusion molding, 3D printing, etc. The adapter 105 includes a tip guide 135 at a distal end. The tip guide 135 can project in a plane substantially orthogonal to a longitudinal axis of the probe 10 / probe adapter 105. As described later in this document, the guide plate 130 can be detachably attached to the tip guide 135. The tip guide 135 can include a groove 207 through which the needle 25 can 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). Although the adapter 105 shown in the figures illustrates a particular configuration, it should be understood that different configurations can be implemented based on the configuration of the ultrasound probe with which the needle guide device 100 is to be used. Also, although not shown in the figures, in use, a sterile sheath or other cover can be placed over or on top of the ultrasound probe 10 before attaching the ultrasound probe 10. Figure 3 is an isometric view illustrating the syringe holder assembly 140. As shown in the figures, the body member 110 includes a generally frame-like structure with longitudinal sides 312 that receives and supports the sliding member 115, the frame member 120, and the syringe cartridge member 125. The syringe holder assembly 140 is described in more detail in relation to the following figures. Figures 4A and 4B are side and rear isometric views, respectively, illustrating the connection of the syringe holder assembly 140 to the probe adapter 105. As shown in Figures 3, 4A, and 4B, the body member 110 may further include a plurality of clamping elements 315 on a lower portion of both longitudinal sides 312. The clamping elements 315 are spaced to engage the connecting rails 200 on the adapter 105. In particular, each clamping element 315 may include a prong or slot member configured to engage a portion of the lower part of the connecting rail to secure the syringe holder assembly 140 to the adapter 105, while simultaneously permitting longitudinal positioning of the syringe holder assembly 140 relative to the ultrasound probe 10. In one implementation, during assembly, as shown in Figures 4A and 4B, a downward force is exerted on the body member 110, causing the clamping elements 315 to engage with an edge portion of the connecting rails 200. A continued downward force causes the clamping element 315 to extend outward, allowing the prong members or slots of the clamping element 315 to slide over the connecting rails 200 and fully engage with them. In other implementations, the clamping elements 315 may not include prong members but may instead include non-angled internal projections. In such an embodiment, the body member 110 can slide longitudinally over the connecting rails 200 during assembly. As shown in Figures 3, 4A, and 4B, the side sides 312 may include a plurality of path-adjustment channels 335 and path-selection slots 340. In the illustrated embodiment, the body member 110 includes four opposing pairs of path-adjustment channels 335 and four opposing pairs of path-selection slots 340. In other implementations, more or fewer path-adjustment channels 335 and / or path-selection slots 340 may be used. Also, although pairs of channels 335 and slots 340 are described for the corresponding longitudinal sides 312, in some implementations, the channel(s) 335 and / or slot(s) 340 may be provided on one side or on alternate sides of the body member 110. According to the embodiments described herein, each of the path-adjustment channels 335 forms a generally angled channel having a plurality of flat portions 337 and angled portions 339 corresponding to a number of possible path positions. In the illustrated embodiment, each path-adjustment channel 335 includes four flat portions 337 and three angled portions 339 spaced between each flat portion 337. Although not restricted herein, in one implementation, the vertical distance between the bottom of a first (e.g., lower) flat portion 337 and the bottom of a fourth (e.g., higher) flat portion 337 is in the range of approximately 0 to approximately 10 centimeters (cm), more preferably from approximately 0.5 to approximately 5 cm, and even more preferably from approximately 0.5 to approximately 1.5 cm.In the same illustrative embodiment, the longitudinal distance between the center of the first flat portion 337 and the center of the fourth flat portion 337 is in the range of approximately 0 to approximately 15 cm, more preferably from approximately 2 to approximately 15 cm, and even more preferably from approximately 5 to approximately 12 cm. Each of the path adjustment channels 335 is configured to receive the corresponding selection pin 350 of the sliding member 115, thereby restricting the movement of the sliding member 115 to those positions defined by the path adjustment channels 335. The path selection slots 340 are spaced and positioned to correspond to the flat portions 337 in the path adjustment channels 335. As described below, one of the path selection slots 340 is configured to receive a corresponding portion of the sliding member 115 to positively retain the sliding member 115 in the position defined by one of the flat portions 337 and prevents unintentional movement along the path adjustment channel(s) 335 during use. As shown in Figure 3, a portion of the frame member 120 extends through an opening in the front of the body member 110 (e.g., between the longitudinal sides 312). More specifically, tabs 360 of the frame member 120 extend beyond a front end of the body member 110 and are configured to engage the guide plate 130 as described below. By sliding the sliding member 115 into In relation to the body member 110, the selection pins 350 can be positioned on different flat portions 337 of the path adjustment channels 335. For example, a handle 370 of the sliding member 115 can be pushed or pulled to change the position of the selection pins 350, which, correspondingly, changes the parallel path (e.g., distance above the joining rails 200) provided by the frame member 120 and the tabs 360. Figures 5A and 5B are isometric views illustrating the syringe holder assembly 140 in elevated (e.g., higher) and lowered (e.g., lower) parallel path configurations, respectively, relative to the probe adapter 105. The syringe holder assembly 140 can position a syringe 15 with a needle 25 at any of multiple distances from the ultrasound probe to provide an injection path parallel to a longitudinal axis of the probe 10. As described above, a practitioner can select a parallel path for a particular application / patient. Figures 6A and 6B are side and rear isometric views illustrating the syringe 15 coupled to the 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 joining clamps 602 or other coupling elements, each adjacent to a release hole 604. The guide plate 130 may also include a set of tip height selection holes 606, a plate alignment lug 608, and a set of rail alignment slots 610. The number of tip height selection holes 606 can correspond to the number of different flat portions 337 that can be selected using the path adjustment channels 335 on the body member 110. Each tip height selection hole 606 is configured to guide the needle 25 in a particular parallel path. That is, the radial spacing between each of the tip height selection holes 606 (e.g., relative to probe 10) can correspond to the radial distance between the different flat portions 337, so that the needle 25 is assured a path parallel to probe 10 when a needle 25 is inserted through a tip height selection hole 606 that corresponds to one of the flat portions 337.According to one implementation, a practitioner can insert the qapq Ln / zznz / e / γΐΛΐ needle 25 through a chosen tip height selection hole 606 before inserting the syringe 15 into the syringe holder assembly 140. Figures 7A and 7B are symmetrical views illustrating the connection of syringe 15 and needle guide plate 130 with syringe holder assembly 140 and probe adapter 105. As shown in Figure 7A, syringe 15 and guide plate 130 can be inserted simultaneously into syringe holder assembly 140, with needle 25 extending through guide plate 130. As shown in Figure 7B, syringe 15 can be inserted into syringe cartridge member 125. When syringe 15 is inserted into syringe cartridge member 125, the tip of needle 25 is positioned adjacent to tip guide 135 with guide plate 130 on needle 25 between body member 110 and tip guide 135. When syringe 15 is in syringe cartridge member 125, the rail alignment slots 610 of guide plate 130 can fit around the rails 200 of probe adapter 105. 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 with the tip guide 135, as shown in Figures 1 and 7C. A plate alignment protrusion 608 can be configured to fit into the groove 207 of the tip guide 135. The plate alignment protrusion 608 can pass through the groove 207 of the tip guide 135 so as to prevent the needle 25 from contacting the tip guide 135 during insertion and retraction. According to one implementation, 602 joining clamps can be configured to engage the adapter 105 when the plate alignment lug 608 is inserted through the slot 207.More specifically, the clamps 602 can be configured to align with the opposite edges 209 of the tip guide 135 when the plate alignment projection 608 is inserted into the groove 207 of the tip guide 135. Figures 8A and 8B are isometric views illustrating the positions of the needle guide device 100 and syringe 15 during an injection. With the probe 110 inserted into a patient, preferably until the tip guide 135 is in contact with the patient's skin, the syringe holder assembly 140 can be pushed longitudinally forward along the connecting rails 200 from the orientation shown in Figures 1 and 7C to the orientation shown in Figure 8B. 8A. 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, thereby achieving a needle injection depth in the patient of up to approximately 10 cm, more preferably up to approximately 7 cm, even more preferably from approximately 4 to approximately 5 cm. When the syringe holder assembly 140 moves fully forward, the 360 ​​tabs of the frame member 120 are inserted into the release holes 604 of the guide plate 130. As it passes the holes 604, each of the 360 ​​tabs is inserted between a rim 209 and a connecting clamp 602, pushing (e.g., outward) the connecting clamps 602 adjacent to each of the release holes 604 and causing the connecting clamps 602 to disengage from the tip guide 135.While causing clamps 602 to separate from tip guide 135, inserting tabs 360 into release holes 604 also causes tabs 360 to grip / hold guide plate 130. With the needle 25 in the patient, a practitioner can apply opposing (e.g., compressive) forces to projections 365 and a syringe retraction holder 367. As shown in Figure 8B, the projections 365 can be moved longitudinally backward toward the syringe retraction holder 367. The force on the projections 365 forces the cylinder flange 22 backward toward the plunger flange 32, causing the cylinder 20 to retract and release its contents through the needle 25 when the needle 25 is withdrawn from the patient. Figures 9A and 9B are isometric views illustrating a retracted position of the needle guide device 100 and syringe 15 after an injection. At the end of an injection, a practitioner can slide the syringe holder assembly 140 longitudinally backward on the connecting rails 200 (e.g., while the probe 10 remains inside the patient). The guide plate 130, due to engagement with the tabs 360, retracts with the syringe holder assembly 140. After retraction of the syringe holder assembly 140 and guide plate 130, the guide plate 130 can be pushed longitudinally forward to separate it from the tabs 360 and the syringe holder assembly 140, as shown in Figure 9B. For example, a practitioner can gently grasp the sides of the guide plate 130 to flex it and release the tabs 360 from the release holes 604. According to one implementation, the guide plate 130 can remain supported on a distal portion of the needle 25. Figures 10A-C are isometric illustrations of the ejector body mechanism of the syringe cartridge member 125 during ejection of the syringe 15 from the needle guide device 100. A release member 373 of the syringe cartridge member 125 can be lifted (e.g., by a practitioner), causing the syringe cartridge member 125 to rotate the syringe 15 out of the frame member 120, as shown in Figures 10A and 10B. With the syringe cartridge member 125 in the raised position, a practitioner has unobstructed access to the plunger flange 32 and / or the cylinder 20 of the syringe 15, which can be grasped and removed from the syringe holder assembly 140 with the guide plate 130 still connected to the needle 25, as shown in Figure 10C. Therefore, syringe 15 and guide plate 130 can be removed and disposed of without the practitioner coming into contact with the contaminated portions of syringe 15 or guide plate 130. Figures 11A–11D are isometric views illustrating another embodiment of a probe adapter and needle guide plate. Figures 11A and 11B show side and rear perspective views of a guide plate 1130 installed on the needle 25 of syringe 15, similar to the arrangement described above in relation to Figures 7A and 7B. Similar to the above description, the combination of syringe 15 and guide plate 1130 can be inserted into the syringe holder assembly 140 simultaneously, with the needle 25 extending through the guide plate 1130 and the distal end of the needle 25 adjacent to the tip guide 1135 of probe adapter 1105. Unlike the guide plate 130 described above, the guide plate 1130 may include only one hole 1106 configured to receive the needle 25. The tip guide 1135 includes two or more slots 1107 at different heights configured to receive the plate alignment lug 1108. Each of the slots 1107 may correspond to one of the selectable parallel paths described above in relation to, for example, Figure 3. Therefore, although only two slots 1107 are shown in Figures 11A-11D, in other implementations the tip guide 1135 may include more than two slots 1107. Figures 11C and 11D show side and rear perspective views of a guide plate 1130 attached to the tip guide 1135, similar to the Ln / zznz / e / γALA orc arrangement described above in relation to Figures 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 with the tip guide 1135, as shown in Figures 11C and 11D. The plate alignment protrusion 1108 can be configured to fit into a selected groove 1107 of the tip guide 1135. According to one implementation, selecting a particular parallel path for the syringe holder assembly 140 can align the needle 25 and guide plate 1130 with a corresponding groove 1107 of the tip guide 1135. According to one implementation, the system and methods described herein can be used to perform multiple injections in a radial pattern. After a first injection (e.g., as described above), while the probe 10 remains in the patient, the radial insertion distance of the syringe holder assembly 140 can be adjusted (e.g., as described above in relation to Figures 5A and 5B), if necessary. A new combination of syringe 15 and guide plate 130 can be inserted into the syringe holder assembly 140 (as described in Figures 7A-7C), and the probe 10 can be rotated to a preferred next injection orientation for the patient. A second or subsequent injection can then be performed using the process described above. Preferably, a new guide plate 130 is used for each subsequent injection. The present invention also provides a method for performing an injection, the method comprising: (a) attaching a probe adapter (140) to an ultrasound probe (10), wherein the probe adapter (105) includes a tip guide (135, 1135) at a distal end; (b) attaching a syringe holder assembly (140) to the probe adapter (140), wherein the syringe holder assembly is longitudinally slidable with respect to the probe adapter (140); (c) insert the ultrasound probe (10) into a patient; (d) adjust the syringe holder assembly (140) to provide a selected radial distance for a syringe needle (25) from the ultrasound probe (10); qrpq Ln / zznz / e / γΐΛΐ (e) insert the syringe (15) into the syringe holder assembly (140) and align a syringe needle (25) with the tip guide (135, 1135); (f) slide the syringe holder assembly (140) distally to push the needle past the tip guide (135, 1135) and into the patient; (g) slide the syringe holder assembly (140) back to retract the needle (25) from the patient, and (h) remove the syringe (15) from the syringe holder assembly (140). Preferably, the insertion of the syringe (15) into the syringe holder assembly (140) further comprises (i) providing a guide plate (130, 1130) with a projection (608, 1108) configured to be received by the tip guide (135, 1135) and a coupling element (602) configured to detachably join the guide plate (130, 1130) to the tip guide (135, 1135); (ii) inserting the syringe needle (25) through a hole (606) in the guide plate (130, 1130); and (iii) inserting the syringe (15) into the syringe holder assembly (140) after inserting the syringe needle (25) through the hole (606). Preferably, the insertion of the syringe (15) into the syringe holder assembly (140) further comprises selecting the hole from among the multiple holes (1107) of the tip guide (1135), wherein each of the multiple holes (1107) corresponds to a different radial distance for the syringe needle (25) with respect to the ultrasound probe (10).Preferably, the insertion of the syringe (15) into the syringe holder assembly (140) further comprises sliding the guide plate (130, 1130) along the syringe needle (25) until the guide plate (130, 1130) engages with the tip guide (135, 1135). Preferably, the guide plate (130, 1130) slides along the syringe needle (25) until the guide plate (130, 1130) engages with the tip guide (135, 1135). This may further include the step of moving the guide plate (130, 1130) to couple the protrusion (608, 1108) with one of the multiple slots of the tip guide (135, 1135), where each of the multiple slots corresponds to a different radial distance for the syringe needle (25) with respect to the ultrasound probe (10). Preferably, when sliding the syringe holder assembly (140) backwards to retract the needle (25) from the patient, the syringe needle (25) does not come into contact with the tip guide (135, 1135), in particular to avoid any possible contamination of the tip guide (135, 1135). Preferably, if the syringe holder assembly (140) slides distally QRPQ ίΠ / ZZΖηZ / B / YΙΛΙ to push the needle (25) past the tip guide (135, 1135) and into the patient, the syringe holder assembly (140) engages the guide plate (130, 1130) and releases the guide plate (130, 1130) from its attachment to the tip guide (135, 1135). More preferably, by sliding the syringe holder assembly (140) back to retract the needle (25) from the patient, the syringe holder assembly (140) retracts the guide plate (130, 1130) away from the tip guide (135, 1135). In a preferred embodiment of the method according to the present invention, the method further comprises the step of separating 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 syringe needle (25). Preferably, the step of removing the syringe (15) from the syringe holder assembly (140) of the method according to the present invention further comprises removing the syringe (15) and the guide plate (130, 1130) while the syringe needle (25) remains inserted through the guide plate (130, 1130). Preferably, the method according to the present invention is performed using any puncture device according to the present invention. Furthermore, the puncture device according to the present invention is preferably configured for use in a method according to the present invention. Figure 12 is a flowchart of an illustrative process for performing injections using a parallel-path puncture device guide, according to an implementation described herein. As shown in Figure 12, process 1200 may include attaching a probe adapter to an ultrasonic probe (block 1205) and attaching a syringe holder assembly to the probe adapter (block 1210). For example, as described above in relation to Figures 2A–4B, the probe adapter 105 may be attached to the probe 10, and the syringe holder assembly 140 may be engaged with the rails 200 of the probe assembly 105. The process 1200 may also include inserting the probe into a patient (block 1215), and adjusting the syringe holder assembly to a selected radial distance for the syringe needle (block 1220). For example, as described above in relation to Figures 5A and 5B, a handle 370 on the sliding member 115 can be pushed or pulled to change the position of the selection pins 350, which, correspondingly, changes the parallel path (e.g., a radial distance above the connecting rails 200) that the frame member 120 defines for the syringe 15. Process 1200 may further include inserting a syringe into the syringe holder assembly and aligning a syringe needle with a tip guide (block 1225). For example, according to one embodiment, block 1225 may include the steps in Figure 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, e.g., a cell suspension. In a preferred embodiment, sliding back the inserted syringe cartridge (125) containing a syringe (15) filled with a substance or composition results in the simultaneous administration of the substance or composition to the patient. Preferably, the substance or composition is intended to be administered to the patient by performing process 1200.In another example, as described in relation to Figures 11A-11D, a practitioner can insert the needle 25 through a selected hole 1106 of the guide plate 1130, insert the syringe 15 into the syringe holder assembly 140, and then attach the guide plate 1130 to a selected slot 1107 of the tip guide 1135. In yet another implementation, the tip guide 1135 can include multiple holes corresponding to the parallel paths for which the syringe holder assembly is fitted, and the needle 25 can be inserted through a selected hole of the tip guide 1135. The 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 backward to retract the needle from the patient (block 1235). For example, as described above in relation to Figures 8A-9B, with the probe 110 inserted into a patient, the syringe holder assembly 140 can be pushed longitudinally forward along the connecting rails 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, a practitioner can squeeze projections 365 and syringe retraction bracket 367, causing syringe 15 to release or deliver its contents through needle 25.Preferably, the projections 365 move a defined length toward the retraction support 367 to cause movement of the needle 25 relative to the transducer. This length is preferably from approximately 2 to approximately 10 cm, more preferably from approximately 2 to approximately 5 cm, and even more preferably approximately 3 cm in length. Upon completion of the injection, a practitioner can slide the syringe holder assembly 140 longitudinally backward on the connecting rails 200, while the probe 10 remains inside the patient. The 1200 process may further include removing the syringe from the syringe holder assembly and disposing of the syringe (block 1240). For example, the syringe cartridge member 125 can be rotated to lift the syringe 15 out of the frame member 120, as shown in Figures 10A and 10B. With the syringe cartridge member 125 in the raised position, a practitioner can grasp the plunger flange 32 and / or the cylinder 20 of the syringe 15 to remove the syringe 15 from the syringe holder assembly 140 with the guide plate 130 still connected to the needle 25, as shown in Figure 10C. Thus, the syringe 15 and guide plate 130 can be removed and disposed of without the practitioner coming into contact with the soiled portions of the syringe 15 or guide plate 130. Process 1200 may also include determining whether additional injections are needed (block 1245). If no additional injections are needed for the patient (block 1245 - No), process 1200 may include removing the ultrasound probe from the patient (block 1250). If additional injections are needed for the patient (block 1245 - Yes), process 1200 may return to process block 1220 to perform another injection with a new syringe and guideplate, if necessary. With reference to figure 13, process block 1225 may include inserting a needle through a hole, in a needle guide, corresponding to the selected radial distance for the syringe needle (block 1305), inserting the syringe into a syringe holder assembly with the needle guide oriented on the needle axis and the rail alignment slots supported on the probe adapter joining rails (block 1310), and sliding the needle guide forward along the needle axis to join the needle guide to the probe adapter at the tip guide (block 1315). For example, before inserting syringe 15 into syringe holder assembly 140, a practitioner can insert needle 25 through a selected hole 606 of guide plate 130, so that the selected hole 606 corresponds to the parallel path to which syringe holder assembly 140 is adjusted.As described in relation to Figures 6A7C, the practitioner can insert the syringe 15 into the syringe holder assembly 140, with the guide plate 130 supported on the joining rails 200, and slide the guide plate 130 forward to join it to the tip guide 135 of the probe holder 105. The implementations described herein provide a guide device to facilitate the placement of a puncture device (e.g., a needle) in a defined position relative to an ultrasound probe. Preferably, a substance and / or composition can be administered to a patient via the puncture device (e.g., a needle). The guide device provides additional support to the needle tip near the needle's injection site to maintain a selected trajectory during injection. The additional support retracts automatically for easy removal with the used syringe after injection. The guide device minimizes contact with contaminated components and allows for syringe insertion, alignment, and withdrawal for multiple different injections without removing the ultrasound probe from the patient. The foregoing description of implementations provides illustration and description, but is not intended to be exhaustive nor to limit the invention to the precise form disclosed. Modifications and variations are possible in light of prior learning or may be acquired from the practice of the invention. For example, while a series of blocks has been described with respect to Figure 12, the order of the blocks may be modified in other embodiments. Furthermore, independent blocks may be implemented in parallel. In one embodiment of the present invention, the puncture device guide is suitable for medical use. Medical use herein refers to use comprising the prevention and / or treatment of a disease in a subject, preferably a human, animal, or mammal. Preferably, medical use comprises the prevention and / or treatment of urinary incontinence, anal incontinence, overactive bladder, underactive bladder, anal fistula(s), hemorrhoids, (chronic) inflammation, myopathies, neuropathies, and / or prostate neoplasms. More preferably, medical use refers to use in the prevention and / or treatment of anal incontinence, more preferably urge fecal incontinence and / or passive fecal incontinence. To permit medical use of a device, the device is preferably sterile when in use. Therefore, the device is preferably designed to be sterilizable prior to use.Preferably, sterilization is achieved 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 sterilizable material, such as steel, ceramic, and / or plastic. More preferably, the device is made of sterilizable material comprising plastic, more preferably a terpolymer, and even more preferably an acrylonitrile-butadiene-styrene copolymer. It is also preferred that the material from which the device is made be biocompatible. Biocompatibility, as used herein, refers to compliance with the specifications of ISO 10993-1:2018, more preferably compliance with the specifications for contact with intact skin and / or intact mucous membranes, as defined in ISO 10993-1:2018.Preferably, the material of the device according to the present invention, which preferably meets the biocompatibility specifications, is selected from steel, ceramic, and / or plastic, more preferably from a class of terpolymers, and even more preferably from acrylonitrile-butadiene-styrene copolymers. The selection of the device material from any acrylonitrile butadiene styrene, such as Lustrian® 633 ABS (natural) (Bayer), is also preferred. It is even more preferable that the device according to the present invention be sterilizable and biocompatible and, therefore, especially suitable for medical use. Preferably, the puncture device guide according to the present invention is assembled from multiple parts or components, preferably from 1 to 10 parts or components, more preferably from 1 to 6, and even more preferably 5 or 6 parts or components.Preferably, the puncture device guide according to the present invention is assembled from 5 different parts or components, preferably the adapter 105, the body member 110, the sliding member 115, the punch member 120, and the cartridge member 125. If the puncture device guide according to the present invention comprises a guide plate 130, 1130, it is preferably assembled from 6 different parts or components, specifically, preferably the adapter 105, the body member 110, the sliding member 115, the frame member 120, the cartridge member 125, and the guide plate 130, 1130. These components are preferably manufactured using a single mold. Preferably, the number of molds required for the production of the parts or components of the puncture device guide is equal to or less than the number of parts or components.Preferably, the number of molds required for the production of the parts or components of the puncture device is from 1 to 10, more preferably from 1 to 6, and even more preferably 5 or 6. Preferably, 5 or 6 different molds are required for the production of the puncture device guide component. More preferably, each of the 5 or 6 molds is designed to produce each of the parts or components of the puncture device guide comprising an adapter 105, a body member 110, a sliding member 115, a frame member 120, a cartridge member 125, and optionally, a guide plate 130. It is also preferred that one or more of the different components or parts be produced multiple times for use with a patient, wherein preferably one or more parts are interchangeable when multiple injections are performed on a patient.Preferably, the guide plate 130, 1130 is manufactured multiple times to allow for the use of a new guide plate 130, 1130 after each injection. Preferably, the puncture device guide according to the present invention has a length of approximately 5 to approximately 30 cm, a width of approximately 1 cm to approximately 5 cm, and a height of approximately 1 cm to approximately 5 cm, making it suitable for medical use. Therefore, in a preferred embodiment 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 selection of a material from steel, ceramic, and / or plastic.Even more preferably the device is made of sterilizable plastic, more preferably a terpolymer, even more preferably an acrylonitrile-butadiene-styrene copolymer. The present invention also provides a puncture device guide as described herein for use in a method of 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 of treating and / or preventing urinary incontinence, anal incontinence, overactive bladder, underactive bladder, anal fistula(s), hemorrhoids, (chronic) inflammation, myopathies, neuropathies, and / or prostate neoplasms. Preferably, in such methods, the pharmaceutically active substances and / or compositions are administered at the site of the injury or disease. Preferably, in such methods for treating and / or preventing urinary and / or anal incontinence, the pharmaceutically active substances and / or compositions are administered into the anal and / or urinary sphincter apparatus.Preferably in such methods for treating and / or preventing overactive and / or underactive bladder, the pharmaceutically active substances and / or compositions are administered into the bladder. Preferably in such methods for treating and / or preventing anal fistula(s), the pharmaceutically active substances and / or compositions are administered into the anal fistula(s). Preferably in such methods for treating and / or preventing hemorrhoids, the pharmaceutically active substances and / or compositions are administered into the hemorrhoids. Preferably in such methods for treating and / or preventing prostate cancer, the pharmaceutically active substances and / or compositions are administered into the malignant prostatic tissue.Preferably in such methods for treating and / or preventing chronic inflammation, myopathies, or neuropathies, the pharmaceutically active substances and / or compositions are administered at the site of inflammation, the site of the manifested myopathy, or the site of the manifested neuropathy, respectively. Preferably, the pharmaceutically active substances are selected from autologous and / or allogeneic cells. In one embodiment of the present invention, the puncture device guide is used for the cell injection procedures, as already described in document EP2120976B1. The administration of cells to a specific tissue or lesion site comprises a therapeutically effective number of cells in solution or suspension, e.g., approximately 1 x 10⁶ to approximately 6 x 10⁶ cells per 100 μL of injection solution. The injection solution is preferably a physiologically acceptable medium, with or without autologous serum.The acceptable physiological medium may be, by way of non-limiting example, physiological saline solution or a phosphate-buffered solution. Preferably, cells are administered into the anal sphincter apparatus as a treatment for anal incontinence to care for, improve, and / or repair the external and / or internal anal sphincter. Preferably, the cells are injected into or near the external and / or internal anal sphincter and survive and differentiate into mature muscle cells to augment the sphincter and / or improve its function. The viability and long-term survival of myogenic progenitor cells according to this embodiment have been previously demonstrated (Messner et al., 2021; Thurner et al., 2020). Alternatively, it is preferred that the puncture device guide be used for the prevention of anal incontinence by administering cells to augment and / or reinforce the existing incontinence apparatus.The feasibility of administering cells into muscle tissue for the treatment of fecal incontinence has already been demonstrated (Frudinger et al., 2018). The inventors found that the puncture device guide according to the present invention is particularly useful for the prevention and / or treatment of anal incontinence, as it is especially precise and safe for injecting a needle into the anal sphincter apparatus and / or administering cells into the anal sphincter apparatus. The greater precision and safety of the device according to the present invention could lead to more effective prevention and / or treatment of these conditions. The present invention also provides a guide plate (130, 1130) as described herein. This guide plate preferably comprises a hole (606) for receiving the needle (25) through which a projection (608, 1108) is configured to be received by the tip guide (135, 1135) of a puncture device guide according to the present invention is passed. The guide plate (130, 1130) further preferably comprises a coupling element (602) configured to detachably connect the guide plate (130, 1130) to the tip guide (135, 1135) of a puncture device guide according to the present invention. Preferably, the guide plate (130, 1130) further comprises: multiple holes (606) at different radial distances, wherein each of the multiple holes (606) corresponds to one of the radial distances for the path of the needle (25) of a puncture device guide according to the present invention.The guide plate (130, 1130) may further comprise a release hole (604) adjacent to the coupling element (602), wherein the release hole (604) is configured to receive a tab (360) therein that releases the coupling element (602) from the tip guide (135, 1135) of a piercing device guide according to the present invention. Although the invention has been described in detail above, it is expressly understood that it will be obvious to those skilled in the relevant art that the invention may be modified without departing from the spirit of the invention. Various changes of form, design, or arrangement may be made to the invention without departing from the scope of the invention. The different combinations illustrated above may be combined into a single embodiment. Therefore, the above description should be considered illustrative rather than limiting, and the true scope of the invention is as defined in the following claims. The following examples illustrate the present invention but are not intended to be limiting. Example 1 - Force measurements by needle deflection The syringe holder assemblies according to Figure 7 were tested with and without the guide plate (130) attached to demonstrate the functional effect of the guide plate. The Terumo Agani 21Gx2 (0.8*50mm) regular bevel 11° needle (Ref. AN*2150R1) was used as the puncture device (25) in the assembly and was 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 then connected to a BK8848 ultrasound probe. Next, a force transducer (HSE F30 force transducer, type 372, serial number: 97551) was coupled to a Venier control type 805 (Hugo Sachs Elektronik, HSE, Germany. Range: 0-20 mm, resolution 0.5 mm / revolution) for uniaxial movement.The force transducer was calibrated with a 10 mN calibration weight (HSE calibration weight 1 cN = 10 mN = 1 Gram) using an amplifier (HSE Plugsys TAM-A Transducer Amplifier Module) connected to a personal computer running ACAD data acquisition software (HSE, Germany) to receive and display the measured forces. Following this, syringe holder assemblies (with or without a guide plate) were slid along the probe adapter shaft (105) to achieve the configuration shown in Figure 8A. The needle tip was then placed on the force transducer hook, the ultrasound probe was fixed, and the vernier control was rotated to allow axial movement of the needle in 0.5 mm increments from 0.5 mm to 1.5 mm. At each increment, the force generated at the force transducer was recorded as a measure of needle stability within the assembly.Higher forces were interpreted as greater stability, since more force is required to deflect the needle. The measurement results are shown in Table 1. QAPQ ίΠ / ZZΖηZ / Β / YΥΙΛΙ and in Figure 14. It was found that the highest forces in the syringe holder assembly with guide plate compared to the syringe holder assembly without guide plate were recorded at 0.5 mm, 1.0 mm, and 1.5 mm needle tip deviation. No difference could be determined at a deviation of 2.0 mm due to the maximum detectable force of the system. qapq Ln / zznz / e / γΐΛΐ Table 1: Results of force measurements on needle tips at different deviations when attached to different sets of syringe holders. Deviation [mm] Force generated [mN] Syringe holder assembly (Without guide plate) Syringe holder assembly (With guide plate) 0.5 25.0 32.1 1.0 47.0 70.4 1.5 72.0 >100 2.0 >100 >100 Example 2 - Precision measurements of the guide in muscle tissue To address the accuracy of guiding a puncture device through muscle tissue, different sets of syringe holders (one equivalent to document EP2170440A2 and a device according to Figure 7, which may or may not include guide plate 130) were attached to a BK8848 ultrasonic transducer, which was covered with a gel-filled latex sheath. Each set of syringe holders was then fitted with 1 ml BBraun syringes and 21-gauge, regular-bevel, long lancet needles. The BK8848 ultrasonic transducer was connected to a BK FlexFocus ultrasonic system to visualize the signals recorded by the transducer. The syringe holder sets were placed in a water bath, and the needle was guided forward along the axis of the BK8848 force transducer until the needle tip reached the transducer's transverse detection window.The needle tip visible on the ultrasound system for each set of syringe holders was marked with an x ​​to allow for subsequent measurement of the accuracy of guiding a puncture device into tissue. Porcine muscle tissue was prepared by cutting holes in the tissue with scalpels to allow the BK8848 transducer to enter the hole, thus mimicking an endocavitary examination. Each set of syringe holders was then used to guide a total of 12 needles into individual locations within the muscle tissue, each to a maximum depth of 5 cm, which should allow the needle to reach the transducer's sensor window. For each needle that penetrated the muscle tissue, the position of the needle tip visible on the ultrasound system was marked, and the distance from the previously fixed x position was measured in mm to determine how much the needle deviated as it moved through the muscle tissue.The mean and standard deviation values ​​of the repeated measurements were calculated to compare the accuracy of each syringe holder assembly. As can be seen in Table 2, the syringe holder assembly of the present invention, which includes the guide plate 130, resulted in the smallest needle deviation, of 1.92 ± 0.58 mm, compared to a device equivalent to EP2170440A2, which resulted in a deviation of 1.98 ± 0.35 mm, and to the syringe holder assembly of Figure 7, without the guide plate 130, which resulted in a needle deviation of 2.23 ± 0.85 mm. QRPQ ίΠ / ΖΖηΖ / Β / ΥΙΛΙ Table 2: Results of needle deflection measurements in porcine muscle tissue. Syringe holder assembly Needle tip deviation in muscle tissue compared to target location in water bath [mm] According to figure 7 with guide plate 130 1.92 ± 0.58 According to figure 7 without guide plate 130 2.23 ±0.85 According to document EP2170440A2 1.98 ±0.35 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., Müller, J., Blumer, M., Hofmann, J., Marksteiner, R., Couillard-Despres, S., Troppmair, J., Ófner, 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-Després, 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. A puncture device guide, comprising: an adapter (105) configured to be fixedly attached to an ultrasound probe (10); a syringe holder assembly (140) configured to slide onto the adapter (105) and receive a syringe (15) thereon; wherein the syringe holder assembly (140) is configured to slide over the probe adapter (105) in an axial direction relative to the ultrasound probe (10); wherein the syringe holder assembly (140) is configured to permit selective adjustment of a radial distance for a needle trajectory (25) of the syringe (15) with respect to the ultrasound probe (10); wherein the adapter (105) includes a tip guide (135, 1135) for selectively aligning a distal end of the needle (25) with the radial distance for the trajectory;and wherein, when the ultrasound probe (10) is inserted into a patient, the syringe assembly is configured to slide forward in the adapter to insert the needle past the tip guide into a patient.

2. The puncture device guide of claim 1, further comprising: a guide plate (130, 1130), the guide plate including: a hole (606) for receiving the needle (25) through it, a projection (608, 1108) configured to be received by the tip guide (135, 1135), and a coupling element (602) configured to detachably join the guide plate (130, 1130) to the tip guide (135, 1135).

3. The puncture device guide of claim 2, wherein the guide plate (130, 1130) further comprises: multiple holes (606) at different radial distances, wherein each of the multiple holes (606) corresponds to one of the radial distances for the needle path (25). qrpq Ln / zznz / e / γΐΛΐ 4. The puncture device guide according to any of claims 2 to 3, wherein the tip guide (135, 1135) further comprises: multiple grooves (1107) at different radial distances configured to receive the projection (608, 1108) of the guide plate (130, 1130), wherein each of the multiple grooves (1107) corresponds to one of the radial distances for the needle path.

5. The puncture device guide according to any of claims 2 to 4, wherein the guide plate (130, 1130) further comprises: a release hole (604) adjacent to the coupling element (602), wherein the release hole (604) is configured to receive a tab (360) therein that releases the coupling element (602) from the tip guide (135, 1135).

6. The puncture device guide of claim 5, wherein the syringe holder assembly (140) further comprises the tab (360), and wherein, the syringe holder assembly (140) slides forward in the adapter (105), the tab 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).

7. The puncture device guide according to any of claims 2 to 6, wherein the syringe holder assembly (140) is configured to slide backward in the adapter (105) to retract the needle (25) from the patient and back past the tip guide (135, 1135), and wherein, when the syringe assembly (140) slides backward, the guide plate (130, 1130) is held attached to the tabs.

8. The puncture device guide according to any of claims 1 to 7, wherein the syringe assembly (140) is configured to slide backward into the adapter (105) to retract the needle (25) from the patient and back past the tip guide (135, 1135).

9. A method for performing an injection, the method comprising: attaching a probe adapter (140) to an ultrasound probe (10), wherein the probe adapter (105) includes a tip guide (135, 1135) at a distal end; attaching a syringe holder assembly (140) to the probe adapter (140), wherein the syringe holder assembly is longitudinally slidable with respect to the probe adapter (140); inserting the ultrasound probe (10) into a patient; adjusting the syringe holder assembly (140) to provide a selected radial distance for a syringe needle (25) from the ultrasound probe (10); inserting the syringe (15) into the syringe holder assembly (140) and aligning a syringe needle (25) with the tip guide (135, 1135); slide the syringe holder assembly (140) distally to push the needle past the tip guide (135, 1135) and into the patient;slide the syringe holder assembly (140) backward to retract the needle (25) from the patient, and remove the syringe (15) from the syringe holder assembly (140).; 10. The method of claim 9, wherein the insertion of the syringe (15) into the syringe holder assembly (140) further comprises: providing a guide plate (130, 1130) with a projection (608, 1108) configured to be received by the tip guide (135, 1135) and a coupling element (602) configured to detachably join the guide plate (130, 1130) to the tip guide (135, 1135); inserting the syringe needle (25) through a hole (606) in the guide plate (130, 1130), and inserting the syringe (15) into the syringe holder assembly (140) after inserting the syringe needle (25) through the hole (606).

11. The method according to any of claims 9 to 10, wherein the insertion of the syringe (15) into the syringe holder assembly (140) further comprises: selecting the hole from among the multiple holes (1107) of the QRPQ ίΠ / ZZΖηZ / Β / YΥΙΛΙ tip guide (1135), wherein each of the multiple holes (1107) corresponds to a different radial distance for the syringe needle (25) with respect to the ultrasound probe (10).

12. The method according to any of claims 9 to 11, wherein the insertion of the syringe (15) into the syringe holder assembly (140) further comprises: sliding the guide plate (130, 1130) along the syringe needle (25) until the guide plate (130, 1130) joins the tip guide (135, 1135).

13. The method according to any of claims 9 to 12, wherein the sliding of the guide plate (130, 1130) along the syringe needle (25) until the guide plate (130, 1130) engages with the tip guide (135, 1135), further comprises: moving the guide plate (130, 1130) to engage the projection (608, 1108) with one of the multiple grooves of the tip guide (135, 1135), wherein each of the multiple grooves corresponds to a different radial distance for the syringe needle (25) from the ultrasound probe (10).

14. The method according to any of claims 9 to 13, wherein, when sliding the syringe holder assembly (140) backwards to retract the needle (25) from the patient, the syringe needle (25) does not come into contact with the tip guide (135, 1135).

15. The method according to any of claims 9 to 14, wherein, by sliding the syringe holder assembly (140) distally to push the needle (25) beyond the tip guide (135, 1135) and into the patient, the syringe holder assembly (140) engages the guide plate (130, 1130) and releases the guide plate (130, 1130) from its attachment to the tip guide (135, 1135).

16. The method according to any one of claims 9 to 15, wherein, upon sliding the syringe holder assembly (140) backward to retract the needle (25) from the patient, the syringe holder assembly (140) retracts the guide plate (130, 1130) away from the tip guide (135, 1135).

17. The method according to any of claims 9 to 16, further comprising: separating 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 syringe needle (25).

18. The method according to any of claims 9 to 17, wherein the removal of the syringe (15) from the syringe holder assembly (140) further comprises: removing the syringe (15) and the guide plate (130, 1130) while the syringe needle (25) remains inserted through the guide plate (130, 1130).

19. The method according to any of claims 9 to 18, wherein the method further comprises that the syringe (15) to be inserted into the syringe holder assembly (140) to align a syringe needle (25) with the tip guide (135, 1135) is filled with a substance or composition and wherein sliding back the syringe cartridge (125) inserted with a syringe (15), filled with a substance or composition, results in the simultaneous administration of the substance or composition to the patient.

20. The puncture device guide according to any of claims 1 to 9 configured for medical use, in particular configured to perform a method according to any of claims 9 to 19.

21. A puncture device guide according to any one of claims 1 to 9 or 20, wherein the device 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 selection of a material selected from steel, ceramic, and / or plastic, preferably selected from an acrylonitrile-butadiene-styrene terpolymer and copolymer.

22. The puncture device guide according to any of claims 1 to 9, 20 or 21 for use in a method of treating the human or animal body by surgery or therapy, in particular for use in a method of treating and / or preventing urinary incontinence, anal incontinence, overactive bladder, underactive bladder, anal fistula(s), hemorrhoids, inflammation, in particular chronic inflammation, myopathies, neuropathies and / or prostate neoplasms, more preferably in a method for treating and / or preventing urge fecal incontinence and / or passive fecal incontinence.

23. A guide plate (130, 1130) comprising a hole (606) for receiving a needle (25) through it, a projection (608, 1108) configured to be received by the tip guide (135, 1135) of a puncture device guide according to any one of claims 1 to 9 or 20 to 21, and a coupling element (602) configured to detachably join the guide plate (130, 1130) to the tip guide (135, 1135) of a puncture device guide according to any one of claims 1 to 9 or 20 to 21.

24. The guide plate (130, 1130) according to claim 23, further comprising: multiple holes (606) at different radial distances, wherein each of the multiple holes (606) corresponds to one of the radial distances for the path of the needle (25) of a puncture device guide according to any of claims 1 to 9 or 20 to 21, and / or a release hole (604) adjacent to the coupling element (602), wherein the release hole (604) is configured to receive a tab (360) therein that releases the coupling element (602) from the tip guide (135, 1135) of a puncture device guide according to any of claims 1 to 9 or 20 to 21.

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