Pneumoperitoneum needle

Abstract

The present invention refers to an improved pneumoperitoneum needle device comprising an external needle formed by a sharp needle and an external needle capsule, and an internal needle positioned inside the external needle. The internal needle has an open lower portion, and an upper portion on which a spring is positioned, configured to promote the retraction and expansion of the internal needle. The pneumoperitoneum needle device, according to the present invention, further comprises a capsule connected to the external needle and a valve configured to control the passage of fluid through the device. There is also a top housing connected to the capsule, wherein the top housing stores an embedded electronic control system. The embedded electronic control system is connected to a pressure sensing mechanism and a visual feedback mechanism of the detected pressure. In addition, the device comprises a rod positioned through the capsule inside the internal needle. Said rod being configured to transmit the pressure exerted on the human tissue to the pressure sensing mechanism.

Description

Specification of Patent of Invention for "PNEUMOPERITONEUM NEEDLE".Field of the Invention

[0001] The present invention relates to medical devices used in minimally invasive surgical procedures. More specifically, the invention relates to a pneumoperitoneum needle, also known as a Veress needle, which is an instrument used to create a pneumoperitoneal space in the abdominal cavity by means of gas insufflation.Description of the State of the Art

[0002] The Veress needle is a device used in laparoscopic procedures to create a pneumoperitoneal space. Laparoscopy is a surgical technique that uses a laparoscope, an instrument equipped with an endoscopic camera and illumination, to provide a detailed view of the inside of the abdomen during the operation. This approach aims to perform minimally invasive procedures, with small localized incisions, in contrast to traditional surgical methods.

[0003] The first stage of laparoscopy is the creation of the pneumoperitoneum, which enlarges the space between the abdominal wall and the viscera, allowing for the insertion of trocars through which the surgical instruments will pass. To achieve this, it is necessary for the tip of the needle to reach the peritoneal space, which is the space between the abdominal viscera and the abdominal wall, to create an actual space. For this end, it is necessary to distend the abdominal wall and displace the intestinal loops by inflating the abdominal cavity with carbon dioxide.

[0004] This procedure is performed by inserting a Veress needle into the abdomen. The insertion of the needle is done blindly, that is, the surgeon relies only on touch to guide the needle through the abdominal tissues. During this process, it is necessary for the needle to pierce all the layers of the abdominal wall to reach the abdominal cavity, which isthe space between the viscera and the parietal peritoneum, the last layer of tissue in the abdominal wall. In the process of needle penetration, there is a positive pressure due to the resistance that the abdominal wall offers, however, upon reaching the peritoneal space, this pressure becomes negative, as it is an empty space.

[0005] Access to the abdominal cavity is one of the main critical points of the procedure, as there is a risk of injuring internal organs, blood vessels, or other critical structures. This risk is exacerbated by the difficulty in determining the exact depth of needle insertion, especially in patients with different morphologies or anatomical conditions. Thus, the lack of mechanisms that limit the depth of insertion can lead to accidental injury to the layers of abdominal tissue or other underlying structures, increasing the risk of postoperative complications.

[0006] In addition, the absence of an internal parameter monitoring system during insertion can make it difficult to immediately detect problems during the procedure, so complications arising from improper operation may not be identified until they cause significant damage.

[0007] The purpose of the Veress needle (pneumoperitoneum needle) is to penetrate the interior of the abdominal cavity, which is the virtual space between the visceral peritoneum that covers the abdominal viscera and the parietal peritoneum, which covers the inner surface of the abdominal wall. The currently existing method using the Veress needle does not provide reliable and objective information that the needle has reached the exact desired location to safely start the gas insufflation process. The absence of safety indicators in this procedure is related to the emergence of complications resulting from the use thereof.

[0008] Conventional Veress needles generally do not provide sufficient feedback to the operator about the insertion depth or needle position, which can affect the accuracy and safety of the procedure.Thus, the existing Veress needles on the market have significant limitations regarding these aspects, and therefore there is a continuous need for innovations that address these issues, providing greater safety and control during needle insertion in the patient.Objectives of the Invention

[0009] The present invention aims to provide a pneumoperitoneum needle that has a simplified structure, with the purpose of objectively identifying that the needle tip has reached the desired location, and offering visual feedback to the operator during use. The main objective is to increase safety and control during needle insertion in the patient. This visual feedback allows the operator to more accurately monitor the insertion process, reducing the risk of errors and improving the effectiveness of the procedure.Brief Description of the Invention

[0010] The present invention proposes to solve the drawbacks of the prior art by providing an improved pneumoperitoneum needle device.

[0011] The pneumoperitoneum needle device according to the present invention comprises an external needle formed by a sharp needle and an external needle capsule, and an internal needle positioned inside the external needle. The internal needle has an open lower portion, and an upper portion on which a spring is positioned, configured to promote the retraction and expansion of the internal needle.

[0012] The pneumoperitoneum needle device, according to the present invention, further comprises a capsule connected to the external needle and a valve configured to control the passage of fluid through the device. There is also a top housing connected to the capsule, wherein the top housing stores an embedded electronic control system. The embedded electronic control system is connected to a pressure sensing mechanism and a visual feedback mechanism of the detected pressure.

[0013] In addition, the device comprises a rod positioned through the capsule inside the internal needle. Said rod being configured to transmit the pressure exerted on the human tissue to the pressure sensing mechanism.Brief Description of the Figures

[0014] The present invention will be described in more detail below based on execution examples represented in the drawings.

[0015] Figure 1 shows a perspective view of an embodiment of the invention of pneumoperitoneum needle in the assembled configuration.

[0016] Figure 2 is a front view of an exemplary shape of the external needle element of the pneumoperitoneum needle of the present invention.

[0017] Figure 3 is a front view of an exemplary shape of the internal needle element of the pneumoperitoneum needle.

[0018] Figure 4 is a front view of the internal needle of Figure 2 with a spring and a spring stop.

[0019] Figure 5 is a front perspective view of the external needle of Figure 2 in which the internal needle of Figure 3, a capsule, and a valve are mounted.

[0020] Figure 6 is a front perspective view of the rod element.

[0021] Figure 7 is a front view of the internal needle of Figure 2, with a capsule and valve attached, and the rod of Figure 6 arranged through the capsule and the internal needle.

[0022] Figure 8 is a front perspective view of the top housing element.

[0023] Figure 9 is a front-perspective view of the rod cursor element.

[0024] Figure 10 is a front view of the assembly of the housing top, rod cursor, and capsule elements.

[0025] Figure 11 is a cross-sectional view of the assembly of Figure 10 with the rod 18.Detailed Description of the Invention

[0026] Figure 1 illustrates an exemplary embodiment of the invention in its assembled configuration. The pneumoperitoneum needle 10 comprises an external needle 1 1 connected to a capsule 13. Capsule 13 in turn is connected to a valve 14 and a top housing 12. Inside the external needle 11 there is arranged an internal needle 15.

[0027] The external needle 11 of the present invention, as illustrated in Figure 2, comprises a sharp needle 11a and an external needle capsule 11 b.

[0028] The sharp needle 11a is configured to cut patient tissues, thus allowing the puncture of the pneumoperitoneum needle 10. In addition, sharp needle 11a usually represents the element of the pneumoperitoneum needle 10 that will be held by the operator during the operation of this surgical equipment.

[0029] The external needle capsule 1 1 b, in turn, is configured to join external needle 11 to the remaining elements of the pneumoperitoneum needle 10. The external needle capsule 11 b is connected to capsule 13, preferably by means of threading, and is connected to the sharp needle 11a, preferably by means of pressing. Additionally, in the preferred embodiment, external needle capsule 11 b comprises a knurled configuration on its external surface that facilitates the disassembly of the pneumoperitoneum needle 10.

[0030] Inside external needle 11 , an internal needle 15 is inserted, illustrated in an exemplary configuration in Figure 3. Internal needle 15 according to the present invention comprises a lower end and an upper end, wherein both ends are open allowing a passage of fluid.

[0031] Furthermore, as illustrated in Figure 4, the upper end of internal needle 15 is designed to house a spring 16 configured to allow the retraction and expansion of internal needle 15, respectively into and out of the external needle 11 . This retraction and expansion mechanismis configured so that internal needle 15 remains ejected when it is not being pressed, and when pressed, it retracts into outer needle 11 , so that pneumoperitoneum needle 10 is able to keep sharp needle 11a out of direct contact with the patient's tissues when it is not being used for cutting.

[0032] For example, in the puncture phase of pneumoperitoneum needle 10, the pressure exerted on needle 10 causes spring 16 to compress, allowing internal needle 15 to retract into external needle 11 . In the moment the desired depth is reached, the pressure ceases and spring 16 is relaxed, expanding internal needle 15 out of external needle 11. In this way, internal needle 15 protects the internal tissues and organs from unwanted punctures or damage by the end of external needle 11.

[0033] Preferably, a spring stop 17 is arranged on spring 16, which acts as a barrier for spring 16 and has an internal space to accommodate internal needle 15 when spring 16 is compressed.

[0034] As illustrated in Figure 5, the spring bulkhead 17 is also configured to be connected to external needle 1 1 and to a capsule 13, preferably by thread.

[0035] Capsule 13 is designed to create an internal channel that facilitates the circulation of fluids that will be used during the surgical procedure. In addition, capsule 13 is also configured to accommodate a valve 14, which carries out the function of regulating the flow of fluids, including gases and liquids, during surgery.

[0036] In a simplified alternative embodiment of the pneumoperitoneum needle 10 that does not have the spring bulkhead 17, the lower part of capsule 13 is configured to serve as a support for the spring 16, limiting the movement thereof. Still in this alternative configuration, the internal channel of capsule 13 allows the safe passage of internal needle 15, and capsule 13 is connected directly to externalneedle 11.

[0037] The pneumoperitoneum needle 10 according to the present invention further comprises a rod 18. An exemplary configuration of rod 18 is illustrated in Figure 6. Rod 18 is arranged through capsule 13 and inside internal needle 15 as illustrated in Figure 7. The length of rod 18 is greater than that of the external needle 11 and internal needle 15 to promote contact of rod 18 with the patient's tissue. To ensure safety and minimize the risk of patient harm, the lower end of rod 18 is preferably equipped with a ball-shaped tip. This spherical configuration reduces the likelihood of injury when coming into contact with tissue during the procedure.

[0038] The pneumoperitoneum needle 10 of the present invention further comprises a pressure sensing mechanism with at least one pressure sensor, not illustrated, configured to detect the resistance of the layers of the abdomen during the insertion of pneumoperitoneum needle 10. The pressure sensing mechanism is connected to an embedded electronic control system stored in the top housing 12 exemplarily illustrated in Figure 8.

[0039] In particular, this embedded electronic control system is stored in an internal cavity of the top housing 12. The embedded electronic control system comprises microcontrollers with specific algorithms for processing the information received by the pressure sensing mechanism. The embedded electronic control system according to the present invention provides electronic versatility by means of interchangeable circuits that meet the precision and sensitivity requirements necessary for the optimal operation thereof.

[0040] Optionally, the embedded electronic control system can include additional features, such as an intuitive user interface and safety alarms to alert about variations or abnormal pressures.

[0041] The storage of the electronic system in top housing 12ensures the protection thereof against external interference and maintains the surgical environment sterile. In addition, the electronic system is powered by a power source that ensures its continuous and stable operation throughout the surgical procedure. The top housing 12 further includes a hole configured to allow the passage of cables.

[0042] Preferably, the power supply of the electronic system is carried out by an external source of power, such as batteries or cables connected to surgical equipment. However, alternative configurations are possible, for example with the use of rechargeable power cells or even wireless power technologies such as inductive charging.

[0043] The pneumoperitoneum needle 10, according to the present invention, further comprises a visual feedback mechanism associated with the embedded electronic control system, which works together with the pressure sensing mechanism to provide a clear and immediate visual indication of the detected pressure status. The use of pressure sensing with real-time visual feedback is especially advantageous for alerting the surgeon to potential complications during the procedure and allows for quick and accurate interpretation by healthcare professionals. In addition, the real-time monitoring of internal pressure allows immediate and precise adjustments of the pneumoperitoneum needle 10, increasing safety and efficiency during the procedure.

[0044] The pneumoperitoneum needle 10 of the present invention aims to avoid various complications during the surgical procedure. For example, if the internal pressure does not increase adequately in relation to the ambient pressure, which may indicate a possible perforation, the professional can immediately stop the insertion, minimizing risks to the patient. In addition, if there is an abrupt drop in internal pressure, suggesting that the needle may be outside the abdominal cavity, the insertion will be stopped to prevent damage to internal organs such as intestines or blood vessels.

[0045] Preferably, visual feedback is provided by LEDs arranged in top housing 12, especially RGB LEDs. In an optional embodiment of the present invention, the device is equipped with three LEDs to provide clear visual indications about the internal pressure during the procedure. The LEDs include a green LED, which indicates that the pressure is within the ideal range; a yellow LED, which signals that the pressure is below the ideal range; and a red LED, which alerts when the pressure is above the ideal range. Each LED is activated based on the detection of a predetermined pressure range, allowing the operator to receive realtime alerts on the patient's internal pressure status. This configuration provides an efficient way to continuously monitor and easily interpret the pressure status during the insertion procedure.

[0046] The patient's internal pressure is detected by means of the movement of rod 18, which is configured to transmit the pressure exerted on the human tissue to the pressure sensing mechanism. Preferably, the pressure sensing mechanism comprises a plurality of strain gauge pressure sensors, particularly four strain gauge pressure sensors.

[0047] In one embodiment of the invention, the pressure sensors are positioned directly on rod 18, allowing for precise measurement of the applied pressure. In this configuration, the reliability of the collected data is enhanced and, consequently, greater accuracy of the procedure is possible. Direct pressure sensing offers a faster and more accurate response, crucial for minimally invasive procedures.

[0048] Alternatively, the pressure sensors are positioned on a lower surface of top housing 12 that comes into contact with rod 18.

[0049] In yet another alternative, the sensors can be positioned on other elements of the pneumoperitoneum needle 10, as long as they allow contact with rod 18 and are capable of detecting the pressure exerted on the patient's body. For example, pressure sensors can also be arranged in capsule 13, or in any combination of rod 18, top housing12, and capsule 13.

[0050] In the preferred embodiment, the invention further includes a rod cursor 19, which is exemplified in the configuration illustrated in Figure 9. Rod cursor 19 is positioned between top housing 12 and capsule 13, as shown in Figure 10. This rod cursor 19 is designed to connect to top housing 12 in a detachable way, and can be fixed, for example, by means of a thread system. This design allows rod cursor 19 to be easily assembled and disassembled as needed, facilitating the maintenance and adjustment of the system. Additionally, preferably, rod cursor 19 is connected to capsule 13 by a quick coupling, to allow its removal after the drilling procedure has been completed.

[0051] Figure 11 is a cross-sectional view representing the assembly of rod cursor 19 connected to top housing 12 and capsule 13, with rod 18 passing through rod cursor 19 and capsule 13. Rod cursor 19 is configured to allow rod 18 to travel a certain vertical distance to trigger the sensing mechanism.

[0052] In addition, the pneumoperitoneum needle 10 is preferably constructed of surgical steel, known as 316L steel. This material contains molybdenum in its composition, which makes the equipment highly resistant to corrosion compared to other stainless steel alloys, thus being more durable. Alternatively, other materials may be considered, such as titanium alloys or advanced polymer materials that can offer specific properties, such as greater lightness or enhanced biocompatibility.

[0053] The pneumoperitoneum needle 10 according to the present invention, as previously described, has a modular design with detachable connections. Particularly, after the needle is inserted into the patient's abdominal cavity, using the pressure sensing and visual feedback mechanisms, the components responsible for the safe insertion of the needle can be easily disconnected. These componentsinclude top housing 12, rod 18, and rod cursor 19. The removal of these elements allows the connection of other devices to capsule 13 to proceed with the laparoscopic surgical procedure.

[0054] Further, the modularity of the present invention facilitates the maintenance and sterilization of the parts that compose it. Additionally, this modular configuration makes it simpler to replace individual components, and results in a more versatile and adaptable device for different clinical situations.

Claims

CLAIMS1. Pneumoperitoneum needle device characterized by comprising: an external needle (11) formed by a sharp needle (11a) and an external needle capsule (11 b); an internal needle (15) positioned inside external needle (11), wherein the internal needle (15) has an open lower portion, and wherein a spring (16) is positioned in its upper portion, configured to promote the retraction and expansion of the internal needle (15); a capsule (13) connected to the external needle (11) and a valve (14), wherein the valve (14) is configured to control the passage of fluid through the device; a top housing (12) connected to capsule (13), wherein the top housing (12) stores an embedded electronic control system, wherein the embedded electronic control system is connected to a pressure sensing mechanism and a visual feedback mechanism of the detected pressure; and a rod (18) positioned through the capsule (13) inside the internal needle (15), the rod (18) being configured to transmit the pressure applied over the human tissue to the pressure sensing mechanism.

2. Pneumoperitoneum needle device according to claim 1 , characterized in that that the pressure sensing mechanism comprises a plurality of pressure sensors, preferably strain gauge sensors.

3. Pneumoperitoneum needle device according to claim 2, characterized in that the pressure sensors are arranged in at least one of the top housing (12), the capsule (13), and the rod (18).

4. Pneumoperitoneum needle device in accordance with any of the preceding claims, characterized in that the visual feedback mechanism comprises LEDs arranged in the top housing (12), whereinthe LEDs are configured to provide a visual indication of the pressure status obtained by the at least one pressure sensor.

5. Pneumoperitoneum needle device according to claim 4, characterized in that the LEDs are colored RGB LEDs.

6. Pneumoperitoneum needle device according to any of the preceding claims, characterized by further comprising a rod cursor (19) coupled between the capsule (13) and the top housing (12) and configured to limit the vertical movement of the rod (18).

7. Pneumoperitoneum needle device according to any of the preceding claims, characterized by further comprising a spring bulkhead (17) between the external needle (11) and the capsule (13).

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