Surgical puncturing and access device for semi-rigid or soft layers of material

The trocar-cannula system addresses the inefficiencies of existing devices by enabling controlled and instantaneous tissue penetration, ensuring stable access for emergency procedures like tracheostomy and maxillary sinus perforation, overcoming physical and psychological barriers.

WO2026085635A1PCT designated stage Publication Date: 2026-04-30UNIV DE LA FRONTERA
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Patent Information

Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
UNIV DE LA FRONTERA
Filing Date
2024-10-23
Publication Date
2026-04-30

AI Technical Summary

Technical Problem

Existing devices for emergency tracheostomy or cricoconiotomy lack the ability to efficiently and easily penetrate semi-rigid or soft tissue layers, often requiring significant physical force and posing risks of slippage, with limited cannula diameter and psychological barriers in emergency situations.

Method used

A piercing and access device comprising a trocar-cannula system with a driving device, basal element, and flexible membrane, allowing controlled and instantaneous penetration of tissue, followed by fixation of the cannula for stable access.

Benefits of technology

Facilitates controlled and instantaneous penetration of semi-rigid or soft tissue layers, providing stable access for fluid transfer and reducing psychological and physical barriers, suitable for emergency procedures like tracheostomy and maxillary sinus perforation.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to a surgical puncturing and access device (1000) for layers of semi-rigid or soft material, which allows a cannula to be placed by inserting a trocar, for the transfer of liquid or gaseous fluids in intracorporeal cavities or in lumens (300). The device comprises: an insertion unit (100) for inserting a trocar-cannula assembly (1), formed by an essentially cylindrical external tubular piece (2) that contains a puncturing unit (50) and a drive unit (60) in an interior channel (30) thereof, the proximal part of the external cylindrical tubular piece (2) being connected, during operation, to a base unit (200) by means of a quick connection, the trocar-cannula assembly (1) being disposed inside a guide channel (33) in the puncturing unit (50); and a base unit (200) formed by a flexible base piece (7) with a thin adhesive sheet (8) that attaches same to the contact surface.
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Description

[0001] SURGICAL PERFORATION AND ACCESS DEVICE FOR SEMI-RIGID OR SOFT MATERIAL LAYERS

[0002] DESCRIPTIVE MEMORANDUM

[0003] TECHNICAL FIELD OF THE INVENTION

[0004] The present invention relates to the field of medical devices, specifically to devices for emergency situations and in the clinical setting for use by individuals trained in first aid. In particular, it provides a piercing and access device for layers of semi-rigid or soft material or tissue, allowing the insertion of a cannula via a trocar for the transfer of liquid or gaseous fluids into intracorporeal natural cavities. BACKGROUND OF THE INVENTION

[0005] Currently there are different tissue perforating devices, however, all of them lack the characteristics of the device presented here, such as for emergency tracheostomy or cricoconiotomy.

[0006] From US5090408A, a system for continuously supplying supplemental therapeutic oxygen to a patient to augment atmospheric breathing is known, comprising an oxygen supply source for continuously delivering low-volume, low-pressure oxygen to a patient at relatively low pressures and relatively low flow rates to supplement normal atmospheric breathing; flexible oxygen delivery tube devices for delivering oxygen from said oxygen supply source to the patient; and a one-piece, continuous, flexible, constant-diameter, elongated tracheal tube member having a continuous, constant-diameter passage extending therethrough and being flexible when inserted into an operative position within the trachea to provide therein an intermediate curved sidewall portion extending between a near-end sidewall portion having an opening ofThe device comprises an unrestricted entry located posterior to the patient's neck and a straight distal lateral wall portion located in and extending downwards within the trachea, having an unrestricted distal outlet located in an upwardly spaced relationship to the patient's bronchi. Also known from EP0407663B1 is a device that expands via a perforator with increasing diameter and a dislodgement protection to the point where a ventilation cannula can be inserted.

[0007] Document EP1027904A1 describes a surgical instrument for emergency medicine. It is a device intended to open the airway by means of a puncture. A permanent cannula is inserted into the trachea via a trocar, and the cannula is then held in place by a base component to prevent dislodgement.

[0008] US Patent No. 3707551 discloses a first aid device comprising: a handle; a substantially straight scalpel-shaped blade extending axially from the handle; a straight, tubular, through-air conduit dimensioned in outside diameter and tapered at one end thereof for insertion into an incision cut in the trachea of ​​a human being, and at the other end having an inside diameter and configuration that detachably hooks onto the end of the handle; the air conduit being longer than the blade to completely enclose the blade therein; the air conduit, when hooked onto the end of the handle above the scalpel, serves to protect the scalpel as a means of covering for cleaning, the air conduit being available as an emergency airway for an incised trachea.Since US4860747A, an ear-piercing device is known to have an instrument with jaws that movable relative to one another. A plunger is provided to drive a pin through the ear into a clasp. To aid sterility, the pin is mounted in a disposable pin holder on one jaw-like mechanical part, and the clasp is mounted in a disposable clasp holder on the other jaw. A protective cover is integral with one of the holders, extends between the jaws, and covers a portion of an arm between the jaws. The device pierces the intended skin using a metal pin and requires that the tissue be accessible from both sides and inserted between the device. Piercing into the lumen of body cavities is not provided.

[0009] The Rusch® QuickTrach® device consists of a trocar with a minimum airway diameter (CH 15), a corresponding cannula, a fixation aid, and a direction indicator for guidance during application. The QuickTrach® device is inserted into the airway via transcutaneous puncture at the level of the choriothyroid ligament. The trocar is then removed, and the elastic plastic tube is guided around the neck using the strap to secure its position. The device does not require surgical intervention in the sense of an incision or dissection.

[0010] For the use of a PCSEC, the device presents several problems: inserting the instrument involves a significant psychological threshold in an emergency situation. Application requires physical force to pierce the choriothyroid ligament and it can slip sideways. The cannula diameter is limited, so only minimal breathing is possible.

[0011] US patent 20050076915A1 describes a surgical instrument for performing tracheostomies, which includes a footplate having an anatomical curvature to follow the contours of the inner wall of the trachea. It also includes a cutting element consisting of at least two cutting edges and an activation element connected to the cutting element and the footplate. Upon activation of the activation element, the cutting element moves toward the footplate, or the footplate moves toward the cutting element, or both move together simultaneously, allowing the tissue between the cutting element and the footplate to be incised. This instrument may also include three cutting edges: a horizontally oriented cutting edge with a left and a right end, and a left vertical cutting edge and a right vertical cutting edge connected or integrated with the left and right ends, respectively.The horizontally oriented cutting edge may have an anatomical curvature to follow the contours of the trachea's outer surface. The cutting edges may also be made of metal. Furthermore, the surgical instrument for performing the tracheotomy procedure includes an elongated body with an anterior and a posterior end, and a handle that extends transversely from the elongated body near the posterior end. The elongated body includes a first shaft and a second shaft, the latter being longitudinally movable. It also includes a cutting portion integral with or connected to the first shaft at its anterior end, and a footplate integral with or connected to the elongated shaft at its anterior end. The handle is mounted on the body and features a lever connected to or integral with the second shaft. Activating the lever moves the footplate of the second shaft closer to the cutting portion, creating a window in the patient's trachea.The elongated body includes a cover, and the first and second axles are housed within this cover. The cover may be tubular. SUMMARY OF THE INVENTION.

[0012] The present invention provides a piercing and access device for semi-rigid or soft material layers, allowing the placement of a trocar for the transfer of liquid or gaseous fluids into cavities, wherein a trocar-cannula is a surgical instrument consisting of an awl or punch and a cannula, which is a hollow tube, comprising:

[0013] a driving device having a substantially cylindrical channel sized to receive a trocar-cannula, driving means for said trocar-cannula arranged within said channel, and a coupling portion with a basal element in a proximal position of the channel;

[0014] said trocar-cannula sized for positioning in the canal and for linear displacement along the canal, wherein said trocar-cannula has a beveled end; and

[0015] said basal element which has a flexible membrane, a through-perforation in the flexible membrane sized to receive the trocar-cannula, and a coupling portion with the driving device;

[0016] Wherein, when the basal element is coupled with the driving device, at least a portion of said through-perforation is configured as an extension of said channel to receive the trocar-cannula.

[0017] Upon firing the firing unit, the trocar-cannula penetrates or perforates the tissue in a controlled and instantaneous manner to the lumen or biological cavity in a human or animal; the trocar-cannula is fixed in the base unit due to friction with the penetrated tissue and friction of the trocar-cannula head with the fitting portion of the base unit; the trocar comes out along with the decoupling of the firing unit from the base unit, leaving the cannula as an access route installed in the tissue.

[0018] Its main functions include, among other things, perforating the upper airway and placing an emergency trocar to facilitate subsequent patient treatment in a medical unit; perforating the bladder wall to release urine; and perforating the maxillary sinus during surgery. BRIEF DESCRIPTION OF THE FIGURES

[0019] Fig. 1 illustrates a schematic longitudinal cross-sectional view of a first embodiment of the device (1000) that is the subject of the present invention.

[0020] Fig. 2 illustrates a schematic longitudinal cross-section view of a second embodiment of the device (1000) that is the subject of the present invention, with a pistol-grip handle.

[0021] Fig. 3 illustrates a schematic longitudinal cross-sectional view of the second embodiment of the device (1000) that is the subject of the present invention, prior to perforation of the semi-rigid or soft tissue.

[0022] Fig. 4 illustrates a schematic longitudinal cross-sectional view of the second embodiment of the device (1000) that is the subject of the present invention, after perforation of the semi-rigid or soft tissue.

[0023] Fig. 5 illustrates a perforation sequence of semi-rigid or soft tissue using the device (1000) of Fig. 1.

[0024] Fig. 6 illustrates a first example of use of the device (1000) that is the subject of the present invention, in a laparotomy.

[0025] Fig. 7 illustrates a second example of use of the device (1000) that is the subject of the present invention, in a thoracotomy.

[0026] Fig. 8 illustrates a third example of use of the device (1000) that is the subject of the present invention, in a cystotomy.

[0027] Fig. 9 illustrates a fourth example of use of the device (1000) that is the subject of the present invention, in a sinusotomy.

[0028] Figure 10 illustrates in detail the firing unit (100) and the base unit (200) of the device (1000) in a mechanical version. Figure 11 illustrates in detail the firing unit (100) of the device (1000) in an electro-magnetic version.

[0029] Fig. 12 illustrates in detail the firing unit (100) of the device (1000) in a compressed gas version.

[0030] Fig. 13 illustrates a version of the basal unit (200) of the device with angled access.

[0031] Fig. 14 illustrates a version of the firing unit that allows modification of the penetration length.

[0032] Fig. 15 Shows detail of the trocar-cannula (1) and the friction coupling in the base fitting portion (45) of the basal unit (200).

[0033] DETAILED DESCRIPTION OF THE INVENTION

[0034] The present invention will now be described in detail, with reference to the figures accompanying this application.

[0035] In a first object of the present invention, a surgical perforation and access device (1000) is provided for semi-rigid or soft material layers, which allows the placement of a cannula by firing a trocar for the transfer of liquid or gaseous fluids into intra-corporeal cavities or lumens (300), comprising:

[0036] a) a firing unit (100) of a trocar-cannula (1) formed of an essentially cylindrical external tubular piece (2) in whose inner channel (30) it contains a drilling unit (50) and a driving unit (60), the cylindrical external tubular piece (2) when in operation, in its proximal part is joined by a quick coupling to a basal unit (200):

[0037] or the drilling unit (50) has a trocar-cannula (1) that can be adjusted to different sizes and surgical drilling applications, a trocar-guide drive plunger joining piece (3),

[0038] or said trocar-cannula (1) disposed within said guide channel (33) of the tubular piece (2), and a quick-coupling portion (36) with a basal unit (200) in a proximal position of the guide channel (33); the trocar-cannula (1) is dimensioned for positioning in the guide channel (33) and for linear displacement along the guide channel (33), wherein said trocar-cannula (1) has a beveled end (37); and

[0039] b) The basal unit (200) consists of a flexible base piece (7) with a thin adhesive sheet (8) that fixes it to the surface (skin or mucous membrane) that makes contact around the point to be perforated,

[0040] or it has a central perforation (34) of the flexible base piece (7) and a quick-coupling portion of the base unit (35) that can be joined to the quick-coupling portion (36) of the firing unit (100),

[0041] or said basal unit (200) sized to receive the trocar-cannula (1), wherein, when the basal unit (200) is coupled with the drive device (100), at least a portion of said central base perforation (34) is configured as an extension of said channel (33) to receive the trocar-cannula (1);

[0042] Upon firing of the firing unit (100), the trocar-cannula (1) penetrates the tissue in a controlled and instantaneous manner to the lumen (300); the cannula (43) of the trocar-cannula (1) is fixed in the base unit (200) due to friction with the penetrated tissue (300) and the friction of the head (44) of the trocar-cannula (1) with the base fitting portion (45) of the base unit (200); the trocar (46) is withdrawn along with the decoupling of the firing unit (100) from the base unit (200), leaving the cannula (43) as an access pathway installed in the tissue. In a preferred embodiment, without limiting the scope of the present invention, the drive device further comprises a trocar-cannula loading chamber in a distal portion of the channel (33).

[0043] In another preferred embodiment, without limiting the scope of the present invention, the drive unit (60) of the trocar-cannula (1) comprises a guide drive plunger (4) that can be moved within the guide channel (33) of the outer tubular piece (2) by means of a drive subunit (70), a trigger button (5) and a safety cap (6).

[0044] In a more preferred embodiment, without limiting the scope of the present invention, the drive unit (60) may be mechanical, electric or compressed gas.

[0045] In a preferred embodiment, without limiting the scope of the present invention, in one of its mechanical versions the drive subunit (60) further comprises the push button (5), which pushes a waisted stem (9) towards its proximal part (38) and with a radial stop extension (39) at its most distal part, a trigger spring (10) keeps it against the bottom wall of the piece (2), in turn the release stem (9) slides through the inside of a cylindrical guide piece (11) fixed inside to the cylindrical tubular piece (2), the stem (9) on its front part, has one (or two) cavity for a ball (40), a locking ball (12) which keeps a drive spring (13) compressed, and locks the plunger (4) positioned inside the inner guide channel (33).The device is armed after removing the safety (6) and is activated after pressing the button (5), this causes the stem (9) to move and the balls (12) to enter the waist of the stem (38) and in this way the drive spring (13) is unlocked and expands instantly pushing the plunger (4), which, in turn, through the piece (3), pushes the trocar-cannula (1) a preset distance.

[0046] In another of its preferred embodiments, without this limiting the scope of the present invention, in another of its mechanical versions, it has a pistol-type grip (14) and the drive spring (13) is directly compressed by the guide plunger (4) which locks into a locking piece (15) which moves and connects with the trigger (16).

[0047] In a preferred embodiment, without limiting the scope of the present invention, the plunger (4) has a tubular portion for quick coupling (41) with the connecting piece (3) that goes with the trocar-cannula (1) on the proximal face of said plunger.

[0048] In a preferred embodiment, without limiting the scope of the present invention, the base unit (200) comprises a cannula (43) projecting distally from the flexible base piece (7) and containing a central perforation (34). In a preferred embodiment, without limiting the scope of the present invention, the coupling portion (35) of the base unit (200) is an outer diameter expansion distal to the tubular fitting portion (41), and the coupling portion (36) of the firing device (100) is a radial overhang with a dimension corresponding to the diameter expansion of the tubular portion (1) proximal to the inner guide channel (33).In another preferred embodiment, without limiting the scope of the present invention, the tubular fitting portion (41) of the flexible base piece (7) has greater axial stiffness than the axial stiffness of the flexible base piece (7), said axial stiffness being measured in the distal-proximal direction. In this way, for example, and without limiting the scope of the present invention, the tubular portion (41) can be configured as a drilling guide for the trocar-cannula (1).

[0049] In a preferred embodiment, without limiting the scope of the present invention, the drive subunit (70) comprises a trigger (5) operatively connected to the guide drive plunger (4). In another preferred embodiment, without limiting the scope of the present invention, the firing unit (100) is configured such that the trocar-cannula (1) cannot rotate within the channel (33) of the firing unit (100). In another preferred embodiment, without limiting the scope of the present invention, the channel comprises at least one inner rail extending in a longitudinal direction of the channel (33), and the trocar-cannula (1) comprises at least one projection dimensioned accordingly to said at least one inner rail.

[0050] In another preferred embodiment, without limiting the scope of the present invention, the drive device (100) further comprises a movable stop (which does not wear) operatively coupled with the drive means (60) and with a screw (which does not wear), such that the rotation of said screw limits the displacement of said movable stop in the inner channel (31), allowing adjustment of the drilling depth by means of a controlled limitation of the stroke of the trocar-cannula (1). In another preferred embodiment, without limiting the scope of the present invention, the screw is operatively connected with displacement adjustment means, which indicates the stroke limitation of the trocar-cannula (1).

[0051] Similarly, in another preferred embodiment, without limiting the scope of the present invention, the drive device further comprises a movable stop (which does not wear down), operatively coupled with the channel (33) and with a screw (which does not wear down), such that the rotation of said screw limits the displacement of said movable stop within the channel (33), allowing fine adjustment of the drilling depth by limiting the stroke of the trocar-cannula (1). In another preferred embodiment, without limiting the scope of the present invention, the screw is operatively connected with displacement adjustment means, which indicate the stroke limitation of the trocar-cannula (1).

[0052] In another preferred embodiment, without limiting the scope of the present invention, the external tubular piece (1) is divided into two parts, proximal and distal, such that a rolled proximal external piece (31) is screwed into the distal external piece (32) and this allows the drilling distance to be adjusted.

[0053] In a more preferred embodiment, without limiting the scope of the present invention, the drive unit (60) in its electric version comprises a non-magnetic cylinder (17) that pushes the piston (4) by means of a solenoid (18) that moves a ferromagnetic core (19), which in turn pushes the non-magnetic cylinder (17). Electrical conductor wires (20) connect to an electrical switch (21) that connects to an electric battery (22). In another more preferred embodiment, without limiting the scope of the present invention, the drive unit (60) in its electric version can be connected to an electrical network by means of a plug.

[0054] In a preferred embodiment, without limiting the scope of the present invention, the propulsion unit (60) in its gas-powered version comprises a compressed air firing valve (23), an internal trigger (24), a bridge rod (25), a compressed air pistol cylinder (26), an external button trigger (27) that is pushed by the push button (5), a return spring (28), and a guide fork (29) that pushes the bridge rod (25) through the button trigger (27).

[0055] In another preferred embodiment, without limiting the scope of the present invention, the base unit (200) is formed by a flexible base piece (7) with a thin adhesive sheet (8)

[0056] In another preferred embodiment, without limiting the scope of the present invention, the flexible base piece (7) is made of a flexible material that allows it to be tilted.

[0057] In a preferred embodiment, without limiting the scope of the present invention, the manual trigger button (5), for any of the three drive versions, mechanical, electric or compressed gas, can be pushed or replaced by a remote trigger unit (90) by remote control.

[0058] In a preferred embodiment, without limiting the scope of the present invention, the part (3) of the firing unit (100) and the orifice (34) of the base unit (200) can be changed to allow other diameters for the trocar-cannula part (1).

[0059] In a preferred embodiment, without limiting the scope of the present invention, the main material of the device is a disposable, biocompatible polymer material. In another preferred embodiment, without limiting the scope of the present invention, the main material of the device is a sterilizable, surgical-grade metal material.

[0060] In a preferred embodiment, without limiting the scope of the present invention, the cannula (43) of the trocar-cannula (1) and the base fitting portion (45) of the basal unit (200) have an interference fit.

[0061] In the context of the present invention, the expression “at least one” should be understood to mean one or more of the elements referred to. The number of elements does not limit the scope of the present invention and will depend on the specific application of the device (1000) that is the subject of the present invention. Furthermore, if more than one element is provided, these elements may or may not be identical to each other without limiting the scope of the present invention.

[0062] In the context of the present invention, the term "plurality" shall be understood to mean two or more of the elements referred to herein. The number of elements comprising such a plurality does not limit the scope of the present invention and shall depend upon the specific application of the device (1000) that is the subject of the present invention. Furthermore, the elements comprising the plurality may or may not be identical to one another without this limiting the scope of the present invention.

[0063] In the context of the present invention, without limiting its scope, relative directions such as up, down, forward, backward, left, right, longitudinal, transverse, and the like, shall be understood as referring to the device (1000) that is the subject of the present invention when it is in normal use. Additionally, without limiting its scope, proximal and distal directions shall be understood as referring to a subject possessing the layers of semi-rigid or soft tissue material (300) to be perforated when the device (1000) that is the subject of the present invention is in normal use. Furthermore, without limiting its scope, the longitudinal direction shall be understood as extending substantially parallel to the proximal-distal direction.

[0064] APPLICATION EXAMPLES

[0065] It should be understood that the different options previously described for different technical characteristics of the device (1000) that is the subject of the present invention, may be combined with each other, or with other options known to a person normally versed in the subject, in any way provided without this limiting the scope of the present application.

[0066] The semi-rigid or soft material layers (300) to be perforated can be selected, for example, and without limiting the scope of the present invention, from the group consisting of skin and subepithelial tissue, adipose tissue, cartilaginous tissue, connective tissue, muscle tissue, and bone tissue, individually or collectively. Therefore, the device (1000) that is the subject of the present invention can be used, for example, and without limiting the scope of the present invention, to perform tracheostomies, maxillary and paranasal sinuscopies, laparotomies, cystotomies, thoracotomies, thoracentesis, and access to arterial and venous blood vessels, among other procedures, as illustrated, for example, and without limiting the scope of the present invention, in Figures 3 to 9.

[0067] The shape, materials, and dimensions of the firing unit (100), the trocar-cannula (1), or the base unit (200) do not limit the scope of the present invention and may depend, for example, on the specific operation to be performed, as well as on the layers of semi-rigid or soft surface material (300) to be perforated. For example, and without limiting the scope of the present invention, the firing unit (100), the trocar-cannula (1), and / or the base unit (200) may be made of a biocompatible material, which may be selected from the group consisting of biocompatible ceramics, biocompatible polymers, biocompatible metals and alloys, biocompatible composite materials, or a combination thereof.

[0068] Furthermore, the dimensions of the firing unit (100), the trocar-cannula (1), or the base unit (200) may depend, without limiting the scope of the present invention, on the specific perforation to be performed. For example, and without limiting the scope of the present invention, the trocar-cannula (3) may have a diameter of between 1.5 mm and 15 mm and a length of between 10 mm and 150 mm. Similarly, the base unit (200) may have a flexible base piece (7) with a surface area of ​​between 1 cm² and 1 cm². 2 and 50 cm 2 and a thickness of between 0.5 mm and 5 mm. The dimensions of the firing unit (100), in turn, may depend on the dimensions of the trocar-cannula (1) and the basal unit (200), as well as the shape and nature of the drive unit (50).

[0069] The following are examples of embodiments of the present invention. It should be understood that these examples are described to provide a better understanding of the present invention, but in no way limit the scope of the protection sought. Furthermore, details of technical features specified in different examples may be combined with each other, or with other preferred embodiments previously described in Figures 3 to 9, in any manner provided without limiting the scope of the present invention. Parts List

[0070] Parts

[0071] 1. Trocar-cannula

[0072] 2. External tubular piece

[0073] 3. Trocar-piston drive joint 4. Guide piston

[0074] 5. Trigger button

[0075] 6. Secure lid

[0076] 7. Flexible base piece

[0077] 8. Adhesive sheet

[0078] 9. Release stem

[0079] 10. Trigger spring

[0080] 11. Cylindrical guide piece

[0081] 12. Locking ball

[0082] 13. Drive spring

[0083] 14. Pistol-type grip

[0084] 15. Locking piece

[0085] 16. Trigger

[0086] 17. Non-magnetic cylinder 18. Solenoid

[0087] 19. Ferromagnetic core

[0088] 20. Electrical conductors

[0089] 21. Electric switch trigger

[0090] 22. Electric battery

[0091] 23. Trigger valve

[0092] 24. Internal trigger

[0093] 25. Bridge rod

[0094] 26. Compressed air balloon

[0095] 27. External button trigger

[0096] 28. Trigger spring

[0097] 29. Short guide rod

[0098] 30. Slanted base piece

[0099] 31. Proximal external piece with rounded edges 32. Distal external piece Parts

[0100] 33. Inner guide channel

[0101] 34. Central drilling

[0102] 35. Base unit coupling portion (200) 36. Firing unit coupling portion (100) 37. Beveled end

[0103] 38. Stem waist (9)

[0104] 39. Radial extension stop (9)

[0105] 40. Ball cavity

[0106] 41. Tubular portion for unit fitting 42. Piston friction fitting portion 43. Cannula

[0107] 44. Trocar-cannula head

[0108] 45. Portion of base lace

[0109] 46. ​​Exchange

[0110] Units and Subunits

[0111] 50. Drilling Unit

[0112] 60. Drive Unit

[0113] 70. Drive Subunit

[0114] 80. Discharge mechanism

[0115] 90. Remote trigger unit

[0116] 100. Firing unit

[0117] 200. Basal Unit

[0118] 300. Lumen-cavity

Claims

CLAIMS 1. A surgical perforation and access device (1000) for semi-rigid or soft material layers, enabling the placement of a cannula by firing a trocar for the transfer of liquid or gaseous fluids into intracorporeal cavities or lumens (300), CHARACTERIZED in that it comprises: a) a firing unit (100) of a trocar-cannula (1) formed of an essentially cylindrical external tubular piece (2) in whose inner channel (30) it contains a drilling unit (50) and a driving unit (60), the cylindrical external tubular piece (2) when in operation, in its proximal part is joined by a quick coupling to a basal unit (200): or the drilling unit (50) has a trocar-cannula (1) that can be adjusted to different sizes and surgical drilling applications, a trocar-guide drive plunger joining piece (3); or said trocar-cannula (1) disposed within said guide channel (33) of the tubular piece (2), and a quick-coupling portion (36) with a basal unit (200) in a proximal position of the guide channel (33); the trocar-cannula (1) is dimensioned for positioning in the guide channel (33) and for linear displacement along the guide channel (33), wherein said trocar-cannula (1) has a beveled end (37); and b) the base unit (200) consists of a flexible base piece (7) with a thin adhesive sheet (8) that fixes it to the surface that makes contact around the point to be drilled, or it has a central perforation (34) of the flexible base piece (7) and a quick-coupling portion of the base unit (35) that can be joined to the quick-coupling portion (36) of the firing unit (100) or said base plate (200) sized to receive the trocar-cannula (1), wherein, when the base unit (200) is coupled with the drive device (100), at least a portion of said central base perforation (34) is configured as an extension of said channel (33) to receive the trocar-cannula (1); Upon firing of the unit (100), the trocar-cannula (1) is moved in a controlled and instantaneous manner; the cannula (43) of the trocar-cannula (1) is fixed in the basal unit (200) due to friction from the penetrated material and the friction of the head (44) of the trocar-cannula (1) with the base fitting portion (45) of the basal unit (200); the trocar (46) comes out together with the decoupling of the firing unit (100) from the basal unit (200), leaving the cannula (43) installed.

2. The device of claim 1, CHARACTERIZED in that the driving device further comprises a trocar-cannula loading chamber in a distal portion of the canal (33).

3. The device (1000) of claim 1, CHARACTERIZED in that the drive unit (60) of the trocar-cannula (1) comprises a guide drive plunger (4) that can be moved within the guide channel (33) of the outer tubular piece (2) by means of a drive subunit (70), a trigger button (5) and a safety cap (6).

4. The device (1000) of claim 1, CHARACTERIZED in that the drive unit (60) can be mechanical, electric or compressed gas.

5. The device (1000) of claim 1, CHARACTERIZED in that the drive subunit (60) further comprises the push button (5), which pushes a waisted stem (9) towards its proximal part (38) and with a radial stop extension (39) at its most distal part, a trigger spring (10) keeps it against the bottom wall of the piece (2), in turn the release stem (9) slides inside a cylindrical guide piece (11) fixed inside to the cylindrical tubular piece (2), the stem (9) on its front part, has one (or two) cavity for a ball (40), a locking ball (12) which keeps a drive spring (13) compressed, and locks the plunger (4) positioned inside the inner guide channel (33).The device is armed after removing the safety (6) and is activated after pressing the button (5), this causes the stem (9) to move and the balls (12) to enter the waist of the stem (38) and in this way the drive spring (13) is unlocked and expands instantly pushing the plunger (4), which, in turn, through the piece (3), pushes the trocar-cannula (1) a preset distance.

6. The device (1000) of claim 1 and 3 CHARACTERIZED in that in another of its mechanical versions, it has a pistol-type grip (14) and the drive spring (13) is directly compressed by the guide plunger (4) which locks into a locking piece (15) which moves and connects with the trigger (16).

7. The device (1000) of claim 3, CHARACTERIZED in that the plunger (4) has a tubular portion for quick coupling (41) with the connecting piece (3) that goes with the trocar-cannula (1) on the proximal face of said plunger.

8. The device (1000) of claim 1, CHARACTERIZED in that the base unit (200) comprises a cannula (43) projecting distally from the flexible base piece (7) and containing a central perforation (34).

9. The device (100) of claim 8, CHARACTERIZED in that the coupling portion (35) of the base unit (200) is an outer diameter expansion at a distal position of the tubular socket portion (41) and in that the coupling portion (36) of the firing device (100) is a radial excess with a dimension corresponding to the diameter expansion of the tubular portion (1) at a proximal position of the inner guide channel (33).

10. The device (1000) of claim 8, CHARACTERIZED in that the tubular fitting portion (41) of the flexible base piece (7) has a greater axial stiffness than the axial stiffness of the flexible base piece (7), said axial stiffness being measured in the distal-proximal direction.

11. The device (1000) of claim 1, CHARACTERIZED in that the Drive subunit (70) comprises a trigger (5) operatively connected to the guide drive piston (4).

12. The device (1000) of claim 1, CHARACTERIZED in that the firing unit (100) is configured in such a way that the trocar-cannula (1) cannot rotate within the channel (33) of the firing unit (100).

13. The device (1000) of claim 12, CHARACTERIZED in that the channel comprises at least one inner rail extending in a longitudinal direction of the channel (33) and the trocar-cannula (1) comprises at least one projection dimensioned accordingly to said at least one inner rail.

14. The device (1000) of claim 1, CHARACTERIZED in that another version of the driving device (100) further comprises a movable stop operatively coupled with the driving means (60) and with a screw, such that the rotation of said screw limits the displacement of said movable stop in the inner channel (31), allowing an adjustment of the drilling depth, through a controlled limitation of the stroke of the trocar-cannula (1).

15. The device (1000) of claim 14, CHARACTERIZED in that the screw is operatively connected with displacement graduation means, which indicates the stroke limitation of the trocar-cannula (1).

16. The device (1000) of claim 1, CHARACTERIZED in that the driving device further comprises a movable stop operatively coupled with the channel (33) and with a screw, such that the rotation of said screw limits the displacement of said movable stop within the channel (33), allowing fine adjustment of the drilling depth, by means of a limitation of the stroke of the trocar-cannula (3).

17. The device (1000) of claim 13, CHARACTERIZED in that the screw is operatively connected with displacement graduation means, which indicates the stroke limitation of the trocar-cannula (3).

18. The device (1000) according to claim 2, CHARACTERIZED in that the drive unit (60) in its electric version comprises a non-magnetic cylinder (17) that pushes the plunger (4), through the actuation of a solenoid (18) that moves a ferromagnetic core (19) which pushes the non-magnetic cylinder (17), electrical conducting wires (20) connect to an electric switch (21) which connects to an electric battery (22).

19. The device (1000) according to claims 2 and 9 CHARACTERIZED in that the drive unit (60) in its electric version can be connected to an electrical network by means of a plug.

20. The device (1000) according to claim 2, CHARACTERIZED in that the propulsion unit (60) in its gas version comprises a compressed air firing valve (23), an internal trigger (24), a bridge rod (25), a compressed air pistol cylinder (26), an external button trigger (27) that is pushed by the push button (5), a return spring (28), and a guide fork (29) that pushes the bridge rod (25) through the button trigger (27).

21. The device (1000) according to claim 2, CHARACTERIZED in that in another version the base unit (200) is formed by a flexible base piece (7) with a thin adhesive sheet (8) 22. The device (1000) according to claim 2, CHARACTERIZED in that in another version of the base piece (7), it is made of a flexible material that allows it to be tilted.

23. The device (1000) according to claim 2, CHARACTERIZED in that in another version of the external tubular piece (1), it is divided into two parts, proximal and distal, such that a rolled proximal external piece (31) is screwed into the distal external piece (32) and this allows adjusting the drilling distance.

24. The device (1000) according to claim 1, CHARACTERIZED in that in another version the manual firing button (5), for any of the three drive versions, mechanical, electric or compressed gas, can be pushed or replaced by a remote firing unit (90) by remote control.

25. The device (1000) according to claim 1, CHARACTERIZED in that in other versions the part (3) of the firing unit (100) and the orifice (34) of the basal unit (200) can be changed and allow other diameters for the trocar-cannula part (1).

26. The device (1000) according to claim 1, CHARACTERIZED in that in one version the main material of the device is disposable biocompatible polymer material.

27. The device (1000) according to claim 1, CHARACTERIZED in that in another version the main material of the device is made of sterilizable surgical metallic material.

28. The device (1000) according to claim 1, CHARACTERIZED in that the cannula (43) of the trocar-cannula (1) and the base fitting portion (45) of the basal unit (200) have an interference fit.

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