A guided skin expansion device and its application

Abstract

The present invention provides a guide skin expansion device and its application, which includes a clamp body. The clamp body is a clamp-like structure formed by a left clamp arm and a right clamp arm that are hinged by a pin after crossing. The front end face of the left clamp arm is connected to a left limb extending forward, and the front end face of the right clamp arm is connected to a right limb extending forward. The free ends of the left limb and the right limb overlap to form a guide head for penetrating a skin opening and for allowing a guide wire to pass through. The clamp body has an open state and a closed state. The guide skin expansion device is divided into a guide section, an expansion section, and a handheld section. The guide section guides the guide head. On the one hand, the guide wire can pass through the guide head, that is, guide the guide wire. On the other hand, the guide head can penetrate the skin opening to prepare for the next step of expansion. The expansion section is composed of a left limb and a right limb. When the guide head penetrates the skin opening, the left limb and the right limb are separated, and then the jaws are opened. The jaws can expand and expand the skin opening, and the cannula can enter the blood vessel through the expanded skin opening, which is convenient for promotion and use.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and specifically relates to a guide skin expansion device and its application, which is particularly suitable for ECMO intubation. Background Art

[0002] Current intubation techniques mainly include percutaneous puncture, semi-open surgically guided percutaneous puncture, and open surgical incision and catheterization. All three options require direct insertion of the sheath into the blood vessel through gradual expansion of the sheath or through violent intubation to achieve the purpose of catheterization.

[0003] However, whether it is gradual expansion of the skin sheath or violent intubation, there are problems such as a single expansion plan, complicated tools, complex steps, and difficulty in mastering. Especially in gradual expansion, the sheath cannot be shaped and has no physiological curvature, which causes it to be folded under the skin and difficult to enter the blood vessels. Even if it enters the blood vessels, it may puncture the blood vessels, damage the blood vessels, and even cause blood vessel rupture and hematoma formation. Therefore, there is a high risk. At the same time, since multiple expanders are needed for gradual expansion, the cost is high and it is not easy to promote its use. Summary of the Invention

[0004] The purpose of the embodiments of the present invention is to provide a guided skin expansion device and its application to overcome the above technical defects.

[0005] To solve the above technical problems, the present invention provides a guided skin expansion device, which includes a clamp body, which is a clamp-like structure formed by a left clamp arm and a right clamp arm that are intersected and hinged by a pin. The front end surface of the left clamp arm is connected to a left limb extending forward, and the front end surface of the right clamp arm is connected to a right limb extending forward. The free ends of the left limb and the right limb overlap to form a guide head for penetrating the skin opening and allowing the guide wire to pass through.

[0006] The clamp body has two states, open and closed;

[0007] When the clamp body is in an open state, the left limb and the right limb are separated from each other, and the left clamp arm and the right clamp arm are separated from each other, forming a clamp mouth that can expand the skin opening;

[0008] When the clamp body is in a closed state, the left limb and the right limb are tightly closed to each other, and the left clamp arm and the right clamp arm are tightly closed to each other, and the closed position forms a guide wire channel for the guide wire to pass through;

[0009] The guide wire can be passed through the left or right clamp arm.

[0010] Furthermore, both the left limb and the right limb are made of semi-rigid plastic, and both the left limb and the right limb are provided with at least one bending point for forming a jaw, and the bending point divides the limb into at least two sections.

[0011] Preferably, the guide wire channel is divided into two sections, namely the front guide wire channel and the rear guide wire channel. The front guide wire channel is a tubular channel composed of a strip groove opened on the inner side of the limb arm of the left limb and a strip groove opened on the inner side of the limb arm of the right limb. The rear guide wire channel is a tubular channel composed of a strip groove opened on the inner side of the forearm of the left forceps arm and a strip groove opened on the inner side of the forearm of the right forceps arm.

[0012] Furthermore, a flat circular hole for the guide wire to pass through is opened near the hinge point of the forearm of the left clamp arm, and the flat circular hole is communicated with the strip groove of the left clamp arm.

[0013] Preferably, the forearm of the right clamp arm is provided with an oblong hole for the guide wire to pass through near the hinge point, and the oblong hole is communicated with the strip groove of the right clamp arm.

[0014] Furthermore, the guide head is a truncated cone-shaped tubular structure, its small diameter end is a smooth head that can penetrate the skin opening, and its large diameter end is forked to form a left limb and a right limb, and a radial hole is provided at the bifurcation. The central axis of the radial hole is parallel to the central axis of the pin shaft at the hinge of the left clamp arm and the right clamp arm, and the radial hole is connected to the strip groove of the left limb and the strip groove of the right limb.

[0015] Preferably, the pliers body is a split structure, wherein the left pliers arm is connected to the left limb by plugging, and the right pliers arm is connected to the right limb by plugging.

[0016] Furthermore, the left forceps arm and the right forceps arm are both made of stainless steel or hard plastic, and the left limb and the right limb are both disposable sterilized products made of semi-rigid plastic.

[0017] Preferably, the tail of the left pliers arm and the tail of the right pliers arm are both provided with finger rings for holding and opening and closing the pliers body, and locking teeth that can be engaged and locked or staggered and loosened are respectively provided on opposite sides of the two finger rings.

[0018] The present invention also protects an application of a guided skin expansion device, comprising the following steps:

[0019] The operator holds the guide wire that has been inserted into the patient's body, inserts the free end of the guide wire into the guide head, passes through the guide wire channel, and finally leads it out from the oblong hole of the left clamp arm or the oblong hole of the right clamp arm. The clamp body is pushed until the guide head penetrates the patient's skin opening, the jaws are opened, the skin opening and subcutaneous tissue are expanded, the guide skin expansion device is pulled out, and the ECMO cannula is inserted along the guide wire.

[0020] The beneficial effects of the present invention are as follows:

[0021] (1) The bending points of the left and right limbs of the guided skin expansion device cooperate with the radial holes of the guide head to form jaws after bending. The jaws of the jaws can be opened to expand the skin opening, and the guide wire channels of the guide head and the jaws can play the role of guiding the guide wire, so that the guided skin expansion device can both expand the skin and guide the guide wire.

[0022] (2) The clamp body of the guided skin expansion device is a split structure. Its left limb is plugged into the left clamp arm, and its right limb is plugged into the right clamp arm. When in use, the left limb and the right limb can be replaced according to the patient's blood vessel inner diameter to adapt to the different patient's blood vessel inner diameter. There is no need to replace the entire device, which saves costs and is convenient for promotion and use.

[0023] (3) The left and right forceps arms are made of stainless steel or medical-grade polycarbonate or other hard plastics, bonded to the left and right limbs, and sterilized as a whole for single use to prevent contamination caused by incomplete sterilization.

[0024] In order to make the above contents of the present invention more clearly understood, preferred embodiments are given below and described in detail with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 It is a structural schematic diagram of the guiding and expanding skin device in the open state.

[0026] Figure 2 It is a structural schematic diagram of the guiding and expanding skin device in a closed state.

[0027] Figure 3 It is a schematic diagram of the partial structure of the guiding and expanding skin device in the closed state.

[0028] Figure 4 It is a schematic diagram of the partial structure of the guiding and expanding skin device in the open state.

[0029] Figure 5 It is a schematic diagram of the plug-in structure of the left clamp arm and the left limb, or the right clamp arm and the right limb.

[0030] Description of reference numerals:

[0031] 1. Clamp body; 2. Left clamp arm; 3. Right clamp arm; 4. Left limb; 5. Right limb; 6. Guide head; 7. Jaws; 8. Guide wire channel; 9. Bending point; 10. Strip groove; 11. Oval hole; 12. Radial hole; 13. Finger ring; 14. Locking tooth; 15. Insert; 16. Oval hole; A. Plug-in point between left clamp arm and left limb; B. Plug-in point between right clamp arm and right limb. DETAILED DESCRIPTION

[0032] The following describes the embodiments of the present invention through specific embodiments. Those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification.

[0033] It should be noted that, in the present invention, the up, down, left and right in the figure are regarded as the up, down, left and right of the guiding and expanding skin device described in this specification.

[0034] Exemplary embodiments of the present invention will now be described with reference to the accompanying drawings. However, the present invention may be embodied in many different forms and is not limited to the embodiments described herein. These embodiments are provided so as to provide a thorough and complete disclosure of the present invention and fully convey the scope of the present invention to those skilled in the art. The terminology used in the exemplary embodiments shown in the accompanying drawings is not intended to limit the present invention. In the accompanying drawings, identical elements are denoted by the same reference numerals.

[0035] Unless otherwise specified, the terms used herein (including technical and scientific terms) have the meanings commonly understood by those skilled in the art. Furthermore, it is understood that terms defined in commonly used dictionaries should be understood to have meanings consistent with the context of their relevant fields and should not be interpreted as idealized or overly formal.

[0036] First embodiment:

[0037] The first embodiment of the present invention relates to a guided skin expansion device, referring to Figure 1 The invention comprises a clamp body 1, which is a clamp-like structure formed by a left clamp arm 2 and a right clamp arm 3 that are hingedly connected by a pin after crossing. The front end surface of the left clamp arm 2 is connected to a left limb 4 extending forward, and the front end surface of the right clamp arm 3 is connected to a right limb 5 extending forward. The free ends of the left limb 4 and the right limb 5 overlap to form a guide head 6 for penetrating the skin opening and allowing the guide wire to pass through.

[0038] The clamp body 1 has two states, namely, an open state and a closed state;

[0039] When the clamp body 1 is in the open state, Figure 1 As shown, the left limb 4 and the right limb 5 are separated from each other, and the left clamp arm 2 and the right clamp arm 3 are separated from each other, forming a clamp mouth 7 that can expand the skin opening;

[0040] When the clamp body 1 is in the closed state, Figure 2 As shown, the left limb 4 and the right limb 5 are tightly closed to each other, and the left forceps arm 2 and the right forceps arm 3 are tightly closed to each other, and the closed position forms a guidewire channel 8 for the guidewire to pass through;

[0041] The guide wire can pass through the left clamp arm 2 or the right clamp arm 3.

[0042] Taking ECMO cannulation as an example, the working process of the guide and skin expansion device protected by this embodiment is as follows:

[0043] Step a. First, use the Seldinger method to puncture the patient's blood vessels with a puncture needle. After aspirating fresh blood, insert a short ordinary guide wire through the puncture needle.

[0044] Step b. Insert a 5F sheath and flush with heparinized saline;

[0045] Step c. After inserting the exchange long guide wire through the sheath, withdraw the sheath;

[0046] Step d. Insert the skin expansion device through the long guide wire, open the jaws and expand the skin and subcutaneous tissue to the appropriate size;

[0047] Step e. Pull out the guide expansion device;

[0048] Step f. Insert an ECMO-coated cannula of appropriate inner diameter along the long guide wire.

[0049] Specifically, step d includes: the operator holds the guide wire that has been inserted into the patient's body, inserts the free end of the guide wire into the guide head 6, passes through the guide wire channel 8, and finally comes out from the left clamp arm 2 or the right clamp arm 3, pushes the clamp body 1 until the guide head 6 penetrates the patient's skin opening, opens the jaws 7, and expands the skin opening and subcutaneous tissue.

[0050] The size of the jaws is determined by the curvature and length of the left limb 4 and the right limb 5. In actual application, if you want to adjust the size of the jaws, you can choose left limbs 4 and right limbs 5 of different lengths or curvatures to suit various diameters of cannulas.

[0051] The guide wire enters from the guide head 6, passes through the guide wire channel 8, and finally passes through the clamp body 1. During this process, the guide skin expansion device is in a closed state, that is, the guide wire is in a closed environment, which can avoid contamination of the guide wire. In addition, when passing out the guide wire, the guide skin expansion device can be opened appropriately to slightly separate the left limb 4 and the right limb 5, and slightly separate the left clamp arm 2 or the right clamp arm 3, so as to observe the guide wire and pass the guide wire out of the clamp body 1.

[0052] In this embodiment, the guiding skin expansion device is divided into three sections, namely the guiding section, the expansion section and the hand-held section, wherein the guiding section guides the guide head 6, and the guiding section has two functions. On the one hand, the guide wire can be inserted from the guide head 6, that is, to guide the guide wire. On the other hand, the guide head 6 can penetrate the skin opening to prepare for the next step of expansion; the expansion section is composed of the left limb 4 and the right limb 5. When the guide head 6 penetrates the skin opening, the left clamp arm 2 and the right clamp arm 3 are operated to separate the left limb 4 and the right limb 5, and then the jaws 7 are opened. The jaws 7 can expand the skin opening, and the cannula can enter the blood vessel from the expanded skin opening; the hand-held section is composed of the left clamp arm 2 and the right clamp arm 3. Its main function is to drive the left limb 4 and the right limb 5 to close by closing the left clamp arm 2 and the right clamp arm 3, or to drive the left limb 4 and the right limb 5 to separate by separating the left clamp arm 2 and the right clamp arm 3.

[0053] The clamp body 1 is a clamp-like structure formed by crossing the left clamp arm 2 and the right clamp arm 3 and hinged by a pin. Its structure is similar to that of an elbow hemostatic forceps, and the head is an arc-shaped curved structure (which is conducive to close contact with the patient's skin). Since the elbow hemostatic forceps is a common and mature structure in the medical field, it will not be described in detail here.

[0054] The guiding skin expansion device has a guiding section and an expansion section, which can enable the device to simultaneously expand the skin opening and guide the guide wire. It is particularly suitable for ECMO intubation, avoiding the problem of damage to blood vessels or even vascular rupture and hematoma caused by conventional skin expansion devices. The guiding skin expansion device with a suitable size of jaws can be selected according to actual conditions. It is low in cost and can be widely used.

[0055] Second embodiment:

[0056] This embodiment relates to a guided skin expansion device, referring to Figure 1 The invention comprises a clamp body 1, which is a clamp-like structure formed by a left clamp arm 2 and a right clamp arm 3 that are hingedly connected by a pin after crossing. The front end surface of the left clamp arm 2 is connected to a left limb 4 extending forward, and the front end surface of the right clamp arm 3 is connected to a right limb 5 extending forward. The free ends of the left limb 4 and the right limb 5 overlap to form a guide head 6 for penetrating the skin opening and allowing the guide wire to pass through.

[0057] The clamp body 1 has two states, namely, an open state and a closed state;

[0058] When the clamp body 1 is in the open state, Figure 1 As shown, the left limb 4 and the right limb 5 are separated from each other, and the left clamp arm 2 and the right clamp arm 3 are separated from each other, forming a clamp mouth 7 that can expand the skin opening;

[0059] When the clamp body 1 is in the closed state, Figure 2 As shown, the left limb 4 and the right limb 5 are tightly closed to each other, and the left forceps arm 2 and the right forceps arm 3 are tightly closed to each other, and the closed position forms a guidewire channel 8 for the guidewire to pass through;

[0060] The guide wire can pass through the left clamp arm 2 or the right clamp arm 3.

[0061] The left limb 4 and the right limb 5 are both made of semi-rigid plastic, and the limb arms of the left limb 4 and the limb arms of the right limb 5 are each provided with at least one bending point 9 for forming a jaw 7, and the bending point 9 divides the limb into at least two sections.

[0062] Specifically, the bending of the left limb 4 and the right limb 5 forms the jaws 7. In order to make it easy to bend and maintain a certain shape after bending, this embodiment preferably uses semi-rigid plastics, such as polypropylene, polyvinyl chloride, etc.

[0063] After the guide head 6 penetrates the skin opening, the jaws 7 are gradually opened, so that the left limb 4 and the right limb 5 are slowly separated, that is, the opposite surfaces of the left limb 4 and the right limb 5 are slowly moved away. In this process, the skin opening is also slowly separated along with the left limb 4 and the right limb 5, until it reaches a caliber that allows the cannula to enter, thereby achieving the purpose of expanding the skin opening.

[0064] like Figure 1 and Figure 4 As shown, the limbs of the left limb 4 and the limbs of the right limb 5 are each provided with at least one bending point 9 for forming a jaw 7. When the left limb 4 and the right limb 5 are separated, the left limb 4 or the right limb 5 bends at the bending point 9, that is, the two sections before and after the bending point 9 are not on a straight line. For the convenience of explanation, this embodiment only provides one bending point 9, so that the jaw 7 is diamond-shaped. This is a preferred option, but it is not limited to this shape, or is not limited to one bending point, and can also be other shapes.

[0065] Third embodiment:

[0066] Based on the first or second embodiment, Figure 4 The guide wire channel 8 is divided into two sections, namely the front guide wire channel and the rear guide wire channel. The front guide wire channel is a tubular channel composed of the strip groove 10 opened on the inner side of the limb of the left limb 4 and the strip groove 10 opened on the inner side of the limb of the right limb 5. The rear guide wire channel is a tubular channel composed of the strip groove 10 opened on the inner side of the forearm of the left forceps arm 2 and the strip groove 10 opened on the inner side of the forearm of the right forceps arm 3.

[0067] like Figure 2 As shown, when the guide skin expansion device is in the closed state, the guide wire channel 8 is a closed tubular lumen, which provides a channel for the guide wire and protects the guide wire from contact with other machines; however, the guide wire channel 8 is not always in a closed state. When the guide skin expansion device is in the expanded state, the guide wire channel 8 is open. It can be seen that it is a tubular channel composed of two opposite strip grooves 10 (the radial cross section is semicircular).

[0068] That is to say, the guidewire channel 8 can change its state according to the needs of the operator.

[0069] Fourth embodiment:

[0070] Different from the third embodiment, Figure 3 The forearm of the left clamp arm 2 is provided with an oblong hole 11 for the guide wire to pass through near the hinge point, and the oblong hole 11 is connected to the strip groove 10 of the left clamp arm 2.

[0071] The operator holds the guide wire that has been inserted into the patient's body, inserts the free end of the guide wire into the guide head 6, passes through the guide wire channel 8, and finally leads it out from the oblong hole 11 of the left clamp arm 2, pushes the clamp body 1 until the guide head 6 penetrates the patient's skin opening, opens the jaws 7, expands the skin opening and subcutaneous tissue, pulls out the guide skin expansion device, and inserts the ECMO cannula along the guide wire.

[0072] In order to allow the guide wire to pass through smoothly, this embodiment opens an oblate hole 11 on the left forceps arm 2 that is connected to the strip groove 10. The reason for choosing this shape of the hole is to take into account the shape of the guide wire, but it is not limited to this and can also be other shapes, such as a round hole.

[0073] Fifth embodiment:

[0074] As an alternative to the fourth embodiment, refer to Figure 3 The forearm of the right clamp arm 3 is provided with an oblong hole 11 for the guide wire to pass through near the hinge point, and the oblong hole 11 is connected to the strip groove 10 of the right clamp arm 3.

[0075] The operator holds the guide wire that has been inserted into the patient's body, inserts the free end of the guide wire into the guide head 6, passes through the guide wire channel 8, and finally leads it out from the oblong hole 11 of the right clamp arm 3, pushes the clamp body 1 until the guide head 6 penetrates the patient's skin opening, opens the jaws 7, expands the skin opening and subcutaneous tissue, pulls out the guide skin expansion device, and inserts the ECMO cannula along the guide wire.

[0076] In order to allow the guide wire to pass through smoothly, this embodiment opens an oblate hole 11 on the right forceps arm 3 that is connected to the strip groove 10. The reason for choosing this shape of the hole is to take into account the shape of the guide wire, but it is not limited to this and can also be other shapes, such as a round hole.

[0077] Sixth embodiment:

[0078] This embodiment relates to a guided skin expansion device, referring to Figure 1 The invention comprises a clamp body 1, which is a clamp-like structure formed by a left clamp arm 2 and a right clamp arm 3 that are hingedly connected by a pin after crossing. The front end surface of the left clamp arm 2 is connected to a left limb 4 extending forward, and the front end surface of the right clamp arm 3 is connected to a right limb 5 extending forward. The free ends of the left limb 4 and the right limb 5 overlap to form a guide head 6 for penetrating the skin opening and allowing the guide wire to pass through.

[0079] The clamp body 1 has two states, namely, an open state and a closed state;

[0080] When the clamp body 1 is in the open state, Figure 1 As shown, the left limb 4 and the right limb 5 are separated from each other, and the left clamp arm 2 and the right clamp arm 3 are separated from each other, forming a clamp mouth 7 that can expand the skin opening;

[0081] When the clamp body 1 is in the closed state, Figure 2 As shown, the left limb 4 and the right limb 5 are tightly closed to each other, and the left forceps arm 2 and the right forceps arm 3 are tightly closed to each other, and the closed position forms a guidewire channel 8 for the guidewire to pass through;

[0082] The guide wire can pass through the left clamp arm 2 or the right clamp arm 3.

[0083] The left limb 4 and the right limb 5 are both made of semi-rigid plastic, and the limb arms of the left limb 4 and the limb arms of the right limb 5 are each provided with at least one bending point 9 for forming a jaw 7, and the bending point 9 divides the limb into at least two sections.

[0084] Reference Figure 4 The guide wire channel 8 is divided into two sections, namely the front guide wire channel and the rear guide wire channel. The front guide wire channel is a tubular channel composed of the strip groove 10 opened on the inner side of the limb of the left limb 4 and the strip groove 10 opened on the inner side of the limb of the right limb 5. The rear guide wire channel is a tubular channel composed of the strip groove 10 opened on the inner side of the forearm of the left forceps arm 2 and the strip groove 10 opened on the inner side of the forearm of the right forceps arm 3.

[0085] Reference Figure 4 The guide head 6 is a truncated cone-shaped tubular structure. Its small diameter end is a smooth head that can penetrate the skin opening, and its large diameter end is forked to form a left limb 4 and a right limb 5. A radial hole 12 is provided at the bifurcation. The central axis of the radial hole 12 is parallel to the central axis of the pin shaft at the hinge of the left clamp arm 2 and the right clamp arm 3, and the radial hole 12 is connected to the strip groove 10 of the left limb 4 and the strip groove 10 of the right limb 5.

[0086] The guide head 6 is a truncated cone-shaped tubular structure. Specifically, the guide head 6 is a cone with a smooth head. A tubular channel is provided in the center of the cone. The tubular channel coincides with the axial center line of the cone. The head and tail of the tubular channel pass through it. The guide wire enters from its head and then exits from its tail to enter the guide wire channel 8.

[0087] The structure of the guide head 6 can ensure smooth penetration into the skin opening and provide a passage for the guide wire.

[0088] In order to make the large diameter end of the guide head 6 fork to form the left limb 4 and the right limb 5, a radial hole 12 is provided at the fork. When the left limb 4 and the right limb 5 are separated, part of the force will be decomposed by the radial hole 12, which facilitates the bending of the left limb 4 and the right limb 5.

[0089] Reference Figure 5 The pliers body 1 is a split structure, its left pliers arm 2 is connected to the left limb 4 by plugging, and its right pliers arm 3 is connected to the right limb 5 by plugging.

[0090] Specifically, an insert 15 is provided at the front end of the left clamp arm 2 or the front end of the right clamp arm 3, and a flat hole 16 is provided at the rear end of the left limb 4 or the rear end of the right limb 5. When in use, the insert 15 of the left clamp arm 2 is inserted into the flat hole 16 of the left limb 4, and the insert 15 of the right clamp arm 3 is inserted into the flat hole 16 of the right limb 5 to ensure that the connection is firm, thereby completing the assembly of the guide skin expansion device.

[0091] The split design allows for replacement of guide segments and expansion segments with different outer diameters according to the different inner diameters of the patient's blood vessels to adapt to the different inner diameters of the patient's blood vessels. The entire device can be sterilized and used once to prevent contamination caused by incomplete sterilization.

[0092] It should be noted that the plug-in split structure described in this embodiment is only a preferred solution and is not limited thereto. Other forms of split structures, such as bonding, may also be used.

[0093] Preferably, the left forceps arm 2 and the right forceps arm 3 are both made of stainless steel or hard plastic, and the left limb 4 and the right limb 5 are both disposable sterilized products made of semi-rigid plastic. They are replaceable disposable consumables to prevent cross infection.

[0094] The guided skin expansion device must be sterilized as a whole and used once to prevent contamination due to incomplete sterilization.

[0095] To facilitate the operator's use, the tail of the left clamp arm 2 and the tail of the right clamp arm 3 are both provided with finger rings 13 for holding and opening and closing the clamp body 1, and locking teeth 14 that can be engaged and locked or staggered to loosen are respectively provided on the opposite sides of the two finger rings 13.

[0096] Among them, the finger ring 13 is used to hold and open and close the pliers body 1, and there are locking teeth 14 on the inner side of the handle on both sides near the finger ring 1. When the pliers body 1 is closed, the locking teeth 14 bite into each other to keep the pliers body 1 in a closed state; after the locking teeth 14 bite, the locking teeth 14 can be loosened by pressing the handle on both sides inward with the finger ring 1 and moving it up and down at the same time.

[0097] Seventh embodiment:

[0098] This embodiment provides an application of a guided skin expansion device, including the following steps:

[0099] The operator holds the guide wire that has been inserted into the patient's body, passes the free end of the guide wire through the guide head 6 and the guide wire channel 8 in sequence, and finally leads it out from the oblong hole 11 of the left clamp arm 2 or the oblong hole 11 of the right clamp arm 3, pushes the clamp body 1 until the guide head 6 penetrates the patient's skin opening, opens the jaws 7, expands the skin opening and subcutaneous tissue, pulls out the guide skin expansion device, and inserts the ECMO cannula along the guide wire.

[0100] The guided skin expansion device includes a clamp body 1, which is a clamp-like structure formed by a left clamp arm 2 and a right clamp arm 3 that are intersected and hinged by a pin. The front end of the left clamp arm 2 is connected to a left limb 4 extending forward, and the front end of the right clamp arm 3 is connected to a right limb 5 extending forward. The free ends of the left limb 4 and the right limb 5 overlap to form a guide head 6 for penetrating the skin opening and allowing the guide wire to pass through.

[0101] The clamp body 1 has two states, namely, an open state and a closed state;

[0102] When the clamp body 1 is in the open state, the left limb 4 and the right limb 5 are separated from each other, and the left clamp arm 2 and the right clamp arm 3 are separated from each other, forming a clamp mouth 7 that can expand the skin opening;

[0103] When the clamp body 1 is in a closed state, the left limb 4 and the right limb 5 are tightly closed to each other, and the left clamp arm 2 and the right clamp arm 3 are tightly closed to each other, and the closed position forms a guide wire channel 8 for the guide wire to pass through;

[0104] The guide wire can pass through the left clamp arm 2 or the right clamp arm 3.

[0105] The left limb 4 and the right limb 5 are both made of semi-rigid plastic, and the limb arms of the left limb 4 and the limb arms of the right limb 5 are each provided with at least one bending point 9 for forming a jaw 7, and the bending point 9 divides the limb into at least two sections.

[0106] The guide wire channel 8 is divided into two sections, namely the front guide wire channel and the rear guide wire channel. The front guide wire channel is a tubular channel composed of a strip groove 10 opened on the inner side of the limb of the left limb 4 and a strip groove 10 opened on the inner side of the limb of the right limb 5. The rear guide wire channel is a tubular channel composed of a strip groove 10 opened on the inner side of the forearm of the left clamp arm 2 and a strip groove 10 opened on the inner side of the forearm of the right clamp arm 3.

[0107] The forearm of the left forceps arm 2 is provided with an oblong hole 11 for the guide wire to pass through near the hinge point, and the oblong hole 11 is communicated with the strip groove 10 of the left forceps arm 2.

[0108] The forearm of the right forceps arm 3 is provided with an oblong hole 11 for the guide wire to pass through near the hinge point, and the oblong hole 11 is communicated with the strip groove 10 of the right forceps arm 3.

[0109] The guide head 6 is a truncated cone-shaped tubular structure, whose small diameter end is a smooth head that can penetrate the skin opening, and its large diameter end is forked to form a left limb 4 and a right limb 5. A radial hole 12 is provided at the bifurcation, and the central axis of the radial hole 12 is parallel to the central axis of the pin shaft at the hinge of the left clamp arm 2 and the right clamp arm 3, and the radial hole 12 is connected to the strip groove 10 of the left limb 4 and the strip groove 10 of the right limb 5.

[0110] The pliers body 1 is a split structure, wherein the left pliers arm 2 and the left limb 4 are connected by plugging, and the right pliers arm 3 and the right limb 5 are connected by plugging.

[0111] The left forceps arm 2 and the right forceps arm 3 are both made of stainless steel or hard plastic, and the left limb 4 and the right limb 5 are both disposable sterilized products made of semi-rigid plastic.

[0112] The tail of the left pliers arm 2 and the tail of the right pliers arm 3 are both provided with finger rings 13 for holding and opening and closing the pliers body 1, and locking teeth 14 that can be engaged and locked or staggered and loosened are respectively provided on opposite sides of the two finger rings 13.

[0113] To sum up, the bending points of the left and right limbs of the guided skin expansion device cooperate with the radial holes of the guide head to form jaws after bending. Opening the jaws of the clamp body can expand the skin opening, and the guide wire channel of the guide head and the clamp body can play the role of guiding the guide wire, so that the guided skin expansion device can both expand the skin and guide the guide wire; the clamp body of the guided skin expansion device is a split structure, its left limb is plugged into the left clamp arm, and the right limb is plugged into the right clamp arm. When in use, the left limb and right limb can be replaced according to the patient's blood vessel inner diameter to adapt to the different patient's blood vessel inner diameters. There is no need to replace the entire arm, which saves costs and facilitates promotion and use; the left clamp arm and the right clamp arm are made of stainless steel or hard plastics such as medical-grade polycarbonate, and are bonded to the left and right limbs as a whole. They are sterilized as a whole and used once to prevent contamination caused by incomplete sterilization.

[0114] Those skilled in the art will appreciate that the above-mentioned embodiments are specific examples for implementing the present invention, and that in actual applications, various changes may be made thereto in form and detail without departing from the spirit and scope of the present invention.

Claims

1. A guided skin expansion device, comprising a clamp body (1), wherein the clamp body (1) is a clamp-like structure formed by a left clamp arm (2) and a right clamp arm (3) being hinged by a pin after crossing, and characterized in that: The front end face of the left clamp arm (2) is connected to a left limb (4) extending forward, and the front end face of the right clamp arm (3) is connected to a right limb (5) extending forward. The free end of the left limb (4) and the free end of the right limb (5) overlap to form a guide head (6) for penetrating the skin opening and allowing the guide wire to penetrate. The clamp body (1) has two states, namely an open state and a closed state. The left limb (4) and the right limb (5) are both made of semi-rigid plastic, and the limb of the left limb (4) and the limb of the right limb (5) are both provided with at least one bending point (9) for forming a jaw (7), and the bending point (9) divides the limb into at least two sections; When the clamp body (1) is in an open state, the left limb (4) and the right limb (5) are separated from each other, and the left clamp arm (2) and the right clamp arm (3) are separated from each other, forming a clamp mouth (7) capable of expanding the skin opening; When the clamp body (1) is in a closed state, the left limb (4) and the right limb (5) are tightly closed to each other, and the left clamp arm (2) and the right clamp arm (3) are tightly closed to each other, and the closed position forms a guide wire channel (8) for the guide wire to pass through; The guide wire can pass through the left clamp arm (2) or the right clamp arm (3); The guide head (6) is a cone with a smooth head. A tubular channel is provided at the center of the cone. The tubular channel coincides with the axial center line of the cone. The head and tail of the tubular channel pass through the guide wire. The guide wire enters from the head and exits from the tail to enter the guide wire channel (8).

2. The guided skin expansion device according to claim 1, characterized in that: The guide wire channel (8) is divided into two sections, namely a front guide wire channel and a rear guide wire channel. The front guide wire channel is a tubular channel formed by joining together a strip groove (10) opened on the inner side of the limb of the left limb (4) and a strip groove (10) opened on the inner side of the limb of the right limb (5). The rear guide wire channel is a tubular channel formed by joining together a strip groove (10) opened on the inner side of the forearm of the left clamp arm (2) and a strip groove (10) opened on the inner side of the forearm of the right clamp arm (3).

3. The guided skin expansion device according to claim 2, characterized in that: The forearm of the left clamp arm (2) is provided with an oblong hole (11) for the guide wire to pass through near the hinge point, and the oblong hole (11) is communicated with the strip groove (10) of the left clamp arm (2).

4. The guided skin expansion device according to claim 2, characterized in that: The forearm of the right clamp arm (3) is provided with an oblong hole (11) for the guide wire to pass through near the hinge point, and the oblong hole (11) is communicated with the strip groove (10) of the right clamp arm (3).

5. The guided skin expansion device according to claim 2, characterized in that: The guide head (6) is a truncated cone-shaped tubular structure, wherein the small diameter end thereof is a smooth head that can penetrate into the skin opening, and the large diameter end thereof is bifurcated to form a left limb (4) and a right limb (5), wherein a radial hole (12) is provided at the bifurcation, wherein the central axis of the radial hole (12) is parallel to the central axis of the pin at the hinge of the left clamp arm (2) and the right clamp arm (3), and the radial hole (12) is communicated with both the strip groove (10) of the left limb (4) and the strip groove (10) of the right limb (5).

6. The guided skin expansion device according to claim 1, characterized in that: The clamp body (1) is a split structure, wherein its left clamp arm (2) is connected to the left limb (4) by plugging, and its right clamp arm (3) is connected to the right limb (5) by plugging.

7. The guided skin expansion device according to claim 1, characterized in that: The left clamp arm (2) and the right clamp arm (3) are both made of stainless steel or hard plastic, and the left limb (4) and the right limb (5) are both disposable sterilized products.

8. The guided skin expansion device according to claim 1, characterized in that: The tail of the left clamp arm (2) and the tail of the right clamp arm (3) are both provided with finger rings (13) for holding and opening and closing the clamp body (1), and locking teeth (14) that can be engaged and locked or staggered and loosened are respectively provided on opposite sides of the two finger rings (13).

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