A membrane rupture device for a covered stent

Abstract

The present invention discloses a stent graft membrane rupture device, which relates to the field of medical device technology and includes a handle and a puncture needle assembly; the handle is provided with a push block that can move longitudinally, and the push block is fixedly connected to the puncture needle assembly; the puncture needle assembly includes a puncture needle; the handle is provided with a shell that supports the push block; the handle is also provided with a relative maximum stroke identification assembly, and the relative maximum stroke identification assembly includes a fixed marker, an indicator marker and a longitudinal limiting element; the fixed marker is set on the outer wall of the shell; the indicator marker can move relative to the fixed marker; the indicator marker can indicate the relative maximum stroke of the puncture needle; the longitudinal limiting element can prevent the puncture needle from exceeding the relative maximum stroke; the indicator marker can be linked to the longitudinal limiting element; the puncture needle can be moved back and forth between the relative maximum stroke and the minimum stroke through the push block. The present invention provides a stent graft membrane rupture device, which enables the maximum puncture depth to be adjusted.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a stent graft membrane rupture device. Background Art

[0002] With the continuous development of endovascular revascularization surgery, the application of covered stents has also increased. However, the use of covered stents in some special areas, such as the aortic arch, celiac artery, bilateral renal arteries and superior mesenteric artery, will affect the blood supply to the arterial branches, which greatly limits the use of covered stents in these areas. Currently, stent surgery in these areas can only be performed through improved surgical procedures, such as hybrid surgery, or through improved instruments, such as modular stents, pre-fenestrated stents, branch stents, multi-layer bare stents and other new instrument technologies. However, in the vast majority of cases, the anatomical structure of the aortic arch lesion is extremely complex, and there are significant individual differences. The above technical solutions are strongly dependent on the anatomical structure of the human body's branch vessels, which brings huge challenges to their product standardization and commercialization.

[0003] In situ fenestration of a covered stent is a more advanced technology, which includes two categories: energy fenestration and mechanical fenestration. Energy fenestration uses energy such as laser, radio frequency, and thermocouples to perform the fenestration operation, that is, the energy is used to ablate the covered stent to produce the desired holes. However, this method has high requirements for equipment. If the energy is too high, the stent coating will be carbonized, and its decomposition products may cause thrombosis. Insufficient energy will not achieve the desired fenestration effect. At the same time, energy can not only ablate the stent coating, but also cause damage to surrounding tissues. Therefore, mechanical fenestration has become a relatively conservative but safer fenestration method.

[0004] In the prior art, when a mechanical stent is used to open a window in situ, the maximum puncture depth of the puncture needle cannot be precisely adjusted according to needs, which can easily cause the puncture depth to be too great and accidentally injure the contralateral tissue, or the puncture depth to be insufficient and cause unsuccessful puncture. Summary of the Invention

[0005] The purpose of the present invention is to provide a stent graft membrane rupture device to solve the problems existing in the above-mentioned prior art and to enable the maximum puncture depth to be adjusted.

[0006] To achieve the above object, the present invention provides the following solutions:

[0007] The present invention provides a membrane-covered stent rupture device, comprising a handle and a puncture needle assembly; the handle is provided with a push block capable of longitudinal movement, and the push block is fixedly connected to the puncture needle assembly; the puncture needle assembly comprises a puncture needle; the handle is provided with a shell supporting the push block; the handle is also provided with a relative maximum stroke identification assembly, and the relative maximum stroke identification assembly comprises a fixed marker, an indication marker and a longitudinal limiting element; the fixed marker is arranged on the outer wall of the shell; the indication marker can move relative to the fixed marker; the indication marker can indicate the relative maximum stroke of the puncture needle; the longitudinal limiting element can prevent the puncture needle from exceeding the relative maximum stroke; the indication marker can be linked with the longitudinal limiting element; the puncture needle can be moved back and forth between the relative maximum stroke and the minimum stroke through the push block.

[0008] Preferably, the stent graft membrane breaker has a first state and a second state; in the first state, the relative maximum stroke of the puncture needle coincides with the minimum stroke, and the puncture needle is locked; in the second state, the relative maximum stroke of the puncture needle is greater than the minimum stroke, and the puncture needle is unlocked.

[0009] Preferably, the indicator mark and the longitudinal limiting element are connected via gears or cables or are two parts of an integral whole.

[0010] Preferably, the puncture needle assembly also includes a support tube fixed to the puncture needle; the proximal section of the support tube is fixed to the push block; the proximal section of the support tube is provided with a first limiting portion; the longitudinal limiting element is provided with a second limiting portion; the second limiting portion prevents the puncture needle from exceeding the relative maximum stroke by blocking the longitudinal displacement of the first limiting portion.

[0011] Preferably, the shell is provided with a slit portion which passes through the shell wall and extends longitudinally along the handle; a portion of the push block passes through the slit portion into the interior of the handle and is fixedly connected to the support tube; the shell near the proximal end of the slit portion has a third limiting portion which can prevent the push block from moving longitudinally toward the proximal end of the handle.

[0012] Preferably, the longitudinal limiting element is a cylindrical knob; the proximal section of the cylindrical knob is provided with a knob portion; the distal section of the cylindrical knob is provided with a threaded guide portion; the threaded guide portion has a proximal end and a distal end; the cylindrical knob has a hollow cavity passing through the two end surfaces of the cylindrical knob; a second limiting portion is provided in the hollow cavity and near the proximal end of the threaded guide portion; the proximal end of the threaded guide portion is provided with the indication mark; the support tube can be longitudinally movably arranged in the hollow cavity of the cylindrical knob; the first limiting portion of the support tube is arranged near the proximal end of the cylindrical knob; the threaded guide portion is movably cooperated with the knob limiter inside the handle, the knob portion is arranged outside the handle, and the cylindrical knob passes through the proximal end of the shell.

[0013] Preferably, it further comprises a locking assembly for locking the longitudinal limiting element.

[0014] Preferably, the locking assembly includes a first clutch portion arranged on the first limiting portion and a second clutch portion arranged on the second limiting portion; the first limiting portion is fixedly connected to the support tube; the first clutch portion and the second clutch portion are arranged facing each other; the contact cooperation between the first clutch portion and the second clutch portion can lock the longitudinal position of the longitudinal limiting element relative to the handle.

[0015] Preferably, the puncture needle assembly further comprises a membrane expansion balloon for expanding the puncture hole on the stent graft.

[0016] Preferably, the membrane expansion balloon is arranged on the support tube close to the puncture needle; the support tube includes a metal tube body, and the inner surface and outer surface of the metal tube body are respectively fixed with a polymer lubricating layer; a fluid channel is provided between the two layers of the polymer lubricating layers; the fluid channel is connected to the membrane expansion balloon.

[0017] Compared with the prior art, the present invention has achieved the following technical effects:

[0018] The membrane breaker of the coated stent of the present invention adjusts the relative maximum stroke of the puncture needle assembly through the longitudinal limiting element. The fixed mark can indicate the adjustment range of the relative maximum stroke. The indicating mark is linked with the longitudinal limiting element. The indicating mark indicates the relative maximum stroke after adjustment by the longitudinal limiting element, thereby realizing the adjustable puncture depth of the puncture needle assembly. The push block drives the puncture needle to move back and forth between the relative maximum stroke and the minimum stroke, thereby realizing puncture and withdrawal of the puncture needle. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0020] Figure 1 This is an axonometric view of the membrane rupture device of the stent graft of the present invention;

[0021] Figure 2 This is a front view of the membrane rupture device for the stent graft of the present invention;

[0022] Figure 3 for Figure 2 AA section view;

[0023] Figure 4 Schematic diagram of the push block, support tube and Luer connector of the present invention;

[0024] Figure 5 This is an external schematic diagram of the longitudinal limiting element of the present invention;

[0025] Figure 6 This is a schematic diagram of the interior of the longitudinal limiting element of the present invention;

[0026] Figure 7 This is a schematic diagram of the exterior of the housing and the longitudinal limiting element of the present invention;

[0027] Figure 8 This is a schematic diagram of the interior of the housing and the longitudinal limiting element of the present invention;

[0028] Figure 9 This is a front view of the puncture needle assembly and the membrane expansion balloon of the present invention;

[0029] Figure 10 A top view of the puncture needle assembly and the membrane expansion balloon of the present invention;

[0030] Figure 11 It is a cross-sectional view of the puncture needle assembly and the membrane expansion balloon of the present invention;

[0031] Figure 12 for Figure 11 A partial enlarged view of point Ⅰ;

[0032] Figure 13 for Figure 11 A partial enlarged view of location II;

[0033] Figure 14 Schematic diagram of the push block with plunger ball head, longitudinal limiting element and support tube of the present invention;

[0034] Figure 15 is a cross-sectional view of the handle of the present invention;

[0035] Figure 16 A schematic diagram of a push block with a plunger ball head according to the present invention;

[0036] Figure 17 A schematic diagram of the plunger ball head of the present invention;

[0037] In the figure: 1-handle, 2-puncture needle assembly, 3-push block, 4-housing, 5-relative maximum stroke identification assembly, 6-puncture needle, 7-support tube, 8-fixed mark, 9-indicator mark, 10-Luer connector, 11-longitudinal limit element, 12-knob limiter, 13-first limit part, 14-second limit part, 15-slit part, 16-first clutch part, 17-knob part, 18-threaded guide part, 19-hollow cavity, 20-second clutch part, 21-third limit part, 22-polymer lubricating layer, 23-expanded balloon, 24-fluid channel, 25-plunger ball head. DETAILED DESCRIPTION

[0038] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0039] The purpose of the present invention is to provide a stent graft membrane rupture device to solve the problems existing in the above-mentioned prior art and to enable the maximum puncture depth to be adjusted.

[0040] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the present invention is further described in detail below with reference to the accompanying drawings and specific embodiments.

[0041] Example 1

[0042] like Figures 1 to 8As shown, this embodiment provides a stent graft membrane rupture device, including a handle 1 and a puncture needle assembly 2; the handle 1 is provided with a push block 3 that can move longitudinally, the handle 1 is provided with a shell 4 that supports the push block 3, and the push block 3 is fixedly connected to the puncture needle assembly 2; the puncture needle assembly 2 includes a puncture needle head 6 (for puncturing a hole / window on the stent graft) and a slender support tube 7 fixedly connected to the puncture needle head 6; the proximal end section of the support tube 7 is fixedly connected to the push block 3; the proximal end section of the support tube 7 is provided with a first limit portion 13; the handle 1 is provided with a relative maximum stroke marking assembly 5 (for adjustable / flexible setting of the puncture needle 6 relative to the handle 1 / dilating balloon 2 3, that is, the maximum movement stroke of the puncture needle 6 can have multiple maximum movement strokes (0 to 25 mm in the figure), and the actual maximum movement stroke needs to be adjusted / set according to the specific surgical situation); the relative maximum stroke identification component 5 includes a fixed mark 8 (0 to 25 mm in the figure), an indicator mark 9 (a cursor or pointer coated with a striking color, used to indicate the current relative maximum stroke mark of the puncture needle 6) and a longitudinal limit element 11 (used to prevent the puncture needle 6 from exceeding the relative maximum stroke); the fixed mark 8 is set on the outer wall of the shell 4; the indicator mark 9 can move relative to the fixed mark 8; the longitudinal limit element 11 1 is a cylindrical knob; the cylindrical knob passes through the housing 4 at the proximal end of the handle 1; the proximal end section of the cylindrical knob is provided with a knob portion 17, and the knob portion 17 is arranged on the outside of the handle 1; the distal end section of the cylindrical knob is provided with a threaded guide portion 18; the threaded guide portion 18 has a proximal end and a distal end; the cylindrical knob has a hollow cavity 19 that passes through the two end surfaces of the cylindrical knob; the support tube 7 can be longitudinally movably arranged in the hollow cavity 19 of the cylindrical knob; the first limiting portion 13 of the support tube 7 is arranged near the proximal end of the cylindrical knob; a second limiting portion 14 is provided in the hollow cavity 19 and near the proximal end of the threaded guide portion 18, and the second limiting portion 14 is blocked by The longitudinal displacement of the first limiting portion 13 is blocked to prevent the puncture needle 6 from exceeding the relative maximum stroke; an indicator mark 9 is provided at the proximal end of the threaded guide portion 18; the threaded guide portion 18 is movably matched with the knob limiter 12 inside the handle 1; the shell 4 is provided with a slit portion 15 that penetrates the wall of the shell 4 and extends longitudinally along the handle 1; a part of the push block 3 passes through the slit portion 15 into the interior of the handle 1 and is fixedly connected to the support tube 7; the shell 4 near the proximal end of the slit portion 15 has a third limiting portion 21 that can block the push block 3 from moving longitudinally toward the proximal end of the handle 1; the push block 3 can enable the puncture needle 6 to move back and forth between the relative maximum stroke and the minimum stroke.

[0043] The present embodiment further includes a locking assembly for locking the longitudinal limiting element 11, the locking assembly including a first clutch portion 16 provided on the first limiting portion 13 and a second clutch portion 20 provided on the second limiting portion 14; the first limiting portion 13 is fixedly connected to the support tube 7; the first clutch portion 16 and the second clutch portion 20 are arranged facing each other; the contact and cooperation between the first clutch portion 16 and the second clutch portion 20 can lock the longitudinal position of the longitudinal limiting element 11 relative to the handle 1 (the support tube 7 is fixedly connected to the first limiting portion 13, the support tube 7 is fixedly connected to the push block 3, and the push block 3 is fixedly connected). 3 is restricted by the housing 4, so the first limiting portion 13 cannot rotate circumferentially, while the cylindrical knob moves forward or backward by rotating; the contact and cooperation between the first clutch portion 16 and the second clutch portion 20 couples the cylindrical knob with the first limiting portion 13, thereby preventing the cylindrical knob from further rotating and advancing. That is, the first clutch portion 16 and the second clutch portion 20 restrict the circumferential relative movement of the first limiting portion 13 and the second limiting portion 14, thereby restricting the axial relative movement of the first limiting portion 13 and the second limiting portion 14).

[0044] The membrane rupture device of the coated stent in this embodiment has a first state and a second state; in the first state, the relative maximum stroke of the puncture needle 6 coincides with the minimum stroke (that is, the indicator mark 9 in the figure stops at the position of 0 mm), and the puncture needle 6 is locked (the first clutch part 16 and the second clutch part 20 are in contact and fit); in the second state, the relative maximum stroke of the puncture needle 6 is greater than the minimum stroke, and the puncture needle 6 is unlocked (the first clutch part 16 and the second clutch part 20 are separated).

[0045] Example 2

[0046] In order to realize the integration of the puncture needle assembly 2 and the membrane expansion balloon 23, as shown in FIG. Figures 9 to 13 As shown, this embodiment discloses a puncture needle assembly 2: a support tube 7 comprises a hypotube metal tube, with polymer lubricating layers 22 bonded to both the inner and outer surfaces of the support tube 7; a fluid channel 24 is provided between the two polymer lubricating layers 22; a membrane expansion balloon 23 is bonded to the end of the metal needle tip near the puncture needle 6; the membrane expansion balloon 23 is connected to the fluid channel 24. After a needle with a guidewire punctures the stent graft, the stent graft can be expanded using the membrane expansion balloon 23 attached to the puncture needle without withdrawing the needle.

[0047] like Figures 1 to 8As shown, the membrane rupture device handle 1; the handle 1 housing 4 is provided with a longitudinally movable push block 3, which is fixedly connected to the puncture needle assembly 2; the proximal end of the puncture needle assembly 2 is coaxially sleeved with a longitudinal limiter 11, which is fixedly connected to the Luer connector 10; the longitudinal limiter 11 has a threaded guide; and a knob limiter 12, which flexibly cooperates with the longitudinal limiter 11, is fixed to the end of the handle 1 housing 4. The longitudinal limiter 11 can be adjusted relative to the handle 1 by threading with the knob limiter 12, thereby limiting the movable distance of the Luer connector 10 and the length of the membrane rupture needle.

[0048] like Figures 14 to 17 As shown, a further improvement is made by adding a plunger ball 25 to the push block 3. The internal component (support tube 7) contacts the handle 1 via the plunger ball 25, and the plunger ball 25 can roll relative to the inner wall of the handle 1. The plunger ball 25 can reduce the resistance of the internal component inside the handle 1, thereby improving the feel when removing the needle (because when the needle is rupturing the membrane, the resistance feedback of the rupture membrane is very important to the doctor).

[0049] The present invention uses specific examples to illustrate the principles and implementation methods of the present invention. The above examples are only intended to help understand the method and core concept of the present invention. At the same time, those skilled in the art will find that the specific implementation methods and application scopes may vary based on the concept of the present invention. In summary, the contents of this specification should not be construed as limiting the present invention.

Claims

1. A stent graft membrane rupture device, comprising a handle and a puncture needle assembly; the handle is provided with a push block capable of longitudinal movement, the push block being fixedly connected to the puncture needle assembly; the puncture needle assembly includes a puncture needle head; the handle is provided with a housing supporting the push block; characterized in that The handle is further provided with a relative maximum stroke marking assembly, which includes a fixed mark, an indicator mark and a longitudinal limit element; the fixed mark is provided on the outer wall of the housing; the indicator mark can move relative to the fixed mark; the indicator mark can indicate the relative maximum stroke of the puncture needle; the longitudinal limit element can prevent the puncture needle from exceeding the relative maximum stroke; the indicator mark can be linked to the longitudinal limit element; the puncture needle can be moved back and forth between the relative maximum stroke and the minimum stroke by the push block; The puncture needle assembly further includes a support tube fixedly connected to the puncture needle; a proximal end section of the support tube is fixedly connected to the push block; a first limiting portion is provided at the proximal end section of the support tube; the longitudinal limiting element is provided with a second limiting portion; the second limiting portion prevents the puncture needle from exceeding a relative maximum stroke by blocking the longitudinal displacement of the first limiting portion; The longitudinal limiting element is a cylindrical knob; the proximal end section of the cylindrical knob is provided with a knob portion; the distal end section of the cylindrical knob is provided with a threaded guide portion; the threaded guide portion has a proximal end and a distal end; the cylindrical knob has a hollow cavity that passes through both end surfaces of the cylindrical knob; a second limiting portion is provided in the hollow cavity and near the proximal end of the threaded guide portion; the proximal end of the threaded guide portion is provided with the indicating mark; the supporting tube can be longitudinally movably arranged in the hollow cavity of the cylindrical knob; the first limiting portion of the supporting tube is arranged near the proximal end of the cylindrical knob; the threaded guide portion is movably matched with the knob limiting piece inside the handle, the knob portion is arranged outside the handle, and the cylindrical knob passes through the proximal end of the shell; Also included is a locking assembly for locking the longitudinal limiting element; The locking assembly includes a first clutch portion arranged on the first limiting portion and a second clutch portion arranged on the second limiting portion; the first limiting portion is fixedly connected to the support tube; the first clutch portion and the second clutch portion are arranged opposite to each other; the contact and cooperation between the first clutch portion and the second clutch portion can lock the longitudinal position of the longitudinal limiting element relative to the handle.

2. The membrane rupture device of the stent graft according to claim 1, characterized in that: The stent graft membrane breaker has a first state and a second state; in the first state, the relative maximum stroke of the puncture needle coincides with the minimum stroke, and the puncture needle is locked; in the second state, the relative maximum stroke of the puncture needle is greater than the minimum stroke, and the puncture needle is unlocked.

3. The membrane rupture device for the stent graft according to claim 1, characterized in that: The indicator mark and the longitudinal limiting element are connected via gears or cables or are two parts of an integral whole.

4. The stent graft membrane rupture device according to claim 1, characterized in that: The shell is provided with a slit portion which passes through the shell wall and extends longitudinally along the handle; a portion of the push block passes through the slit portion into the interior of the handle and is fixedly connected to the support tube; the shell near the proximal end of the slit portion has a third limiting portion which can prevent the push block from moving longitudinally toward the proximal end of the handle.

5. The membrane rupture device for the stent graft according to claim 1, characterized in that: The puncture needle assembly also includes a membrane expansion balloon for expanding the puncture hole on the coated stent.

6. The membrane rupture device for the stent graft according to claim 5, characterized in that: The membrane expansion balloon is arranged on the support tube close to the puncture needle; the support tube includes a metal tube body, and the inner and outer surfaces of the metal tube body are respectively fixed with a polymer lubricating layer; a fluid channel is provided between the two layers of the polymer lubricating layers; the fluid channel is connected to the membrane expansion balloon.

Images