Auxiliary sheath kit for valve delivery

Abstract

The present invention relates to the technical field of surgical instruments. An auxiliary sheath tube kit for valve delivery comprises an outer sheath and a primary guide inner core, a guide wire perforation is provided on the primary guide inner core, and the head end of the primary guide inner core is a primary conical guide part which is narrow in front and wide in the back; the outer sheath is a retractable sheath tube, and the outer sheath comprises a proximal end sheath tube part and a distal end sheath tube part which are sequentially connected along the axial direction; the proximal end sheath tube part is provided with a strip-shaped slide groove arranged circumferentially; the distal end sheath tube part is provided with a strip-shaped extension part for axially sliding into the strip-shaped slide groove; the proximal end in the length direction of the strip-shaped slide groove and the distal end in the length direction of the proximal end sheath tube part are switched and clamped with the strip-shaped extension part; the outer sheath also comprises a foldable film, one end of the film is fixedly connected to the proximal end sheath tube part, and the other end of the film is fixedly connected to the distal end sheath tube part. The present invention realizes the improvement of the passability of the instrument without increasing the outer diameter of the sheath tube, and avoids the damage of the blood vessel wall during the instrument delivery process.

Description

Technical Field

[0001] The present invention relates to the technical field of surgical instruments, in particular to a sheath tube. Background Art

[0002] Transcatheter aortic valve replacement (TAVR) is a minimally invasive valve replacement procedure that uses interventional catheter technology to deliver an artificial aortic valve to the original aortic valve, thereby replacing the diseased valve and achieving the treatment goal.

[0003] During TAVR surgery, due to the severe stenosis of the patient's diseased aortic valve, it is difficult for the device to pass through the stenotic aortic lesions. Difficulties in crossing the valve may lead to prolonged surgery time, increased risk of complications, and unsatisfactory surgical results.

[0004] In addition, for patients with ascending aortic dilatation and aortic calcification, the system push process may cause risks such as aortic wall damage and calcification detachment. These challenging anatomical features pose a threat to the success rate and safety of TAVR surgery, and there is currently no dedicated device to address this problem. Summary of the invention

[0005] In view of the problems existing in the prior art, the present invention provides an auxiliary sheath kit for valve delivery to solve at least one of the above technical problems.

[0006] In order to achieve the above-mentioned object, the present invention provides an auxiliary sheath tube kit for valve delivery, comprising an outer sheath and a primary guide inner core, wherein the primary guide inner core is provided with a guide wire perforation for passing a guide wire, the head end of the primary guide inner core is the proximal end of the primary guide inner core, and the head end of the primary guide inner core is a primary conical guide portion which is narrow in front and wide in the back;

[0007] The outer diameter of the primary guide inner core matches the inner diameter of the outer sheath;

[0008] The outer sheath is a retractable sheath tube, and the outer sheath comprises a proximal sheath tube portion and a distal sheath tube portion sequentially connected along the axial direction;

[0009] The proximal sheath portion is provided with a through hole for providing a blood flow channel away from the distal sheath portion;

[0010] The proximal sheath portion is provided with a circumferentially arranged strip-shaped slide groove adjacent to the distal sheath portion, wherein the radial inner side of the strip-shaped slide groove is open and the distal end of the strip-shaped slide groove is open in the axial direction;

[0011] The distal end sheath tube portion is provided with a strip-shaped extension portion adjacent to the proximal end sheath tube portion for axially sliding into the strip-shaped slide groove;

[0012] The proximal end of the strip-shaped slide groove in the length direction and the distal end of the proximal end sheath tube in the length direction are switched to be clamped with the strip-shaped extension part;

[0013] The outer sheath further comprises a foldable film, one end of which is fixedly connected to the proximal sheath tube portion, and the other end of which is fixedly connected to the distal sheath tube portion, and the film covers the strip-shaped extension portion.

[0014] The present invention improves the passability of the device without increasing the outer diameter of the sheath tube, and avoids damage to the blood vessel wall during the device delivery process.

[0015] The present invention realizes the retractability of the outer sheath, and solves the problem that the existing long vascular sheath cannot be retracted and may cause the size mismatch of surgical instruments.

[0016] When the present invention is used, the outer sheath is in an extended state, and the proximal sheath tube portion is pushed along the primary guide inner core to below the aortic valve opening, thereby conveniently providing an instrument delivery channel.

[0017] Further preferably, the outer sheath is in an extended state, and the distal end of the proximal sheath portion in the length direction is switched to engage with the strip-shaped extension portion;

[0018] When the outer sheath is in a shortened state, the proximal end of the strip-shaped slide groove in the length direction is engaged with the strip-shaped extension portion.

[0019] Further preferably, a mastoid structure is provided at the proximal end of the strip-shaped extension;

[0020] The proximal end of the strip-shaped slide groove in the length direction is provided with an arc-shaped slot for clamping the mastoid structure;

[0021] An arc-shaped clamping groove for clamping the mastoid structure is provided at the distal end of the proximal sheath tube portion in the length direction.

[0022] Further preferably, the distal end of the distal sheath portion is provided with a functional interface, the inner wall of the functional interface is connected to an annular water bag, and the annular water bag expands to close the inner cavity of the functional interface;

[0023] The functional interface is connected to a liquid filling and discharging pipeline for filling and discharging liquid into and out of the annular water bag, and the liquid filling and discharging pipeline is connected to the annular water bag.

[0024] Further preferably, the functional interface is connected to a flushing port, and the flushing port is connected to a flushing pipeline;

[0025] The flushing port is located at one side of the proximal end of the annular water bag.

[0026] Further preferably, it further comprises a secondary guide inner core, the secondary guide inner core is provided with a guide wire through hole for passing a guide wire, the head end of the secondary guide inner core is the proximal end of the secondary guide inner core, and the head end of the secondary guide inner core is a secondary conical guide portion which is narrow in front and wide in the back;

[0027] Also included is a secondary guide, the secondary guide comprising an extended sheath portion and a push rod portion sequentially connected along the axial direction;

[0028] The radial cross section of the push rod is an arc-shaped structure with a central angle less than 180°;

[0029] The secondary guide piece is sleeved on the outer side of the secondary guide inner core and is slidably arranged on the inner side of the outer sheath;

[0030] The outer diameter of the primary guide inner core matches the inner diameter of the secondary guide member, and the outer diameter of the secondary guide member matches the inner diameter of the outer sheath.

[0031] Once the proximal sheath tube cannot be pushed below the aortic valve opening when the outer sheath is extended, the secondary guide inner core and the secondary guide member are inserted to extend the accessible path. The arc structure of the push rod is a non-closed tubular structure, which facilitates the provision of space for the instrument to pass through.

[0032] Further preferably, the extension sheath portion and the push rod portion are connected via a transition portion;

[0033] The central angle of the radial cross section of the transition portion gradually decreases from adjacent to the extended sheath portion to adjacent to the push rod portion.

[0034] The provision of the transition portion facilitates a smooth transition between the extended sheath portion and the pushing rod portion, and at the same time, the transition portion facilitates guiding the instrument to pass through.

[0035] Further preferably, the proximal end of the extended sheath portion is provided with a through hole for providing a blood flow channel;

[0036] The extended sheath tube portion is provided with a developing component.

[0037] Further preferably, the outer wall of the primary conical guide portion is covered with a hydrophilic coating.

[0038] Further preferably, the outer wall of the secondary conical guide portion is covered with a hydrophilic coating.

[0039] Compared with the prior art, the present invention has the following beneficial effects:

[0040] 1) Through the optimization of the outer sheath structure, the passability of the device is improved without increasing the outer diameter of the sheath, and the damage to the blood vessel wall during the delivery of the device is avoided. A through hole is set at the proximal end of the outer sheath, which serves to provide a channel for blood flow after the retractable sheath passes through the aortic valve, avoiding blocking the aortic valve orifice.

[0041] 2) Through the functional interface, physiological saline is injected into the annular water bag to achieve the effect of a hemostatic valve, and a flushing port is provided.

[0042] 3) The tip of the primary guide core may be covered with a hydrophilic coating to facilitate passing through the diseased aortic valve opening; a guide wire may pass through the middle of the primary guide core, so that the proximal end of the outer sheath may be transported to the target position along the guide wire.

[0043] 4) A secondary guide inner core and a secondary guide piece are added. When the outer sheath is not long enough to deliver to the target position, the tool can be quickly switched to extend the delivery. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] Figure 1 This is a schematic diagram of an exploded view of a specific embodiment 1 of the present invention;

[0045] Figure 2 It is a schematic diagram of the outer sheath in the specific embodiment 1 of the present invention in an extended state;

[0046] Figure 3 It is a schematic diagram of the connection between the proximal sheath tube portion and the distal sheath tube portion when the outer sheath is in a shortened state according to the specific embodiment 1 of the present invention;

[0047] Figure 4 It is a schematic diagram of the connection between the proximal end sheath tube portion and the distal end sheath tube portion of the outer sheath in the extended state of the specific embodiment 1 of the present invention;

[0048] Figure 5 It is an exploded view of the connection between the proximal end sheath tube portion and the distal end sheath tube portion when the outer sheath is in a shortened state according to the specific embodiment 1 of the present invention;

[0049] Figure 6 This is a schematic diagram of the steps of the method for use of specific embodiment 1 of the present invention;

[0050] Figure 7 This is a schematic diagram of an exploded view of a specific embodiment 2 of the present invention;

[0051] Figure 8 This is a schematic diagram of the steps of using the specific embodiment 2 of the present invention.

[0052] Among them: 1 is a primary guide inner core, 2 is an outer sheath, 21 is a proximal sheath portion, 211 is a strip-shaped slide groove, 22 is a distal sheath portion, 221 is a strip-shaped extension portion, 3 is a film, 4 is a flushing pipeline, 5 is a charging and discharging pipeline, 6 is a functional interface, 7 is an artificial valve system, 8 is a guide wire, 9 is a secondary guide, 91 is an extended sheath portion, 92 is a push rod portion, 93 is a transition portion, and 10 is a secondary guide inner core. DETAILED DESCRIPTION

[0053] The present invention will be further described below in conjunction with the accompanying drawings.

[0054] See also Figures 1 to 6 , Specific embodiment 1: An auxiliary sheath tube kit for valve delivery, comprising an outer sheath 2, and also comprising a primary guide inner core 1, the primary guide inner core 1 is provided with a guide wire perforation for passing a guide wire 8, the head end of the primary guide inner core 1 is the proximal end of the primary guide inner core 1, and the head end of the primary guide inner core 1 is a primary conical guide portion that is narrow in front and wide in the back; the outer diameter of the primary guide inner core 1 matches the inner diameter of the outer sheath 2; the outer sheath 2 is a retractable sheath tube, and the outer sheath comprises a proximal end sheath tube portion 21 and a distal end sheath tube portion 22 that are sequentially connected along the axial direction; the proximal end sheath tube portion 21 is provided with a through hole for providing a blood flow channel away from the distal end sheath tube portion 22; the proximal end sheath tube portion 21 is adjacent to the distal end sheath tube portion 22 A strip-shaped slide groove 211 arranged circumferentially is provided on the side of the proximal and distal end sheath tube portion 22, the radial inner side of the strip-shaped slide groove 211 is open, and the distal end in the axial direction is open; a strip-shaped extension portion 221 for axially sliding into the strip-shaped slide groove 211 is provided on the side of the distal end sheath tube portion 22 adjacent to the proximal end sheath tube portion 21; the proximal end of the strip-shaped slide groove 211 in the length direction and the distal end of the proximal end sheath tube portion 21 in the length direction are switched and clamped with the strip-shaped extension portion 221; the outer sheath 2 also includes a foldable film 3, one end of the film 3 is fixedly connected to the proximal end sheath tube portion 21, and the other end of the film 3 is fixedly connected to the distal end sheath tube portion 22, and the film 3 covers the strip-shaped extension portion 221. The film covers the connection between the proximal end sheath tube portion 21 and the distal end sheath tube portion 22. The material of the film can be PTEF.

[0055] The present invention improves the passability of the device without increasing the outer diameter of the sheath tube, and avoids damage to the blood vessel wall during the device delivery process.

[0056] The present invention realizes the retractability of the outer sheath 2, and solves the problem that the existing long vascular sheath cannot be retracted, which may cause the size mismatch of surgical instruments. When the present invention is used, the outer sheath 2 is in an extended state, and the proximal end sheath tube portion 21 is pushed along the primary guide inner core 1 to below the aortic valve opening. It is convenient to provide an instrument delivery channel. The proximal end refers to the part adjacent to the left ventricle, and the distal end is the part away from the left ventricle.

[0057] The proximal sheath tube portion 21 and the distal sheath tube portion 22 both include an outer sheath and a metal braided layer embedded in the outer sheath. The outer sheath is silicone or rubber.

[0058] The outer wall of the primary conical guide portion is covered with a hydrophilic coating.

[0059] The length of the strip-shaped slide groove 211 is 20-30 cm.

[0060] When the outer sheath 2 is in the extended state, the distal end of the proximal sheath tube 21 in the length direction is switched and engaged with the strip extension part 221 ; when the outer sheath 2 is in the shortened state, the proximal end of the strip slide 211 in the length direction is engaged with the strip extension part 221 .

[0061] The axial length of the primary guide inner core 1 is greater than the length of the outer sheath in the extended state. The primary guide inner core is made of silica gel or rubber.

[0062] The proximal end of the strip extension portion 221 is provided with a mastoid structure; the proximal end of the strip slide 211 in the length direction is provided with an arcuate slot for engaging the mastoid structure; the distal end of the proximal sheath portion 21 in the length direction is provided with an arcuate slot for engaging the mastoid structure.

[0063] The distal end of the distal end sheath tube 22 is provided with a functional interface 6, the inner wall of the functional interface 6 is connected to an annular water bag, the annular water bag expands to close the inner cavity of the functional interface; the functional interface is connected to a liquid filling and discharging pipeline 5 for filling and discharging liquid into the annular water bag, and the liquid filling and discharging pipeline 5 is connected to the annular water bag. The functional interface 6 is connected to a flushing port, and the flushing port is connected to a flushing pipeline 4; the flushing port is located on one side of the proximal end of the annular water bag.

[0064] Directions:

[0065] Step 1, inserting the outer sheath 2 in a shortened state;

[0066] Step 2: Use the guide wire 8 to establish a pathway. The paths of the guide wire 8 are, in sequence, the outside of the body, the aorta, the aortic root, and the left ventricle; see Figure 6 (a)

[0067] Step 3: The outer sheath 2 is in an extended state, and the primary guide inner core 1 is inserted along the guide wire 8, and the outer sheath 2 is pushed along the guide wire 8 to below the aortic valve opening; see Figure 6 (b)

[0068] Step 4: Remove the first level guide core 1, see Figure 6 (c)

[0069] The artificial valve system 7 is pushed along the guide wire 8 to below the aortic valve opening; see Figure 6 (d)

[0070] Step 5: shorten the outer sheath 2 and withdraw the outer sheath 2. Figure 6 (e) in .

[0071] Specific embodiment 2, on the basis of specific embodiment 1, further includes a secondary guide core 10, the secondary guide core 10 is provided with a guide wire perforation for passing the guide wire, the head end of the secondary guide core 10 is the proximal end of the secondary guide core 10, and the head end of the secondary guide core 10 is a secondary conical guide portion that is narrow in front and wide in the back; it also includes a secondary guide member 9, the secondary guide member 9 includes an extended sheath tube portion 91 and a push rod portion 92 connected in sequence along the axial direction; the radial cross-section of the push rod portion 92 is an arc structure with a central angle less than 180°; the secondary guide member 9 is sleeved on the outside of the secondary guide core 10, and is slidably arranged on the inside of the outer sheath; the outer diameter of the primary guide core matches the inner diameter of the secondary guide member 9, and the outer diameter of the secondary guide member 9 matches the inner diameter of the outer sheath.

[0072] Once the proximal sheath tube cannot be pushed below the aortic valve opening when the outer sheath is extended, the secondary guide inner core 10 and the secondary guide member 9 are inserted to extend the accessible path. The push rod 92 is an arc-shaped structure that is not a closed tubular structure, which facilitates the provision of space for the instrument to pass through.

[0073] The secondary guide comprises an outer layer and a metal braided layer buried in the outer layer. The outer layer is made of silicone or rubber. The inner core of the secondary guide is made of silicone or rubber.

[0074] The axial length of the secondary guide inner core 10 is greater than the length of the secondary guide member 9 .

[0075] The axial length of the secondary guide inner core 10 is greater than the axial length of the primary guide inner core 1 .

[0076] The extension sheath portion 91 and the push rod portion 92 are connected via a transition portion 93; the central angle of the radial cross section of the transition portion 93 gradually decreases from the extension sheath portion 91 to the push rod portion 92. The provision of the transition portion 93 facilitates a smooth transition between the extension sheath portion 91 and the push rod portion 92, and at the same time, the transition portion 93 facilitates the guiding of instruments through.

[0077] The extension sheath tube 91 is 40-80 cm.

[0078] A through hole for providing a blood flow channel is opened at the proximal end of the extended sheath tube part 91; a developing member is provided on the extended sheath tube part 91. The outer wall of the secondary conical guide part is covered with a hydrophilic coating.

[0079] Directions:

[0080] Step 1: After the outer sheath 2 is inserted, a guide wire 8 is used to establish a pathway. The paths of the guide wire 8 are, in sequence, the outside of the body, the aorta, the aortic root, and the left ventricle; see Figure 8 (a)

[0081] Step 2: Once the outer sheath 2 cannot extend below the aortic valve opening in the extended state, the outer sheath 2 is shortened, the secondary guide inner core 10 is inserted into the secondary guide member 9, and the head end of the secondary guide member 9 is pushed along the guide wire 8 to below the aortic valve ring plane. Figure 8 (b); the through hole at the head end of the secondary guide 9 is located above the aortic valve opening, and the secondary guide inner core 10 is withdrawn; at this time, the extended sheath portion 91 is partially located within the outer sheath; see Figure 8 (c)

[0082] Step 3: Push the artificial valve system 7 along the guide wire 8 to below the aortic valve opening; see Figure 8 (d)

[0083] Step 4: Pull the push rod 92 to allow the extended sheath tube 91 to enter the outer sheath 2. Figure 8 (e) in .

[0084] The above are only preferred embodiments of the present invention. It should be pointed out that, for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. An auxiliary sheath kit for valve delivery, comprising an outer sheath, characterized in that: It also includes a primary guide inner core, the primary guide inner core is provided with a guide wire through hole for passing a guide wire, the head end of the primary guide inner core is the proximal end of the primary guide inner core, and the head end of the primary guide inner core is a primary conical guide portion that is narrow in front and wide in the back; The outer diameter of the primary guide inner core matches the inner diameter of the outer sheath; The outer sheath is a retractable sheath tube, and the outer sheath comprises a proximal sheath tube portion and a distal sheath tube portion sequentially connected along the axial direction; The proximal sheath portion is provided with a through hole away from the distal sheath portion for providing a passage for blood flow after the telescopic sheath passes through the aortic valve; The proximal sheath portion is provided with a circumferentially arranged strip-shaped slide groove adjacent to the distal sheath portion, wherein the radial inner side of the strip-shaped slide groove is open and the distal end of the strip-shaped slide groove is open in the axial direction; The distal end sheath tube portion is provided with a strip-shaped extension portion adjacent to the proximal end sheath tube portion for axially sliding into the strip-shaped slide groove; The proximal end of the strip-shaped slide groove in the length direction and the distal end of the proximal end sheath tube in the length direction are switched to be clamped with the strip-shaped extension part; The outer sheath also includes a foldable film, one end of which is fixedly connected to the proximal sheath tube portion, and the other end of which is fixedly connected to the distal sheath tube portion, and the film covers the strip-shaped extension portion.

2. The auxiliary sheath kit for valve delivery according to claim 1, characterized in that: The outer sheath is in an extended state, and the distal end of the proximal sheath tube portion in the length direction is engaged with the strip-shaped extension portion; When the outer sheath is in a shortened state, the proximal end of the strip-shaped slide groove in the length direction is engaged with the strip-shaped extension portion.

3. The auxiliary sheath kit for valve delivery according to claim 1, characterized in that: A mastoid structure is provided at the proximal end of the strip-shaped extension; The proximal end of the strip-shaped slide groove in the length direction is provided with an arc-shaped slot for clamping the mastoid structure; An arc-shaped clamping groove for clamping the mastoid structure is provided at the distal end of the proximal sheath tube portion in the length direction.

4. The auxiliary sheath kit for valve delivery according to claim 1, characterized in that: The distal end of the distal sheath tube is provided with a functional interface, the inner wall of the functional interface is connected to an annular water bag, and the annular water bag expands to close the inner cavity of the functional interface; The functional interface is connected to a liquid filling and discharging pipeline for filling and discharging liquid into and out of the annular water bag, and the liquid filling and discharging pipeline is connected to the annular water bag.

5. The auxiliary sheath kit for valve delivery according to claim 4, characterized in that: The functional interface is connected to a flushing port, and the flushing port is connected to a flushing pipeline; The flushing port is located at one side of the proximal end of the annular water bag.

6. The auxiliary sheath kit for valve delivery according to claim 1, characterized in that: It also includes a secondary guide inner core, the secondary guide inner core is provided with a guide wire throughhole for passing the guide wire, the head end of the secondary guide inner core is the proximal end of the secondary guide inner core, and the head end of the secondary guide inner core is a secondary conical guide portion that is narrow in front and wide in the back; Also included is a secondary guide, the secondary guide comprising an extended sheath portion and a push rod portion sequentially connected along the axial direction; The radial cross section of the push rod is an arc-shaped structure with a central angle less than 180°; The secondary guide piece is sleeved on the outer side of the secondary guide inner core and is slidably arranged on the inner side of the outer sheath; The outer diameter of the primary guide inner core matches the inner diameter of the secondary guide member, and the outer diameter of the secondary guide member matches the inner diameter of the outer sheath.

7. The auxiliary sheath kit for valve delivery according to claim 6, characterized in that: The extension sheath portion and the push rod portion are connected via a transition portion; The central angle of the radial cross section of the transition portion gradually decreases from adjacent to the extended sheath portion to adjacent to the push rod portion.

8. The auxiliary sheath kit for valve delivery according to claim 6, characterized in that: The proximal end of the extended sheath portion is provided with a through hole for providing a blood flow channel; The extended sheath tube portion is provided with a developing component.

9. The auxiliary sheath kit for valve delivery according to claim 1, characterized in that: The outer wall of the primary conical guide portion is covered with a hydrophilic coating.

10. The auxiliary sheath kit for valve delivery according to claim 6, characterized in that: The outer wall of the secondary conical guide portion is covered with a hydrophilic coating.

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