Disclosure of Invention
The present disclosure has been made in view of the above-described conventional circumstances, and an object thereof is to provide an intravascular ultrasound imaging system with an isolation bag that can avoid the occurrence of wear, tear, and the like of the isolation bag.
To this end, the present disclosure provides an intravascular ultrasound imaging system with an isolation pouch characterized by comprising an ultrasound catheter having a drive shaft and an ultrasound probe connected to the drive shaft, a retraction device having a retraction main body and a support portion carrying the retraction main body, the retraction main body including a fitting portion connected to the ultrasound catheter, the support portion having a base plate carrying the retraction main body and a fixing portion located on a side of the retraction main body facing the ultrasound probe, the retraction main body being mounted to the base plate and slidably movable along a length direction of the base plate, and an isolation pouch comprising a pouch body, and a clamping portion and a connecting portion provided on the pouch body, the clamping portion having a base and a clamping head fixed to the base via the pouch body, the base being mounted to the fixing portion, the connecting portion having a receiving hole penetrating the pouch body, the receiving hole being configured to be sized to receive the ultrasound catheter, the fitting portion being mounted to the fitting portion and the retraction main body via the receiving hole.
In the intravascular ultrasound imaging system according to the present disclosure, the isolation bag connects the clamping portion with the fixing portion of the support plate and connects the connecting portion with the fitting portion of the pullback main unit, in which case the catheter can be clamped to the clamping portion, and the tip of the catheter can be connected to the connecting portion, whereby the catheter can be clamped to the clamping portion alone, thereby avoiding the possibility of abrasion and tearing of the isolation bag.
In addition, in the intravascular ultrasound imaging system according to the present disclosure, optionally, a predetermined distance is provided between any point on the side of the clamping portion near the connecting portion and any point on the side of the connecting portion near the clamping portion. In this case, the separation bag between the grip portion and the connection portion is set to a proper length, whereby the separation bag between the grip portion and the connection portion is not torn due to an insufficient length during the withdrawal.
In addition, in the intravascular ultrasound imaging system according to the present disclosure, optionally, the connection portion is a clip detachably fixed to the bag main body, the clip being provided with a protrusion shape-matched with the fitting portion. Thereby, the clips can clamp the isolation bag between the clips and be assembled on the assembling part.
In addition, in the intravascular ultrasound imaging system according to the present disclosure, optionally, the protrusion of the connection portion is provided with a notch, and the fitting portion is provided with a positioning post that mates with the notch. Thus, the fitting form of the connecting portion and the fitting portion can be defined by the matching relationship of the notch and the positioning column.
In addition, in the intravascular ultrasound imaging system according to the present disclosure, optionally, the clamping portion includes the clamping head disposed on the base toward an outer side, and the clamping portion further includes a protrusion disposed on the base toward the inner side. In this case, the base can be better matched with the fixing portion, whereby the catheter can be stably retracted by being gripped with the gripping head.
In addition, in the intravascular ultrasound imaging system according to the present disclosure, optionally, the width of the fixing portion is gradually reduced along an end closer to the support portion to an end farther from the support portion, and the fixing portion has a groove that mates with the protrusion of the clamping portion. Thus, the base can be stably fixed to the fixing portion by the inner protrusion.
In addition, in the intravascular ultrasound imaging system according to the present disclosure, optionally, the isolation bag is sleeved on the retraction host and the support portion, and is used for isolating the ultrasound catheter and the retraction device. Thus, the catheter and the withdrawal device can be completely isolated.
In addition, in the intravascular ultrasound imaging system according to the disclosure, optionally, the base further includes a strap disposed on a side edge where the clamping head is located and disposed along an opposite direction to the clamping head. This can further limit the displacement of the base and improve the stability of the base fixed to the fixing portion.
In addition, in the intravascular ultrasound imaging system according to the present disclosure, optionally, the clamping head of the clamping portion is disposed on a central axis of the base, and a width of the base is smaller than a width of the fixing portion. This reduces the weight of the fixing portion.
In addition, in the intravascular ultrasound imaging system according to the disclosure, optionally, the clamping portion further includes a boss disposed between the clamping heads. This can provide a buffer when clamping the catheter.
According to the present disclosure, an intravascular ultrasound imaging system with an isolation bag capable of avoiding the occurrence of abrasion, tearing, and the like of the isolation bag can be provided.
Detailed Description
The present disclosure is described in further detail below with reference to the drawings and detailed description. In the drawings, the same components or components having the same functions are denoted by the same reference numerals, and repetitive description thereof will be omitted.
The retraction device 10 according to this embodiment may be used in an IVUS system (also called intravascular ultrasound imaging system) consisting mainly of an ultrasound catheter, the retraction device 10 and an IVUS host system. The catheter is withdrawn by the withdrawal device 10, which is required to maintain a rapid rotation during withdrawal and a uniform withdrawal speed. However, the present embodiment is not limited thereto, and in some examples, the retraction device 10 according to the present embodiment may also be used for catheter retraction in measuring fractional flow reserve (FFR, fractional Flow Reserve), and the FFR measurement system mainly consists of a pressure measurement catheter, the retraction device 10, and an FFR host system. In other examples, the retraction device 10 according to this embodiment may also be used for catheter retraction in optical coherence tomography (OCT, optical Coherence Tomography), the OCT system consisting essentially of an optical probe catheter, the retraction device 10 and an OCT host system. In addition, in some examples, the retraction device 10 according to the present embodiment may also be used for catheter retraction in phased array intravascular ultrasound imaging-based phased array intravascular ultrasound imaging systems consisting essentially of a phased array ultrasound catheter, the retraction device 10, and a phased array ultrasound host system.
Fig. 1 is a schematic view showing a state of use of an intravascular ultrasound imaging system 1 with an isolation bag 20 according to an embodiment of the present disclosure.
As shown in fig. 1, in the present embodiment, an intravascular ultrasound imaging system 1 with an isolation bag 20 according to the present disclosure includes an ultrasound catheter 2 (sometimes also referred to simply as a "catheter"), a retraction device 10, and an isolation bag 20. The ultrasound catheter 2 may have a drive shaft and an ultrasound probe connected to the drive shaft. The withdrawing device 10 may have a withdrawing main body 11 and a supporting part carrying the withdrawing main body 11, wherein the withdrawing main body 11 may include a fitting part 111 connected to a catheter, and the supporting part may have a base plate 12 carrying the withdrawing main body 11 and a fixing part 13 located at a side of the withdrawing main body 11 facing the ultrasonic probe, and the withdrawing main body 11 is mounted on the base plate 12 and slidably moves along a length direction of the base plate 12. The isolation bag 20 may include a bag body 21, and a clamping part 22 and a connection part 23 provided on the bag body 21, wherein the clamping part 22 has a base 221 and a clamping head 222 fixed to the base 221 via the bag body 21, the base 221 is mounted to the fixing part 13, the connection part 23 has a receiving hole 233 penetrating the bag body 21, the receiving hole 233 is configured to have a size to receive a catheter, the connection part 23 is mounted to the fitting part 111, and the ultrasonic catheter 2 is mated with the pullback main body 11 via the receiving hole 233.
In the intravascular ultrasound imaging system 1 according to the present disclosure, the isolation bag 20 connects the clamping portion 22 with the fixing portion 13 of the support plate and connects the connecting portion 23 with the fitting portion 111 of the pullback main unit 11, in which case the catheter can be clamped to the clamping portion 22 and the tip of the catheter can be connected to the connecting portion 23, whereby the catheter can be clamped to the clamping portion 22 alone, thereby avoiding the possibility of abrasion and tearing of the isolation bag 20.
In this embodiment, the ultrasonic catheter 2 may have a transmission shaft and an ultrasonic probe connected to the transmission shaft.
In some examples, the intravascular ultrasound imaging system 1 may be used for imaging a lesion in a human blood vessel, for example. A doctor or the like can obtain an intravascular ultrasound image of a lesion area (e.g., a stenosis) of a human blood vessel by sending the ultrasound catheter 2 of the intravascular ultrasound imaging system 1 to the lesion area while retracting the ultrasound image.
In some examples, the ultrasound probe of the intravascular ultrasound imaging system 1 and the retraction device 10 may be coupled by a drive shaft.
Fig. 2 is a schematic diagram showing the structure of the retracting device 10 of the intravascular ultrasound imaging system 1 with an isolation bag 20 according to an embodiment of the present disclosure.
As shown in fig. 2, in the present embodiment, the retracting device 10 may have a retracting main body 11 and a supporting portion carrying the retracting main body 11, the retracting main body 11 including a fitting portion 111 (see fig. 3) connected to a catheter, the supporting portion having a base plate 12 carrying the retracting main body 11 and a fixing portion 13 located on a side of the retracting main body 11 toward the ultrasonic probe, the retracting main body 11 being mounted on the base plate 12 and slidably movable along a length direction of the base plate 12.
In some examples, the substrate 12 may be in the shape of an oblong plate. In some examples, the base plate 12 may have a slide rail 121 that allows the pullback host 11 to move along the length of the base plate 12. In some examples, the slide rail 121 may be two parallel rails. In other examples, the length of the sliding rail 121 may be the maximum length that the retraction host 11 can retract.
In some examples, the pullback host 11 may include a translation motor that drives translation of the pullback host 11 and a rotation motor that drives rotation of the drive shaft. Thus, the translation and rotation of the drive shaft can be controlled by retracting the main machine 11. In other examples, the pullback host 11 may include only a translation motor that drives translation of the pullback host 11. This can be applied to a case where rotation is not required. In particular, situations where rotation is not required may include when the retraction device 10 is used to measure catheter retraction in fractional flow reserve or catheter retraction in phased array-based intravascular ultrasound imaging.
In some examples, the width of the fixing portion 13 may be gradually reduced along an end near the supporting portion to an end far from the supporting portion, and the fixing portion 13 has a groove that mates with a protrusion 2211 (see fig. 4) of a clip portion 22 (described later). Thereby, the base 221 (described later) can be stably fixed to the fixing portion 13 by the inner protrusion 2211. In other examples, a groove may be provided at the fixed end 131 (see fig. 3). This can better match the fixation of the clamp 22.
In some examples, the securing portion 13 may be detachably mounted to the base plate 12. Specifically, the fixing portion 13 and the substrate 12 may be connected by a snap-fit, coupling, or adhesion. Thereby, the fixing portion 13 can be replaced easily. In other examples, the securing portion 13 may be integrally formed with the clamping portion 22. This can improve the stability between the clamping portion 22 and the fixing portion 13. In addition, in some examples, the fixing portion 13 may have a clamping head provided at the fixing end 131. In this case, the retracting device 10 may not have the clip portion 22, and the fixing portion 13 is directly coupled to the bag main body 21, whereby the stability of the retracting device 10 as a whole can be improved.
Fig. 3 is a schematic diagram showing the separation of the retrieval device 10 and the isolation bag 20 of the intravascular ultrasound imaging system 1 with the isolation bag 20 according to an embodiment of the disclosure.
In the present embodiment, the isolation bag 20 may include a bag main body 21, and a clamping portion 22 and a connecting portion 23 provided on the bag main body 21. In some examples, the clamp portion 22 and the connecting portion 23 may be disposed inside the isolation bag 20. In other examples, the clip portion 22 and the connecting portion 23 may be embedded in the isolation pouch 20.
In some examples, the pouch body 21 may be bonded to the grip portion 22 and the connection portion 23 by way of thermoplastic. In other examples, the bag body 21 may be inserted between the clamping portion 22 and the connecting portion 23 by snap-fit.
In some examples, a predetermined distance may be provided between any point on the side of the clamping portion 22 near the connecting portion 23 and any point on the side of the connecting portion 23 near the clamping portion 22. Specifically, the predetermined interval may be the length of the bag main body 21 between the nip 22 and the connection 23. Further, the length of the isolation bag 20 between the clamping portion 22 and the connecting portion 23 may be equal to or greater than the distance between the fixed portion 13 after the retraction main unit 11 reaches the maximum retraction distance. In this case, the isolation pouch 20 between the grip portion 22 and the connection portion 23 is set to a proper length, whereby the isolation pouch 20 between the grip portion 22 and the connection portion 23 is not torn due to an insufficient length during the withdrawal.
Fig. 4 is a schematic view showing the structure of the clamping portion 22 of the isolation bag 20 of the intravascular ultrasound imaging system 1 with the isolation bag 20 according to the embodiment of the present disclosure.
In the present embodiment, the clamp 22 includes a base 221 and a clamp head 222 fixed to the base 221 via the bag body 21, and the base 221 can be attached to the fixing portion 13. In some examples, the gripping head 222 may be integrally formed with the base 221. In other examples, the clamp head 222 may be removably mounted to the base 221.
In some examples, the clamping portion 22 may be mounted to the fixed end 131 of the fixed portion 13, with the fixed end 131 being located at one end side of the fixed portion 13.
In some examples, the clip portion 22 may include a clip head 222 disposed on the base 221 toward the outside, and the clip portion 22 may further include a protrusion 2211 disposed on the base 221 toward the inside. Specifically, the grip head 222 may be disposed perpendicularly to the base 221. In this case, the base 221 can be better matched with the fixing portion 13, whereby the catheter can be stably retracted by being gripped with the gripping head 222.
In some examples, the base 221 may be L-shaped. In other examples, when the base 221 has an L-shape, the holding head 222 and the protrusion 2211 may be disposed at different sides, respectively. In other examples, the gripping head 222 and the projection 2211 may also be disposed on the same side. Additionally, in some examples, the base 221 may be in a straight, U-shaped, or other irregular shape.
In other examples, the gripping head 222 may have multiple gripping feet, such as two gripping feet. Specifically, the two clip legs may be disposed opposite to each other with a certain curvature toward the inside. Thus, the clip foot may have inward pressure. In some examples, the clip legs may be in the form of oblong sheets. Thus, the clip legs can be arbitrarily curved and shaped.
Additionally, in some examples, the gripping head 222 may be made of a spring. This can improve the elasticity of the clamp head 222. In other examples, the gripping head 222 may also be configured as a movable mechanism with a spring. Thereby, the adaptability and reliability of the clamp head 222 can be improved.
In other examples, the protrusion 2211 may be a cylindrical protrusion 2211. However, the present embodiment is not limited thereto, and the protrusion 2211 may be formed in a prismatic shape, a spherical shape, a tapered shape, or other irregular shape. Thus, different protrusions 2211 can be designed as needed.
In some examples, when the base 221 is L-shaped, it may include a strip 2212 disposed on a side of the clamp head 222 and along an opposite direction of the clamp head 222. Specifically, the protruding direction of the strip 2212 is perpendicular to the side of the L-shaped base 221 where the gripping head 222 is located, and the protruding direction of the strip 2212 is parallel to the other side of the base 221 where the gripping head 222 is not provided. This can further limit the offset of the L-shaped base 221, and improve the stability of fixing the L-shaped base 221 to the fixing portion 13.
In some examples, the width of the strip 2212 may be less than the width of the base 221. In other examples, the width of the strip 2212 may be equal to the width of the base 221. In addition, in some examples, the height of the protrusion of the strip 2212 may be less than or equal to the height of the other side of the base 221 where the gripping head 222 is not disposed. Thereby, the other side edge can be better fitted, so that the base 221 is fixed to the fixing portion 13.
In some examples, the gripping head 222 of the gripping portion 22 may be disposed on a central axis of the base 221, the base 221 having a width smaller than the width of the fixing portion 13. In other examples, the minimum width of the fixing portion 13 may be slightly larger than the width of the base 221. This reduces the weight of the fixing portion 13.
In some examples, the clamp 22 may include a boss 223 disposed between the clamp heads 222. This can provide a buffer when clamping the catheter. In some examples, the height of the boss 223 may be less than the height of the gripping head 222. Further, the height of the boss 223 may be smaller than the height of the point of application of the clamp head 222. In other examples, the length of the boss 223 may be less than the length of the legs of the gripping head 222. Additionally, in some examples, the boss 223 may have a contact surface that mates with the body of the catheter. This enables the catheter to be supported more stably.
Fig. 5 is a schematic view showing the structure of the connection portion 23 of the isolation bag 20 of the intravascular ultrasound imaging system 1 with the isolation bag 20 according to the embodiment of the present disclosure. Fig. 6 is a schematic diagram showing a cross-sectional structure of an isolation bag 20 of the intravascular ultrasound imaging system 1 with an isolation bag 20 according to an embodiment of the present disclosure.
In the present embodiment, the connection portion 23 may have a receiving hole 233 penetrating the bag body 21, the receiving hole 233 being configured to have a size to receive a catheter, the connection portion 23 being mounted to the fitting portion 111, the ultrasound catheter 2 being mated with the withdrawal main unit 11 via the receiving hole 233. Additionally, in some examples, the pullback host 11 may also cooperate with a pressure measurement catheter in an FFR measurement system or an optical detection catheter in optical coherence tomography through the receiving hole 233. Thus, the pullback device 10 can be used in a variety of application scenarios.
In some examples, the connecting portion 23 may be a clip detachably secured to the bag body 21, the clip being provided with protrusions (231, 232) that match the shape of the fitting portion 111. In some examples, the clip includes an inner clip and an outer clip. Specifically, the protrusions (231, 232) may be provided on the inner buttons. In other examples, the protrusions (231, 232) may be provided on the outer clasp so as to pass through the inner clasp and mate with the fitting portion 111. Thereby, the clips can clamp the isolation bag 20 therebetween and be fitted to the fitting portion 111.
In some examples, the protrusions (231, 232) of the connection portion 23 may partially present an annular protrusion 231. Thereby, the annular projection 231 can be disposed around the receiving hole 233.
In some examples, the protrusions (231, 232) of the connection portion 23 may be provided with a notch 2311, and the fitting portion 111 may be provided with a positioning post that mates with the notch 2311. Specifically, the notch 2311 may be provided at a portion of the annular protrusion 231. Thus, the fitting form of the connection portion 23 and the fitting portion 111 can be defined by the mating relationship of the notch 2311 and the positioning post.
In some examples, an isolation pouch 20 may be sleeved over the withdrawal mainframe 11 and support and used to isolate the ultrasound catheter 2 from the withdrawal device 10. Thereby, the catheter can be completely isolated from the withdrawal device 10. In other examples, the isolation pouch 20 may be entirely wrapped around the pullback main body 11 and the support portion, and have openings for passing signal lines. In this case, the ultrasound catheter 2 and the retraction device 10 can be better isolated.
In other examples, the pouch body 21 may be independent of the grip portion 22 and the connection portion 23. In this case, the pouch body 21 may be coated on the withdrawal main body 11, whereby the clamping portion 22, the fixing portion 13, and the base plate 12 may be replaced as a consumable material independent from the outside of the withdrawal main body 11, thereby improving safety and reliability of the withdrawal apparatus. Additionally, in some examples, the isolation bag 20 may not have a connection 23. In this case, the isolation bag 20 may directly receive the ultrasound catheter 2 through the receiving hole 233 penetrating the bag body 21.
In some examples, the pouch body 21 may be coupled with the grip portion 22 and the connection portion 23 at the time of use. In other examples, the pouch body 21 may have marks for locating the coupling positions of the clamping portion 22 and the connecting portion 23. This can facilitate the medical staff to combine the bag body 21 with the clip portion 22 and the connecting portion 23 when using the bag.
While the disclosure has been described in detail in connection with the drawings and embodiments, it should be understood that the foregoing description is not intended to limit the disclosure in any way. Modifications and variations of the present disclosure may be made as desired by those skilled in the art without departing from the true spirit and scope of the disclosure, and such modifications and variations fall within the scope of the invention.