Convertible catheter sheath

Abstract

The vascular catheter sheath device of the present invention includes a tubular main shaft and a main sleeve, and the main sleeve is attached to the proximal end of the tubular main shaft. A head sleeve is attached to the proximal end of the main sleeve and has a first arm portion and a second arm portion. The head sleeve is attached to the main sleeve with a releasable locking structure. Therefore, the head sleeve is functionally detachably connected to the main sleeve. The head sleeve and the main sleeve can have a matching mechanism that is twisted or snapped together, an example of which is a male locking member on the head sleeve and a female locking member on the main sleeve. Moreover, a side hole is provided on the main sleeve and a side hole is provided on the head sleeve, and when the head sleeve and the main sleeve are in the locking structure, the side hole of the main sleeve and the side hole of the head sleeve are oriented in the same plane.

Description

Technical Field

[0001] The present disclosure generally relates to catheter sheaths for accessing and exiting blood vessels. Background Art

[0002] Various catheter sheaths for accessing and exiting blood vessels already exist. However, existing catheter sheaths do not allow users to place larger intravascular devices during an operation. Therefore, it is desirable to provide a catheter sheath for accessing and exiting blood vessels that can have a releasable proximal sleeve to allow direct access and exit of larger intravascular devices without the need to replace the catheter sheath during an operation. Summary of the Invention

[0003] According to one aspect, the present disclosure provides a vascular catheter sheath device comprising a tubular main shaft (11) having a shaft passage (14). A main sleeve (20) is attached to the proximal end of the tubular main shaft and has a main sleeve passage (23). In a releasable locked configuration, a head sleeve (30) is attached to the proximal end of the main sleeve and has a proximal end, a distal end, and a head passage (62).

[0004] The head sleeve is functionally detachably connected to the main sleeve. As used herein, "functionally detachably" means that it has a mechanism that is specifically designed to be intentionally separated by an operator when performing a medical procedure. The head sleeve and the main sleeve can be coupled by any suitable matching mechanism, such as a twist-fit matching mechanism or a snap-fit matching mechanism.

[0005] The head sleeve may have two or more arms (31, 41). The head sleeve may have a first arm and a second arm. The first arm has a first channel inside, and the second arm has a second channel inside. The first channel of the first arm may be coaxially oriented with the spindle channel. The second channel of the second arm may be oriented at an angle (10° to 65°) to the head channel.

[0006] The various channels of the vascular catheter sheath device can have the same or different diameters. For example, the first channel of the first arm and the second channel of the second arm can be narrower than the head channel. In another embodiment, the inner diameter of the second channel of the second arm can be narrower than the inner diameter of the first channel of the first arm.

[0007] According to another aspect, the present disclosure provides a medical procedure tool comprising various components to be assembled into a vascular catheter sheath device. The tool may include a first component comprising a tubular main shaft and a main sleeve as described herein. The tool may also include a second component comprising a head sleeve as described herein. The tool may also include other components, such as a guide wire, a needle, a fluid line with a stopcock, and the like.

[0008] According to another aspect, the present disclosure provides a method for assembling a vascular catheter sheath device. The method includes providing a first component, the first component including a tubular main shaft and a main sleeve as described herein. The method also includes providing a second component, the second component being a head sleeve as described herein. The method also includes attaching the first component to the second component as described herein. The method also includes attaching a fluid tube having a stopcock as described herein.

[0009] According to another aspect, the present disclosure also provides a method for establishing a vascular access position. The method includes providing a vascular catheter sheath device, the vascular catheter sheath device including a tubular main shaft and a main sleeve, the main sleeve being attached to the proximal end of the tubular main shaft. The catheter sheath device is inserted into a patient's blood vessel through a percutaneous procedure such that the tubular main shaft is located inside the blood vessel and the main sleeve is located outside the blood vessel, thereby enabling it to be manipulated by an operator. The percutaneous procedure for inserting the catheter sheath device can be performed using a guidewire inserted into the blood vessel.

[0010] The method further comprises attaching the head sleeve to the proximal end of the main sleeve. The step of inserting via a percutaneous procedure can be performed before or after the step of attaching the head sleeve to the main sleeve. For example, the vascular catheter sheath device can be fully assembled before the percutaneous insertion process, or the vascular catheter sheath device can be partially assembled before the percutaneous insertion process.

[0011] The vascular catheter sheath device can be used to connect intravascular devices (51, 52, 53). Examples of intravascular devices may include wires (e.g., guidewires), stents, balloons, catheters, etc. The intravascular device may be the following types of catheters, such as infusion catheters, suction catheters, mechanical transmission catheters (e.g., balloon catheters, arterial "rooter" cutting catheters), physiological electrical catheters (e.g., electrode catheters, radiofrequency ablation catheters), electronic sensor catheters (e.g., intravascular ultrasound, optical coherence tomography catheters), etc.

[0012] The intravascular devices used to connect to the catheter sheath can be of different types (e.g., different sizes, different functions, different lengths, different materials, etc.). That is, they do not have to be the same type of intravascular device. For example, one type may be an electronic sensor catheter, while another type may be a fluid delivery catheter.

[0013] In some embodiments, the method further includes inserting a first intravascular device into the first arm. Furthermore, the first intravascular device is advanced through the head channel, the main sleeve channel, and the shaft channel. In some cases, the method further includes inserting a second intravascular device into the second arm, and advancing the second intravascular device through the head channel, the main sleeve channel, and the shaft channel. The second intravascular device can be different from the first intravascular device. For example, the second intravascular device can be narrower than the first intravascular device.

[0014] Depending on the specific situation, the steps of inserting the intravascular device into the catheter sheath device, attaching the main sleeve to the head sleeve, or the steps of separation can be varied. In some embodiments, the method further includes, before attaching the head sleeve to the main sleeve, inserting the first intravascular device into the proximal end of the main sleeve and advancing through the main sleeve channel and the shaft channel. In one case, the first intravascular device is withdrawn from the catheter sheath device, and after attaching the head sleeve to the main sleeve, the second intravascular device is inserted into the proximal end of the first arm or the second arm and advancing through the main sleeve channel and the shaft channel.

[0015] In some cases, the method further includes withdrawing the first intravascular device from the introducer sheath assembly. The head sleeve is separated from the main sleeve to expose the proximal opening of the main sleeve. A second intravascular device is inserted into the proximal opening of the main sleeve and advanced through the main sleeve passageway and the shaft passageway. The second intravascular device is different from the first intravascular device.

[0016] In some embodiments, the method further comprises inserting a first intravascular device into the first arm and advancing it through the channel of the first arm, the head channel, the main sleeve channel, and the shaft channel. When the first intravascular device is located within the introducer sheath device, inserting a second intravascular device into the second arm and advancing it through the channel of the second arm, the head channel, the main sleeve channel, and the shaft channel.

[0017] In some cases, the method further includes inserting a third intravascular device into the proximal end of the main sleeve and advancing it through the main sleeve channel and the shaft channel before attaching the head sleeve to the main sleeve. The third intravascular device can be different from the first intravascular device and the second intravascular device. In some cases, the method further includes withdrawing the third intravascular device from the introducer sheath device before attaching the head sleeve to the main sleeve. After attaching the head sleeve to the main sleeve, the step of inserting the first intravascular device or the second intravascular device into the introducer sheath device is performed.

[0018] As used herein, the use of the word "or" is deemed to include or be equivalent to the expression "and / or" unless its meaning is clear from the context. Thus, for example, the expression "A or B" means A or B, or A and B. Similarly, the expression "A, B or C" means A or B or C or any combination of the three. The terms "first", "second", etc. used with respect to components are used herein only to distinguish between components. They are not used to limit components in a sequential manner, such as not limiting the order of components, not limiting the position of components, or not limiting the priority of components. For example, the first component can be used interchangeably as the second component, and similarly, the second component can be referred to interchangeably as the first component, and these replacements are within the scope of this disclosure. The first component and the second component are not the same component. The terms "first", "second", etc. may refer to different components in different embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 A perspective view of a catheter sheath according to one embodiment of the present disclosure is shown.

[0020] Figure 2 A side view of the catheter sheath is shown.

[0021] Figure 3 An internal view of the catheter sheath is shown.

[0022] Figure 4 The secondary sleeve is shown detached and separated from the primary sleeve of the introducer sheath.

[0023] Figure 5 An internal view of the second sleeve is shown.

[0024] Figure 6 The proximal end of the second sleeve is shown.

[0025] Figure 7 The proximal end of the first sleeve is shown.

[0026] Figure 8 The locking mechanism is shown.

[0027] Figure 9 Shown is an interior view of a catheter sheath with two intravascular devices inserted.

[0028] Figure 10 An internal view of the short arm of the second sleeve showing the insertion of an intravascular device into a guide sheath.

[0029] Figure 11 An internal view of the first sleeve of a guide sheath showing two intravascular devices inserted.

[0030] Figure 12An interior view of the catheter sheath is shown without the second sleeve and with a larger intravascular device inserted therein. DETAILED DESCRIPTION

[0031] In the accompanying drawings, like reference numerals may represent like parts. Certain terms are used for convenience of description, but should not be considered to limit the present invention. The terms "distal" and "proximal" refer to directions "away" and "closer" to the body of a physician inserting an introducer sheath into a patient's body, respectively. The terms include the meanings explicitly mentioned, their derivative meanings, and similar extended meanings.

[0032] Figure 1 、 Figure 2 and Figure 4 Shown is a schematic perspective view and a side view of a catheter sheath according to the present disclosure. In this embodiment, the catheter sheath 10 may include a tubular member 11, a first sleeve 20 (hub), and a second sleeve 30 (hub). The first sleeve 20 may include a side hole 24, which is connected to a three-way stopcock 50. The long arm 31 of the second sleeve 30 includes a side hole 37, which is connected to another three-way stopcock 50. The short arm 41 of the second sleeve 30 has a flushing port 46 and a cap 47 for the flushing port. Optionally, the second sleeve may include more than two arms as needed.

[0033] Figure 3 and Figure 5 An internal view of the catheter sheath 10 is shown. The short arm channel 44 merges into the long arm channel 34. The long arm channel 34 extends to the first sleeve channel 23 and coincides with the first sleeve channel 23 so as to communicate with the main channel 14 of the tubular member 11. The side hole channel 25 is connected to the first sleeve channel 23, and the side hole channel 38 is connected to the long arm channel 34. As shown, the second sleeve 30 has a channel 62 that communicates with various other channels. In addition, the side hole channel is connected to the short arm channel 44.

[0034] Figure 4 The second sleeve is shown separated from the catheter sheath. The distal end 33 of the second sleeve has a male locking member 35 for interconnecting with the first sleeve 20. The male locking member 35 includes at least one locking protrusion 39 formed on the male locking member 35 for rotatably engaging with the female locking member 27 of the first sleeve 20.

[0035] Figure 6 and Figure 7The proximal ends of the second sleeve and the first sleeve are shown, respectively. Hemostatic sealing members 26, 36, 45 are disposed within the proximal ends of the first sleeve and the second sleeve, respectively, to allow passage of instruments entering the blood vessel, and the hemostatic sealing members 26, 36, 45 are capable of sufficient self-sealing to substantially prevent outflow of blood.

[0036] Figure 7 Also shown is a female locking member 27 formed at the proximal end of the first sleeve 20. The female locking member 27 includes at least two locking grooves 28 to rotatably engage with the locking protrusion 39 of the second sleeve 30. For example, the locking protrusion 39 is pushed in and rotated approximately 90° so as to Figure 8 A to Figure 8 D for secure locking or complete release. Figure 8 A shows a state where the second sleeve 30 has not yet been connected. Figure 8 B shows a state where the second sleeve 30 is being inserted by positioning the locking protrusion 39 . Figure 8 C shows a state where the second sleeve 30 is being rotated 90° when the second sleeve 30 is inserted into the female locking member 27 of the first sleeve 20 . Figure 8 D shows a state in which the second sleeve 30 is locked to the first sleeve 20 .

[0037] Figures 9 to 11 FIG. 5 shows an internal view of the catheter sheath with the intravascular devices 51, 52 in place. Figures 9 to 11 As shown, each hemostatic sealing member allows passage of an intravascular device when sealed, with two devices 51 , 52 passing through the main passage 14 of the tubular member 11 .

[0038] Figure 12 The figure shows an interior view of the catheter sheath when a larger intravascular device 53 is in place, without the second sleeve. For example, if the size of the intravascular device 53 is larger than the size of the long arm channel 34 and the short arm channel 44, the physician can remove the second sleeve 30 from the catheter sheath 10 and place the intravascular device 53 directly into the first sleeve channel 23, which conforms to the shape of the main channel 14.

[0039] Tubular components

[0040] like Figure 2 and Figure 3As shown, the catheter sheath 10 includes a tubular member 11 having a proximal end 12, a distal end 13, and a main channel 14. The main channel 14 extends longitudinally between the proximal and distal ends and is open at the proximal and distal ends for inserting intravascular devices therein. The main channel 14 is generally annular and has a large cross-sectional area to accommodate a variety of intravascular devices. The tubular member 11 is formed from an inelastic semi-rigid plastic or coil. Preferably, the tubular member 11 has a maximum size of 30 French.

[0041] First sleeve

[0042] like Figure 9 and Figure 11 As shown, the catheter sheath 10 further includes a first sleeve 20 having a proximal end 21, a distal end 22, and a first sleeve channel 23 extending longitudinally therebetween. The first sleeve 20 is fixedly mounted on the proximal end 12 of the tubular member 11. Preferably, the size and shape of the first sleeve channel 23 conform to the size and shape of the main channel 14 of the tubular member 11 so as to adaptably accommodate a range of intravascular devices.

[0043] The first sleeve 20 includes a hemostatic seal member 26 disposed within the first sleeve 20 to allow passage of an intravascular device through the first sleeve passage 23. The first sleeve 20 also includes a side port 24 disposed between the hemostatic seal member 26 and the distal end 22 of the first sleeve 20 for connection to the three-way stopcock 50. The side port 24 has a side port channel 25 extending to and communicating with the first sleeve passage 23 and the main passage 14 of the tubular member. The first sleeve 20 also includes a female locking member 27 formed in the proximal end 21 of the first sleeve 20.

[0044] Long arm of the second sleeve

[0045] like Figures 2 to 5 As shown, the catheter sheath 10 further includes a second sleeve 30. The second sleeve 30 includes an elongated arm portion 31 having a proximal end 32, a distal end 33, and an elongated arm portion channel 34. The elongated arm portion channel 34 extends between the proximal and distal ends and is open at both the proximal and distal ends for insertion of an intravascular device. The elongated arm portion channel 34 has a longitudinal axis that is generally parallel to the longitudinal axis of the first sleeve channel 23 and the main channel 14 of the tubular member 11. Thus, the main channel 14 communicates with the elongated arm portion channel 34 for coaxial guidance of an intravascular device or passage of fluid therethrough.

[0046] Long arm channel 34 is generally annular and has a large cross-sectional area to accommodate a variety of intravascular devices. Long arm 31 is formed from an inelastic, semi-rigid plastic or roll material. Preferably, long arm channel 34 is approximately 12 French at proximal end 32 and gradually expands to approximately 22 French from the proximal end to the distal end to accommodate the size and shape of first sleeve channel 23 and main channel 14 of the tubular member.

[0047] The long arm portion 31 includes a hemostatic seal member 36 disposed within the long arm portion 31 to allow passage of an intravascular device through the long arm portion passageway 34. The long arm portion 31 also includes a side port 37 disposed between the hemostatic seal member 36 and the distal end 33 of the long arm portion 31. The side port 37 has a side port channel 38 that extends to and communicates with the long arm portion passageway 34 and the main passageway 14 of the tubular member. As seen here, the side port 37 and the side port 24 are positioned on the catheter sheath so that when the catheter sheath is in the locked configuration, the side port 37 and the side port 24 are in the same plane.

[0048] The long arm portion 31 further includes a male locking member 35 for lockably connecting to the female locking member 27 of the first sleeve 20. The second sleeve 30 is releasably connected and secured to the first sleeve 20. Conversely, by rotating 90 degrees, the second sleeve 30 is unlocked from the first sleeve 20 and completely separated from the first sleeve 20. Accordingly, when a larger intravascular device 60 cannot pass through the long arm portion or the short arm portion of the second sleeve 30, by unlocking the second sleeve 30 from the first sleeve 20 and removing the second sleeve 30 from the first sleeve 20, the larger intravascular device 60 can be directly inserted into the first sleeve 20, without the need to replace the guide sheath during the procedure.

[0049] Short arm of the second sleeve

[0050] like Figure 9 and Figure 10 As shown, the second sleeve 30 includes a short arm channel 44, which is provided in the short arm portion 41 so as to communicate with the long arm channel 34 and extends transversely from the longitudinal axis of the main channel 14 of the tubular member 11. When an intravascular device is extended from the main channel 14 into the first sleeve channel 34 of the second sleeve 30, the short arm channel 44 is used to guide another intravascular device into the main channel 14 or allow fluid to enter the main channel 14 of the tubular member.

[0051] The short arm portion 41 further includes a hemostatic sealing member 45 disposed therein to allow passage of intravascular instruments through the short arm portion channel 44. The short arm portion 41 further includes a flushing port 46 and a cap portion 47 disposed between the hemostatic sealing member 45 and the proximal end 43 of the short arm portion 41 for connection to a three-way stopcock 50. The flushing port 46 has a flushing channel 48 that extends to and communicates with the long arm portion channel 34 of the second sleeve 30.

Claims

1. A catheter sheath device for a blood vessel, characterized in that: include: a tubular main shaft having a proximal end, a distal end, and a shaft passage; a main sleeve having a proximal end, a distal end, and a main sleeve passage, the main sleeve being connected to the proximal end of the tubular main shaft; as well as a head sleeve having a proximal end, a distal end, and a head passage, the head sleeve having a first arm having a first passage oriented coaxially with the shaft passage, and a second arm having a second passage oriented at an angle to the head passage; The head sleeve is attached to the proximal end of the main sleeve by a releasable locking structure, and the head sleeve can be unlocked from the main sleeve by the releasable locking structure and can be completely separated from the main sleeve, and an intravascular device that cannot pass through the head channel can be directly inserted into the main sleeve, and the size of the intravascular device that cannot pass through the head channel is larger than the size of the first channel and larger than the size of the second channel.

2. The device according to claim 1, wherein The head sleeve and the main sleeve together have a twisting or snapping matching mechanism.

3. The device according to claim 2, wherein The mating mechanism includes a male locking member located at the distal end of the head sleeve and a female locking member located at the proximal end of the main sleeve, the female locking member being designed to receive the male locking member of the head sleeve.

4. The device according to claim 3, characterized in that The distal end of the head sleeve further includes a locking protrusion, and the proximal end of the main sleeve includes a slot and a groove, wherein the locking protrusion is inserted through the slot and is slidable in the groove.

5. The device according to claim 1, wherein The first channel and the second channel are narrower than the head channel.

6. The device according to claim 5, characterized in that The second channel is narrower than the first channel.

7. The device according to claim 1, wherein The second arm has a proximal opening, a flush port, and a cap movably mounted to the flush port.

8. The device according to claim 1, wherein Also included is a side hole of the main sleeve and a side hole of the head sleeve, wherein the side hole of the main sleeve and the side hole of the head sleeve are oriented in the same plane when the head sleeve and the main sleeve are in a locked configuration.

9. The device according to claim 1, wherein The proximal end of the main sleeve, the proximal end of the first arm, and the proximal end of the second arm each have an opening provided with a hemostatic seal.

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