Patent Application
20230137558
The present invention relates to valves for catheter delivery, and in particular hemostasis valves for a sheath introducer.
A “sheath” or “sheath introducer” includes a tube placed in an artery or vein of a patient during a medical procedure that, when positioned for treatment, has a distal end within the artery or vein and a proximal end outside of the patient. A hemostasis valve at the proximal end of the sheath inhibits blood from exiting the sheath and allows longer sheaths and/or catheters to be inserted through the sheath into the artery or vein.
A problem with some current sheath introducers for catheter delivery is that movement of devices through the sheath can result in a pressure differential between an inner lumen of the sheath and the ambient environment which can potentially allow for air entrainment and/or leakage through the seal of the sheath.
The present invention relates to valves for catheter delivery, and in particular hemostasis valves for a sheath introducer.
An example catheter sheath assembly can include an elongated shaft, a primary hemostatic valve assembly, and a secondary hemostatic valve assembly. The elongated shaft can include a distal end, a proximal end, and a lumen extending along a longitudinal axis and providing a passageway into the proximal end of the shaft and out of the distal end of the shaft. The primary hemostatic valve assembly can fluidically seal to the proximal end of the elongated shaft and include a primary seal. The secondary hemostatic valve assembly can include a secondary seal disposed in a proximal direction in relation to the primary seal such that the primary hemostatic valve assembly and the secondary hemostatic valve assembly define an intermediate chamber disposed at least in part between the primary seal and the secondary seal.
The secondary seal can be movable in relation to the primary seal to thereby change an internal volume of the intermediate chamber. The secondary seal can be configured to slide parallel to the longitudinal axis and within a housing portion of the secondary hemostatic valve assembly. The housing portion can be fixed in relation to the primary seal. The change in volume can be equal to an interior cross-sectional area of the intermediate chamber orthogonal to the longitudinal axis multiplied by a change in longitudinal position of the secondary seal. The secondary seal can be configured to move in response to a pressure differential between the intermediate chamber and an external environment. The internal volume of the intermediate chamber being configured to change in response to a difference in pressure between the intermediate chamber and an external environment.
The secondary hemostatic valve assembly can further include one or more springs configured to change in length to thereby move the secondary valve opening in relation to the primary valve opening. The change in volume can be based at least in part on stiffness of the one or more springs. The one or more springs can be configured to compress to increase the volume of the intermediate chamber.
The primary seal can include a primary valve opening aligned to the longitudinal axis. The secondary seal can include a secondary valve opening aligned to the longitudinal axis.
The intermediate chamber can be fluidically sealed from an external environment by the secondary seal and can be sealed from the lumen of the elongated shaft by the primary seal.
The intermediate chamber can be shaped by a tubular housing portion extending between the secondary seal and the primary seal.
The catheter sheath assembly can further include a handle joining the elongated shaft to the primary hemostatic valve assembly. The handle can be configured to be manipulated to reshape the elongated shaft. The secondary hemostatic valve assembly can include latch extensions configured to slide over a proximal end of the handle and latch to the proximal end of the handle to thereby create the intermediate chamber. Alternatively, the secondary hemostatic valve assembly can be integral to the handle.
The primary valve opening can be expandable to a larger diameter than the secondary valve opening.
The catheter sheath assembly can further include an aspiration port in fluidic communication with the fluidically sealed chamber.
The catheter sheath assembly can further include an interior housing including a funnel opening have a wide proximal end positioned in a distal direction from the secondary seal and a narrow distal end positioned in a proximal direction from the primary seal.
The interior housing can be configured to urge an intralumenal device being inserted into the proximal end of the catheter sheath assembly toward the longitudinal axis and the primary valve opening.
An example assembly can include a secondary valve accessory device and a catheter. The secondary valve accessory device can include a secondary seal, a tubular inner housing extending distally from the secondary seal, and an outer housing structurally supporting the secondary seal and the tubular inner housing. The catheter can include an elongated shaft and an end effector. The elongated shaft can define a longitudinal axis and extend through the secondary seal. The end effector can be positioned within the tubular inner housing.
The outer housing can further include a mating feature configured to engage a proximal end of a sheath introducer. The mating feature can include a latch extension. Additionally, or alternatively, the mating feature can include threads.
The tubular inner housing can include a distal end configured to seal to a proximal end of a primary hemostasis valve of a sheath introducer so that an intermediate chamber is bounded by the tubular inner housing, the secondary seal, and a primary seal of the primary hemostasis valve.
The secondary valve accessory device can include an O-ring disposed around an outer surface of the tubular inner housing.
The tubular inner housing can include a tapered portion having a wider diameter approximate the secondary seal and tapering to a narrow diameter distally from the secondary seal.
The secondary seal can include a secondary valve opening sized to allow the elongated shaft of the catheter to slide longitudinally therethrough and sized to inhibit the end effector of the catheter to slide longitudinally therethrough.
The secondary seal can be configured to translate proximally in relation to the tubular inner housing and outer housing in response to a force applied in a proximal direction to the secondary seal.
The secondary valve accessory device can further include a spring providing a spring force between the secondary seal and the outer housing.
The assembly can further include a sheath introducer including a primary hemostatic valve assembly. The primary hemostatic valve assembly can include a primary seal. The sheath introducer can be attached to the secondary valve accessory device such that the secondary seal is positioned in a distal direction in relation to the primary seal and an intermediate chamber is bounded at least in part by the secondary seal, the primary seal, and the tubular inner housing.
An example method of treatment can include one or more of the following steps presented in no particular order. The example method can include additional steps as would be appreciated and understood by a person having pertinent skill in the art. The example method can be performed using an example assembly as disclosed herein, a variation thereof, or an alternative thereto as would be appreciated and understood by a person skilled in the pertinent art.
An assembly comprising a secondary valve accessory device and a catheter can be selected such that an elongated shaft of the catheter extends through a secondary seal of the secondary valve accessory and an end effector of the catheter is positioned within a tubular inner housing of the secondary valve accessory.
An outer housing of the secondary valve assembly can be attached to a proximal end of a sheath introducer such that the secondary valve is aligned with a primary valve of the sheath introducer and an intermediate chamber is bounded at least in part by the secondary seal, the primary seal, and the tubular inner housing
The catheter shaft can be moved distally to thereby move the end effector of the catheter out of the tubular inner housing and through the primary seal.
These and other aspects of the disclosed technology are described herein along with the accompanying figures. Other aspects, features, and elements of the disclosed technology will become apparent to those skilled in the pertinent art upon reviewing the following description of specific examples of the disclosed technology. While features of the disclosed technology may be discussed relative to certain examples and figures, the disclosed technology can include one or more of the features or elements discussed herein. Further, while one or more examples may be discussed as having certain advantageous features, one or more of such features may also be used with the various other examples of the disclosure discussed herein. In similar fashion, while certain examples, implementations, and embodiments may be discussed below with respect to a given device, system, or method, it is to be understood that such examples can be implemented in various other devices, systems, and methods of the present disclosure.
As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” may refer to the range of values ±20% of the recited value, e.g., “about 90%” may refer to the range of values from 71% to 99%.
As used herein, the terms “comprising” or “containing” or “including” are interpreted to mean that at least the named compound, element, particle, or method step is present in the composition or article or method, but does not exclude the presence of other compounds, materials, particles, method steps, even if the other such compounds, material, particles, method steps have the same function as what is named.
As used herein, the use of the term “external environment” is interpreted to mean an environment external to a medical device or assembly. When referring to the external environment of a medical device, assembly, or portion thereof that is external to a patient, the “external environment” is interpreted to be external to the patient. For instance, the “external environment” can include an environment in which a user interacts with the medical device/assembly.
As used herein, the use of terms such as “having,” “has,” “including,” or “includes” are open-ended and are intended to have the same meaning as terms such as “comprising” or “comprises” and not preclude the presence of other structure, material, or acts. Similarly, though the use of terms such as “can” or “may” are intended to be open-ended and to reflect that structure, material, or acts are not necessary, the failure to use such terms is not intended to reflect that structure, material, or acts are essential. To the extent that structure, material, or acts are presently considered to be essential, they are identified as such.
As used herein, the terms “tubular” and “tube” are to be construed broadly and are not limited to a structure that is a right cylinder or strictly circumferential in cross-section or of a uniform cross-section throughout its length. For example, the tubular structure or system is generally illustrated as a substantially right cylindrical structure. However, the tubular system may have a tapered or curved outer surface without departing from the scope of the present invention.
Ranges described as being between a first value and a second value are inclusive of the first and second values, as well as all values therebetween. Likewise, ranges described as being from a first value and to a second value are inclusive of the first and second values, as well as all values therebetween.
It is also to be understood that the mention of one or more method steps does not preclude the presence of additional method steps or intervening method steps between those steps expressly identified.
The components described hereinafter as making up various elements of the disclosure are intended to be illustrative and not restrictive. Many suitable components that would perform the same or similar functions as the components described herein are intended to be embraced within the scope of the disclosure. Such other components not described herein can include, but are not limited to, for example, similar components that are developed after development of the presently disclosed subject matter.
In some examples presented herein, a secondary valve can be connected to the proximal end of a sheath introducer to work in conjunction with a primary valve of the sheath introducer, thereby resulting in a compound valve system. In some examples, the compound valve system can reduce air entrainment into the sheath introducer compared to a similar sheath introducer lacking the secondary valve because the secondary valve inhibits air from traveling through the compound valve system. Additionally, the compound valve system can be modified to dampen pressure buildups during catheter retraction by allowing internal volume expansion with pressure increase within the sheath introducer with compound valve.
The compound valve system can be integral to the sheath introducer or integral to a secondary valve accessory device that can be attached to a proximal end of the sheath introducer.
In some examples, the secondary valve can be designed to interface with a specific diameter of intralumenal device (e.g., specific catheter shaft diameter). In some such examples, the secondary valve opening can be sized large enough to allow a catheter shaft to pass therethrough but too small to allow a larger end effector to pass therethrough. In some such examples, the secondary valve can be integral to a secondary valve accessory device that can be built onto an end effector introducer tool so that the secondary valve accessory device is integral to the intralumenal device. Such examples can allow easy insertion of a large end effector of a catheter through a primary valve having a larger opening than the secondary valve opening. The smaller secondary valve opening can be effective to reduce risk of leak and air entrainment.
In some examples, the compound valve system can include an aspiration port to reduce pressure between the primary and secondary valves. The aspiration port can be aspirated to remove bubbles to reduce risk of air entrainment. Aspiration can be used in addition to, or as a replacement for internal volume expansion in the compound valve system.
Reference will now be made in detail to examples of the disclosed technology, such as those illustrated in the accompanying drawings. Wherever convenient, the same references numbers will be used throughout the drawings to refer to the same or like parts.
The sheath introducer 110 can be configured similarly to introducers known in the art. The sheath introducer 110 can be deflectable such as described in U.S. Pat. No. 10,046,141 incorporated herein by reference and attached in the Appendix of priority application U.S. 63/272,722, a CARTO VIZIGO® Bi-Directional Guiding sheath by Biosense Webster, and/or a MOBICATH® Sheath by Biosense Webster. Alternatively, the sheath introducer can be fixed similar to a CARDIAGUIDE™ Fixed Sheath by Biosense Webster. The sheath introducer 110 can have an identical structure to known sheath introducers, or a structure similar to known sheath introducers that is modified to include one or more mating features 114 such as, but not limited to, a ridge and/or threads to facilitate attachment.
The sheath introducer 110 can include a primary hemostatic valve assembly 130 having a primary valve opening 132. The primary valve opening can be sized to receive an intralumenal device 150 (see
The secondary valve accessory device 160 can include a secondary valve opening 164 that aligns to the primary valve opening 132 of the sheath introducer 110 when the secondary valve accessory device 160 is attached to the sheath introducer 110. The secondary valve accessory device 160 can include an inner housing 182 having a funnel shape that can function as an introducer tool for an intralumenal device. The secondary valve accessory device 160 can include an O-ring 168 around an outside surface of the inner housing 182 that is positioned to seal to a proximal end of the primary valve assembly 130 to create an intermediate chamber between the primary seal 136 and the secondary seal 180.
For the sake of illustration, the end effector 154 is shown extending distally from the secondary valve accessory device 160. In practice, the end effector 154 can be positioned within the inner housing 182 (see
When the intralumenal device and secondary valve assembly 102 is configured as such, the secondary valve opening 164 can be sized smaller than the primary valve opening 132 because the secondary valve opening 164 can be sized to receive the smaller diameter D1 of the catheter shaft 152 while the primary valve opening is sized to receive the larger diameter D2 of the end effector 154. The tighter seal of the secondary valve opening 164 around the catheter shaft 152 can therefore reduce risk of leak and air entrainment compared to a system in which all seal(s) must be sized to accommodate the larger diameter D2 of the end effector 154.
The secondary valve accessory device 160 can further be configured to detach from the sheath introducer 110 so that subsequent intralumenal devices can be inserted into the sheath introducer 110.
Referring collectively to
As illustrated in
Referring to
The secondary valve accessory device 160 can include a housing 170 providing structural support for the secondary hemostatic valve assembly 162. As in the previous illustrations, the housing 170 can be configured to attach to the sheath introducer 110. Alternatively, the housing 170 can be integral to the sheath introducer 110.
The secondary seal 180 is translated a length L1 upon moving from the first position to the second position. The translation of the secondary seal 180 increases the internal volume of the intermediate chamber 140 by a volume that can be calculated as cross-sectional area of the seal chamber 184 times the translated length L1, where the change in internal volume can be equal to pi×(½ D)2×L1 for a cylindrical seal chamber 184. The increase in volume of the intermediate chamber 140 can be effective to decrease the pressure within the intermediate chamber, and thereby reduce risk of leakage through the secondary valve opening 164. The amount of pressure relieved is a function of increase in internal volume of the intermediate chamber 140 where the greater the change in volume, the greater the amount of pressure relieved.
Pressure damping is therefore determined by spring force and change in internal volume of the intermediate chamber 140. The spring stiffness and/or change in internal volume can be designed to damp a specific pressure profile related to manipulating of a specific intralumenal device through a specific sheath. For instance, an intralumenal device having a large balloon end effector may result in higher pressure differentials compared to a an intralumenal device having a smaller end effector or an end effector with spines when delivered through the same sheath introducer, and the same intralumenal device delivered through a smaller sheath introducer may result in higher pressure differentials compared to the same intralumenal device delivered through a larger sheath. The spring force and volume can be increased for higher pressure differentials and decreased for lower pressure differentials.
The chamber 138 on the distal side of the primary seal 136 (see
The secondary valve accessory device 260 illustrated in
The descriptions contained herein are examples of embodiments of the invention and are not intended in any way to limit the scope of the invention. As described herein, the invention contemplates many variations and modifications of system components, including alternative combinations of components illustrated in separate figures, alternative materials, alternative component geometries, and alternative component placement. Modifications and variations apparent to those having skilled in the pertinent art according to the teachings of this disclosure are intended to be within the scope of the claims which follow.
This application claims the benefit of priority to prior filed U.S. Provisional Patent Application No. 63/272,722 filed on Oct. 28, 2021, which is hereby incorporated by reference as set forth in full herein.
| Number | Date | Country | |
|---|---|---|---|
| 63272722 | Oct 2021 | US |
