Sheath with Mechanism to Stop Bleeding Around Access Site

A medical device delivery system includes a sheath for insertion into an access site and for use in positioning a medical device within a blood vessel. The sheath including a sheath body extending between a distal end and a proximal end. The sheath body defines a sheath lumen for receiving the medical device. A plug is arranged around the sheath body, and the plug is defined by a first disc formed of an expandable material. The first disc is configured to be positioned within the blood vessel and against a wall of the blood vessel such that the plug can seal the access site.

TECHNICAL FIELD

The present disclosure relates to a sheath with a mechanism to stop bleeding around an access site, and more particularly, a repositioning sheath having a plug to stop bleeding around the access site.

BACKGROUND

During processes for insertion of percutaneous circulatory devices or various other implantable medical devices, the device may be inserted into a blood vessel through an introducer sheath inserted at an access site and into the blood vessel. After placement of the device within the body, the introducer sheath may be removed and replaced with a sheath of a smaller diameter to increase blood flow through the blood vessel and thereby reduce ischemia issues for the patient. However, the sheath of a smaller diameter may allow for bleeding at the access site as the sheath size may be less than the size of the access site. There remains a need for reducing bleeding at the access site when the sheath inserted within the access site has a smaller size than the size of the access site formed by a larger sized sheath.

SUMMARY

In Example 1, a medical device delivery system includes a sheath for insertion into an access site and for use in positioning a medical device within a blood vessel including a distal end opposite a proximal end, a sheath body extending between the distal end and the proximal end, the sheath body defining a sheath lumen for receiving the medical device, and a plug arranged around the sheath body, the plug defined by a first disc formed of an expandable material. The medical device delivery system further includes the first disc being positioned within the blood vessel and against a wall of the blood vessel, such that the plug is configured to seal the access site.

In Example 2, the medical device delivery system of Example 1 further includes the first disc being defined by a cylindrical shape.

In Example 3, the medical device delivery system of Example 1 or Example 2 further includes wherein the plug includes a second disc that is positioned adjacent the first disc and coupled to the first disc with a connector portion.

In Example 4, the medical device delivery system of Example 3 further includes wherein the first disc is defined by a first diameter and the second disc is defined by a second diameter, the first diameter being less than or equal to the second diameter.

In Example 5, the medical device delivery system of any of the preceding Examples further includes wherein the plug is composed of a braided material.

In Example 6, the medical device delivery system of any one of the preceding Examples further includes wherein the access site is defined by a diameter and the sheath is defined by a diameter, and the diameter of the sheath is less than the diameter of the access site, such that a gap is formed between the sheath and the blood vessel.

In Example 7, the medical device delivery system of Example 6 further includes wherein the plug is configured for sealing the gap formed between the sheath and the blood vessel.

In Example 8, the medical device delivery system of any one of the preceding Examples further includes wherein the medical device is a blood pump and the medical device delivery system is a blood pump delivery system.

In Example 9, a method for sealing an access site of a blood vessel includes inserting a sheath into a blood vessel, the sheath having a diameter that is less than a diameter of the access site, inserting a plug onto a proximal end of the sheath and arranging the plug around the sheath, the plug including at least a first disc, inserting the plug into the blood vessel with the plug in a collapsed configuration, and expanding the plug such that the first disc is in contact with the blood vessel to seal the access site.

In Example 10, the method of Example 9 further includes wherein when the plug is inserted into the blood vessel in the collapsed configuration, the first disc is inserted through the access site and into the blood vessel.

In Example 11, the medical device delivery system of Example 9 or Example 10 further includes wherein the plug is formed of a self-expanding material such that once the plug is inserted into the blood vessel, the first disc expands to an original position.

In Example 12, the medical device delivery system of any one of Examples 9-11 further includes wherein after expanding the plug, the first disc is arranged within the blood vessel and against the access site.

In Example 13, the medical device delivery system of any one of Examples 9-12 further includes wherein the plug further includes a second disc, and after expanding the plug, the second disc is arranged externally of the blood vessel.

In Example 14, the method of Example 13 further includes wherein the first disc and the second disc each have a cylindrical shape.

In Example 15, the method of Example 13 or Example 14 further includes wherein the first disc has a first diameter and the second disc has a second diameter, the first diameter being less than or equal to the second diameter.

In Example 16, a blood pump delivery system includes a repositioning sheath for insertion into an access site of a blood vessel and for use in positioning a blood pump within the blood vessel. The repositioning sheath further includes a distal end opposite a proximal end, a sheath body extending between the distal end and the proximal end, the sheath body defining a sheath lumen for receiving the blood pump, and a plug arranged around the sheath body and proximally to the distal end of the repositioning sheath. The plug is defined by a first disc having a cylindrical shape and the first disc is formed of an expandable material. The first disc is positioned within the blood vessel and against a wall of the blood vessel such that the plug is configured to seal the access site.

In Example 17, the blood pump delivery system of Example 16 further includes wherein the plug includes a second disc that is positioned adjacent the first disc and coupled to the first disc with a connector portion.

In Example 18, the blood pump delivery system of Example 17 further includes wherein the first disc is defined by a first diameter and the second disc is defined by a second diameter, the first diameter being less than or equal to the second diameter.

In Example 19, the blood pump delivery system of Example 16 further includes wherein the plug is composed of a braided material.

In Example 20, the blood pump delivery system of Example 19 further includes wherein the braided material is flexible such that the first disc is capable for compression.

In Example 21, the blood pump delivery system of Example 16 further includes wherein the access site is defined by a diameter and the repositioning sheath is defined by a diameter, and the diameter of the repositioning sheath is less than the diameter of the access site, such that a gap is formed between the repositioning sheath and the blood vessel.

In Example 22, the blood pump delivery system of Example 21 further includes wherein the plug is configured for sealing the gap formed between the repositioning sheath and the blood vessel.

In Example 23, a blood pump delivery system includes a repositioning sheath for insertion into an access site of a blood vessel and for use in positioning a blood pump within the blood vessel including a distal end opposite a proximal end, a sheath body extending between the distal end and the proximal end, the sheath body defining a sheath lumen for receiving the blood pump, and a plug arranged around the sheath body and proximally to the distal end of the repositioning sheath, the plug defined by a first disc having a cylindrical shape and a second disc having a cylindrical shape, the first disc and the second disc coupled by a connector portion extending between the first disc and the second disc. The first disc is positioned within the blood vessel and against a wall of the blood vessel and the second disc is positioned outside of the blood vessel, such that the plug seals the access site.

In Example 24, the blood pump delivery system of Example 23 further includes wherein the first disc has a diameter that is less than a diameter of the second disc.

In Example 25, the blood pump delivery system of Example 23 further includes wherein the first diameter has a value that is approximately equal to the value of the second diameter.

In Example 26, the blood pump delivery system of Example 24 further includes wherein the connector portion has a diameter that is less than the diameter of the first disc and the diameter of the second disc.

In Example 27, the blood pump delivery system of Example 23 further includes wherein the plug is composed of a flexible, braided material.

In Example 28, the blood pump delivery system of Example 27 further includes wherein the plug is composed of nitinol.

In Example 29, a method for sealing an access site of a blood vessel includes inserting a sheath into a blood vessel, the sheath having a diameter that is less than a diameter of the access sheath, inserting a plug onto a proximal end of the sheath and arranging the plug around the sheath, the plug including at least a first disc and a second disc, inserting the plug into the blood vessel with the plug in a collapsed configuration such that the first disc is inserted through the access site and into the blood vessel, and expanding the plug such that the first disc is in contact with the blood vessel and seals the access site.

In Example 30, the method of Example 29 further includes wherein the plug is formed of a self-expanding material such that once the plug is inserted into the blood vessel, the first disc expands to an original position.

In Example 31, the method of Example 29 further includes wherein after expanding the plug, the first disc is arranged within the blood vessel and against the access site and the second disc is arranged externally of the blood vessel.

In Example 32, the method of Example 29 further includes wherein the first disc and the second disc each have a cylindrical shape.

In Example 33, the method of Example 29 further includes wherein the first disc has a first diameter, and the second disc has a second diameter, the first diameter being less than the second diameter.

In Example 34, the method of Example 33 further includes wherein the first diameter has a value that is approximately equal to the value of the second diameter.

In Example 35, the method of Example 29 further includes wherein the plug is formed of a flexible, braided material.

DETAILED DESCRIPTION

FIG.1illustrates a cross sectional view of a blood vessel V with an introducer sheath100inserted at least partially into the blood vessel V. More specifically, the introducer sheath100is inserted into the blood vessel through an access site A of the blood vessel V. In this way, the introducer sheath100has been inserted through a layer of skin of the patient and into an opening (i.e., the access site A) of the blood vessel V. In some embodiments, the introducer sheath100is used for facilitating the passage of various relatively large medical devices, such as a blood pump, through the introducer sheath100and into the blood vessel V. Hence, the introducer sheath100may be referred to as a large bore introducer sheath. The introducer sheath100is defined by a diameter D1that may be approximately equal to a diameter D2of the access site A. After passage of the blood pump or another type of medical device into the access site A, a smaller sheath (such as a repositioning sheath) may replace the introducer sheath100within the blood vessel V in order to reduce the space that is occupied within the blood vessel V by the sheath100—thus increasing blood flow through the blood vessel V. That is, the repositioning sheath may have a smaller diameter than a diameter of the blood vessel V, ensuring that blood is able to pass around the repositioning sheath and through the blood vessel V.

FIG.2illustrates an exemplary repositioning sheath110positioned within the blood vessel V. The repositioning sheath110may be defined by a generally cylindrical shape defined by an outer body112having a lumen114disposed therein. The lumen114may extend between a proximal end116and a distal end118of the repositioning sheath110. The repositioning sheath110may be formed by various polymeric or metallic materials. In some embodiments, the repositioning sheath110may include an additional surface coating. The surface coating may include, but is not limited to, silicone, PET, or any other applicable polymer. As illustrated, the repositioning sheath110is defined by a third diameter D3. The third diameter D3of the repositioning sheath110may have a value that is less than the value of the diameter D1and/or the diameter D2. For example, in some embodiments, the third diameter D3may range from approximately 4 mm to approximately 9 mm.

Further, as illustrated inFIG.2, the repositioning sheath110may include a plug120that is positioned around an outer surface of the outer body112of the repositioning sheath110. In other words, the plug120may be disposed about the circumference of the repositioning sheath110. As will be described further herein with reference to the various embodiments ofFIGS.3-6, the plug120may be configured for sealing a gap at the access site A that extends between the outer body112of the repositioning sheath110and a wall, (i.e., blood vessel surface) of the blood vessel V. This gap may be formed as a result of the repositioning sheath110having the diameter D3that is less than the diameter D2of the access site A. As such, the plug120may be configured for providing a seal to reduce the amount of blood that may exit through the gap at the access site A between the wall of the blood vessel V and the repositioning sheath110. In some embodiments, the plug120may seal the gap between the blood vessel V and the repositioning sheath110at the access site A and may also extend to seal against various layers of the skin of the patient that extends between the skin opening and the access site A. As will be described further herein, the plug120may be defined as a plug, a balloon, an expandable sheath, an expandable disc element, collar, or any other applicable structure for sealing the access site A.

FIG.3illustrates an enlarged portion of the repositioning sheath110having the plug120defined as a tubular structure disposed about the circumference of the repositioning sheath110. As illustrated, the plug120may have a generally conical shape having an opening extending therethrough for receiving the repositioning sheath110. In some embodiments, the plug120is formed of a rubber material such that the plug120is generally rigid in nature and will seal against a wall of the blood vessel V at the access site A. However, the plug120may be formed of various other materials such as silicone or low durometer polyurethane. Further, the plug120may have a diameter D4and a diameter D5, wherein the diameter D4is less than the maximum diameter D5. In some embodiments, the diameter D5may have a value of between approximately 6 mm and approximately 9 mm. In further embodiments, the diameter D4may have a value of between approximately 3 mm and 4 mm.

During manufacture of the repositioning sheath110and the plug120, the plug120may be formed as a separate structure from the repositioning sheath110and then may be subsequently disposed onto the repositioning sheath110. More specifically, the repositioning sheath110may be inserted into the blood vessel V, and then the plug120may be inserted over the proximal end116of the repositioning sheath110and moved along the repositioning sheath110. Once the plug120is arranged onto the repositioning sheath110, the repositioning sheath110may be pushed further along the repositioning sheath110until the plug120is in sealed engagement with the blood vessel V at the access site A (FIG.1).

FIG.4illustrates an additional embodiment of a plug, illustratively an expandable plug140. The expandable plug140may be a cylindrical plug disposed onto the repositioning sheath110. The expandable plug140has a proximal end142opposite a distal end144. The expandable plug140is defined by a length L1extending therebetween. In some embodiments, the value of length L1ranges between 13 cm and 17 cm. For example, in certain embodiments, the length L1has a value of 15 cm. At the distal end144, the expandable plug140includes a fixation means146that axially secures the location of the expandable plug140onto the repositioning sheath110. In certain embodiments, an actuator152is disposed onto a distal end of the fixation means146. As will be described further, the actuator152may be configured for expanding at least a portion of the expandable plug140for engagement with the blood vessel V at the access site A (FIG.1).

Further, as illustrated, the expandable plug140has a body148extending between the proximal end142and the distal end144. At least a portion of the body148is composed of a braided structure150. The braided structure150may be formed of braided metal, such as a braided nitinol structure. As illustrated, the braided structure150is defined by a length L2and a diameter D6. In some embodiments, the length L2may range from approximately 2 cm and approximately 3.5 cm. In some examples, the length L2may have a value of approximately 2.5 cm. In further embodiments, the diameter D6may have a value ranging between approximately 15 French (Fr) to approximately 20 Fr. For example, in some embodiments, the diameter D6has a value of approximately 15 Fr in a rest configuration and a value of approximately 20 Fr in an expanded configuration, as will be described further herein. With continued reference toFIG.4, the expandable plug140includes a tapered portion141adjacent to the braided structure150, which transitions from the diameter D6of the braided structure150to diameter D3of the repositioning sheath110.

As previously described, the diameter D6of the braided structure150may vary. This is due to the braided structure150being configured for expansion and compression through actuation of the actuator152of the fixation means146. In other words, the expandable structure150may have a rest configuration defined by the braided structure150being in a longitudinally expanded state. Actuation of the actuator152, for example rotation, or in some cases axial translation, of the actuator152, may cause longitudinal or axial compression of the braided structure150. In other words, the length L2of the braided structure150may be reduced. As a result, and as a result of the axial positioning of the braided structure150being secured by the fixation means146, the diameter D6of the braided structure150will increase. As such, actuation of the actuator152may cause the braided structure to expand into sealed engagement with a wall of the blood vessel V surrounding the access site A.

FIG.5illustrates an additional embodiment of a plug for use with the repositioning sheath110, illustratively, a balloon160. As illustrated, the balloon160may be disposed around the outer body112of the repositioning sheath110. The balloon160may be formed of a semi-compliant and/or compliant material such that it may be inflated and deflated upon actuation of the balloon160. For example, the balloon160may be arranged onto the repositioning sheath110in a first, collapsed configuration prior to insertion of the repositioning sheath110into the access site A. After positioning of the repositioning sheath110into the access site A, the balloon160may be inflated such that the balloon160comes into contact with a wall of the blood vessel V to seal the access site A.

FIG.6illustrates an additional embodiment of a plug for use with the repositioning sheath110, illustratively an expandable disc element170. More particularly, the expandable disc element170is arranged around the outer body112of the repositioning sheath110. In embodiments, the expandable disc element170has at least one disc element172. In some embodiments, the expandable disc element170may have a first disc172aand a second disc172band a connector portion or a waist portion174extending therebetween and coupling the first and second discs172a,172b. As illustrated, the first disc172amay have a diameter D7while the second disc172bmay have a diameter D8. In some embodiments, the diameter D7is less than the diameter D8. In other embodiments, the diameter D7may be approximately equal to or greater than the diameter D8. In these embodiments, one of the first disc172aand the second disc172bmay be positioned against a wall of the blood vessel V at the access site A to reduce the bleeding at the access site A. For example, the first disc172amay be positioned within the blood vessel V and against an inner surface of the blood vessel V at the access site A, while the second disc172bmay be positioned outside of the blood vessel V and against an outer surface of the blood vessel V at access site A. However, in various other embodiments, the expandable disc element170may only include the first disc172apositioned within the blood vessel V and against an inner surface of the blood vessel V at the access site A. In further embodiments, the expandable disc element170may include any number of discs.

The expandable disc element170may be composed of a flexible, braided material. For example, in some embodiments, the expandable disc element170is formed of nitinol. In this way, when the expandable disc element170is inserted onto the repositioning sheath110and inserted into the access site A (FIG.1), the first disc172amay be in a compressed configuration wherein the first disc172ais flattened onto the repositioning sheath110and once the first disc172ais positioned within the blood vessel V, the first disc172amay actuated to expand back out into a rest configuration and be positioned against the blood vessel V. In some embodiments, insertion of the expandable disc element170into the access site A is facilitated by tension being applied onto the first disc172ato collapse the first disc172asuch that the diameter D7may have a reduced value. In this way, the first disc172amay be inserted into the blood vessel V. When the first disc172ahas been fully inserted into the blood vessel V, the tension may be released and the first disc172amay expand back to the original positioning.

FIG.7illustrates the embodiment ofFIG.6with a portion of the expandable disc element170arranged around the outer body112of the repositioning sheath110and the repositioning sheath110at least partially disposed within a schematic representation of the blood vessel V. More particularly, the first disc172ais arranged within the blood vessel V while the second disc172bremains positioned externally to the blood vessel V. In this way, repositioning sheath110may be adjusted (for example, pulled proximally) once inserted at least partially into the blood vessel V until the first disc172ais placed against an inner surface of the blood vessel V at the access site A and the second disc172bis positioned on the outer surface of the blood vessel V around the access site A.

Further,FIG.8illustrates an additional embodiment of a plug that may be used in combination with the repositioning sheath110. For example, a flexible collar180is illustrated as arranged around the outer body112of the repositioning sheath110. More specifically, the flexible collar180is arranged around an entire circumference of the repositioning sheath110. In some embodiments, the flexible collar180is arranged around the repositioning sheath110such that the flexible collar180is angled relative to the longitudinal axis L. For example, the flexible collar180may extend at an angle α relative to the longitudinal axis L of the repositioning sheath110. After positioning of the repositioning sheath110into the access site A, the collar180may be positioned such that the collar180comes into contact with a wall of the blood vessel V to seal the access site A. For example, the collar180may be inserted at least partially into the blood vessel V until the collar180is placed against an inner surface of the blood vessel V at the access site A to seal the access site A. In other embodiments, the collar180may be placed against an outer surface of the blood vessel V at the access site to seal the access site A.

A schematic top view of the flexible collar180is shown inFIG.9. As illustrated, the flexible collar180has a generally circular configuration defined by a main body182and a lumen184extending therethrough. The lumen184is illustrated as being generally circular in shape. This allows for the flexible collar180to engage with the outer body112of the repositioning sheath110to provide a seal. Further, while the main body182is illustrated as having a generally circular configuration, the main body182may have varying shape profiles.

Further, in some embodiments, the main body182may include a plurality of slits186extending within the main body182. More particularly, the main body182is defined by an outer surface190and an inner surface192defining the lumen184. The plurality of slits186are illustrated as extending from the outer surface190at least partially into the main body182towards the inner surface192. For example, the plurality of slits186may extend a length L3that is approximately 50% of a length L4extending between the outer surface190and the inner surface192of the main body182. In some embodiments, the length L3may have a value of between approximately 25% and approximately 75%. For example, the value of length L3may have a value ranging between approximately 1 mm and approximately 2 mm. The value of the length L4may have a value ranging between approximately 2 mm and approximately 4 mm. In the illustrative embodiment ofFIG.9, the plurality of slits186includes seven slits186a-186g, however, any number of slits may be incorporated. The plurality of slits186may increase the ease with which that the repositioning sheath110enters and exits the blood vessel V. For example, the plurality of slits186may provide for flexibility to facilitate insertion of the repositioning sheath110while reducing the chances of damage of the blood vessel V. Additionally, the main body182of the flexible collar180may be composed of a flexible polymer such that the flexible collar180maintains flexible to accommodate varying environments and reduce damage of any tissue that the flexible collar180comes into contact with. For example, the flexible collar180may be composed of silicone or low durometer polyurethane.