System and methods to hemostatically close arterial and venous access locations

Abstract

The present invention relates generally to the field of closing of openings in vessel walls, i.e. closure of vascular holes, in particular access to and closure of an access point through the wall of a human vessel, and more specifically to the hemostatic closure and structural support of an opening such as an access point through a fluid filled vessel, particularly a human vessel, be that an artery, vein or other body conduit.

Claims

1. A system for sealing an opening in a wall of a vessel defining a fluid-containing lumen, the system comprising: a. an elongate and expandable support sleeve; and b. a sleeve delivery apparatus arranged to receive the support sleeve, expansion means to in-use expand the support sleeve into engagement with the wall of the vessel.

2. A system according to claim 1, wherein the vessel is a blood vessel.

3. A system according to claim 1, wherein the sleeve delivery apparatus is a sheathless sleeve delivery apparatus.

4. A system according to claim 1, wherein the sleeve delivery apparatus additionally comprises a moveable sheath dimensioned to cover the support sleeve, the sheath being moveable between a first position in which the sheath covers the support sleeve and a second position in which the sheath does not cover the support sleeve.

5. The system of claim 1, wherein the support sleeve is a hollow cylinder.

6. The system of claim 1, wherein the support sleeve is comprised of a polymeric material.

7. The system of claim 1, wherein the support sleeve is comprised of a resorbable material.

8. The system of claim 1, wherein the support sleeve includes an outer abluminal surface, and wherein the abluminal surface is textured.

9. The system of claim 1, wherein the support sleeve includes an outer abluminal surface, and wherein the support sleeve includes a secondary material disposed on or engaged with the abluminal surface to promote platelet activation and recruitment between the abluminal surface and the wall of the vessel.

10. The system of claim 1, wherein the support sleeve includes an outer abluminal surface, and wherein the support sleeve includes a secondary material disposed on or engaged with the abluminal surface to adhere the abluminal surface to the vessel wall.

11. The system of claim 1, wherein the expansion means comprises an inflatable sac.

12. The system of claim 11, wherein the expansion means comprises an inflatable sac, and wherein the support sleeve is positioned about the inflatable sac, the support sleeve and the inflatable sac collectively being folded for transluminal delivery along the vessel.

13. The system of claim 12, wherein the folded support sleeve and inflatable sac are wrapped by a removable sheath.

14. The system of claim 1, wherein the expansion means comprises an expandable lattice structure.

15. The system of claim 1, additionally comprising a guidewire.

16. A method of sealing an opening in a wall of a vessel defining a fluid-containing lumen, the method comprising the steps of: (i) inserting a system according to claim 1 at an insertion site in a vessel remote the opening in the wall of the vessel to be sealed; (ii) moving the sleeve delivery apparatus and the support sleeve such that they are positioned adjacent the opening in the wall of the vessel; and (iii) expanding the expansion means so as to expand the support sleeve into engagement with the wall of the vessel.

17. A method according to claim 16, additionally comprising the steps of: (iv) contracting the expansion means; and (v) removing the sleeve delivery apparatus from the vessel remote the opening in the wall of the vessel.

18. A method according to claim 16, wherein the insertion site for the system is of a smaller size than the opening in the wall of the vessel to be sealed.

Description

DRAWINGS

[0054] FIG. 1 shows a radial artery access site for the Support Sleeve Delivery System (<6Fr) in the right wrist of a patient;

[0055] FIG. 2 is a partial cut-away view of the support sleeve delivery apparatus of FIG. 1;

[0056] FIG. 3 is a perspective view of a partial cut-away of the support sleeve delivery apparatus, the inflated balloon pressing the sleeve against the vessel wall;

[0057] FIG. 4 is a partial cut-away side view of the support sleeve delivery apparatus of FIG. 3;

[0058] FIG. 5 is a partial cut-away view of the sleeve which remains in place after the balloon has been deflated and the delivery system removed; and

[0059] FIG. 6 is a bar chart showing adhesion of PDO strips to fresh tissue, the PDO strips having varying thicknesses of collagen coating applied to their surface. Numerical values under the X-axis are the measured force (N).

SEALING SLEEVE EMBODIMENT

[0060] One aspect/embodiment of the present disclosure is directed to providing an apparatus and method to effectively seal the large bore access point that is used to gain entry into the central vasculature; that large bore access point being used to facilitate the exchange of tools used during a large bore percutaneous transcatheter procedure.

Design Solution

[0061] The design solution of this invention is to deliver a cylindrical support sleeve to the site of the access point in the lumen wall using an inflatable balloon catheter (or a self-expanding stent-type structure which is permanently attached to its delivery system and removed once the sleeve has been deployed). The sleeve is sized appropriately for the lumen diameter and the incision size/length. The delivery system used to deliver the support sleeve enters the patient’s body using a minimally invasive access point at some other location in the patient’s body. The delivery system travels over a guidewire which facilitates smooth transluminal delivery of the device to the correct deployment location. For example, the delivery system might enter the body through a minimally invasive access point in the radial artery of the patient’s wrist (FIG. 1) and transluminally traverse over a guidewire to the large bore incision that was made in the femoral artery for the purposes of facilitating tool exchange during a TAVR procedure. The delivery system (with sleeve) will remain in an undeployed low-profile state until it reaches the appropriate location for deployment. This positioning will typically be guided by some method of external vision system (e.g. ultrasound guidance or X-Ray fluoroscopy). The undeployed sleeve may be contained within a retractable sheath/covering in order to maintain a low-profile as it travels to the correct location and to ensure it does not contact blood until it is ready to be deployed.

[0062] Once at the correct location (FIG. 2), the sleeve will be deployed through the inflation of the balloon or the expansion of a self-expanding stent-type structure. This will cause the sleeve to be pressed against the inner wall of the vessel and immediately seal the large bore incision (FIG. 3, FIG. 4). In the case of a blood-containing lumen, upon deployment the sleeve will initiate the blood coagulation cascade on the abluminal side of the sleeve. The resulting thrombus will act to adhere the sleeve to the inner wall of the lumen and result in instant hemostasis at the large bore incision point. The sleeve may contain some additional thrombus-inducing mechanisms on its abluminal surface such as a surface texturing (to increase the real surface area of the micro-structure) or the use of an additional material that will induce increased platelet activation and recruitment. Upon deflation of the balloon (or retraction of the self-expanding stent-like structure), the fluid pressure in the vessel will act in concert with the adhesion that has been enacted between the abluminal surface of the sleeve and the lumen wall itself. This dual mechanism ensures that hemostasis persists after the balloon is deflated and the sleeve remains in place as the delivery system is removed (FIG. 5). The delivery guidewire can remain in place for the entirety of the closure procedure until the physician is confident that hemostasis has been effected and large bore closure is complete.

[0063] The delivery system is removed from the patient’s body via its own minimally invasive incision point (e.g. the access point in the radial artery) which, upon final removal of the delivery guidewire and access Introducer sheath, can be closed through a simple external compression device (since this access incision will be typically be in the region of 5Fr - 6 Fr).

Procedure

[0064] The procedure for using the above design is described below and is illustrated in FIGS. 1 - 5.

[0065] Step 1: Obtain access into the radial artery 10 using standard procedures and position a 6Fr Introducer sheath 11 into the artery 10 in the arm 20 of a patient to facilitate tool exchange into this artery.

[0066] Step 2: Insert a guidewire 12 (0.014″ (0.3556 mm) or 0.018″ (0.4572 mm)) into the radial artery 10 and advance it to the location of the large-bore incision site 30 to be sealed/closed in blood vessel 40.

[0067] Step 3: Insert the delivery system 50 containing the support sleeve 52 over the guidewire 12 and advance it to the location of the large-bore incision site 30 in blood vessel 40 to be sealed/closed (FIG. 2: wrapped balloon-sleeve combination 51 at the incision site 30 pre-deployment). Position correctly (using appropriate imaging methodologies) so that the support sleeve 52 is centrally positioned across the location of the large-bore incision site 30 to be sealed/closed.

[0068] Step 4: If the embodiment contains a protective sheath/covering over the sleeve-balloon combination 51, retract the protective sheath/covering which covers the undeployed sleeve thereby exposing the wrapped sleeve-balloon combination.

[0069] Step 5: The balloon 60 is inflated, thereby deploying the sleeve 52 and firmly pressing it against the inner wall of the lumen of the blood vessel 40.

[0070] Step 6: The physician will observe an immediate cessation of pulsatile flow at the skin level of the large bore access site.

[0071] Step 7: After a short number of seconds, the balloon can be deflated again leaving the support sleeve 52 in position. Hemostasis will persist- the insertion site 30 is sealed.

[0072] Step 8: Delivery system and delivery guidewire 12 are removed via the minimally invasive access location in the wrist. Closure of this minimally invasive access location can be effected through a simple external compression device.

Advantages

[0073] Advantages associated with this closure support sleeve and the above-described procedure are significant and include the following:

[0074] 1. Instant hemostatic closure through the use of a full cylindrical support sleeve delivered directly to the incision in the lumen wall.

[0075] 2. The method of delivery through the inflation of a balloon applies focused pressure directly at the location where the incision in the lumen wall is. This means that compression of bleeding location is absolutely focused where it is most needed. This avoids the need for the physician to blindly apply compression over the access site through the skin of the patient which is time consuming, often not directed at the location required and requires physical effort on the part of the physician/nurse.

[0076] 3. The cylindrical sleeve provides structural support to the injured vessel and helps with the healing process since it instantly takes pressure off the injury site once deployed.

[0077] 4. The risk of a pseudoaneurysm forming around the incision is greatly reduced since the incision site (and the vessel itself) is supported by the sleeve. This protects the weakened vessel during the healing process.

[0078] 5. The risk of a local hematoma forming around the incision is greatly reduced since the sealing ability provided by the sleeve is optimized due to the dual action of the adhesive effect provided by the coagulating blood between sleeve and vessel wall and the action of the vessel pressure acting to press the sleeve against the vessel wall post-delivery.

[0079] 6. Given that the sleeve is bioresorbable, there will be no artefact left at the incision site after resorption has been completed. Furthermore, there will be no foreign material left in the tissue tract (i.e. the large-bore tract through which the TAVR tools were exchanged during the primary procedure) and so there will be no fibrosed tissue local to the incision site post-healing. This is important since it means that this location is not lost to that patient as an access point for future large-bore interventions as the tissue will heal close to its original integrity.

Collagen Coating of Polydioxanone (PDO) Strips

[0080] This experiment was undertaken in order to determine the adhesion (bonding) between PDO coated with collagen and fresh tissue.

[0081] PDO strips were coated with Type I collagen using cold plasma deposition and pressed against fresh tissue in the presence of blood. The resulting test pairs were then subjected to tensile testing in order to determine the adhesive force between the PDO coupon and the tissue can be measured. A surgical glue was used as the control in place of the Type I collagen.

[0082] As illustrated in FIG. 6, the varying thicknesses of collagen achieved excellent results in terms of adhesion of the PDO strips to fresh tissue. This demonstrates that the use of a secondary material to promote platelet activation and recruitment can result in excellent hemostatic adhesion (bonding) of the support sleeve to the wall of the vessel.

[0083] Many modifications and other embodiments of the inventions set forth herein will come to mind to one skilled in the art to which these disclosed embodiments pertain having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Therefore, it is to be understood that embodiments of the invention are not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the invention. Moreover, although the foregoing descriptions and the associated drawings describe example embodiments in the context of certain example combinations of elements and/or functions, it should be appreciated that different combinations of elements and/or functions may be provided by alternative embodiments without departing from the scope of the disclosure. In this regard, for example, different combinations of elements and/or functions than those explicitly described above are also contemplated within the scope of the disclosure. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

[0084] It should be understood that although the terms first, second, etc. may be used herein to describe various steps or calculations, these steps or calculations should not be limited by these terms. These terms are only used to distinguish one operation or calculation from another. For example, a first calculation may be termed a second calculation, and, similarly, a second step may be termed a first step, without departing from the scope of this disclosure. As used herein, the term “and/or” and the “/” symbol includes any and all combinations of one or more of the associated listed items.

[0085] As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises”, “comprising”, “includes”, and/or “including”, when used herein, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. Therefore, the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting.

[0086] Other aspects of the invention include the following:

[0087] Aspect 1. A system for sealing an incision in a wall of a vessel defining a fluid-containing lumen, comprising: [0088] a. an elongate and expandable support sleeve; and [0089] b. a sleeve delivery system arranged to receive the support sleeve and to transluminally deliver said support sleeve along the vessel such that a medial portion of the support sleeve is adjacent to the incision, the sleeve delivery system being further arranged to laterally expand the support sleeve into engagement with the wall of the vessel about the incision so as to seal the incision.

[0090] Aspect 2. The system of Aspect 1, wherein the support sleeve is a hollow cylinder.

[0091] Aspect 3. The system of Aspect 1, wherein the support sleeve is comprised of a polymeric material.

[0092] Aspect 4. The system of Aspect 1, wherein the support sleeve is comprised of a resorbable material.

[0093] Aspect 5. The system of Aspect 1, wherein the support sleeve includes an outer abluminal surface, and wherein the abluminal surface is textured.

[0094] Aspect 6. The system of Aspect 1, wherein the support sleeve includes an outer abluminal surface, and wherein the support sleeve includes a secondary material disposed on or engaged with the abluminal surface to promote platelet activation and recruitment between the abluminal surface and the wall.

[0095] Aspect 7. The system of Aspect 1, wherein the support sleeve includes an outer abluminal surface, and wherein the support sleeve includes a secondary material disposed on or engaged with the abluminal surface to adhere the abluminal surface to the wall.

[0096] Aspect 8. The system of Aspect 1, where the sleeve delivery system is arranged to receive the support sleeve into engagement with an expander device, and wherein the expander device comprises an inflatable sac arranged to expand upon actuation thereof to laterally expand the support sleeve.

[0097] Aspect 9. The system of Aspect 1, where the sleeve delivery system is arranged to receive the support sleeve into engagement with an expander device, and wherein the expander device comprises an expandable lattice structure arranged to expand upon actuation thereof to laterally expand the support sleeve.

[0098] Aspect 10. The system of Aspect 1, where the sleeve delivery system is arranged to receive the support sleeve about a guide wire, and wherein the guide wire is arranged to extend through the vessel to proximate the incision such that the support sleeve is directed to the incision along the guide wire.

[0099] Aspect 11. The system of Aspect 1 where the sleeve delivery system includes an expander device, wherein the expander device comprises an inflatable sac, and wherein the support sleeve is received about the inflatable sac with the support sleeve and the inflatable sac collectively being folded to achieve a low profile for transluminal delivery along the vessel.

[0100] Aspect 12. The system of Aspect 11 where the folded support sleeve and inflatable sac are wrapped by a sheath to maintain the low profile for transluminal delivery along the vessel, the sheath being removable prior to expansion of the support sleeve.

REFERENCE SIGNS

[0101] 10 - radial artery [0102] 11 - introducer sheath [0103] 12 - guide wire [0104] 20 - arm [0105] 30 - Incision site / tissue tract [0106] 40 - blood vessel [0107] 50 - delivery system [0108] 51 - wrapped balloon-sleeve combination at the incision site pre-deployment [0109] 52 - support sleeve [0110] 60 - balloon pressing the sleeve against the vessel wall. [0111] 70 - support sleeve (across large-bore incision 30)