US20020022822A1 - Sheath-mounted arterial plug delivery device - Google Patents

Abstract

A method of facilitating hemostasis of a blood vessel puncture. The method includes the steps of inserting a tubular device into a puncture in a blood vessel to establish access to the blood vessel, providing a vessel closure system around the tubular device, introducing a hemostatic material into a space between the tubular device and vessel closure system, and delivering the hemostatic material adjacent to the puncture to facilitate hemostasis of the puncture.

Description

• This application claims priority under 35 U.S.C. § 119 to provisional U.S. patent application Ser. No. 60/218,431, filed Jul. 14, 2000, which is incorporated herein by reference in its entirety.[0001]
FIELD OF THE INVENTION
• The present invention relates to a method and system for facilitating hemostasis of a blood vessel.[0002]
BRIEF DESCRIPTION OF THE RELATED ART
• Numerous arterial puncture closure devices are known in the prior art. These include many mechanisms, such as plugs, sutures, intra-vascular structures and more. While these prior art devices vary in size and theory, they all require placement of distinct closure devices through a procedural sheath, sheath exchanges, or sheath removal prior to placement. By their very nature, these devices represent a separate procedure for access site closure after access site establishment/maintenance. The decision to use these devices is often based upon the instant availability of the device and competing demand for the doctor's time at the moment of sheath removal.[0003]
• An additional challenge of puncture closure devices comes when they are deployed many hours after access has been established. In these cases, time and additional access site manipulation contribute to potential infection.[0004]
• What is needed is a single device which establishes and maintains access to a puncture site, and closes the access site upon the completion of a procedure. In this way, the closure of the puncture site could become a standard of care, not subject to device availability, competing demand for doctor time, or site infection due to delayed deployment.[0005]
• Accordingly, it would be desirable to provide a method and system that enable the user to access a blood vessel with a sheath that also incorporates a means for access site closure. Furthermore, upon completion of the interventional procedure, the closure device is deployed to close the puncture and the sheath is removed.[0006]
SUMMARY OF THE INVENTION
• The present invention provides an improved method and system for facilitating hemostasis of a blood vessel puncture.[0007]
• In accordance with one aspect of the present invention, a method of facilitating hemostasis of a blood vessel puncture includes the steps of inserting a tubular device into a puncture in a blood vessel to establish access to the blood vessel; providing a vessel closure system around the tubular device; introducing a hemostasis promoting material into a space between the tubular device and vessel closure system; and delivering the hemostatic material adjacent to the puncture to facilitate hemostasis of the puncture.[0008]
• In accordance with a further aspect of the present invention, a method of facilitating hemostasis of a blood vessel puncture, the method includes inserting a procedural access sheath through a tissue tract and into a puncture in a blood vessel; providing a vessel closure system around the access sheath and at least partially in the issue tract; and performing a vascular procedure with the vessel closure system in the tissue tract.[0009]
• In accordance with another aspect of the present invention, a system for facilitating hemostasis of a blood vessel puncture, the system including a delivery cannula configured to be received around an access sheath; a hemostasis promoting material within the delivery cannula for facilitating hemostasis of a blood vessel puncture when delivered adjacent to the puncture; a proximal stop for preventing proximal motion of the hemostasis promoting material within the delivery cannula when the access sheath is withdrawn proximally from the delivery cannula; and a pusher for delivering the sponge material from the delivery cannula.[0010]
BRIEF DESCRIPTION OF THE DRAWINGS
• The invention will now be described in greater detail with reference to the preferred embodiments illustrated in the accompanying drawings, in which like elements bear like reference numerals, and wherein:[0011]
• FIG. 1[0012]ais a perspective view of a first embodiment of a delivery cannula according to the present invention positioned for delivery of a hemostatic promoting material;
• FIG. 1[0013]bis a perspective view of the delivery cannula of FIG. 1awith the access sheath being removed;
• FIG. 1[0014]cis a perspective view of the delivery cannula of FIGS. 1aand1bwith the hemostatic promoting material being ejected;
• FIG. 1[0015]dis a perspective view of an alternative embodiment of a delivery cannula with a side staging chamber;
• FIG. 1[0016]eis a perspective view of the delivery cannula of FIG. 1dwith the hemostatic promoting material in the delivery cannula;
• FIG. 2[0017]ais a perspective view of a delivery cannula according to an alternative embodiment;
• FIG. 2[0018]bis a perspective view of a delivery cannula according to an alternative embodiment;
• FIG. 3[0019]ais a perspective view of a delivery cannula according to an alternative embodiment;
• FIG. 3[0020]bis a perspective view of a delivery cannula according to an another embodiment;
• FIG. 4[0021]ais a perspective view of a delivery cannula according to an another embodiment; and
• FIG. 4[0022]bis a perspective view of a delivery cannula according to an alternative embodiment.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• The present invention provides an access system that enables the user to access a blood vessel with a sheath that also incorporates a means for performing site closure. Upon completion of the interventional procedure, the closure device is deployed to close the puncture and the sheath is removed.[0023]
• As shown in FIG. 1[0024]a, an access system for facilitating hemostasis of a blood vessel includes adelivery cannula10 positioned coaxially around anaccess sheath20, and a hemostatic promotingmaterial30 within thedelivery cannula10 for facilitating hemostasis of a blood vessel puncture when delivered adjacent to the puncture. In one preferred embodiment, thehemostatic material30 is a hydrated and compressed sponge.
• The[0025]delivery cannula10 as shown in FIG. 1ais dimensioned such that itsproximal end12 can attach to theaccess sheath20 at or near the access sheathproximal end22, and such that thedelivery cannula10distal end14 terminates proximal to thedistal end24 of theaccess sheath20. Further, thedelivery cannula10 incorporates an annularproximal stop40 fitting slideably around theaccess sheath20 and removably within thedelivery cannula10. Theproximal stop40 is positioned within thedelivery cannula10 such that itsdistal end44 defines the proximal boundary of a coaxialhemostatic material space26. Theproximal end42 of theproximal stop40 is positioned at or near theproximal end12 of thedelivery cannula10. Theproximal stop40 may include aproximal flange46 to facilitate proper placement within thedelivery cannula10.
• While the[0026]hemostatic material space26 described herein is coaxial, it can be appreciated that many other configurations are possible. Thehemostatic material space26 is defined by the outside of theaccess sheath20 and the inside of thedelivery cannula10 and may be continuous, discontinuous, symmetrical, or nonsymmetrical.
• In one preferred embodiment as shown in FIG. 1[0027]a, the access system is prepared by attaching thedelivery cannula10 to theaccess sheath20 as described above. Thehemostatic material30 is then introduced into thecoaxial space26 between thedelivery cannula10 and accesssheath20.
• In another preferred embodiment, as shown in FIGS. 1[0028]d&1ethehemostatic material30 is introduced into thecoaxial space26 by hydrating an absorbable sponge in astaging chamber portion50 of thedelivery cannula10 and advancing the sponge through aside port48 of the delivery cannula into a delivery position surrounding theaccess sheath20. The hydrating of the absorbable sponge is performed with asyringe90 and asyringe plunger92. A removable distal stop or vent52 may be provided to help position thehemostatic material30 within the system. Alternatively, the distal stop or vent52 may be soluble and/or absorbable such that it remains in place during advancement of the system into the vascular access site and then dissolves to allow delivery of the hemostatic material. A distal stop or vent52 of this type may be made of gelatin, polyglycolic acid, or other suitable material known to one skilled in the art.
• The system can then be placed much like an[0029]ordinary access sheath20 as shown in FIG. 1a.The removable distal stop or vent52 is removed (if present) and the system is placed over aguidewire54 and into the vascular access site such that the portion of theaccess sheath20 extending distally beyond the distal end of thedelivery cannula10 extends through avessel puncture55 and into avessel57 and the distal end of thedelivery cannula10 resides at or near the outerblood vessel wall58. A bleed-back hole60 in theaccess sheath20 can be utilized to provide bleed-back as an indication that thedistal end14 of thedelivery cannula10 is within a predetermined proximity with respect to theblood vessel58. The lack of bleed-back62 indicates a more proximal location of thedelivery cannula10. Thedelivery cannula10 may be positioned using only bleed-back62 as an indicator of position, or may be more precisely located by utilizing tactile feedback as the enlarged distal end of thedelivery cannula10 encounters the outerblood vessel wall58.
• Bleed-[0030]back62 is facilitated by providing adilator70 within theaccess sheath20 that fits closely over theguidewire54 at itsdistal end74 such that it substantially prevents blood from entering thedilator70. Further, thedilator70 fits closely within thedistal access sheath20 such that it substantially prevents blood from entering the access sheath. In this way, blood is restricted from entering theaccess sheath20 until the bleed-back hole60 enters theblood vessel58. Blood entering the bleed-back hole60 might then exit the patient through a number of paths.
• If the[0031]access sheath20 was provided with a seal at itsproximal end22, the blood might enter a hole in thedilator70 and then exit theproximal end72 of thedilator70. Alternatively, blood could flow between thedilator70 andaccess sheath20 to an exit in theintroduction port76 and stop-cock78 as shown in FIG.1a.If theaccess sheath20 has no proximal seal, the blood could exit theproximal end22 of theaccess sheath20.
• In operation, the access systems of the present invention are used as follows. The interventional procedure is conducted as usual with the[0032]delivery cannula10 andhemostatic material30 in place during the procedure. At the end of the interventional procedure, theaccess sheath20 portion of the system is detached from thedelivery cannula10 and fully withdrawn while thedelivery cannula10 andproximal stop40 remain stationary as shown in FIG. 1b. Theproximal stop40 prevents thehemostatic material30 from moving proximally duringaccess sheath20 removal. This portion of the procedure may take place with or without aguidewire54 in place.
• The[0033]proximal stop40 is then removed from thedelivery cannula10 and apusher80 having an outside diameter just smaller than the inside diameter of thedelivery cannula10 is placed over the guidewire54 (if present) and advanced until it contacts the proximal portion ofhemostatic material30. As shown in FIG. 1c,thehemostatic material30 is then delivered by moving thedelivery cannula10 proximally with respect to thepusher80.
• In one preferred embodiment, the[0034]pusher80 is held stationary while thedelivery cannula10 is withdrawn. It is also understood that thepusher80 can be advanced while thedelivery cannula10 is held stationary. It is further understood that any combination of these techniques can result in delivery ofhemostatic material30. After deliveringhemostatic material30 into the desired site, the guidewire54 (if present) and thepusher80 andcannula10 are removed from the puncture tract.
• In an alternative embodiment, as shown in FIG. 2[0035]a,aproximal stop40 is positioned within thedelivery cannula10 such that itsdistal end44 defines the proximal boundary of the coaxialhemostatic material space26. Theproximal end42 of theproximal stop40 terminates at theproximal end12 of thedelivery cannula10.Detent86 features such as bumps or ratchets may be included on the inside of thedelivery cannula10 or the outside of theproximal stop40 to releasibly hold theproximal stop40 in place. Upon completion of the interventional procedure, theaccess sheath20 portion of the system is withdrawn while thedelivery cannula10 andproximal stop40 remain stationary as shown in FIG. 2a. Theproximal stop40 prevents thehemostatic material30 from moving proximally duringaccess sheath20 removal. This portion of the procedure may take place with or without aguidewire54 in place.
• A[0036]pusher80 shown in FIG. 2b, having adistal portion83 with an outside diameter similar to the previously removedaccess sheath20 and a length similar to theproximal stop40 is then placed over the guidewire54 (if present) and advanced into theproximal stop40 until itsdistal end84 is approximately aligned with thedistal end44 of theproximal stop40. Thepusher80 may be provided with aproximal shoulder85 to facilitate this alignment. As shown in FIG. 2b, thehemostatic material30 is then delivered by moving thedelivery cannula10 proximally with respect to thepusher80 andproximal stop40. In one preferred embodiment, thepusher80 andproximal stop40 are held stationary while thedelivery cannula10 is withdrawn. Thepusher80 may include aproximal flange88 to beneficially limit its movement with respect to thedelivery cannula10. After deliveringhemostatic material30 into a desired site, the guidewire54 (if present) and system are removed.
• In an alternative embodiment, as shown in FIG. 3[0037]a, a longerproximal stop40 is positioned within thedelivery cannula10 such that itsdistal end44 defines the proximal boundary of the coaxialhemostatic material space26. Theproximal end42 of theproximal stop40 extends beyond theproximal end12 of the delivery cannula10 a distance equal to or greater than the length of the coaxialhemostatic material space26. Upon completion of the interventional procedure, theaccess sheath20 portion of the system is detached from thedelivery cannula10 and fully withdrawn while thedelivery cannula10 andproximal stop40 remain stationary. Theproximal stop40 is held in place manually or with a locking mechanism to prevent thehemostatic material30 from moving proximally duringaccess sheath20 removal. This portion of the procedure may take place with or without aguidewire54 in place.
• As shown in FIG. 3[0038]b, apusher80 having an outside diameter similar to the previously removedaccess sheath20 and a length similar to theproximal stop40 is then placed over the guidewire54 (if present) and advanced into theproximal stop40 until itsdistal end84 is approximately aligned with thedistal end44 of theproximal stop40. Thepusher80 may be provided with a proximal flange to facilitate this alignment. Thehemostatic material30 is then delivered by moving thedelivery cannula10 proximally with respect to thepusher80 andproximal stop40 as shown in FIG. 3b. In one preferred embodiment, thepusher80 andproximal stop40 are held stationary while thedelivery cannula10 is withdrawn. Theproximal stop40 may include a proximal flange to beneficially limit its movement with respect to the delivery cannula. After deliveringhemostatic material30 into desired site, the guidewire54 (if present) and system are removed.
• In still another embodiment shown in FIG. 4[0039]a, aproximal stop40 similar to that just described is used to deliver the hemostatic material without the use of apusher80. A system incorporating this type ofproximal stop40 is placed within an access site. At the end of the interventional procedure and prior toaccess sheath20 removal, thedelivery cannula10 is moved proximally with respect to theproximal stop40 as shown in FIG. 4a. In this way thehemostatic material30 is delivered to the desired site with theaccess sheath20 still in place. Theaccess sheath20 provides hemostasis at thepuncture site98 duringhemostatic material30 delivery and also preventshemostatic material30 from entering thepuncture site98.
• As shown in FIG. 4[0040]b, thedelivery cannula10 andproximal stop40 are then held stationary to stabilize thehemostatic material30 while theaccess sheath20 is removed. Thedelivery cannula10 andproximal stop40 can then be removed from the site. Note that the guidewire54 (if present) can be removed before theaccess sheath20 is removed, when theaccess sheath20 is removed, after theaccess sheath20 is removed, or after thedelivery cannula10 andproximal stop40 are removed.
• Other means of positioning the hemostatic material within the system include placing the hemostatic material within the distal lumen of the[0041]delivery cannula10 and then passing theaccess sheath20 through it.
• In another preferred embodiment the[0042]hemostatic promoting material30 is placed in the cannula by placing a hydrated sponge within thedistal end14 of thedelivery cannula10. Thedistal end24 of theaccess sheath20 with a stylet or obturator placed within it is then advanced into theproximal end12 of thedelivery cannula10 and through the sponge until thedistal access sheath20 protrudes beyond thedistal end14 of thedelivery cannula10. The stylet or obturator is then removed to ready the system for placement into an access site.
• The absorbable sponge material can be absorbed by the body in a period of time between several days and several months depending on the absorbable sponge material used. A pledget formed of commercially available Gelfoam material will be absorbed by the body within 1 to 6 weeks. However, the pledget material may be engineered to provide different rates of absorption. For example, Gelfoam can be designed to be absorbed at different rates by varying the degree of cross-linking Preferably, the pledget is designed to be absorbed in less than one month.[0043]
• Although the invention is primarily intended for delivery of absorbable sponge, non-absorbable sponge may also be delivered with the devices, systems, and methods of the present invention. A non-absorbable sponge may be desirable where it will be necessary to locate the blood vessel puncture after the procedure.[0044]
• While an amorphous or discontinuous sponge structure may be used in the present invention, a continuous structure of the delivered absorbable sponge pledget provides more secure and reliable placement of a plug of material against the blood vessel puncture than a paste or liquid. The continuous sponge structure can even facilitate partial withdrawal, removal, or movement of the ejected pledget.[0045]
• The absorbable sponge material can be hydrated with a clotting agent such as thrombin, a contrast agent, another beneficial agent, a combination of agents, or the like. Alternatively, the pledget material itself may contain an agent such as a clotting agent, a contrast agent, another beneficial agent, a combination of agents, or the like.[0046]
• The absorbable sponge pledget may be presoaked with a beneficial agent such as thrombin for delivery of the beneficial agent to the punctured blood vessel. Alternatively, the pledget may be hydrated with a beneficial liquid agent used as the hydrating fluid within a syringe. Further, the beneficial agent may be delivered to the pledget after the pledget is ejected at the blood vessel puncture site through the lumen of the[0047]pusher80, through thedelivery cannula10, through theaccess sheath20 or through thedilator70.
• Because the amount of subcutaneous fat and tissue between the[0048]skin64 and theblood vessel wall58 varies between patients from approximately 0.5 cm to 15 cm or more the system may be provided in different lengths for use in different patients. The pledget size and shape may also be varied for different patients. The absorbable sponge material should form a complete plug over the puncture site without expanding into the blood vessel or exiting the skin of the patient. In some instances where the amount of subcutaneous tissue is great it may be desirable to deliver multiple pledgets in spaced apart positions along the tract leading to the puncture site.
• The particular size and shape of the access system may vary depending on the size of the access site, amount of subcutaneous tissue, and the size of pledget to be delivered. According to one example of the present invention, a pledget is formed from a rectangular piece of pre-compressed Gelfoam approximately 2 by 3 cm with a thickness of 0.15 cm. The Gelfoam is rolled or folded into a pledget having a length of approximately 3 cm. An introducer for delivery of this pledget to a patient with an average amount of subcutaneous tissue has a staging chamber length of about 2.5 to 6 cm, preferably approximately 3 cm, a staging chamber inner diameter of about 0.12 to 1.5 cm, preferably about 0.3 cm to about 0.6 cm, and a delivery chamber which is typically longer than the staging chamber and has an inner diameter smaller than that of the staging chamber of about 1 cm or less, preferably approximately 0.33 cm or less. The particular length of the delivery chamber depends on both the subcutaneous tissue depth of the patient and the linear expansion of the pledget as it moves from the staging chamber to the delivery chamber. An angle made by a wall of the tapered section[0049]38 with a longitudinal axis of the adaptor may vary from about 5° to 90°, but is preferably between about 30° and 60°, more preferably approximately 45°. The tapered section38 is illustrated with a substantially planar interior surface, when shown in cross section. However, the tapered section may also have a convex or concave surface in cross-section. This example of pledget and introducer configurations is merely exemplary of the present invention.
• In addition, the[0050]hemostatic promoting material30 may be inserted into the cannula in a dry form and hydrated in the cannula. Alternatively, the hemostatic material may be hydrated prior to staging in the cannula, hydrated after delivery or any combination thereof.
• While the invention has been described in detail with reference to the preferred embodiments thereof, it will be apparent to one skilled in the art that various changes and modifications can be made and equivalents employed, without departing from the present invention.[0051]

Claims (46)

1. A method of facilitating hemostasis of a blood vessel puncture, the method comprising:

inserting a tubular device into a puncture in a blood vessel to establish access to the blood vessel;

providing a vessel closure system around the tubular device;

introducing a hemostasis promoting material into a space between the tubular device and vessel closure system; and

delivering the hemostatic material adjacent to the puncture to facilitate hemostasis of the puncture.

2. The method ofclaim 1, further comprising a step of withdrawing the tubular device prior to delivery of the hemostatic material.

3. The method ofclaim 1, further comprising a step of hydrating an absorbable sponge material in a staging chamber portion of the vessel closure system.

4. The method ofclaim 3, further comprising a step of advancing the absorbable sponge material into a delivery position.

5. The method ofclaim 1, further comprising a step of locating the puncture by using a bleed-back hole in the vessel closure system.

6. The method ofclaim 1, further comprising a step of the locating the puncture by using tactile feedback.

7. The method ofclaim 1, further comprising a step of hydrating the hemostatic material with a syringe.

8. The method ofclaim 1, further comprising a step of positioning the hemostatic material within the system using a distal stop or vent.

9. The method ofclaim 1, further comprising a step of placing the tubular device and vessel closure system over a guidewire.

10. The method ofclaim 1, further comprising a step of facilitating bleed-back by providing a dilator within the tubular device.

11. The method ofclaim 1, further comprising a step of removing a proximal stop from the vessel closure system.

12. The method ofclaim 1, further comprising a step of advancing the hemostatic material with a pusher and delivering the hemostatic material by moving the vessel closure system proximally with respect to the pusher.

13. The method ofclaim 12, further comprising a step of holding the pusher stationary while the vessel closure system is withdrawn.

14. The method ofclaim 12, further comprising a step of advancing the pusher while the vessel closure system is held stationary.

15. The method ofclaim 9, further comprising a step of removing the guidewire after the hemostatic material is delivered.

16. The method ofclaim 1, further comprising a step of removing the vessel closure system after the hemostatic material is delivered.

17. The method ofclaim 11, further comprising a step of removing the tubular device while the vessel closure system and proximal stop remain stationary.

18. The method ofclaim 1, further comprising a step of advancing a pusher into the proximal stop and moving the vessel closure system proximally with respect to the pusher and the proximal stop.

19. The method ofclaim 1, further comprising a step of withdrawing the vessel closure device while holding the pusher and proximal stop stationary.

20. The method ofclaim 1, further comprising a step of withdrawing the vessel closure system and moving the vessel closure system proximal with respect to the proximal stop.

21. The method ofclaim 1, further comprising a step of placing the hemostatic material within the vessel closure system and then passing the tubular device through the vessel closure system.

22. The method ofclaim 1, further comprising a step of placing a hydrated sponge within the vessel closure system and withdrawing the tubular device prior to delivery of the hydrated sponge.

23. The method ofclaim 21, further comprising a step of advancing a stylet or obturator into the tubular device.

24. A method of facilitating hemostasis of a blood vessel puncture, the method comprising:

inserting a procedural access sheath through a tissue tract and into a puncture in a blood vessel;

providing a vessel closure system around the access sheath and at least partially in the tissue tract; and

performing a vascular procedure with the vessel closure system in the tissue tract.

25. A system for facilitating hemostasis of a blood vessel puncture, the system comprising:

a delivery cannula configured to be received around an access sheath;

a hemostatic promoting material within the delivery cannula for facilitating hemostasis of a blood vessel puncture when delivered adjacent to the puncture;

a proximal stop for preventing proximal motion of the hemostatic promoting material within the delivery cannula when the access sheath is withdrawn proximally from the delivery cannula; and

a pusher for delivering the sponge material from the delivery cannula.

26. The system ofclaim 25, wherein the delivery cannula is received coaxially around the access sheath.

27. The system ofclaim 25, wherein the delivery cannula is received asymmetrically around the access sheath.

28. The system ofclaim 25, wherein the hemostatic promoting material is an absorbable sponge.

29. The system ofclaim 25, wherein the hemostatic promoting material is a hydrated and compressed sponge.

30. The system ofclaim 25, wherein the delivery cannula has a staging chamber.

31. The system ofclaim 25, further comprising a distal stop or vent.

32. The system ofclaim 31, wherein the distal stop or vent is soluable.

33. The system ofclaim 31, wherein the distal stop or vent is absorbable.

34. The system ofclaim 31, wherein the distal stop or vent is removable.

35. The system ofclaim 25, wherein the access sheath has a bleed-back hole.

36. The system ofclaim 25, further comprising a dilator.

37. The system ofclaim 36, wherein the dilator fits over a guidewire.

38. The system ofclaim 25, further comprising an introduction port.

39. The system ofclaim 25, further comprising a stop cock.

40. The system ofclaim 25, wherein the delivery cannula has detent features.

41. The system ofclaim 40, wherein the detent is at least one bump.

42. The system ofclaim 40, wherein the detent is at least one ratchet.

43. The system ofclaim 40, wherein the detent is on an inside of the delivery cannula.

44. The system ofclaim 40, wherein the detent is on an outside diameter of the vessel closure system.

45. The system ofclaim 25, wherein the proximal stop has a proximal flange to facilitate proper placement within the delivery cannula.

46. The system ofclaim 25, wherein the hydration of the hemostatic material is performed with a syringe.

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