WO2009101505A2

WO2009101505A2 - A device for the haemostasis of vascular punctures

Info

Publication number: WO2009101505A2
Application number: PCT/IB2009/000239
Authority: WO
Inventors: Mauro Bonino; Imad Sheiban
Original assignee: Mauro Bonino; Imad Sheiban
Priority date: 2008-02-15
Filing date: 2009-02-09
Publication date: 2009-08-20
Also published as: ITBO20080102A1; WO2009101505A3

Abstract

A device for the haemostasis of vascular punctures, comprising a cylindrical dispensing element, associated with a guide thread and containing a quantity of haemostatic agent, with a proximal extremity accessible to an operator and at least one opening for the dispensing of a haemostatic agent in the percutaneous region comprised between the vessel wall and the epidermal surface, and also comprising means for the positioning of a distal extremity of the device with respect to the puncture of the vessel.

Description

A DEVICE FOR THE HAEMOSTASIS OF VASCULAR PUNCTURES

* * * * *

DESCRIPTION The object of the present invention is a device for the haemostasis of vascular perforations, and in particular of the open vascular accesses from introducers used in haemodynamic and radiologic intervention procedures. It is specified that by vascular access is intended the "puncture of a blood vessel" which, during the execution of a diagnostic or interventional procedure, is performed with a large-bore needle creating a hole in the- vessel itself. Through the vascular access thusly obtained it is possible to position an introducer (or catheter) that allows continuous access to the vessel to be maintained for the entire duration of the procedure. At the end of the procedure it is then necessary to proceed with the removal of the introducer from the vessel and then to provide for closure of the hole itself (haemostasis) created in the vessel wall by the introducer. Therefore, the object of the present invention is a device for the haemostasis of vascular accesses and in particular of the vascular accesses with the use of an introducer used in percutaneous procedures for diagnostic and intervention purposes in the fields of Cardiology and Radiology.

More in particular, the present invention concerns a device for haemostasis through the dispensing of a haemostatic agent on the surface of the vessel, point of access, in the region comprised between the vessel itself and the epidermal surface of the patient. Currently the known devices are constituted of a catheter that can be inserted by the percutaneous route arriving to the proximity of the perforation, where the haemostatic agent is released, for example, in the form of a collagen cartridge.

In these known devices the haemostatic component is dispensed in proximity of the perforation so that once the catheter is extracted the blood flow finds a "plug" that prevents its escape and realises the haemostasis. Devices of this type are described in US 2007123816. However, the known type of devices present some inconveniences, in particular concerning the efficacy of their use, that is, the rapidity with which complete haemostasis is obtained.

In fact, in this type of application vascular obstruction phenomena may arise, potentially dangerous to patient health, if the haemostatic agent is accidentally applied, through the perforation, in direct contact with the blood inside the vessel. For this reason, the devices of the known type envision the use of substances of relatively low efficacy as haemostatic agents or in combination with additional elements such as sponges or swabs, which imply a relatively long waiting time before complete haemostasis is reached.

In this context, the technical task of the present invention is to propose a device for the rapid haemostasis of vascular accesses that offers superior application safety.

According to the invention, the haemostatic agent alone is dispensed subcutaneously at a distance from the vessel perforation, so that it will rapidly induce the transformation of the patient's blood into a structurally stable clot that allows haemostasis of the vascular access, when in contact with the blood escaping from the vessel puncture, once the introducer is removed. The rapidity of coagulation, in combination with the blood pressure force (particularly for arterial applications) guarantees that the haemostatic does not penetrate inside the vessel and at the same time that complete haemostasis is achieved very rapidly.

Preferably, haemostasis can be favoured by digital compression from the operator on the site involved for a time of 2-5 minutes, indicatively .

Furthermore, it has been found that the efficacy of haemostasis is improved with the use of latest generation haemostatics, that is, those with a thrombin component, which have the advantage of introducing a very rapid physiological haemostasis without the aid of other extraneous material. The specified technical task and objects are substantially achieved by a device comprising the technical characteristics disclosed in one or more of the annexed claims.

Further features and advantages of the present invention will be more clear from the indicative, and thus not limiting, description of preferred embodiments as illustrated in the annexed drawings wherein: figure 1 shows a first embodiment of the device, in a lateral view in elevation; - figure 2 shows a view in transverse section of the device in figure 1; figure 3 shows a prospective view of the device in figure 1; figure 4 shows a prospective view of a second embodiment of the device; figure 5 shows a prospective view of a third embodiment of the device; figure 6 shows a detail of a fourth embodiment of the invention; figure βa shows a variant of the embodiment in figure 6; figure 7 shows a prospective view of the embodiment of the device in figure 6; - figure 8 shows a prospective view of a fifth embodiment of the device; figure 9 shows a prospective view of the device in figure 8 in a second operative configuration; - figure 10 shows a prospective view of a sixth embodiment of the device; figure 11 shows a prospective view of a seventh embodiment of the device; figure 12 shows a preferred form of embodiment of the guide of the device.

With reference to the annexed figures, a device 1 for the haemostasis of vascular punctures according to the invention comprises a guide element 2 for the passage of a guide thread 3 of known type, and which in use must be introduced from the outside of the epidermal surface into the inside of a blood vessel 4 through a perforation 5.

In a preferred embodiment, the guide 2 comprises a lumen 30 extending from a distal extremity 12 up to an intermediate point 14 of the device accessible by an operator. Alternatively (figure 11) the guide thread 3 can run parallel and adjacent to the device and be guided along a continuous channel 26 or an arrangement of guide passage sections. A dispenser element 6 that can assume different configurations, detailed below, but in any case comprising a cylindrical body 7 capable of containing a quantity 8 of haemostatic agent to be dispensed to obtain the haemostasis of the perforation 5 must also be associated with the guide element 2. In addition, the dispenser should also have a proximal extremity 9 (preferably an access of the Luer-Lock type) accessible to an operator for supplying the haemostatic agent, and at least one opening 10 for the dispensing of the haemostatic agent in the percutaneous region comprised between the vessel perforation and the epidermal surface 11.

For the purpose of allowing the location of the dispensing openings in the proximity of the perforation 5 the device also comprises a positioning system, which in the case described in the figures is constituted by the lumen 30 extending from a distal extremity 12 to an external point 14 visible to the operator, for example consisting of a transparent section of the body of the device with one or more reference marks (figure 7) or by a section of the channel extending outside of the cylindrical body (figure 1).

The extremity 12 of the lumen 30 is arranged in a position intermediate between the proximal portion of the dispenser and the distal extremity 13.

With this solution, when the distal extremity 12 of the lumen 30 is inside of the vessel, the blood pressure acts so that blood rises along the channel until it arrives at point 14. Retracting the device, when the extremity 12 passes the vessel wall, the blood pressure drops and blood is no longer visible at point 14, thus informing the operator about the exact position of the extremity 12 and therefore of the dispensing openings 10 of the device with respect to the access (perforation) 5 outside the vessel .

According to the invention, the guide thread 3 can be provided with a distal extremity 31 of variable diameter by means of which the opening 36 of the distal extremity 13 of the device can be closed on demand for the purpose of preventing the entrance of arterial blood through the opening 13 itself.

This operation (retraction of the guide thread to block the opening 36) is envisioned in order to guarantee that when the arterial, or venous, blood does not rise to point 14, this is due to the position of point 14 outside of the vessel and therefore to guarantee that also the openings 10 for the release of the haemostatic are outside of the hole 5 in the vessel itself. In particular, the guide thread can have the most distal last 5-7 cm, located in the vessel, at a diameter variable and of a progressively larger diameter with respect to the diameter of the opening 36 of the tip 13 of the device. Alternatively, or in combination with the lumen 30, it is possible to envision the association of the device with a radio-opaque element whose position may be detected and controlled from outside for example by radioscopy (x-ray) . Figure 5 shows an example of a sheath 15 and a tip 16 in correspondence of the distal extremity of the device, realised in radio-opaque material. According to the invention, the dispenser 6 comprises one or more openings 10 for release of the haemostatic agent from the cylindrical body 7, which are positioned at a determined distance L from the distal extremity 13, and in particular from the opening 36 of the extremity 13. With this solution, once the dispenser is positioned with the extremity 13 in correspondence of or slightly retracted with respect to the perforation 5 one is certain that the dispensing of the haemostatic agent occurs in a position removed with respect to the perforation itself, thus avoiding the risk of emitting the agent inside the vessel. According to the invention, the use of a haemostatic agent alone, that is, not imbedded in fibrous matrices, sponges, swabs or other, in combination with the pressure of the blood flow exiting from the vessel 4 allows the instantaneous attainment of the creation outside of the vessel 4 of a coagulation "plug", which rapidly determines complete haemostasis.

Preferably, the extremity 13 of the device that must penetrate through the epidermal surface has a helpful shape or in any case is bevelled and realised in metal or in a rigid plastic material.

In the embodiment shown in figures 1-4 the guide tool is partially coaxial with the cylinder 7 of the dispenser and said dispensing opening 10 is constituted by windows formed in the external cylindrical wall of the cylinder.

In a different example, shown in figure 5, the guide 2 and the dispenser 6 are parallel but not coaxial, while in another example shown in figures 6, 7, 11, the guide is constituted by a parallel channel 26 applied laterally to the cylindrical body of the dispenser. In these cases, the dispensing opening 10 is arranged at a distal extremity 29 of the cylindrical body 7. Advantageously, in this embodiment, the lateral arrangement of the channel 26 allows the operator to perceive the moment in which the opening 10 contacts the vessel wall 4 during the phase of introduction of the catheter and therefore to appropriately position the opening 10 with respect to the puncture 5 during the haemostatic dispensing phase.

Also with reference to figures 6, 7 the opening 10 can be normally open or normally closed and comprise a valve 19 constituted for example by clamshell valves that can be opened on demand by the effect of a pressure induced by the haemostatic agent or exerted by means of a mandrel 18 insertable in the cylinder 7 for the opening of the valve.

Preferably, the valve 19 comprises one or more valve parts openable separating along pre-established lines or hinges 20 to create a perivascular space accessible to the haemostatic agent.

In an advantageous form of embodiment, the parts of the valve 19 define also a dome like geometry, with the purpose of favouring the introduction of the dispenser through the epidermal surface.

According to the invention, the haemostatic agent used is a single- or two-component agent comprising thrombin. In the first case, the use of the product Floseal^tm from Baxter^tm and possible similar products was particularly advantageous.

The product Tissucol^tm, also from Baxter¹"¹, was used as a two-component haemostatic.

In this case and in general when a two-component fibrin is used as haemostatic (fibrinogen and thrombin) wherein thrombin is at high concentration (e.g. 500 IU/ml) it was found convenient to create two respective containment lumens 35 in the dispenser cylinder 7 of the haemostatic for the two components that converge at the valve 19 of the opening 10 which will be forced open allowing the two components to mix and to polymerise into fibrin.

Alternatively, the two lumens 35 can converge in a single chamber 37 which ends at the dispensing window 10 (for example with the solution in figure 6a) so to keep the two components separate until the moment immediately preceding the dispensing time to the percutaneous region, thus avoiding premature formation of the coagulate. It is stressed that the employment of a single chamber 37 shown in figure βa is a further extension of the concept of figure 6, concerning the use of lower dosages of Thrombin (e.g. 100-150 IU/ml) with which the two components (Thrombin + Fibrinogen) can stay for a few seconds after mixing, without however, polymerising yet in the "single chamber", to then exit with the forcing open of the valve 19.

In a preferred embodiment, the two components could be dispensed by the action of a double piston 38 with respective plungers 39 for each lumen 35. It is intended that in addition to the product Tissucol^tm a different product can also be used with a pharmaceutical formulation such as human fibrin adhesive . In a further preferred embodiment, shown in figures 8- 10, the device comprises a system active from inside of the vessel to allow the controlled and temporary occlusion of the vessel puncture during the dispensing of haemostatic agent. Preferably, the occlusion system comprises an inflatable balloon 22 that can change from a non expanded configuration (figure 8) in which it remains inside of the space of the device and can pass through the perforation 5 by means of an introducing cylinder 21, and an expanded configuration (figures 9, 10) in which it occludes the perforation 5 from inside the vessel .

For example, the expansion of the balloon can be commanded through a conduit 24 communicating with the balloon 22 and with an external connection 23 associable with a source of emission/aspiration of a liquid constituted for example of a mixture of physiological solution plus contrast liquid. Use of the balloon allows the attainment with more safety that the haemostatic agent does not accidently penetrate inside of the perforation 5 during its dispensing .

In figure 10 a washer 25 is also schematically represented which in the different embodiments described, can be mounted movably and externally with respect -to the body of the device and kept in contact with the epidermal surface 11 with the aim of avoiding the escape of haemostatic material from the percutaneous region during extraction of the device. The invention has been described with reference to a preferred embodiment, but it is intended that equivalent modifications could be made without departing from the field of protection of the present industrial patent.

Claims

1. A device for the haemostasis of vascular punctures, comprising a cylindrical guide (2), for the passage of a guide thread (3) apt to be introduced from outside the epidermal surface (11) of a patient into a blood vessel (4) through a puncture (5) in the vessel wall; a dispenser, associated with said guide and comprising a cylindrical body (7) containing a quantity of haemostatic agent (8), a proximal extremity (9) accessible by an operator, and at least one opening

(10) in the cylindrical body for the dispensing of a haemostatic agent in the percutaneous region comprised between the vessel wall and the epidermal surface; means for the positioning of a distal extremity (13) of the device with respect to the puncture of the vessel; means to dispense on demand a quantity of haemostatic agent through said dispensing opening; characterised in that said dispensing opening (10) is arranged in a distal section of the device at a determined distance (L) from the distal extremity (13) of the device without intermediate barriers between said opening (10) and said distal extremity (13), to precisely and safely dispense the haemostatic agent in one point of said percutaneous region removed with respect to the puncture of the vessel and directly exposed to the blood flow exiting from the puncture (5) itself.

2. The device according to claim 1, wherein said guide (2) and said dispenser are coaxial, and said dispensing opening (10) is constituted by windows formed in the external cylindrical wall of said cylindrical body (7).

3. The device according to claim 1, wherein said guide (2) and said dispenser are parallel and said dispensing opening (10) is arranged at a distal extremity of the cylindrical body (7) .

4. The device according to one of the previous claims, wherein said opening is normally closed by a valve (19) that can be opened on demand by the effect of a pressure.

5. The device according to claim 4, wherein said valve can be opened by the effect of a pressure induced in the haemostatic agent.

6. The device according to one of the claims 4 - 5, comprising a mandrel (18) for the opening of said valve.

7. The device according to one of the claims 4 - 6, wherein said valve comprises one or more valve components openable by separation along pre-established lines to create a perivascular space accessible to the haemostatic agent.

8. The device according to one of the claims 4 - 7, wherein said valve components define a dome-like geometry.

9. The device according to one of the previous claims, wherein said haemostatic agent is an agent comprising thrombin, for example, Floseal^tm.

10. The device according to one of the previous claims, wherein said haemostatic is a two-component haemostatic agent, for example Tissucol^tm and said cylindrical body (7) comprises two respective separate containment chambers (35) each with a dispensing window (10) .

11. The device according to one of the previous claims, wherein said distal extremity of the device has a bevelled shape and is in metallic or rigid plastic material to favour percutaneous introduction.

12. The device according to one of the previous claims, wherein said positioning means comprise a first lumen (30) extended from a distal extremity (12) accessible to blood flow if located inside of the blood vessel, to a rising point (14) of said blood flow visible to an operator, the distal extremity (12) being in an intermediate position between the distal extremity of the device (13) and the dispensing opening (10) with the purpose of allowing the safe positioning of the dispensing openings (10) outside of the blood vessel itself.

13. The device according to claim 12, wherein said visible rising point is arranged in a transparent material section of the device.

14. The device according to one of the previous claims, wherein said guide of the guide thread comprises a second lumen (26) adjacent to the body of the dispenser and extended from a distal extremity of the guide to an intermediate point of the device accessible by an operator.

15. The device according to one of the previous claims, wherein said guide of the guide thread comprises at least two points (34) of guided passage of the thread adjacent and fixed to the cylindrical body.

16. The device according- to one of the previous claims, wherein said guide comprises a distal extremity (31) of variable diameter through which the opening (36) of the distal extremity (13) of the device can be closed on demand for the purpose of avoiding the entrance of arterial blood through the opening itself.

17. The device according to claim 16, wherein the guide thread has a distal section extended between 1 and 7 cm, which in use is located in the vessel, with a variable diameter progressively greater with respect to the diameter of the opening of the tip of the device.

18. The device according to one of the previous claims, comprising means for the temporary occlusion of the puncture in the vessel during dispensing of the haemostatic agent, active from inside the vessel.

19. The device according to claim 18, wherein said occlusion means comprise an inflatable balloon (22) .

20. The device according to one of the previous claims, wherein said positioning means comprise a radio-opaque element (15, 16) detectable from outside.

21. The device according to one of the previous claims, comprising a washer (25) that can be mounted to slide externally with respect to the body of the device and kept in contact with the epidermal surface of the patient with the purpose of avoiding the escape of haemostatic material from the percutaneous region during extraction of the device.