WO2012038495A2 - A valve unit and a device for sealing a puncture hole in a vessel wall - Google Patents

A valve unit and a device for sealing a puncture hole in a vessel wall Download PDF

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Publication number
WO2012038495A2
WO2012038495A2 PCT/EP2011/066477 EP2011066477W WO2012038495A2 WO 2012038495 A2 WO2012038495 A2 WO 2012038495A2 EP 2011066477 W EP2011066477 W EP 2011066477W WO 2012038495 A2 WO2012038495 A2 WO 2012038495A2
Authority
WO
WIPO (PCT)
Prior art keywords
valve unit
valve
self
closing
introducer
Prior art date
Application number
PCT/EP2011/066477
Other languages
French (fr)
Other versions
WO2012038495A3 (en
Inventor
Niklas Borg
Fredrik Mahlin
Anna Norlin-Weissenrieder
Fredrik Preinitz
Original Assignee
St Jude Medical Systems Ab
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by St Jude Medical Systems Ab filed Critical St Jude Medical Systems Ab
Publication of WO2012038495A2 publication Critical patent/WO2012038495A2/en
Publication of WO2012038495A3 publication Critical patent/WO2012038495A3/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3462—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3937—Visible markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers

Definitions

  • a sealing device for sealing a puncture hole in a vessel wall.
  • the device comprises an inner sealing member, an outer locking member and a retaining member.
  • the inner sealing member is adapted to be positioned at an inner surface of the vessel wall, while the outer member is adapted to be positioned at an outer surface of the vessel wall.
  • the inner and outer members sandwich the vessel wall, and are held together by the retaining member, to thereby seal the puncture hole in the vessel wall.
  • WO 2009/155236 discloses a method and apparatus for sealing a puncture in a tubular tissue structure or the wall of a body cavity.
  • a bioabsorbable member is introduced into the puncture hole and into the body cavity, and drawn together to form a plug inside the body cavity to seal said puncture hole.
  • the described devices demands that a member is introduced inside the body cavity and then retracted to seal the puncture hole from the inside of the body cavity. Measures have to be taken to ensure that the inner member introduced inside the body cavity is correctly positioned and does not block blood flow through the vessel which could jeopardize the health of the patient. It is also important to close the puncture in a rapid way, to reduce the time the puncture is laid open. A device comprising several members which are to be positioned in relation to the puncture, might take unnecessarily long time to position to stop the bleeding.
  • a self-closing extravascular valve unit for sealing a puncture hole in a vessel wall
  • the valve unit essentially has the shape of a hollow tube with a main axis A.
  • the valve unit comprises: a collar part with a first outer diameter dl ; a tubular part with a second outer diameter d2 adapted to the size of said puncture hole, and a valve part; wherein the first diameter dl is greater than said second diameter d2 and the valve part includes a one-way valve adapted to prevent fluid from entering the valve unit when the valve unit is inserted in the puncture hole.
  • valve unit is at no stage inserted into the interior of the vessel and accordingly does not obstruct the flow in the vessel.
  • the collar part acts as a barrier for further advancement of the valve unit into the vessel and secures that the valve unit is not disposed inside the vessel.
  • a device for sealing a puncture hole in a vessel wall comprises an elongated introducer adapted for introduction through said puncture hole and a self-closing extravascular valve unit, wherein the valve unit is slidably arranged on the introducer.
  • the device enables a rapid deployment of the valve unit, as the valve unit is slidably arranged on the introducer.
  • Figure 1 illustrates a valve unit in an open state according to one embodiment of the invention.
  • Figure 2 illustrates the valve unit in figure 1 along cross-section B-B.
  • Figure 3 illustrates a valve unit in a relaxed state according to another embodiment of the invention.
  • Figure 4 illustrates the valve unit in figure 1 along cross-section C-C.
  • Figure 5 illustrates a valve unit in a closed state according to a further embodiment of the invention.
  • Figure 6 illustrates the valve unit in figure 1 along cross-section D-D.
  • Figure 7 illustrates a valve unit in a closed state according to a still further embodiment of the invention.
  • Figure 8 illustrates the valve unit in figure 7 in an open state.
  • Figure 9 illustrates a valve unit according to a further embodiment of the invention, when inserted in a puncture hole of a vessel wall.
  • Figure 10 illustrates a device according to one embodiment of the invention.
  • Figure 1 1 illustrates a device according to another embodiment of the invention.
  • Figure 12 illustrates a device according to a further embodiment of the invention.
  • Figure 13 shows a flow chart for a method according to the invention.
  • FIGS 1 to 6 illustrates a self-closing extravascular valve unit 4 for sealing a puncture hole in a vessel wall, when the valve unit 4 is in different states which will be explained in the following.
  • the valve unit 4 has essentially the shape of a hollow tube with a main axis A.
  • the valve unit 4 generally comprises a collar part 3, a tubular part 2 and a valve part 1.
  • the collar part 3 has a first outer diameter dl .
  • the tubular part 2 has a second outer diameter d2 adapted to the size of the puncture hole.
  • the first diameter dl thus the outer diameter of the collar part 3
  • is greater than the second diameter d2 thus the outer diameter of the tubular part 2 at least when the valve unit 4 is positioned in the puncture hole.
  • the greater diameter dl of the collar part 3 ensures that the valve unit 4 is not disposed inside the vessel.
  • the valve part 1 includes a one-way valve adapted to prevent flow from entering the valve unit 4 when the valve unit 4 is inserted in the puncture hole.
  • a one-way valve is generally adapted to allow fluid to flow in one direction through the valve unit 4. If fluid wants to flow in the other direction, the valve is sealed and no fluid is allowed to enter the valve unit 4.
  • the tubular part 2 and valve part 1 have a length L adapted to the width of the vessel wall surrounding the puncture hole.
  • the length L is essentially the same length as the width of the vessel wall surrounding the puncture hole.
  • the length L is preferably between 0.1 and 3 mm, more preferably between 0.2 and 1.5 mm.
  • the first outer diameter dl is greater than the second outer diameter d2, such that the collar part 3 can act as a barrier for further advancement of the valve unit 4 into the vessel when the valve unit 4 is inserted into the puncture hole of the vessel.
  • the first outer diameter dl is
  • the second outer diameter d2 is preferably between 0.1 and 9 mm.
  • the valve unit 4 is according to one embodiment made of a bioresorbable material.
  • Bioresorbable materials for example, PEG (polyethylene glycol) hydrogel materials, PGA (polyglycolytic acid), PLGA ( copoly lactic acid/glycolic acid), PDLG (50/50 DL- Lactide/glycolide copolymer), polyhydroxybutyrate, DL-lactide/L-lactide, triemethylene carbonate, para-dioxanone and ⁇ -caprolactone copolymers, lactide polymer, glycolide polymer, and the like, can be used as material for the valve unit 4.
  • Other bioresorbable material alternatives for the valve unit 4 material are, for example, polyanhydrides, polyvinylalcohol, polyorthoesters, and polycarbonates.
  • the valve unit 4 material can also be made from a variety of water soluble monosaccharides or disaccharides (sugars) consisting of, or a blend of, or a chemical combination of fructose, glucose, galactose, mannose, sucrose, lactose, pectin, dextrose or other sugar-based products, as well as carbohydrates, such as alginate, chitosan, and hyaluronic acid.
  • the valve unit 4 can also be made from biologically derived polymeric structures, such as collagen.
  • the valve unit 4 material can also be made from water soluble salts, such as NaCl, KC1, CaCl 2 , and MgCl 2 , or water soluble oxyhydroxides, such as hydroxides, phosphates, carbonates, and mixes thereof or a biodegradable metal, such as magnesium, iron, manganese, zinc or alloys thereof.
  • the metallic degradable material can also be alloyed with trace elements of metallic or non-metallic elements, such as Ca, K, Na, C, or N.
  • the valve unit 4 can be made from various combinations of the above materials, such as mixtures, block-polymers, and reinforced structures.
  • the valve unit 4 comprises an active substrate coating to promote ingrowth of the valve unit 4 into the vessel wall.
  • the valve unit 4 may further comprise an elastic material, preferably with an elasticity of 12-80 on the Shore A hardness scale.
  • the valve unit 4 is then preferably resilient and can be threaded onto a member, i.e. an introducer. According to one embodiment, it is the valve part 1 of the valve unit 4 that comprises an elastic material.
  • Figure 1 is showing the valve unit 4 in a relaxed state when the valve unit 4 is not arranged on an introducer and not inserted in a puncture hole in a vessel wall.
  • the valve part 1 is in a relaxed state when no force or pressure is acting upon it.
  • the valve part 1 has the shape of a truncated cone with a narrowing circular cross-section in the distal direction of the valve part 1.
  • Figure 2 is showing the valve part 1 in figure 1 in cross-section along the line B-B. From this view it can be seen that there is still an opening in the distal part of the valve unit 4 in the relaxed state.
  • the opening is closed when the valve unit 4 is in a relaxed state.
  • the valve unit 4 then has the function of a diaphragm check valve, where the diaphragm automatically flexes back to its original closed state when no pressure acts upon the valve.
  • the relaxed state is also a closed state of the valve.
  • Figure 3 is showing the valve unit 4 in figure 1 in an open state when the valve unit 4 is arranged on an introducer.
  • the valve unit 4 is adapted to be slidably arranged on an introducer, to be able to position said valve unit 4 in a puncture hole in a vessel wall.
  • the inner diameter of the valve unit 4, thus the inner diameter of the collar part 3, the tubular part 2 and the valve part 1 is then of a size such that the valve unit 4 can be arranged on an introducer.
  • the inner diameter of the collar part 3 and the tubular part 2 is between 0.1 to 10 mm.
  • Figure 4 is showing the valve part 1 in figure 3 in cross-section along the line C-C. According to other embodiments, the valve unit 4 may be in an open state also when it is in a relaxed state.
  • Figure 5 is showing the valve unit 4 in figure 1 and 3 in a closed state.
  • the valve unit 4 is in a closed state when the valve unit 4 is released from the introducer, i.e. inserted in the puncture hole of the vessel wall.
  • the tubular part 2 has essentially the same diameter d2 as the tubular part 2 in figure 1 and 3.
  • the valve part 1 is here compressed such that no fluid is allowed to enter the valve unit 4.
  • the valve part 1 has in this embodiment one outer diameter in one direction that is essentially the same as the diameter d2 of the tubular part 2. This is illustrated in figure 6, which is showing the valve part 1 in figure 5 in cross- section along the line D-D.
  • the closed state is at least partly achieved by a fluid flow in the vessel and/or a pressure difference between the inside and outside of the vessel.
  • the fluid flow inside the vessel may apply a pressure upon the valve unit 4 such that the valve unit 4 achieves said closed state. If the pressure inside the vessel is larger than the pressure outside the vessel, the valve part 1 of the valve unit 4 will be compressed as a pressure will be exerted on the valve part 1 from the inside of the vessel due to the pressure difference.
  • the valve unit 4 is mainly maintained in place in the puncture hole due to friction between the outer surface of the tubular part 2 and the puncture hole.
  • the tubular part 2 may in this embodiment comprise an outer surface with a rough coating to provide extra friction.
  • the valve unit 4 comprises attachment means such as barbs adapted to hold the valve unit 4 securely in place in the puncture hole.
  • the valve part 1 advantageously comprises at least one lip 5 adapted to prevent flow from entering the valve unit 4 in said closed state.
  • the lip or lips 5 are preferably arranged on the valve part 1.
  • the lip 5 is arranged on the valve part 1 such that is adapted to be actuated to achieve said closed state when a fluid flow is acting on the lip 5, and/or arranged on the valve part 1 such that it is adapted to be actuated to achieve said closed state when a pressure is acting on the lip 5.
  • the self-closing extravascular valve unit 4 comprises at least two lips 5.
  • the valve unit 4 illustrated in figures 1 to 6 comprises two lips 5 adapted to prevent flow from entering the valve unit 4 in said closed state.
  • the valve unit 4 achieves this state when the lips 5 are pressed together by said fluid flow and/or pressure difference, which is illustrated in figure 6.
  • a valve unit 4 according to one embodiment is shown, comprising three lips 5.
  • Figure 7 is illustrating the valve unit 4 in a closed state
  • figure 8 is illustrating the valve unit 4 in an open state.
  • the lips 5 are separated by reinforcement portions 6.
  • the reinforcement portions 6 are here illustrated in conjunction with a valve unit 4 with three lips 5 in figure 7 and 8, but it is understood that
  • reinforcement portions 6 may be used in valve unit 4s together with any number of lips 5.
  • the function of the reinforcement portions 6 is to force the lips 5 to be pressed together in certain directions, to ensure a secure sealing of a valve unit 4.
  • the reinforcement portions 6 are according to one embodiment essentially in the same position in an open state as in a closed state.
  • the thickness of the tubular portion and, if present, the reinforcement portions 6 are according to one embodiment greater than the thickness of the lips 5.
  • the tubular portion and the reinforcement portions 6 preferably have a thickness that is adapted to withstand forces that may arise from the fluid flow in the vessel and/or a pressure difference between the interior of the vessel and the exterior of the vessel.
  • the lips 5 advantageously have a thickness such that the lips 5, when acted upon by a force from a fluid flow and/or a pressure difference between the interior and the exterior of the vessel, are pressed together to stop fluid from entering the valve unit 4.
  • the valve unit 4 comprises a haemostatic agent.
  • the haemostatic agent promotes haemostasis, and will contribute to stop any fluid flow from the puncture hole.
  • Figure 9 illustrates an embodiment of the invention, comprising a collar part 3 that is inclined in relation to the axis A with an inclination angle a between 1 and 80°.
  • the insertion procedure is often performed inclined in relation to the vessel wall of the patient.
  • the collar part 3 will be able to be adjacent to the outer surface of the vessel wall along the whole circumference of the puncture hole, when the valve unit 4 is inserted in the puncture hole.
  • the valve unit 4 is an integral valve unit 4.
  • the valve unit 4 is according to this embodiment made in one piece.
  • the invention also relates to a device 8 for sealing a puncture hole in a vessel wall as illustrated in figure 10.
  • the device 8 comprises an elongated introducer 7 adapted for introduction through the puncture hole, and a self-closing extravascular valve unit 4 as described according to any of aforementioned embodiments.
  • the valve unit 4 is preferably slidably arranged on the introducer 7.
  • the device 8 comprises an insertion tool 9 adapted to apply a force on the valve unit 4 to advance the valve unit 4 in the distal direction of the introducer 7.
  • the insertion tool 9 is preferably adapted to exert a force on the collar part 3 of the valve unit 4, and preferably on the proximal side of the collar part 3.
  • the insertion tool 9 has a tubular shape. The insertion tool 9 may then be slidably arranged on the introducer 7.
  • the introducer 7 comprises according to one embodiment a hydrophilic surface.
  • the valve unit 4 and the insertion tool 9 may then easily slide along the introducer 7.
  • the insertion tool 9 comprises a hydrophilic inner surface.
  • the self-closing extravascular valve unit 4 and/or the insertion tool 9 comprise according to one embodiment a radio-opaque material.
  • the valve unit 4 and/or the insertion tool 9 will be visible on an X-ray picture.
  • the position of the valve unit 4 inside the body thus can be determined, as well as the position of the insertion tool 9.
  • valve unit 4 In figure 12 an embodiment of the valve unit 4 is illustrated, where the valve unit 4 comprises a foldable collar part 3.
  • the valve unit 4 is here arranged on an introducer 7.
  • the valve unit 4 is illustrated in a first state where the collar part 3 is folded out and is in this first state arranged in tight relationship with the introducer 7 along the whole length L c of the collar part 3. In this state the valve unit 4 may be advanced on the introducer 7 with a reduced risk for the valve unit 4 to get stuck on its way through surrounding tissue.
  • the collar part 3 preferably has essentially the same outer diameter d2 as the tubular part 2 and the valve part 1 , when arranged on an introducer 7.
  • the collar part 3 When the valve unit 4 is arranged in position in a puncture hole in a vessel wall, or just before it is positioned, the collar part 3 is folded up such that the collar part 3 now has a diameter dl that is greater than the diameter d2 of the tubular part 2 and the valve part 1.
  • the valve unit 4 When the collar part 3 is folded up, the valve unit 4 is in a state referred to as the second state.
  • the length of the collar part 3 is in its second state is less than L c .
  • the collar part 3 has a function of a foldable collar wherein the collar part 3 is adapted to be folded out in a first state, and folded up in a second state.
  • an insertion tool 9 adapted to both withhold the collar part 3 in its first state wherein it is folded out, and to advance the valve unit 4 along the introducer 7 may be needed.
  • the insertion tool 9 can be provided with two insertion tubular parts, one tubular part adapted to withhold the collar part 3 in its first state, and one tubular part adapted to advance the valve unit 4 along the introducer 7.
  • the collar part 3 is transformed from its first state to its second state by e.g. withdrawal of the tube that withholds the collar part 3 in its first state.
  • the valve unit 4 and the introducer 7 and/or insertion tool 9 comprise orientation means to facilitate orientation of the valve through an insertion procedure. If the valve unit 4 should be inserted at an angle in relation to the vessel wall, then it is important to guide the valve unit 4 such that the inclined collar part 3 is positioned correctly in relation to the vessel wall. If the valve unit 4 is rotated, the collar part 3 may not be positioned adjacent to the outer vessel wall. To facilitate orientation of the valve unit 4, the valve unit 4 is provided with an orientation mark that should be aligned with another orientation mark on the introducer 7 and/or the insertion tool 9. The user may then correctly orient and position the valve unit 4 be keeping track of the orientation mark on the introducer 7 and/or the insertion tool 9.
  • the invention also relates to a method for sealing a puncture hole in a vessel wall.
  • the method is illustrated in a flow chart shown in figure 13, and comprises the steps of:
  • valve unit 4 providing an elongated introducer 7 adapted for introduction through the puncture hole.
  • the introducer 7 is provided with a slidably arranged self-closing extravascular valve unit 4 on the insertion tool 9, the valve unit 4 comprises a collar part 3, a tubular part 2 and a valve part 1 including a one-way valve adapted to prevent flow from entering the valve unit 4;
  • valve unit 4 may be securely and rapidly positioned in a puncture hole.
  • step S2 or S3 it is possible to perform any procedure requiring introducer 7 access into a bodily organ.
  • the procedure may e.g. include insertion of a surgical instrument for performing a surgical procedure for example coronary intervention such as FFR measurement, baloon dilation, deploying a stent, or any other procedure requiring a guide wire or catheter to be inserted into a blood vessel or other organ.

Abstract

The invention relates to a self-closing extravascular valve unit (4) for sealing a puncture hole in a vessel wail, wherein the valve unit (4) has essentially the shape of a hollow tube with a main axis (A). The valve unit (4) comprises: a collar part (3) with a first outer diameter (d1); a tubular part (2) with a second outer diameter (d2) adapted to the size of said puncture hole, and a valve part (1); wherein the first diameter (d1) is greater than said second diameter (d2), and the valve part (1) includes a one-way valve adapted to prevent flow from entering the valve unit (4) when the valve unit (4) is inserted in the puncture hole. The invention further relates to a device (8) for sealing a puncture hole in a vessel wall.

Description

A valve unit and a device for sealing a puncture hole in a vessel wall
Field of the invention
The present invention relates to the field of sealing devices for the sealing of a
percutaneous puncture in a vessel wall and in particular to a self-closing extravascular valve unit to be used in conjunction with such a device according to the preambles of the independent claims.
Background of the invention
It is important to stop the bleeding during and after a surgery. The insertion of e.g. a catheter creates a puncture through the body cavity, and upon removal of the catheter a puncture opening is left through which blood may escape and potentially cause great blood loss if not controlled. Several methods and devices are known to stop the bleeding by closing the puncture.
In US 6,508,828, for example, a sealing device is disclosed for sealing a puncture hole in a vessel wall. The device comprises an inner sealing member, an outer locking member and a retaining member. The inner sealing member is adapted to be positioned at an inner surface of the vessel wall, while the outer member is adapted to be positioned at an outer surface of the vessel wall. In use, the inner and outer members sandwich the vessel wall, and are held together by the retaining member, to thereby seal the puncture hole in the vessel wall.
Another kind of sealing device is known from WO 2009/155236, which discloses a method and apparatus for sealing a puncture in a tubular tissue structure or the wall of a body cavity. A bioabsorbable member is introduced into the puncture hole and into the body cavity, and drawn together to form a plug inside the body cavity to seal said puncture hole.
The described devices demands that a member is introduced inside the body cavity and then retracted to seal the puncture hole from the inside of the body cavity. Measures have to be taken to ensure that the inner member introduced inside the body cavity is correctly positioned and does not block blood flow through the vessel which could jeopardize the health of the patient. It is also important to close the puncture in a rapid way, to reduce the time the puncture is laid open. A device comprising several members which are to be positioned in relation to the puncture, might take unnecessarily long time to position to stop the bleeding.
It is thus an object of the present invention to provide a less complex device for sealing a puncture in a vessel wall than previous sealing devices, and in particular a device which increases the safety of the patient.
Summary of the invention
The above-mentioned object is achieved by a self-closing extravascular valve unit for sealing a puncture hole in a vessel wall, wherein the valve unit essentially has the shape of a hollow tube with a main axis A. The valve unit comprises: a collar part with a first outer diameter dl ; a tubular part with a second outer diameter d2 adapted to the size of said puncture hole, and a valve part; wherein the first diameter dl is greater than said second diameter d2 and the valve part includes a one-way valve adapted to prevent fluid from entering the valve unit when the valve unit is inserted in the puncture hole. Accordingly, a less complex unit than prior known sealing units is achieved, which facilitates a correct deployment of the unit and thereby a correct sealing of a puncture in a vessel wall. Preferably, the valve unit is at no stage inserted into the interior of the vessel and accordingly does not obstruct the flow in the vessel. The collar part acts as a barrier for further advancement of the valve unit into the vessel and secures that the valve unit is not disposed inside the vessel.
According to another aspect, the above-mentioned object is achieved by a device for sealing a puncture hole in a vessel wall. The device comprises an elongated introducer adapted for introduction through said puncture hole and a self-closing extravascular valve unit, wherein the valve unit is slidably arranged on the introducer. The device enables a rapid deployment of the valve unit, as the valve unit is slidably arranged on the introducer.
Preferred embodiments are set forth in the dependent claims and in the detailed description.
Short description of the appended drawings
Below the invention will be described in detail with reference to the appended figures, of which:
Figure 1 illustrates a valve unit in an open state according to one embodiment of the invention.
Figure 2 illustrates the valve unit in figure 1 along cross-section B-B.
Figure 3 illustrates a valve unit in a relaxed state according to another embodiment of the invention.
Figure 4 illustrates the valve unit in figure 1 along cross-section C-C.
Figure 5 illustrates a valve unit in a closed state according to a further embodiment of the invention.
Figure 6 illustrates the valve unit in figure 1 along cross-section D-D.
Figure 7 illustrates a valve unit in a closed state according to a still further embodiment of the invention.
Figure 8 illustrates the valve unit in figure 7 in an open state.
Figure 9 illustrates a valve unit according to a further embodiment of the invention, when inserted in a puncture hole of a vessel wall.
Figure 10 illustrates a device according to one embodiment of the invention.
Figure 1 1 illustrates a device according to another embodiment of the invention.
Figure 12 illustrates a device according to a further embodiment of the invention.
Figure 13 shows a flow chart for a method according to the invention.
Detailed description of preferred embodiments of the invention
Figures 1 to 6 illustrates a self-closing extravascular valve unit 4 for sealing a puncture hole in a vessel wall, when the valve unit 4 is in different states which will be explained in the following. The valve unit 4 has essentially the shape of a hollow tube with a main axis A. The valve unit 4 generally comprises a collar part 3, a tubular part 2 and a valve part 1. The collar part 3 has a first outer diameter dl . The tubular part 2 has a second outer diameter d2 adapted to the size of the puncture hole. The first diameter dl , thus the outer diameter of the collar part 3, is greater than the second diameter d2, thus the outer diameter of the tubular part 2 at least when the valve unit 4 is positioned in the puncture hole. The greater diameter dl of the collar part 3 ensures that the valve unit 4 is not disposed inside the vessel. The valve part 1 includes a one-way valve adapted to prevent flow from entering the valve unit 4 when the valve unit 4 is inserted in the puncture hole. A one-way valve is generally adapted to allow fluid to flow in one direction through the valve unit 4. If fluid wants to flow in the other direction, the valve is sealed and no fluid is allowed to enter the valve unit 4.
According to one embodiment, the tubular part 2 and valve part 1 have a length L adapted to the width of the vessel wall surrounding the puncture hole. Advantageously, the length L is essentially the same length as the width of the vessel wall surrounding the puncture hole. Thus, when the valve unit 4 is inserted in the puncture hole, essentially no part of the valve unit 4 is inserted into the interior of the vessel. The length L is preferably between 0.1 and 3 mm, more preferably between 0.2 and 1.5 mm. The first outer diameter dl is greater than the second outer diameter d2, such that the collar part 3 can act as a barrier for further advancement of the valve unit 4 into the vessel when the valve unit 4 is inserted into the puncture hole of the vessel. When the valve unit 4 is positioned in the puncture hole, the portion of the collar part 3 that exceeds the diameter d2 of the tubular part 2, thus the portion of the collar part 3 with a diameter dl minus d2, is adjacent to the outer vessel wall. The first outer diameter dl is
advantageously between 0.5 and 12 mm, and the second outer diameter d2 is preferably between 0.1 and 9 mm.
The valve unit 4 is according to one embodiment made of a bioresorbable material.
Bioresorbable materials, for example, PEG (polyethylene glycol) hydrogel materials, PGA (polyglycolytic acid), PLGA ( copoly lactic acid/glycolic acid), PDLG (50/50 DL- Lactide/glycolide copolymer), polyhydroxybutyrate, DL-lactide/L-lactide, triemethylene carbonate, para-dioxanone and ε-caprolactone copolymers, lactide polymer, glycolide polymer, and the like, can be used as material for the valve unit 4. Other bioresorbable material alternatives for the valve unit 4 material are, for example, polyanhydrides, polyvinylalcohol, polyorthoesters, and polycarbonates. In addition, all the above materials can be combined into block-polymers as desired to adjust material properties. The valve unit 4 material can also be made from a variety of water soluble monosaccharides or disaccharides (sugars) consisting of, or a blend of, or a chemical combination of fructose, glucose, galactose, mannose, sucrose, lactose, pectin, dextrose or other sugar-based products, as well as carbohydrates, such as alginate, chitosan, and hyaluronic acid. The valve unit 4 can also be made from biologically derived polymeric structures, such as collagen. The valve unit 4 material can also be made from water soluble salts, such as NaCl, KC1, CaCl2, and MgCl2, or water soluble oxyhydroxides, such as hydroxides, phosphates, carbonates, and mixes thereof or a biodegradable metal, such as magnesium, iron, manganese, zinc or alloys thereof. The metallic degradable material can also be alloyed with trace elements of metallic or non-metallic elements, such as Ca, K, Na, C, or N. The valve unit 4 can be made from various combinations of the above materials, such as mixtures, block-polymers, and reinforced structures.
According to another embodiment, the valve unit 4 comprises an active substrate coating to promote ingrowth of the valve unit 4 into the vessel wall. The valve unit 4 may further comprise an elastic material, preferably with an elasticity of 12-80 on the Shore A hardness scale. The valve unit 4 is then preferably resilient and can be threaded onto a member, i.e. an introducer. According to one embodiment, it is the valve part 1 of the valve unit 4 that comprises an elastic material.
Figure 1 is showing the valve unit 4 in a relaxed state when the valve unit 4 is not arranged on an introducer and not inserted in a puncture hole in a vessel wall. The valve part 1 is in a relaxed state when no force or pressure is acting upon it. According to this embodiment, the valve part 1 has the shape of a truncated cone with a narrowing circular cross-section in the distal direction of the valve part 1. Figure 2 is showing the valve part 1 in figure 1 in cross-section along the line B-B. From this view it can be seen that there is still an opening in the distal part of the valve unit 4 in the relaxed state. According to a preferred embodiment, the opening is closed when the valve unit 4 is in a relaxed state. The valve unit 4 then has the function of a diaphragm check valve, where the diaphragm automatically flexes back to its original closed state when no pressure acts upon the valve. In this embodiment the relaxed state is also a closed state of the valve.
Figure 3 is showing the valve unit 4 in figure 1 in an open state when the valve unit 4 is arranged on an introducer. According to this embodiment, the valve unit 4 is adapted to be slidably arranged on an introducer, to be able to position said valve unit 4 in a puncture hole in a vessel wall. The inner diameter of the valve unit 4, thus the inner diameter of the collar part 3, the tubular part 2 and the valve part 1 , is then of a size such that the valve unit 4 can be arranged on an introducer. According to one embodiment, the inner diameter of the collar part 3 and the tubular part 2 is between 0.1 to 10 mm. In this open state the valve part 1 is tensioned to fit on the introducer. This tensioning is enabled by
incorporating an elastic material in the valve unit 4. Figure 4 is showing the valve part 1 in figure 3 in cross-section along the line C-C. According to other embodiments, the valve unit 4 may be in an open state also when it is in a relaxed state.
Figure 5 is showing the valve unit 4 in figure 1 and 3 in a closed state. The valve unit 4 is in a closed state when the valve unit 4 is released from the introducer, i.e. inserted in the puncture hole of the vessel wall. The tubular part 2 has essentially the same diameter d2 as the tubular part 2 in figure 1 and 3. The valve part 1 is here compressed such that no fluid is allowed to enter the valve unit 4. The valve part 1 has in this embodiment one outer diameter in one direction that is essentially the same as the diameter d2 of the tubular part 2. This is illustrated in figure 6, which is showing the valve part 1 in figure 5 in cross- section along the line D-D.
According to one embodiment, the closed state is at least partly achieved by a fluid flow in the vessel and/or a pressure difference between the inside and outside of the vessel. The fluid flow inside the vessel may apply a pressure upon the valve unit 4 such that the valve unit 4 achieves said closed state. If the pressure inside the vessel is larger than the pressure outside the vessel, the valve part 1 of the valve unit 4 will be compressed as a pressure will be exerted on the valve part 1 from the inside of the vessel due to the pressure difference.
The valve unit 4 is mainly maintained in place in the puncture hole due to friction between the outer surface of the tubular part 2 and the puncture hole. The tubular part 2 may in this embodiment comprise an outer surface with a rough coating to provide extra friction. According to one embodiment, the valve unit 4 comprises attachment means such as barbs adapted to hold the valve unit 4 securely in place in the puncture hole.
The valve part 1 advantageously comprises at least one lip 5 adapted to prevent flow from entering the valve unit 4 in said closed state. The lip or lips 5 are preferably arranged on the valve part 1. When the valve unit 4 is provided with one lip 5, the lip 5 is arranged on the valve part 1 such that is adapted to be actuated to achieve said closed state when a fluid flow is acting on the lip 5, and/or arranged on the valve part 1 such that it is adapted to be actuated to achieve said closed state when a pressure is acting on the lip 5.
According to a further embodiment, the self-closing extravascular valve unit 4 comprises at least two lips 5. The valve unit 4 illustrated in figures 1 to 6 comprises two lips 5 adapted to prevent flow from entering the valve unit 4 in said closed state. The valve unit 4 achieves this state when the lips 5 are pressed together by said fluid flow and/or pressure difference, which is illustrated in figure 6.
In figure 7 and 8 a valve unit 4 according to one embodiment is shown, comprising three lips 5. Figure 7 is illustrating the valve unit 4 in a closed state, and figure 8 is illustrating the valve unit 4 in an open state. According to one embodiment, the lips 5 are separated by reinforcement portions 6. The reinforcement portions 6 are here illustrated in conjunction with a valve unit 4 with three lips 5 in figure 7 and 8, but it is understood that
reinforcement portions 6 may be used in valve unit 4s together with any number of lips 5. The function of the reinforcement portions 6 is to force the lips 5 to be pressed together in certain directions, to ensure a secure sealing of a valve unit 4. The reinforcement portions 6 are according to one embodiment essentially in the same position in an open state as in a closed state. The thickness of the tubular portion and, if present, the reinforcement portions 6 are according to one embodiment greater than the thickness of the lips 5. The tubular portion and the reinforcement portions 6 preferably have a thickness that is adapted to withstand forces that may arise from the fluid flow in the vessel and/or a pressure difference between the interior of the vessel and the exterior of the vessel. The lips 5 advantageously have a thickness such that the lips 5, when acted upon by a force from a fluid flow and/or a pressure difference between the interior and the exterior of the vessel, are pressed together to stop fluid from entering the valve unit 4.
According to one embodiment, the valve unit 4 comprises a haemostatic agent. The haemostatic agent promotes haemostasis, and will contribute to stop any fluid flow from the puncture hole.
Figure 9 illustrates an embodiment of the invention, comprising a collar part 3 that is inclined in relation to the axis A with an inclination angle a between 1 and 80°. When a valve unit 4 is inserted in a puncture hole, the insertion procedure is often performed inclined in relation to the vessel wall of the patient. According to this embodiment, the collar part 3 will be able to be adjacent to the outer surface of the vessel wall along the whole circumference of the puncture hole, when the valve unit 4 is inserted in the puncture hole.
According to one embodiment, the valve unit 4 is an integral valve unit 4. Thus, the valve unit 4 is according to this embodiment made in one piece.
The invention also relates to a device 8 for sealing a puncture hole in a vessel wall as illustrated in figure 10. The device 8 comprises an elongated introducer 7 adapted for introduction through the puncture hole, and a self-closing extravascular valve unit 4 as described according to any of aforementioned embodiments. The valve unit 4 is preferably slidably arranged on the introducer 7. According to one embodiment illustrated in figure 11 , the device 8 comprises an insertion tool 9 adapted to apply a force on the valve unit 4 to advance the valve unit 4 in the distal direction of the introducer 7. The insertion tool 9 is preferably adapted to exert a force on the collar part 3 of the valve unit 4, and preferably on the proximal side of the collar part 3. According to one embodiment, the insertion tool 9 has a tubular shape. The insertion tool 9 may then be slidably arranged on the introducer 7.
The introducer 7 comprises according to one embodiment a hydrophilic surface. The valve unit 4 and the insertion tool 9 may then easily slide along the introducer 7. According to another embodiment, the insertion tool 9 comprises a hydrophilic inner surface.
The self-closing extravascular valve unit 4 and/or the insertion tool 9 comprise according to one embodiment a radio-opaque material. Thus, the valve unit 4 and/or the insertion tool 9 will be visible on an X-ray picture. The position of the valve unit 4 inside the body thus can be determined, as well as the position of the insertion tool 9.
In figure 12 an embodiment of the valve unit 4 is illustrated, where the valve unit 4 comprises a foldable collar part 3. The valve unit 4 is here arranged on an introducer 7. In the figure, the valve unit 4 is illustrated in a first state where the collar part 3 is folded out and is in this first state arranged in tight relationship with the introducer 7 along the whole length Lc of the collar part 3. In this state the valve unit 4 may be advanced on the introducer 7 with a reduced risk for the valve unit 4 to get stuck on its way through surrounding tissue. Further, in this first state the collar part 3 preferably has essentially the same outer diameter d2 as the tubular part 2 and the valve part 1 , when arranged on an introducer 7. When the valve unit 4 is arranged in position in a puncture hole in a vessel wall, or just before it is positioned, the collar part 3 is folded up such that the collar part 3 now has a diameter dl that is greater than the diameter d2 of the tubular part 2 and the valve part 1. When the collar part 3 is folded up, the valve unit 4 is in a state referred to as the second state. The length of the collar part 3 is in its second state is less than Lc. Thus, in this embodiment the collar part 3 has a function of a foldable collar wherein the collar part 3 is adapted to be folded out in a first state, and folded up in a second state. To advance the valve unit 4 along the introducer 7 in its first state, an insertion tool 9 adapted to both withhold the collar part 3 in its first state wherein it is folded out, and to advance the valve unit 4 along the introducer 7 may be needed. For example the insertion tool 9 can be provided with two insertion tubular parts, one tubular part adapted to withhold the collar part 3 in its first state, and one tubular part adapted to advance the valve unit 4 along the introducer 7. The collar part 3 is transformed from its first state to its second state by e.g. withdrawal of the tube that withholds the collar part 3 in its first state.
According to a further embodiment, the valve unit 4 and the introducer 7 and/or insertion tool 9 comprise orientation means to facilitate orientation of the valve through an insertion procedure. If the valve unit 4 should be inserted at an angle in relation to the vessel wall, then it is important to guide the valve unit 4 such that the inclined collar part 3 is positioned correctly in relation to the vessel wall. If the valve unit 4 is rotated, the collar part 3 may not be positioned adjacent to the outer vessel wall. To facilitate orientation of the valve unit 4, the valve unit 4 is provided with an orientation mark that should be aligned with another orientation mark on the introducer 7 and/or the insertion tool 9. The user may then correctly orient and position the valve unit 4 be keeping track of the orientation mark on the introducer 7 and/or the insertion tool 9.
The invention also relates to a method for sealing a puncture hole in a vessel wall. The method is illustrated in a flow chart shown in figure 13, and comprises the steps of:
SI : providing an elongated introducer 7 adapted for introduction through the puncture hole. The introducer 7 is provided with a slidably arranged self-closing extravascular valve unit 4 on the insertion tool 9, the valve unit 4 comprises a collar part 3, a tubular part 2 and a valve part 1 including a one-way valve adapted to prevent flow from entering the valve unit 4;
S2: advancing the introducer 7 into the puncture hole;
S3 : applying a force on the collar part 3 with an insertion tool 9, such that the valve unit 4 is slidably advanced on the introducer 7 in a distal direction, until the valve part 1 and tubular part 2 are inserted into the puncture hole and the collar part 3 abuts the outer surface of the vessel wall and a resistance in advancement of the valve unit 4 is felt in the insertion tool 9;
S4: withdrawing the introducer 7 in the proximal direction while the insertion tool 9 is maintained in place, until the valve unit 4 is released from the introducer 7 and the puncture hole is sealed by valve unit 4. Accordingly, the valve unit 4 may be securely and rapidly positioned in a puncture hole.
After step S2 or S3, it is possible to perform any procedure requiring introducer 7 access into a bodily organ. The procedure may e.g. include insertion of a surgical instrument for performing a surgical procedure for example coronary intervention such as FFR measurement, baloon dilation, deploying a stent, or any other procedure requiring a guide wire or catheter to be inserted into a blood vessel or other organ.
The present invention is not limited to the above-described preferred embodiments. Various alternatives, modifications and equivalents may be used. Therefore, the above embodiments should not be taken as limiting the scope of the invention, which is defined by the appending claims.

Claims

Claims
1. Self-closing extravaseular valve unit (4) for sealing a puncture hole in a vessel wall, c h r a c t e r i z e d i n that said valve unit (4) essentially has the shape of a hollow tube with a main axis A and comprises
- a collar part (3) with a first outer diameter dl;
- a tubular pari (2) with a second outer diameter d2 adapted to .the size of said, puncture hole;
- a valve part (I);
wherein said first diameter dl is greater than said second diameter d2 and said valve part (1) includes a one-way valve adapted to prevent flow from entering the valve unit (4) when said valve unit (4) is inserted i said puncture hole.
2. Self-closing extravaseular valve unit (4) according to claim 1 , wherein the length L of said tubular part (2). and said valve part (1) is -adapted to the width of the vessel wail surrounding the puncture hole.
3. Self-closing extravaseular valve unit (4) according to claim wherein said length L is between 0, 1 and 3 mm, more preferably between 0.2 and 1.5 mm.,
4. Self-closing extravaseular valve unit (4) according to any of the preceding claims, wherein said first outer diameter dl. is between 0.5 and 12 mm.
5. Self-closing extravaseular valve unit (4) according to any of the preceding claims, wherein said valve unit (4) is adapted to be s!idabi arranged on an introducer (7).
6. Self-closing extravaseular valve unit (4) according to claim 5, wherein said valve -unit (4) is in an open state when arranged on said introducer (7), and in a closed state when released from said introducer (7).
7. Self-dosing exiravascular valve unit (4) according to claim 6, wherein said closed state is at least partly achieved by a fluid flow in said vessel and/or a pressure difference between the inside and outside of the vessel.
8. Self-closing exiravascular valve unit (4) according to claim 6 or 7, wherein said valve part (1) comprises one lip (5) adapted to prevent Sow from entering the valve unit (4) in said closed state.
9. Self-closing exiravascular valve unit (4) according to claim 6 or 7, wherein said valve part (!) comprises at least two lips (5) adapted to prevent flow from .catering the valve unit (4) in said closed state.
I.0. Self-closing exiravascular valve unit (4) according to claim 9. wherein said lips (5) are separated by reinforcement portions (6).
I I . Self-closing exiravascular valve unit (4) according to any of the preceding claims, wherein said valve part (1) has a shape of a truncated cone with a narrowing circular cross-section in the distal direction of the valve part (1).
12. Self-closing extra vascular valve unit (4) according to any of the preceding claims, wherein said valve unit (4) comprises an elastic- material.
13. Self -closing exiravascular valve unit (4) according to any of the preceding claims, wherein said valve unit (4) comprises a haemostatic agent.
14. Self-closing exiravascular valve unit (4) according to any of the preceding claims, wherein said valve unit (4) comprise a radio-opaque material.
15. Self-closing exiravascular valve u it (4) according to any of the preceding claims, comprising a collar part (3) that, is inclined in relation to said axis A with an inclination- angle between 1 and 80°.
16. Self-closing extravaseuiar valve -unit (4) according to any of the preceding claims, wherein the valve unit (4) is made of a bioresorbable material,
17. Self-closing extravascular valve unit (4) according to any of the preceding claims, wherein the valve unit (4) comprises a fbldabie collar part (3).
18. A device for sealing a puncture hole in a vessel wall, the device (8) comprises
- an elongated introducer (7) adapted for introduction through said puncture hole,
- a self-closing extravascular valve unit (4) according to any of the preceding claims, wherein said valve unit (4) is s!idably arranged on said introducer (7).
19. A device according to claim 18, comprising a insertion tool (9) adapted to apply a force on said valve unit (4) to advance said valve unit (4) in the distal direction of the introducer (7),
20. A device according to claim 19, wherein said insertion tool (9) has a tubular shape.
21. A device according to any of claims 1.8 to 20, wherein said introducer ( 7) comprises a hydropliilic surface.
22. A device according to any of claims 18 to 21, wherein said insertion tool (9) comprises a hydrop ilic inner surface.
23. A device according to any of claims 1 to 22, wherein said valve unit (4) and said introducer (7) and/or insertion tool (9) comprise orientation means to facilitate orientation of the valve through an insertion procedure.
PCT/EP2011/066477 2010-09-24 2011-09-22 A valve unit and a device for sealing a puncture hole in a vessel wall WO2012038495A2 (en)

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US38617810P 2010-09-24 2010-09-24
SE1050991A SE535552C2 (en) 2010-09-24 2010-09-24 A valve assembly and means for sealing a puncture hole in a vessel wall
US61/386,178 2010-09-24
SE1050991-7 2010-09-24

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