WO2011056125A1

WO2011056125A1 - Introducer access assembly

Info

Publication number: WO2011056125A1
Application number: PCT/SE2010/051166
Authority: WO
Inventors: Fredrik Mahlin
Original assignee: St. Jude Medical Systems Ab
Priority date: 2009-11-03
Filing date: 2010-10-27
Publication date: 2011-05-12
Also published as: EP2496153A1

Abstract

An elongated introducer access assembly (2) provided with a first tubular channel (8) having a longitudinal axis (10) and running from a first proximal end opening (12) to a distal end opening (14) of the assembly and being adapted to receive a first tubular medical device. The assembly is provided with a second tubular channel (16) having a second proximal end opening (18) and being arranged in an angled direction in relation to the longitudinal axis of the first tubular channel, the second tubular channel enters the first tubular channel at a junction (20) and an intersectional angle (alpha) between the first and second tubular channel. The assembly comprises a cutting unit (22) adapted to provide an opening cut through a part of a first tubular medical device arranged in said first tubular channel such that a second tubulardevicemay be inserted into said second tubular channel and into thef irsttubular medical device via said opening cut.

Description

Title

Introducer access assembly

Field of the invention

The present invention relates to an introducer access assembly according to the preamble of the independent claim.

Background of the invention

A medical introducer is generally used to gain access to internal organs in order to introduce another medical device into the body. Within the scope of the present invention the other medical device may typically be a pressure sensor catheter inserted into arteries, inter alia to measure blood pressure within arteries, e.g. in coronary vessels, in order to detect and localize constrictions. When such a measurement procedure is terminated the medical device is withdrawn, the introducer is maintained in place, and it is sometimes required to close and properly seal the artery. In that case a closing device may be inserted into the vessel in order to close the incision through the vessel wall. Introducers from different manufacturers might vary considerably in shape, length, structure etc.

In particular the proximal end of the introducer may have very different structures.

During the above-described procedure when performing pressure measurements within the body there is an overall requirement, both from the patient and the physician, that the whole procedure should be as smooth as possible.

During insertion of a closing device it is considered important to be able to easily and correctly gain access to the lumen of the introducer in order to insert the closing device. The inventor has realised that a more streamlined procedure, both for the patient and for the physician is achieved if the introducer, already inserted into the patient, is maintained and used as a guide to the introducer required to perform e.g. insertion of a closing device. Thus, the object of the present invention is to achieve an introducer assembly enabling a more user- friendly procedure that is safe to use for the patient.

Summary of the invention

The above-mentioned object is achieved by the present invention according to the independent claim.

Preferred embodiments are set forth in the dependent claims.

Thus, the present invention relates to an elongated introducer access assembly comprising a distal end and a proximal end, and provided with a first tubular channel having a longitudinal axis and running from a first proximal end opening to a distal end opening of said assembly and being adapted to receive a tubular medical device. The assembly is provided with a second tubular channel having a second proximal end opening running from the proximal end of the assembly, said second tubular channel being arranged in an angled direction in relation to the longitudinal axis of the first tubular channel,

and that the second tubular channel enters the first tubular channel at a junction proximally to the distal end of the assembly, and that an intersectional angle is formed between the first tubular channel and the second tubular channel,

wherein the assembly further comprises a cutting unit adapted to provide an opening cut through a part of a first tubular medical device arranged in said first tubular channel such that a second tubular device may be inserted into said second tubular channel and into the first tubular medical device via said opening cut.

By use of the present invention an opening cut is achieved in the introducer wall in a controlled and safe way such that a tubular medical device may be guided and inserted into a vessel in a safe and controlled manner. The tubular medical device may be e.g. another introducer specifically designed to receive e.g. a closing device as described above.

It will then be necessary to gain access to the lumen of the introducer, which is achieved, by use of the present invention, by making an opening cut in the wall of the introducer through which opening cut the new introducer may be inserted into the introducer and then further to a desired position.

One further advantage of the present invention is that the access assembly may function as a handle when the second tubular medical device is inserted into the introducer during the following procedure, e.g. the closing of a vessel.

According to one embodiment of the present invention the introducer access assembly is attached to, or adapted to be attached to, a closure device introducing system such that the assembly easily may be positioned and fixated around an introducer in order to provide an opening cut in the introducer where a closing device may be inserted into the introducer and into a vessel in order to close an incision through the vessel wall.

Short description of the appended drawings

Figures la and lb show different views of the introducer access assembly according to one embodiment of the present invention.

Figure 2 illustrates the use of the introducer access assembly according to one

embodiment of the present invention.

Figures 3-6 show the introducer access assembly according to another embodiment of the present invention in different states.

Detailed description of preferred embodiments of the invention

The present invention will now be described in detail with references to the appended drawings.

Figure la shows, to the right, a perspective view of the assembly, and to the left a view from the distal side. Figure lb shows, from left to right, a side view where the distal end of the assembly is down in the figure, a top view showing the two halves of the assembly in a disassembled state, and a side view along A-A showing the inner side of one of the halves.

With references to figures la and lb the present invention relates to an elongated introducer access assembly 2 comprising a distal end 4 and a proximal end 6, and provided with a first tubular channel 8, having a longitudinal axis 10, and running from a first proximal end opening 12 to a distal end opening 14 of the assembly and being adapted to receive a first tubular medical device (not shown).

The assembly is provided with a second tubular channel 16 having a second proximal end opening 18 running from the proximal end of the assembly. The second tubular channel is arranged in an angled direction in relation to the longitudinal axis of the first tubular channel.

The second tubular channel enters the first tubular channel at a junction 20 proximally to the distal end of the assembly. An intersectional angle is formed between the first tubular channel and the second tubular channel. The angle is indicated as a in the figure.

The inner diameters of the tubular channels are naturally related to the outer diameters of the tubular devices to be arranged in the channels, preferably such that a steady fit is achieved for the device arranged in the first channel and that the second tubular medical device may easily be inserted into the second channel but at the same time be securely guided into the channel and into the first tubular device in the first channel via the opening cut.

The assembly further comprises a cutting unit 22 adapted to provide an opening cut through a part of a first tubular medical device arranged in said first tubular channel such that a second tubular device may be inserted into the second tubular channel and into the first tubular medical device via the opening cut. Preferably, the cutting unit has a flat structure to be inserted into the assembly via a mating slit in the assembly. In one embodiment, the cutting unit is arranged in the slit in one of the halves of the assembly and when the halves are assembled around an introducer the cutting unit is pushed into the assembly resulting in that an opening cut is made in the introducer and the edge part of the cutting unit then continues into the opposing half where it is accommodated. The size of the cutting unit must be such that when fully inserted into the assembly no part exists at the other side of the assembly.

The cutting edge has preferably a razor blade structure and is made from metal, e.g.

stainless steel. It may also be possible to achieve a cutting edge in other materials, e.g. certain plastic materials.

The cutting unit is arranged at a location distally to the junction and comprises a recess 24 adapted to accommodate a first tubular medical device arranged in the first tubular channel when the cutting unit is fully pushed into the assembly. Preferably, the recess has a semicircular shape. The cutting unit is arranged such that the opening cut is essentially perpendicular to the longitudinal axis of the first tubular channel and the cutting edge 26 (partly seen in figure la) is arranged such that it cuts through at least 1/2 and up to approximately 3/4 of the diameter of a first tubular medical device arranged in the first tubular channel. The exact size of the opening cut is naturally dependent upon the diameter of the second tubular device to be inserted into the introducer via the second tubular channel and opening cut.

The cutting unit further comprises a pushing means 28 arranged at the outside of the assembly for moving the cutting unit into the housing in order to provide said opening cut.

The intersectional angle a, i.e. the angle between the first and second tubular channels, is less than 45°, preferably in the interval of 20° and 40°. The angle must not be too small in that then it would be difficult for the second tubular medical device to enter the opening cut. On the other hand, if the angle is too large, it would also be difficult for the second tubular medical device to enter the opening, and the insertion may also be hindered if the bend at the junction is too sharp. In the shown embodiment the first tubular channel is straight and the second tubular channel is also straight but forms an angled channel together with the distal part of the first tubular channel distally to the junction.

An obvious reason for the first tubular channel being straight is that it is easy to arrange the assembly around e.g. an introducer. One might naturally also consider a variant where the axis of the first tubular channel is slightly curved and also the second channel being slightly curved, the channels may then approximate the letter "Y". Also combinations where one of the channels is curved and the other is straight is also possible. According to a preferred embodiment the assembly comprises at least one fixation member 30 arranged at the inner surface of the first tubular channel adapted to fixate the first tubular medical device arranged in the first tubular channel in the longitudinal direction. Preferably, the fixation member is arranged proximally to the junction. The fixation member may be in the form of a protrusion, a short pin, or a track or consists of an inert or rough material at the inner surface of the first tubular channel.

As shown in the figures the assembly comprises two halves adapted to be assembled and positioned such that a tubular medical device may be arranged in the first channel, and also adapted to be separated from each other. In the figures one embodiment is illustrated where the two halves are two non-connected parts when the assembly is in its non- assembled state. In another embodiment the two halves are connected to each other by at least one hinge (not shown). The hinge or hinges may be arranged at one of the longer sides of the assembly such that the assembly may be folded around the introducer to be arranged in the first channel.

The assembly is further provided with mating means 32 for fastening and orientating the two halves in relation to each other during assembling. The mating means may comprise a number of extending pins at one half of the assembly and mating depressions/holes at the other half to receive the pins such that a frictional connection is achieved. Preferably the assembly is a separate device that is attached to an introducer when desired. However, according to another embodiment the assembly instead is integrated with a tubular medical device arranged in the second channel. According to still another embodiment of the present invention one of said halves is attached to, or adapted to be attached to, a closure device introducing system which is adapted to automatically, or semi-automatically, introduce a closure device into a vessel in order to close an incision through the vessel wall.

In a typical use of the assembly the first tubular medical device to be arranged in the first tubular channel is an introducer used e.g. when inserting measurement catheters into the body, e.g. via artery vessels. In such a use of the assembly the second tubular device to be inserted into the second tubular channel and into the tubular medical device via the opening cut is a so-called closure device used to seal and close a vessel inside the body.

Figures 3-6 illustrate one embodiment of the introducer access assembly according to the present invention.

According to this embodiment the introducer access assembly is an attachable part, or an integrated part, of a closure device introducing system 50. A closure device introducing system is adapted to automatically, or semi-automatically, introduce a closure device into a vessel in order to close an incision through the vessel wall.

Figures 3-6 illustrate different procedural steps performed when using the introducer access assembly according to this embodiment of the invention.

The assembly 2' comprises two main parts, a support unit 42 and a locking unit 40 movably attached to each other by a joint 44 enabling the parts to move (indicated by an arrow) in relation to each other from an open state which is illustrated in figure 3 to a closed state which is illustrated in figure 4 (and also in figures 5 and 6). The joint 44 is preferably arranged at one side of the supporting unit and locking unit such that, when the assembly is in its open state, the introducer easily may be arranged at the support unit. The support unit is preferably provided with a small depression (not shown) running along the entire unit. The locking unit is provided with a recess 46 running along a lower side of the entire locking unit and that in combination with the support unit 42 form the first tubular channel. The second tubular channel 16' is a channel running within the locking unit 40 from the part of the locking unit attached to, or adapted to be attached to, the closure device introducing system 50 and opens into the recess close to the joint 44. The assembly 2' according to this embodiment is also provided with a cutting unit 22'. The cutting unit and its function are described in detail in connection with the other embodiments and will not be repeated again.

During use of the introducer access assembly according to this embodiment, the support unit 42 is positioned such that an introducer 34, e.g. inserted into a vessel of a patient, rests in the small depression of the support unit. The locking unit is then moved to lie in contact with the support unit ensuring that the introducer is positioned in the recess that, in combination with the depression of the support unit, forms the first tubular channel.

Figure 4 shows the entire closure device introducing system 50 provided with an introduces access assembly 2 being in the ready-to-use closed state. Figure 5 shows in greater detail the introducer access assembly in this state. When the assembly is in its closed state it is important that it remains in that state. In order to achieve that, the support unit and the locking unit are preferably provided with some locking means, e.g. knobs and mating indentations that provide for a frictional lock.

The cutting unit is then pushed into the assembly (see figure 6) providing an opening cut through a part of the introducer (also referred to as the first tubular medical device) and a closure device (also referred to as the second tubular medical device) may now be inserted into the introducer by the closure device introducing system.

Preferably the assembly essentially is made from plastic, but other materials may also be possible, e.g. metal, combinations of metal and plastic.

Advantageously, the assembly is a disposable device, and must be possible to sterilize prior use.

Figure 2 illustrates the use of the assembly according to another embodiment of the present invention. To the right in the figure the two halves of the assembly are shown when the halves are disconnected from each other after an opening cut is achieved in an introducer 34 and tubular medical device 36 being inserted into the opening cut 38.

To the left in the figure the introducer is shown having a tubular medical device inserted into the opening cut. In the figure is also shown a tubular arrangement 39 connected to the proximal end of the introducer 34.

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

1. An elongated introducer access assembly (2) comprising a distal end (4) and a proximal end (6), and provided with a first tubular channel (8) having a longitudinal axis (10) and running from a first proximal end opening (12) to a distal end opening (14) of said assembly and being adapted to receive a tubular medical device,

c h a r a c t e r i z e d i n that

said assembly is provided with a second tubular channel (16) having a second proximal end opening (18) and running from the proximal end of the assembly, said second tubular channel being arranged in an angled direction in relation to the longitudinal axis of the first tubular channel,

and that the second tubular channel enters the first tubular channel at a junction (20) proximally to the distal end of the assembly, and that an intersectional angle (a) is formed between the first tubular channel and the second tubular channel,

wherein the assembly further comprises a cutting unit (22) adapted to provide an opening cut through a part of a first tubular medical device arranged in said first tubular channel such that a second tubular device may be inserted into said second tubular channel and into the first tubular medical device via said opening cut.

2. Introducer access assembly according to claim 1, wherein the cutting unit is arranged at a location distally to the junction.

3. Introducer access assembly according to claim 1 or 2, wherein the cutting unit comprises a recess (24) adapted to accommodate the first tubular medical device arranged in said first tubular channel.

4. Introducer access assembly according to claim 3, wherein the recess has a semicircular shape.

5. Introducer access assembly according to claim 1, wherein the cutting unit is arranged such that the opening cut is essentially perpendicular to the longitudinal axis of said first tubular channel.

6. Introducer access assembly according claim 1, wherein the cutting unit comprises a cutting edge (26) that is arranged such that it cuts through at least 1/2 of the diameter of a first tubular medical device arranged in said first tubular channel.

7. Introducer access assembly according to claim 1, wherein the cutting unit comprises a cutting edge that is arranged such that it cuts through a maximum of 3/4 of the diameter of a first tubular medical device arranged in said first tubular channel.

8. Introducer access assembly according to claim 1, wherein the cutting unit comprises a pushing means (28) arranged at the outside of the assembly for moving the cutting unit into the housing in order to provide said opening cut.

9. Introducer access assembly according to claim 1, wherein the intersectional angle is less than 45°, preferably in the interval of 20° and 40°.

10. Introducer access assembly according to claim 1, wherein the assembly comprises at least one fixation member (30) arranged at the inner surface of the first tubular channel adapted to fixate a first tubular medical device arranged in said first tubular channel in the longitudinal direction.

11. Introducer access assembly according to claim 10, wherein said at least one fixation member is in the form of a protrusion, a short pin, or a track or consists of an inert or rough material.

12. Introducer access assembly according to any preceding claim, wherein the assembly comprises a support unit (42) and a locking unit (40) movably attached to each other by a joint (44) enabling the parts to move in relation to each other from an open state to a closed state and that the locking unit is provided with a recess (46) running along a lower side of the entire locking unit and that in combination with the support unit (42) form the first tubular channel when the assembly is in its closed state.

13. Introducer access assembly according to claim 12, wherein the support unit is provided with a small depression running along the entire unit such that, when the assembly is in its open state, the a first tubular medical device may be arranged at the support unit.

14. Introducer access assembly according to claim 12, wherein the assembly is attached to, or adapted to be attached to, a closure device introducing system (50).

15. Introducer access assembly according to any of claims 1-11, wherein the assembly comprises two halves adapted to be assembled and positioned such that a first tubular medical device may be arranged in said first channel, and also adapted to be separated from each other.

16. Introducer access assembly according to claim 15, wherein said two halves are connected to each other by at least one hinge.

17. Introducer access assembly according to claims 15 or 16, wherein the assembly comprises mating means (32) for fastening and orientating said two halves in relation to each other during assembling.

18. Introducer access assembly according to any of claims 15-17, wherein one of said halves is attached to, or adapted to be attached to, a closure device introducing system.

19. Introducer access assembly according to claim 1, wherein the assembly is integrated with a tubular medical device arranged in the second channel.