WO1997043963A1

WO1997043963A1 - Surgical devices for use in installation of thoracic drainage

Info

Publication number: WO1997043963A1
Application number: PCT/GB1997/001336
Authority: WO
Inventors: Anthony Damien Redmond
Original assignee: Anthony Damien Redmond
Priority date: 1996-05-18
Filing date: 1997-05-16
Publication date: 1997-11-27
Also published as: AU2904097A; GB9709844D0; GB9610460D0; GB2313316B; GB2313316A

Abstract

A surgical drain insertion device, for insertion of a drain into a person's body, comprising a penetrator (36) having a head (31) connected by a shank (32) to a tip (33); and is characterised in that the device further comprises a duct concentric with the shank, which duct provides an opening (11) through which a drainage tube (15) can be inserted into the duct; and in that the shank (32) of the penetrator has a male threaded portion (34) adjacent to the tip (33) so that the penetrator can be rotated to separate muscle fibres to create a passage in the body wall of a person and to bring the drainage tube (15) into the fluid flow connection with the body cavity adjacent to said body wall.

Description

SURGICAL DEVICES FOR USE IN INSTALLATION OF THORACIC

DRAINAGE

This invention concerns surgical devices, for example, for use in the decompression of the thoracic cavity which is usually an emergency procedure when fluid, e.g. air and/or blood, occupies the space between the chest wall and the lungs causing one or both of the lungs to be compressed leading to collapse of the lung or lungs; and the remedial action currently involves insertion of a drainage tube into the thoracic cavity to remove such fluid.

In current techniques for insertion of drainage tubes:- 1. The skin is cleansed and anesthetised.

2. The skin is incised.

3. Either -

(a) a penetrator in the form of a sharp trochar is pushed blindly through the subcutaneous tissue and muscle into the chest, and the thoracic drainage tube is passed over the trochar and into the chest, or

(b) the subcutaneous tissue and muscle are incised and the tube passed directly into the chest.

If 3(a) is used there is a risk of plunging the sharp trochar into the lung or heart. This risk is increased in an emergency when there may be no time for prior X-ray confirmation of a collapsed lung. If the diagnosis was wrong the trochar will inevitably pierce the lung and provoke a life threatening crisis.

If 3(b) is used an inexperienced surgeon may have difficulty dissecting quickly through all the tissues and without damaging blood vessels. Again in an emergency there may not have been confirmation of a collapsed lung by X-ray and if the diagnosis was wrong the lung may easily be cut.

Avoidance of these problems inherent in current methods requires a level of surgical skill not always accrued by those required to carry out the procedure particularly in an emergency. The need to insert chest tubes in an emergency is an uncommon experience for most doctors, particularly in their early years. They may know the theory but have difficulty executing their knowledge safely in the presence of a life threatening emergency.

In order to enable these problems to be solved the present invention provides a surgical drain insertion device comprising a duct and a penetrator, and is characterised in that a shank of the penetrator has a blunt tip and a male threaded portion adjacent to the blunt tip so that the penetrator can be rotated to separate muscle fibres to create a passage in the chest wall and cause the duct to enter the thoracic cavity.

The invention further provides a surgical drain insertion device comprising a penetrator and a duct. wherein the penetrator comprises a shank and a head, and the shank comprises a tip of tapered blunt ended form, a male threaded portion adjacent to the tip and a cylindrical portion between the threaded portion and the head; and wherein said duct is located around or extends through the cylindrical portion.

More particularly, the present invention provides a surgical drain insertion device, for insertion of a drain into a person's body, comprising a penetrator having a head connected by a shank to a tip; and is characterised in that the device further comprises a duct concentric with the shank, which duct provides an opening through which a drainage tube can be inserted into the duct; and in that the shank of the penetrator has a male threaded portion adjacent to the tip so that the penetrator can be rotated to separate muscle fibres to create a passage in the body wall of a person and to bring the drainage tube into fluid flow connection with the body cavity adjacent to said body „all.

The tip preferably has a rounded end so as to be of non-piercing form. The male thread preferably has a rounded, smooth or non-cutting profile. The head is preferably shaped to facilitate manual rotation of the penetrator, e.g. is of bi-winged form.

A bore preferably extends axially of the penetrator, and the head end of said bore is preferably closed by a removable plug.

In some embodiments said bore constitutes said duct; and said bore can be adapted to have a drainage tube connected thereto or inserted thereinto. Also, for or during initial penetration of the chest wall, a trochar may be inserted into said bore.

In preferred embodiments said duct is provided by a tube member located around said shank to leave the tip and male threaded portion of the penetrator exposed.

The tube member preferably has a securing device at one end, which preferably abuts the head. The internal diameter of the tube member is preferably only very slightly larger than the overall diameter of the cylindrical portion. The overall diameter of the male threaded portion is preferably about the same as and not significantly larger than the overall diameter of the cylindrical portion. A small part of the cylindrical portion preferably also projects from the tube member.

The securing device preferably comprises a plastics member, integral with the tube member, having a central ^ hole and a plurality of lugs around the hole which lugs can be bent so that one or a plurality thereof can be sutured to the skin and another or a plurality thereof can be brought into confrontation with a drainage tube inserted through the hole into the tube member and then be secured tightly around the drainage tube by means of thread, adhesive tape and/or a bonding adhesive to bind or bond the lug or lugs to the tube externally of the point of entry of the drainage tube into the tube member.

The lugs need not be symmetrical, but are conveniently so as to minimise the risk of mis-selection during emergency procedures. The minimum number of such lugs is preferably four, with two diametrically opposed ones thereof forming a first array, and the other two thereof forming a second array.

The face of the member intended to abut the person's skin is preferably smooth and planar for the comfort and wellbeing of the patient.

The opposite surface of the member may be ribbed or otherwise profiled to increase the security with which the drainage tube is gripped.

Where adhesive is used to secure the lugs to the tubing, said adhesive may be pre-applied to the lugs and covered with a peel-off tape prior to the lugs being brought into engagement with the drainage tube.

The invention will be described further, by way of example, with reference to the accompanying diagrammatic drawings, wherein: - FIGURE 1 shows an insertion device of the invention in partial longitudinal cross-section;

FIGURE 2 is a perspective view showing a tube member of the device in an in-use condition sutured to the skin of a person;

FIGURE 3 is a perspective view showing the modified tube member;

FIGURES 4 and 5 are diagrams showing an incision in a chest wall;

FIGURE 6 is a part sectional diagram showing a penetration of the insertion device partially inserted into the chest via the incision; and

FIGURES 7 and 8 show two modified forms of insertion device of the invention.

Referring to FIGURES 1 and 2 of the invention the insertion device comprises a tube member 10 and a penetrator 30 to convey a central tubular part 19 of the member 10 through a chest wall 23 (FIGURES 4 to 6) until lugs 13 of the member 10 abut the skin 20 of the wall 23 and can be sutured by stitches 21 to the skin 20 to hold the tube member 10 in position. Thereafter a drainage tube 15 is inserted via the member 10 into the thoracic cavity 24 (FIGURE 6) and a further pair of lugs 14 are bent and tied, bound or bonded around the tube 15 to secure the tube in position. In this embodiment, the internal passage in the part 19 constitutes a duct, for drainage purposes.

As shown in FIGURE 3, in its natural state the lugs

13 and 14 form a disc around a central hole 11 at one end of the duct defined by the tubular part 19, the lugs 13 and

14 being separated by slots 12 and having suturing or tying holes 16 therein. The lugs 13 and 14 thus collectively serve as a securing device on the tube member 10.

Referring again to FIGURE 1, the penetrator 30 comprises a head 31 and a shank 32 which in turn comprises a tip 33, a male threaded portion 34 adjacent the tip, a cylindrical portion 35 and an optional internal bore 36 extending axially through the penetrator.

The tip 33 is of blunt, e.g. rounded, non-piercing form, and the thread on the portion 34 is of rounded, non- cutting profile.

The tube member 10 is located around the portion 35 so that, when the lugs 13,14 abut the head 31, the tip 33, portion 34 and part of the portion 35 are left exposed, and, optionally, the head end of the bore 36 is closed by a removable plug 37.

The head 31 comprises two diametrically opposed wings 38 to facilitate rotation of the penetrator 30. In use, a minimal incision 25 is made in the skin of chest wall as diagrammed, in FIGURES 4 and 5; the tip 33 is inserted into the incision until the tip and the leading edge of the thread of the threaded portion 34 pass through 5 the subcutaneous tissue to engage the intercostal muscular tissues 26; and the penetrator is rotated to cause the fibres of the muscle tissue to be gently parted as the penetrator is driven through the chest wall until at least the tip enters the thoracic cavity 29. Removal of the plug

!0 37 at this point in time can be used to test the position of the wall 27 of the lung 28. If said wall 27 is in its natural position (as shown in FIGURE 6) it will block access to the bore 36, but if the diagnosis and penetration location are correct, the wall 27 will have been displaced,

15 by fluid, away from the wall 23, e.g. to the position shown in broken lines, and the fluid will flow through the bore 36. If this is so the penetrator is driven into the chest until the tube member 10 is in position in the chest wall, and the penetrator is then removed to allow the drainage

20 tube 15 to be inserted into said duct and the member 10 secured to both the skin and the tube as previously described.

The invention is not confined to the details of the 25 foregoing example, and many variations and modifications thereof are possible within the scope of the invention.

For example, and referring to FIGURE 7 (in which the same reference numbers are used to denote parts the same as or functionally equivalent to parts denoted by reference numbers hereinbefore) the penetrator 30 may be adapted so that the function of the duct in the tube member 10 is assumed by a widened form of the bore 36 in the penetrator 30 so that the penetrator can be left in position in the chest during drainage. Additional ports 43 may be provided in the tip 33 to admit fluid into the duct. The interior of this penetrator 30 may be widened to provide a female socket 40 for the tube 15 (or a male spigot, not shown, at the head end onto which the tube 15 can be fastened); and the wings 38 may have flanges 41 with suture holes 16 therein for fastening to the skin. The penetrator 30 shown in FIGURE 7 has flexible lugs 14 projecting axially from the head end for fastening to the tube 15 as previously described.

For further example, and referring to FIGURE 8 (in which the same reference numbers are used again) , the penetrator 30 is combined with the tube member 10 so that the blunt tip 33, threaded portion 34 and said duct are integrated into tubular part 19. The function of the head 31 is assumed by making the lugs 14 thinner and radially shorter than the lugs 13 so that the latter can be gripped for rotation of the device.

For support during penetration, a blunt rigid trochar may be inserted into the penetrator, but it may well be preferable to insert a pointed sharp trochar 50 (indicated in broken lines ) of a length commensurate with the point 51 projecting from the tip 33.

The duct in the penetrator 30, tube member 10 or combined duct and penetrator may have (as well as or instead of a terminal port 44 e.g. in the hollow tip 33) ports 45 in the threaded portion 34 or ports 46 further along the shank 32 or tube 19 as illustrated for example in FIGURE 8. Also, the thread may extend around the shoulder of the rounded tip 33.

In the embodiments shown in FIGURES 3 and 8 ports 42 may be provided adjacent the end of the part 19 to admit fluid into the duct, especially in cases wherein the tubing 15 is connected to the member 10 by a standard tube coupling instead of being inserted into the member 10. In such an instance, the lugs 14 may be used to secure the coupling and/or the tube 15 to the member 10.

The lugs 13,14 may be of any suitable number, size and shape.

Although the member 10 and penetrator are preferably of moulded plastics, any suitable material or materials may be employed for the construction thereof.

The invention further provides and includes a surgical device or a drain insertion method comprising any novel part, arrangement of parts, functional feature or step disclosed herein or in the accompanying drawings. The device of the invention has many advantages over current techniques, e.g. :-

1. Minimal tissue trauma. 2. Minimal surgical skill required.

3. It is quick and easy to apply in an emergency.

4. There is minimal risk of damaging vital structures particularly when the emergency diagnosis may be wrong.

The above features make it particularly useful in an emergency especially when X-ray facilities are not available. The tube member or duct alone will resolve a life threatening collapse of the lung.

The tube member or ducted penetrator can be fixed more securely by the lugs than can be achieved by any currently available method of fixing drainage tubes.

Although the device is primarily intended for and is described with reference to the insertion of drains into the thoracic cavity, the device has further utility in inserting drains into any cavity bounded in part by muscular tissue adjacent thereto, e.g. the abdominal cavity. Further, the device, when fastened to the skin, also provides a secure connection and flow path for fluid to be pumped into such a cavity.

Further, the plug 37 may be replaced by or comprise a bursting diaphragm or one way outlet valve, whereby to close off the passage until the pressure in the chest cavity rises above a predetermined threshold. An equivalent pressure release plug, diaphragm or valve may be inserted in the central hole 11.

Claims

1. A surgical drain insertion device, for insertion of a drain into a person's body, comprising a penetrator (30) having a head (31) connected by a shank (32) to a tip (33); and is characterised in that the device further comprises a duct concentric with the shank (32), which duct provides an opening (11) through which a drainage tube (15) can be inserted into the duct; and in that the shank (32) of the penetrator has a male threaded portion (34) adjacent to the tip (33) so that the penetrator (30) can be rotated to separate muscle fibres to create a passage in the body wall of a person and to bring the drainage tube (15) into the fluid flow connection with the body cavity adjacent to said body wall.

2. A device as claimed in Claim 1 wherein the tip (33) has a rounded end so as to be of non-piercing form.

3. A device as claimed in Claim 1 or 2 wherein the male thread has a rounded, smooth or non-cutting profile, and the head (31) is shaped to facilitate manual rotation of the penetrator.

4. A device as claimed in Claim 1, 2, or 3 wherein a bore (36) extends axially of the penetrator, and the head end of said bore (36) is closed by a removable plug (37).

5. A device as claimed in Claim 1, 2 or 3 wherein said duct is formed as a bore (36) in the penetrator so that a drainage tube can be inserted thereinto.

6. A device as claimed in Claim 5 further comprising a trochar (50) insertable into said bore (36).

7. A device as claimed in any preceding claim further comprising a securing device (13:14) located around the duct adjacent said opening (11) in the duct and securable to both the drainage tube (15) and to the body wall through which the duct is inserted to hold the tube (15) in position.

8. A device as claimed in any one of Claims 1 to 3 wherein said duct is a tube member (10) located around said shank (32) to leave the tip (33) and male threaded portion (34) of the penetrator exposed.

9. A device as claimed in Claim 8 the tube member (10) has a securing device (13:14) at the end adjacent to said opening, which securing device can abut the head (31).

10. A device as claimed in Claim 8 or 9 wherein the internal diameter of the tube member ( 10) is only very slightly larger than the overall diameter of the cylindrical portion (35), so that it fits slidably as a sleeve on the cylindrical portion (35).

11. A device as claimed in any preceding claim wherein the overall diameter of the male threaded portion (34) is about the same as and not significantly larger than the overall diameter of the cylindrical portion (35).

12. A device as claimed in Claim 8, 9, 10 or 11 wherein a small part of the cylindrical portion (35) also projects from the tube member.

13. A device as claimed in Claim 12 wherein the securing device comprises a plastics member, integral with the tube member (10), having a central hole (11) to provide said aperture and a plurality of lugs (13,14) around the hole which lugs (13,14) can be bent so that one or a plurality thereof can be sutured to the skin of the body wall and another or a plurality thereof can be brought into confrontation with a drainage tube (15) inserted through the hole (11) into the tube member (10) and then be secured tightly around the drainage tube by fixing means, such as thread, adhesive tape and/or a bonding adhesive, to fix the lug or lugs (13,14) to the tube externally of the point of entry of the drainage tube (15) into the tube member (10).

14. A device as claimed in Claim 13 wherein the lugs (13,14) are symmetrical, with two diametrically opposed ones (13) thereof forming a first array, and another two (14) thereof forming a second array.