GB2272159A - Surgical/diagnostic aid - Google Patents

Surgical/diagnostic aid Download PDF

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Publication number
GB2272159A
GB2272159A GB9223560A GB9223560A GB2272159A GB 2272159 A GB2272159 A GB 2272159A GB 9223560 A GB9223560 A GB 9223560A GB 9223560 A GB9223560 A GB 9223560A GB 2272159 A GB2272159 A GB 2272159A
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GB
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Patent type
Prior art keywords
tube
device
balloon
sleeve
inflated
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
GB9223560A
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GB9223560D0 (en )
Inventor
Andreas G Constantinides
Original Assignee
Andreas G Constantinides
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Filing date
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02Dilators made of swellable material

Abstract

The aid comprises a hollow tubular member (1) having one end adapted to be passed through a natural opening or artificial incision in the body, an inflatable sleeve (2) surrounding the tubular member adjacent its one end, and an inflation tube (3), one end (5) of which opens into the interior of the sleeve and the other end (4) of which may be connected to a source of inflating fluid. After the device has been inserted into a body opening or incision, the sleeve (2) is inflated for the temporary and local dilation or retraction of body tissues and organs in surgical and/or diagnostic procedures. <IMAGE>

Description

SURGICAL/DIAGNOSTIC AID This invention relates generally to surgical/diagnostic aids and is more especially concerned with a device which can be used for the temporary and localised dilation or retraction of body tissues and organs to assist in surgical and/or diagnostic procedures.

Diagnostic endoscopies and operations outside the peritoneum, in the pelvic region and in the retroperitoneal space frequently require the introduction of gas under pressure. That gas can create iatrogenic emphysema which may be scattered beyond the immediate area under examination. This does not render any assistance to the doctor in his procedure and the emphysema can cause the patient great discomfort.

In the case of gas inflation of the intraperitoneal cavity of the abdomen, the pressure is generalised which means that areas outside the doctor's immediate field of operation are also under pressure for a prolonged period. This can permit the passage of fluids and bacteria to other spaces which can thereby become contaminated. Because of the generalised pressure, there is always the danger of gas escaping beyond the intraperitoneal cavity in the tissues creating emphysema in adjacent tissues.

Because the gas is free within the abdomen, there is a big risk of absorption of gas by the tissues, creating toxication of the patient (acidosis). Also, the generalised pressure can cause closure of traumatised vessels which may start bleeding after deflation when the operation has been completed.

Also generalised gas pressure in the upper abdomen elevates both halves of the diaphragm and as a result there is unnecessary pressure passed to the lungs and the heart.

In order to perform most endoscopic procedures (diagnostic or therapeutic) visibility of the region under observation is achieved by expansion and pressure, which is applied not only to the precise area under observation or operation, but also to a far more generalised area. For example, in sigmoidoscopy, the whole of the large bowel is inflated to the degree necessary to enable step-by-step observation of the whole length of the bowel. Because the whole of the large bowel is inflated, the patient frequently suffers discomfort. More important, in the case of diverticulae, the generalised pressure in the bowel introduces a distinct risk of perforation, not only in the area under observation but also elsewhere because the pressure is uncontrolled and therefore affects other areas.Also, such generalised and uncontrolled inflation of the organ results in non-homogeneous dilation so that there is frequently less dilation than that required for observation purposes at certain locations and at other places more dilation than necessary.

In oesophagoscopy, where at times some expansion of the oesophagus is required in order to permit observation of tiny lesions, the doctor cannot expand the oesophagus by gas pressure because that pressure cannot be retained.

Inflatable balloons are now widely used in medicine for various purposes. For example, a balloon is used around catheters of Foley's type to support such catheters in place. They are used also around <RTI>Sengstaken</RTI> tubes to support the tubes and to compress bleeding vessels. A balloon is used additionally in Fogarty's catheter for the extraction of clots and biliary stones. Another use of inflated balloons is for the dilation of vessels. Finally, balloons around tubes are used to seal the trachea and the main bronchi or the abdominal cavity to prevent leakage of gases.

According to the invention, there is now provided a surgical/diagnostic aid comprising a hollow tubular member having one end adapted to be passed through an opening or incision in the body; an inflatable sleeve surrounding the tubular member adjacent the one end thereof; and means enabling the sleeve to be inflated within the body.

The sleeve can be inflated in the fashion of a balloon to dilate or distend or retract a body organ or to retract or separate body tissues to enable surgical or diagnostic procedures to be carried out more simply and efficiently than hitherto. Also, the hollow tubular member can be used to permit passage of a variety of surgical and/or diagnostic devices into the body organ or tissues, for example endoscopes and surgical instruments.

According to one aspect of the invention, the hollow tubular member is of rigid construction so that surgical and/or diagnostic instruments can be readily passed into and out of the body through the hollow tubular member. Examples of such devices are described in detail below. According to another aspect of the invention, however, the hollow tubular member is of a flexible material. A device according to the invention which incorporates such a flexible tubular member finds particular utility with flexible surgical and/or diagnostic instruments, such as flexible endoscopes, with which the device is able to be flexed and manipulated within the body.

The present invention will now be described in greater detail by way of example only with reference to the accompanying drawings, in which: Figure 1 is a side view of a first form of surgical/diagnostic aid according to the invention; Figure 2 is a front view of the device shown in Figure 1 together with an associated introduction tool; and Figure 3 is a side view of a second form of surgical/diagnostic aid according to the invention, together with an associated introduction tool.

Referring to the drawings, the device shown in Figure 1 consists of a hollow tube 1, a flexible sleeve 2 surrounding the tube 1 adjacent its lower end and an inflation tube 3 which passes along the interior of the tube 1 with a connector or valve 4 at its upper end external of tube 1 and opening into the interior of the sleeve 2 at its lower end 5.

The sleeve 2 is tightly sealed at its upper and lower edges 6 and 7 around the tube 1 so that fluid introduced through the tube 3 into the sleeve 2 will inflate the sleeve in balloon fashion. The fluid is preferably a gas such as air or carbon dioxide or a liquid such as isotonic saline, the escape of any of which from the balloon into a body cavity or organ will cause no particular harm to the patient.

The tube 1 can be of any length between about 16 and 30 cm, of external diameter between about 7 and 18 mm and of internal diameter between about 6 and 15 mm, depending on the use to which it is to be put. The tube 1 will be formed of a physiologically inert and X-ray transparent material, preferably of a plastics material that is non-toxic, inexpensive, tough and shatterproof such as polycarbonate, polypropylene or polyacrylate. The sleeve 2 must, of course, be of a material with sufficient flexibility and elasticity that it can be readily inflated without bursting or rupturing, and sufficiently strong to resist puncturing or tearing upon contact with surgical instruments. Suitable materials are various natural and synthetic elastomers, such as polybutylene rubber.

The inflation tube 3 may have an external diameter of about 0.5 to 2 mm and will be formed of a flexible material, for example butyl rubber or silicone rubber. It is preferably fastened in place along the interior of the tube 1 by slight tension between the two places where it passes through the tube 1, or it can be lightly attached by means of an adhesive. Alternatively, the inflation tube 3 can pass along the exterior of the tube 1 or can be incorporated into the wall of the tube 1.

The sleeve 2 is, as stated above, sealed to the tube 1 along the upper and lower edges 6 and 7 of the sleeve 2. Such sealing can be achieved by adhesive bonding and/or by seating integral beads along the upper and lower edges of the sleeve in complementary annular grooves in the outer surface of the tube 1.

Introduction of the device shown in Figure 1 into an incision some 2 to 3 cm long in the body, can be greatly assisted by the use of an introduction tool 8, shown in Figure 2 of the drawings. The tool 8 consists of a rod 9 which is a comfortable fit within the hollow tube 1 and having along its length a groove 10 which will accommodate the inflation tube 3 on the interior of the tube 1 (although such a groove will not be necessary when the inflation tube 3 passes along the exterior of the tube 1). The rod has a downwardly facing flange or shoulder 11 against which the upper edge of the tube 1 will bear in order to push the tube 1 and tool 8 through a suitable incision. The tool 8 can then be withdrawn, either before or after partial or complete inflation of the sleeve 2.The tool 8 has a blunt and rounded lower end 12 to assist its smooth insertion into the body and to avoid damage to underlying organs or tissue.

Introduction of the device into an incision will be assisted also by the application to the device of a lubricant for example a conventional surgical lubricant.

After insertion of the device, the sleeve 2 can be inflated to the desired size by passing an inflating gas or liquid through the tube 3 into the sleeve 2. The resulting balloon, which may be coloured in order to enable the surgeon to visually distinguish the balloon from the surrounding tissue or organs under observation, may be spherical, cylindrical or conical in shape in order to assist the surgeon in the particular manipulative procedures he wishes to undertake. The conical shape can be achieved with a device which incorporates two separate balloons as described below with reference to Figure 3 of the drawings. The advantage of such a device incorporating two separate balloons is that the doctor can achieve a conical or reverse conical-shaped retractor depending upon the degree to which the two balloons are inflated.Also, the surface texture of the balloon can be selected according to the procedures for which it is to be used. For example, for procedures outside the peritoneum, it is of advantage if the surface of the balloon is smooth. In contrast, for procedures in the abdominal cavity, the surface of the balloon may be slight rough for better retraction of the slippery abdominal organs.

The balloon on the device illustrated in Figures 1 and 2 enables a doctor to create space between anatomical planes of tissues. For example, when the device is introduced between the muscles of the abdominal wall and the parietal peritoneum and the balloon is then inflated, there is achieved an easy separation of the muscles from the peritoneum.

Similarly, in the case of the pelvis there can be achieved an excellent field of view to extraperitoneal structures like the pelvic lymphoglands, pelvic vessels, the internal inguinal ring and inferior epigastric vessels.

When the device is introduced in the peritoneal cavity and the balloon is inflated, there is obtained a very good field of view to all of the abdominal cavity. Using the balloon as the retractor on the stomach and on the transverse colon, the gall bladder and the hilum of the liver can be observed. Using the balloon as a retractor on the fundus of the stomach, good vision of the left lobe of the liver and the cardiac region is obtained. With the inflated balloon between the folds of the mesentery, it is possible to observe the spaces between the folds and the loops of the bowel. Pelvic organs also can be observed easily.

These are only a few examples of intraperitoneal diagnostics using the device described above.

A device in which the tube has an internal diameter of 15 mm or so can be used to perform <RTI>rectosigmoidoscopies.</RTI> In such a procedure, the balloon dilates the rectum and the sigmoid only around the field of observation with good vision and at the same time the inflated and lubricated balloon enables the doctor to advance the whole length (30 cm) of the device into the rectosigmoid.

In a modification of the device described above, the tubular member is formed of a thin and elastic material and the sleeve is formed of a material of greater resilience and less elasticity so that when the balloon is inflated, the pressure within it will compress the walls of the tubular member around a flexible endoscope, for example, to keep the device firmly attached to the endoscope. To ensure that firm attachment, the diameter of the flexible elastic tubular member should be slightly smaller than the diameter of the flexible endoscope. Also, the outer surface of the balloon (sleeve) in this embodiment should be very smooth and the inner surface of the flexible tubular member should, however, be slightly roughened and this will be an additional factor for safer attachment of the device onto the endoscope.

It is clear that in this latter embodiment, the role of the balloon is two-fold; first, with inflation of the balloon, the organ is dilated; and second, with the pressure inside the balloon, the device will be firmly attached to the endoscope.

Additionally, in this device the inflation tube should preferably have an outer diameter of 0.5 mm and a length corresponding to that of the flexible endoscope (for example, greater than 100 cm) and should be made of a more rigid material so that it will not collapse when the device is disposed around a flexible endoscope and the balloon is inflated.

By way of example of the use of such a device, a balloon of certain length located around the end portion of a gastroscope when lubricated and inflated can produce gentle dilation of the oesophagus, offering the doctor a better view of the oesophagus with the consequential better possibility of recognising and diagnosing even very small lesions.

Similarly, a balloon of this type attached around the end portion of a colonoscope can result in certain advantages during colonoscopy.

In a further modification of the device described above with reference to Figures 1 and 2, two separate balloons can be incorporated into a single device by positioning two separately inflatable sleeves on the tube. Such a device is illustrated in Figure 3 and includes a hollow tube 13, two flexible sleeves 14 and 15 arranged end-to-end adjacent the lower end of the tube 13, and two separate inflation tubes 16 and 17 one for each sleeve. The device is shown in Figure 3 together with its introduction tool 18 having in this case a more pointed tip 19 (which enables it to be used for thoracic puncture, for example) and a handle 20 by means of which it can be grasped manually.

For observing the pleural cavity and the lung, the tube 13 of the device shown in Figure 3 should be of a smaller diameter and the introduction tool 18 should have the special tip shown in the drawing, which can be used for the puncture of the thoracic wall through a small skin incision which is usually made previously. In such a procedure, the lower balloon (sleeve 15) is inflated as soon as the tube enters the cavity of the pleura so as to assist the advancement of the tube, and the upper balloon (sleeve 14) is inflated in order to assist in the retraction of the outer surface of the lung. With less inflation of the upper balloon and more inflation of the lower balloon, it is possible to enter the anatomical fissures between the lobes of the lung to examine those spaces also. Depending on the conditions, a rigid or flexible endoscope can be passed through the tube 13.This procedure assists examination of the surface of the lung all the way round, under less pneumothorax, under pressure on the lung locally and not generalised pressure, with the part of the lung under examination being more expanded.

Illumination and visibility of the operative field can be achieved either by introducing a rigid or a flexible endoscope through the tube or by attaching at the ophthalmic outer end of the tube 1 or the tube 13 an ordinary endoscopic light source. For example, when the device is inserted through an abdominal incision 2 to 3 cm long and is placed under the right diaphragm and the balloon is inflated, by passing a flexible endoscope of appropriate size through the tube it is possible to view all the surface of the liver above the coronary ligament and all the surface of the liver to the right side of the coronary ligament. This procedure is greatly assisted when the balloon is rotated on the upper surface of the liver.

In this way it is possible too to inspect a larger area of the abdominal surface of the right diaphragm.

In those cases more than one device is used, the light source can be moved from one tube to another according to the requirements of each procedure. The same, of course, applies to the introduction of instruments.

For the purpose of introducing surgical instruments, it is generally necessary to introduce a second or third device of the same or a smaller diameter through small incisions or punctures, as the purpose of the first device will generally be to illuminate the operative field using an endoscopic light source. If the ophthalmic outer end of the tube is used as an ordinary endoscopic light source, then instruments can be introduced through the same device when the lens is removed.

The instruments that can be used in conjunction with devices of the invention can be known, common surgical instruments for rigid endoscopy or instruments manufactured for the purpose of labaroscopic surgery using general gas inflation of the abdomen.

The pressure in the balloons of the devices of the invention can be readily controlled, and by using the inflated balloon or balloons of more than one device in the manner of as ordinary mechanical retractors, it is possible to establish clear lines of vision in the area of examination or operation without having to apply continuous and generalised pressure.

Also, in the process of such procedures, the balloons can be moved slightly in different directions for the purpose of the operative procedure and so that the pressure even locally is not continuous.

Through these devices it is possible to can apply suction in short intervals or continuously, keeping the operative field clear. This cannot be achieved so easily in the case of free gas inflation because the free gas is then sucked out unnecessarily. Also, the patient never suffers from iatrogenic emphysema because even when there occurs an accidental break of the balloon, the air escapes freely from the operative field through the tube on which the balloon is located.

In many cases, it is possible to pass with clear observation ordinary needles of wide bore through the abdominal wall without fear of gas escape. Through these needles there can be passed threads or guide wires necessary for various procedures, and the needles can then be removed.

Also, the devices can be moved by pushing or rolling in any direction desired, forwards and backwards, rotary and lateral. In order to get the best of the operative field, the balloons can be inflated or deflated as required. The variety of movement in combination with the ability to inflate and deflate the balloons provides the possibility of working in a larger operative area.

Claims (8)

CLAIMS:
1. A surgical/diagnostic aid comprising: a hollow tubular member having one end adapted to be passed through an opening or incision in the body; an inflatable sleeve surrounding the tubular member adjacent the one end thereof; and means enabling the sleeve to be inflated within the body.
2. A device according to claim 1, wherein the means comprises an inflation tube one end of which opens into the interior of the sleeve and the other end of which includes a connector for attachment to a source of inflating fluid.
3. A device according to claim 2, wherein the inflation tube passes for at least a part of its length along the interior of the hollow tubular member.
4. A device according to any one of claims 1 to 3, in which the hollow tubular member is of rigid construction.
5. A device according to any one of claims 1 to 4, in which the hollow tubular member is of rigid construction.
6. A device according to any one of claims 1 to 3, in which the hollow tubular member is of flexible construction.
7. A device according to claim 1, substantially as described herein with reference to Figures 1 and 2 of the accompanying drawings.
8. A device according to claim 5, substantially as described herein with reference to Figure 3 of the accompanying drawings.
GB9223560A 1992-11-10 1992-11-10 Surgical/diagnostic aid Withdrawn GB9223560D0 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
GB9223560A GB9223560D0 (en) 1992-11-10 1992-11-10 Surgical/diagnostic aid

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Application Number Priority Date Filing Date Title
GB9223560A GB9223560D0 (en) 1992-11-10 1992-11-10 Surgical/diagnostic aid

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GB2272159A true true GB2272159A (en) 1994-05-11

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