JP2003535622A - Barrett's esophageal cytology device - Google Patents

Abstract

SUMMARY OF THE INVENTION A method and apparatus for obtaining esophageal cells for diagnostic purposes comprises a distal end of a flexible support to the patient's stomach through the esophagus and mouth such that the proximal support end protrudes from the mouth. Part consists of inserting. Inflate the balloon at the distal support end and withdraw the support until the inflated balloon engages the sphincter at the gastric entrance. The support location is marked in place from the patient's dental arch as the inflated balloon engages the sphincter at the stomach entrance. With the balloon deflated, the support is withdrawn so that the marker location is adjacent to the patient's dental arch. The support is withdrawn a second predetermined distance and the position of the second support adjacent the patient's dental arch is marked. A cell collection member is laid from within the distal end of the support such that the cell collection member is positioned in the esophagus at a predetermined distance from the sphincter. The support is reciprocated over a second predetermined distance, and the cell collecting member is laid so that cells from the esophagus within the second predetermined distance from the sphincter are deposited on the cell collecting member. The cell collection member is retracted into the support so as not to engage the esophageal wall and the support is withdrawn from the patient.

Description

Detailed Description of the Invention

[0001]

【Technical field】

The present invention relates to cell collection for cytological examination, and more particularly to methods and devices for collecting Barrett's esophageal cells for cytological studies.

[0002]

[Background technology]

Barrett's esophagus is a condition in which cells lining the esophagus near the entrance to the stomach become abnormal due to exposure to gastric acid. Barrett's esophagus is typically about 8 cm from the gastric entrance
Extend away. This condition is often a precursor to esophageal cancer, so it is important to detect abnormal cells that not only suggest esophageal cancer but also show Barrett's esophagus.

Barrett's esophagus and esophageal cancer are diagnosed by visual inspection of the esophagus lining, collecting cells from the esophagus lining and subjecting them to cytological examination. The procedure for collecting cells was such that the diagnosis of Barrett's esophagus or esophageal cancer would be quite expensive. During gross examination of the esophageal lining, the patient was anesthetized for this process using an endoscope. The visualization process allows the physician to determine the location of the cells of interest. The cell collection device can be inserted through the endoscope to engage the esophageal lining at the area where the cells of interest are located.

Various devices for collecting cells have been proposed. Among these were inflatable balloons, which were inserted through the endoscope into the esophagus, inflated, and rubbed on the lining to collect cells. The balloon was deflated to remove. These devices were not entirely satisfactory in collecting sufficient numbers of cells for testing. Brushes were also used to collect cells. Each brush was effective in collecting a sufficient number of cells, but was configured to brush the entire length of the esophagus upon removal. This was undesirable because cells collected from the area of the esophagus near the gastric entrance would detach from the brush upon withdrawal of the brush from the esophagus. This type of cell loss not only reduces the number of cells available for testing, but also deposits cells in areas of the esophagus where there are no abnormal cells.

The present invention provides a new and improved method and device for collecting cells from the esophagus for cytological examination, where the process of collecting cells is relatively inexpensive and the area of the esophagus from which the cells are obtained. It does not require the use of an endoscope or the like to position the cell, and the area of the esophagus remote from the stomach does not contact the cell collection device.

[0006]

DISCLOSURE OF THE INVENTION

The present invention provides a method for obtaining esophageal cells for diagnostic purposes, which involves placing the distal end of a flexible support through the esophagus and the mouth so that the proximal support end projects from the mouth in the patient's stomach. And expand the expandable member at the end of the distal support and withdraw the support until the expanded member engages the sphincter at the gastric entrance, the expanded member engaging the sphincter at the gastric entrance. Marking the position of the support at a predetermined distance from the patient's dental arch when mating, retracting the expanded member and retracting the support so that the labeled position is adjacent to the patient's dental arch and removing the second support. Withdraw a predetermined distance and mark the position of the second support adjacent to the patient's dental arch, and lay a cell collection member from the distal end of the support so that the cell collection member is located within the predetermined distance from the sphincter muscle And the support is reciprocated over a second predetermined distance, and The cell collecting member is laid so that cells from the esophagus within the second predetermined distance from the muscle are arranged in the cell collecting member, and the cell collecting member is conditioned so as not to engage with the wall of the esophagus, and the support body It is characterized by being pulled out from.

A cytology device embodying the present invention comprises a flexible support, a gastric sphincter positioning system, a cell collection system and a marker member that can be adjustably moved by the physician along the support.

The support has a flexible end that can be inserted through the esophagus into the patient's stomach and a proximal end that projects from the patient's mouth when the distal end is in the patient's esophagus. It is composed of a sexual support. The disclosed gastric sphincter positioning system comprises a balloon attached to a support at the distal end, an inflation unit at the proximal support end, and an inflation-deflation channel that communicates the balloon to the inflation unit. The disclosed cell collection system includes a brush disposed at a distal support end, a brush actuator extending from the brush to a proximal support end, and a retracted position connected to the brush actuator to place the brush within the support. And a handle for axially moving the brush relative to the support between a laying position in which the brush is located beyond and adjacent to the distal end.

Further features and advantages will be apparent from the following description with reference to the accompanying drawings.

[0010]

BEST MODE FOR CARRYING OUT THE INVENTION

A cytology device 10 made in accordance with the present invention is shown in FIGS. 1-5, which comprises a flexible support 12, a gastric sphincter positioning system 14, and a cell collection system 16. The support is an elongated flexible member that is inserted into the patient's stomach through the esophagus and mouth. The gastric sphincter positioning system 14 is supported by the support 12 and acts to position the sphincter with respect to the support. The cell collection system 16 is the support 1
It is laid to collect cells from the area of the esophagus that is supported by 2 and extends a short distance from the gastric entrance toward the patient's mouth. When the cells are collected, the device 10 is withdrawn from the patient without further contact between the cell collection system and the esophageal wall.

The illustrated support 12 is an elongated flexible member that supports the positioning system 14 and the cell collection system 16. The support length allows one support end (ie, distal end) 30 to be inserted into the patient's mouth and pass through the esophagus to the stomach, while the other end (ie, proximal end) 32 is Is sufficient to remain outside the patient's body, which is more accessible to the patient. The flexibility and diametrical dimensions of support 12 allow it to be inserted with minimal patient discomfort.

The illustrated support 12 is formed by a flexible plastic tube having a generally cylindrical shape that defines a central passage 34 (see FIG. 3). Illustrated support 1
2 has an outer diameter dimension of about 0.25 inches. The systems 14, 16 are manipulated by the physician from the proximal tube end 32, while the positioning and collection functions are performed at the distal tube end 30. The illustrated support is formed of a transparent plastic material such as PVC, silicone, urethane or a thermoplastic elastomer such as c-flex, so that the tube contents can also be viewed from the outside of the tube, but the support is desired if desired. It can also be configured to be opaque.

The gastric sphincter positioning system 14 includes an expandable member 40 attached to a support at a distal end 30 and an expander system at a proximal support end 32 that allows a physician to control the expansion of the member 40. And 42. When support 12 is inserted into a patient such that expandable member 40 is located in the stomach, member 40 is expanded to a diameter dimension large enough to pass through the gastric sphincter. The support 12 is then withdrawn until the member 40 engages the sphincter and the further withdrawal of the support is strongly impeded. This allows the sphincter to be positioned with respect to the patient's body, and moreover the area of the esophageal wall just above the sphincter where the cells to be examined are found. Then doctor 40
Is contracted to its initial diameter dimension and the distal end of support 12 is withdrawn from the stomach into the esophagus above the sphincter.

In the device shown, the expandable member 40 is formed by a balloon. Balloons 4
0 is formed by a thin cylindrical sheath of elastomeric material (eg, c-flex), which is hermetically attached to the support 12 at its opposite ends 40a, 40b.
Balloon 40 communicates with expander system 42 via an inflation-deflation channel 44 extending between the balloon and the proximal support end. As shown, the support 12 extends a short distance beyond the distal balloon end 40b.

In the device shown, the balloons are attached to the support by plastic sleeves 46 that extend a short distance from each balloon end along the exterior of the support over the balloon ends. The sleeve 46 is deflated to provide airtight engagement with both the balloon end and the support 12, sealing the balloon in place at the distal support end. In the illustrated device, adhesive is applied to the sleeves so that they bond to the support 12 and balloon 42. Although sleeves 46 have been shown to be formed from heat-shrinkable mylar, they may be constructed of any suitable material that can be applied with heat, chemistry or other means to shrink until resiliently engaged with the lower support member. You can also In addition, the balloon can be attached to the support by any other suitable or conventional method of hermetic bonding.

The illustrated expander system 42 operates to inflate and deflate the balloon 40 under physician control. The illustrated system 42 includes an expansion-deflation channel 44.
Blunt end needle 50 extending to and communicating with the expansion hose 4 airtightly connected to the needle 50
0, a check valve 54 connected to a hose 52 distal to the needle 50, and a syringe 56 for inflating and deflating the balloon through the valve 54 and channel.

The blunt end needle 50 is a conventional needle having a tubular cannula section that extends through the support wall to the channel 44 and enlarged end mount 50a. In the illustrated device, the needle 50 is hermetically secured to the support 12 by friction, glue, and a heat-shrinkable urethane adhesive 58 wrapped around the support and needle, and upon heating, needle-support Flow to seal the joint.

The hose 52 has an end mounting portion 52a screwed to the needle mounting portion 50a, and is airtightly coupled to the needle mounting portion at a predetermined position with a suitable adhesive. The opposite hose ends are hermetically connected to the valve 54.

As shown in FIG. 5, the valve 54 is a conventional check valve having a tubular valve body 54 a and a resilient compressible valve member 54 b seated on the valve body to prevent flow through the body to the hose 52. Is. The proximal end of the valve body has a central port 6 that is aligned with the valve member.
Form 0. The valve member generally seats across the port to prevent flow into hose 52.

The illustrated syringe 56 may be removably connected to the valve 54 by a suitable connecting structure. The syringe 56 is constructed with a threaded discharge end 62 that is screwed onto the valve body 54a. When the syringe is fully threaded into the valve body, the discharge end 62 engages the valve member 54b and resiliently depresses and unseals it to allow flow to the hose 52. The syringe contains an atmosphere that causes the balloon to be inflated as it is pushed through the valve 54 as the physician advances the syringe plunger. The balloon is deflated by the doctor retracting the syringe plunger. The plunger is shown with a thumb pad that can be manipulated by a doctor. When the balloon is not in use, it deflates and the syringe is removed from the valve body. The valve closes again and ensures that the balloon remains fully deflated.

In the illustrated device 10, the body 12 is an extruded plastic tube with an inflation-deflation channel 44 formed by a narrow passage extruded into the body wall to extend with the central body passage 34. The body wall is cut in radial alignment with the passageway 44 at the location where the blunt needle should be located. The notch is sufficient to allow passage 44 to be accessible and to penetrate the body wall sufficiently for direct insertion of the needle into the passage.

By forming a small hole 68 in the body wall within the balloon 40 and extending to the passage 44, the balloon can be inflated and deflated through the passage 44. The end of the passageway 44 that opens at the distal body end is plugged with a suitable urethane adhesive, although other plug closure techniques can be used. Although the device 10 is shown with expansion-deflation channels 44 formed in the wall of the extrudate 12, alternative constructions are possible, including a separate expansion-deflation tube extending with the body 12.

The device 10 of FIGS. 1-7 is illustrated with a display mechanism 70 that signals a physician when the gastric sphincter positioning system is activated. In this embodiment, mechanism 70 provides a signal in response to balloon inflation and deflation. The mechanism 70 illustrated in FIGS. 1-7 produces a visual indication when the balloon 40 is inflated. 1 to 7 show a tubular housing 71 integrally formed with the check valve body 54a, a flexible diaphragm 72 sealed in the housing 71, a pop-up button 73 provided in the housing 71, and a button. 7 shows a mechanism 70 with a spring 74 that reacts with the housing to bias the button relative to the diaphragm 72.
The housing end spaced from the valve body 54a defines an opening 75 aligned with the button 73 so that the button can protrude from the housing 71 through the opening 75. The housing end proximal to the valve body 54a is shown communicating with the valve housing 54a via a small diameter bleed hole 76 that restricts the flow of air between the housing 71 and the valve body 54a.

When inflating the balloon 40, the air from the valve body 54a escapes into the housing 71 until the pressure within the housing 71 is sufficient to push the diaphragm 72 against the force of the spring 74 in the direction of the button. . The diaphragm moves the button to open the opening 7
It projects through 5 and thus signals that the balloon is inflated. Due to the restricted flow through the bleed hole 76, the button projects from the housing 71 after a short delay time.

When the syringe plunger retracts and deflates the balloon, air from within the housing 71 escapes through the hole 76 to the valve body 84a, gradually reducing the pressure behind the diaphragm. As the pressure behind the diaphragm decreases, the button 73 is pressed against the diaphragm by atmospheric pressure around the syringe 74 and device 10 causing the button to retract into the housing 71. This retraction signals that the balloon has deflated. The delay time before the button retracts ensures that the physician is fully retracted before attempting to remove the distal end of the device 10 from the patient's stomach. Although balloon 40, channel 44 and inflation-deflation unit 42 are shown, other types of expandable members and units can be used. For example, a radially displaceable finger may be positioned at the distal body end to allow the body 12 to move between a radially extended position and a retracted position.
It can be actuated by an operating cable that extends through to the proximal body end and is accessible to the physician. Any suitable or conventional expandable member and inflation unit can be used.

The cell collection system 16 is configured and arranged to collect cells from the area of the esophageal wall under examination without contacting other portions of the esophageal wall. The illustrated cell collection system includes a cell collection member 90 that engages the esophageal wall to provide the member 90.
The cells are laid in a cell collection state in which cells attached to the cells are detached. After collecting the cells,
The practitioner can actuate member 90 so that body 12 no longer contacts the esophageal wall as it is withdrawn from the esophagus. Thus, the collection member does not contact the esophageal wall region beyond the point where each cell is collected, and the cells collected by member 90 are not
Do not settle on the esophageal wall when removing.

In the illustrated cell collection system 16, member 90 is formed by a cell collection brush supported at the distal body end and an actuator 94 that operates the brush between its operating states. The brush 90 is constructed and arranged to be delivered within the distal end of the body 12 during insertion and removal of the body from the patient, but if desired, the distal body end may be used to brush cells from the esophageal wall. It can also be laid from.

The illustrated brush is a twisted wire cable, bristles wound around the body wire and protruding radially from the body, and fixed to the protruding end of the body 100 to secure the device 1
It comprises a central body 100 formed by a beaded tip 102 that ensures that the 0 distal end smoothly engages the healing canal of a patient without causing damage. The bristles shown are formed from nylon and the bead tips are a suitable non-reactive plastic.

The actuator 94 includes a flexible link 110 that extends from the proximal body end 32 to the brush 90 and a brush 90 that is located at the proximal body end and that a doctor presses and pulls on the link 110 to lay and brush the brush 90. And a handle assembly 112 that can be retracted. Link 110 is illustrated as comprising a cable 110a formed of a twisted wire and extending through a central passage 34 and a sheath tube 110b surrounding the cable. The cable 110a is fixed to the brush 90 by a connecting member 113 crimped on both the brush main body 100 and the cable 110a.

In the device illustrated by FIGS. 1-7, the sheath 110 b extends into the central passage 34. The sheath 110b is illustrated as a thin tube, loosely surrounding the cable link and "floating" within the passageway 34. Sheath is Teflon (registered trademark)
Alternatively, it may be formed of some other low friction material to allow easy movement of the cable links axially along the sheath. The sheath is relatively stiff and encloses the cable links fairly close together, supporting the cable 90 as it does not tend to bend as it is pushed out of the body end.

In the illustrated device 10, the central brush body 100 is formed by a relatively fine wire that is shear cut after the cells have been harvested. The cut brush is discarded into the sample container for subsequent cytological examination. A colored coding band 114 is secured to the body 100 between the connecting member 113 and the brush bristles to facilitate proper removal of the brush. Band 114 shows where to cut the brush,
Thus, the central body 100 is cut, but the thick cable 110a does not damage the cutting shear.

The handle assembly 112 includes a guide mount 120 fixed to the proximal body end,
A thumb ring member 122 that can be manipulated by the physician when laying and retracting the brush
And a cable support sleeve 124 secured to the thumb ring that guides the cable movement to the cable and guide mount 120, further with the proximal cable end at the end of the guide mount 120 as the brush is being laid. Prevents cable bending that might occur when protruding from the section. The sleeve 124 is a rigid member that is fitted and fixed to the cable.

The illustrated thumb ring and guide attachments are configured such that they are welded together and remain frictionally in place with each other when the brush 90 is fully laid, and thus the proximal end of the brush and body 12. The dimensional relationship between and should be kept constant as the device 10 is operated. The guide mounting part is the sleeve 1 when the brush is laid.
It has a central hole that forms a sliding fit relationship with 24. Guide mounting part and sleeve 12
The tight fit between 4 and 4 effectively seals the flow of air between them. The handle assembly 112 can be of any suitable or conventional construction and will not be described in detail here.

When inserting the device 10 into a patient, it is essential to know where the brush 9 is located relative to the patient's esophagus when cells are being collected. To minimize the cost and complexity of the process, it is advantageous to be able to accurately determine brush position without the use of x-ray imaging techniques and without endoscopic verification landmarks or measurements.
The device 10 enables the physician to accomplish these goals simply and effectively.

Upon initial insertion of device 10 into the patient's stomach, the balloon is inflated and the device is withdrawn until resistance is encountered. In this situation, the position of the balloon is known to be within the patient's stomach which engages the sphincter. This positioning of the device 10 marks the position of the body 12 aligned with the patient's dental arch (i.e., upper anterior teeth or gum). The distance between the proximal end of the balloon and the brush as it is laid is a known degree. The physician marks a body position spaced from the first mark by a distance corresponding to the dimension between the balloon proximal end and the laying brush plus a distance corresponding to the expected length of the sphincter. When the second marker body position is aligned with the patient's dental arch, the physician approximately confirms that the laying brush is located at the distal end of the esophagus.

The location of Barrett's cells in the esophagus is typically limited to the esophageal wall extending about 8 cm from the distal end of the esophagus. Therefore, the main body 12 has a third position 8 cm apart from the second position.
It is labeled at the location.

In this situation, the body 12 is positioned so that the second position is aligned with the dental arch and the brush is laid. The body 12 is withdrawn until the third position is aligned with the dental arch and the movement is repeated several times until the Barrett cell area of the esophagus is completely brushed. The brush is then retracted into the body 12 and the device 10 is removed from the patient. In the device illustrated in FIGS. 1-7, a labeling unit 128 is used by the physician to position the area of the esophageal wall where cells should be collected. The marking unit 128 includes marking members 130, 132 and 134 which are adjustably positioned on the support body to provide a macroscopic indication of the position of the support relative to the esophagus and the first, second and third body positions described above, respectively. Label. The device 10 is used by the doctor
The marking members 130, 13 respectively located on the marking member 135 movable along 2
Shown with 2,134. The illustrated marking member 134 is a flexible, transparent tube that surrounds and frictionally engages the body 12. The member 135 is the main body 12
It is possible to position it at a desired position on the upper side and maintain the friction in the adjusted position.

The marker member 130 is shown as being formed of a bead-like member that surrounds and is secured to the body member 135. Marker 130 is positioned at the end of member 135 proximal to handle assembly 112. The member 130 engages the patient's front upper teeth or gum (dental arch) to mark the first body position. Members 132 and 13
4 marks the second and third body positions respectively. The members 132 and 134 rest on the member 135 so that the second and third body positions are marked after the first position is established.

Each of the marking members 132, 134 is shown as being formed by a band or ring that surrounds the member 135 and is fixed in place. Although each band is shown shrink-fit in place, it may be attached in any other suitable manner. Further, they may be formed by indicia printed directly on the member 135 by the supplier of the device or by the physician during the diagnostic process.

In the illustrated device 10, the body 12 is shown generally at 140, which can be used to help position the marking member and be used to brush the precisely positioned position of the esophagus beyond the normal position of Barrett's cells. A display is provided. The illustrated indicia 140 is formed on the outer surface of the body 12 using a dark opaque material. The displays are separated by a predetermined number of millimeters. The display 140 is dark and especially
2 and member 135 are relatively easy to see where they are composed of a substantially transparent plastic material.

The illustrated cell collection system 16 also optionally includes a cell collection system 150 to ensure that some cells that may be lost are collected for analysis. After the esophageal wall has been brushed, the brush 90 is retracted into the body 12 to allow removal of the esophageal wall above the device Barrett cell area without brushing. When retracting the brush, the bristles engage the distal retracted end as it slides through the aperture in the distal end of body 12. The material supported by the bristles, including the recovered cells, becomes detached from the bristles as they pass and is deposited on the distal end of the body 12 and is lost as the body is withdrawn from the esophagus. The illustrated device 10
The material removed from the brush 70 during retreat at
Is supplied to the main body and is held so as not to be lost.

With reference to the device illustrated by FIGS. 1-7, a cell collection system 150 includes a syringe assembly 152, a hose 154 removably connected to the syringe assembly, a hose 154, and a central body passageway 34. Blunt end needle 156 that communicates with the main body 1
2 and a mounting portion 158 for fixing the needle 156. As the brush 70 is retracted to the end of the body 12, the plunger 152a of the syringe assembly 152 is quickly withdrawn, creating a reduced pressure within the passageway 34. A material that separates from the brush on retraction and adheres to the tip of the body is injected into the passage 34 when a reduced pressure is generated.

In the illustrated device 10, the syringe assembly 152, hose 154, needle 156 and attachment 158 may all be of the same construction as the needle 50, hose 52 and syringe 56. The syringe assembly 152 is configured to be removable from the hose when not in use. It should be noted that the fit between the guide mount 120 and the support sleeve 120 has a seal to prevent the ingress of atmospheric air as would occur if a reduced pressure were established in the passage 34. .

FIGS. 8 and 9 of the drawings show a device 10 configured with an alternative labeling unit 160 and an alternative inflation-deflation signaling mechanism 162.

The marking unit 160 comprises marking members 170, 172 and 174 which are adjustably positioned on the support to provide a macroscopic indication of the position of the support with respect to the esophagus and the first, second and third bodies respectively. Mark the location. The device 10 is illustrated with marking members 170, 172, which are each shown by a physician to the body 12
Located on a marking member 175 that is movable along. The illustrated marking member 175 is a flexible, transparent tube that surrounds and frictionally engages the body 12. The member 175 can be positioned in a desired position on the body 12 and is frictionally maintained in the adjusted position.

The marking member 170 is shown formed with a dental arch that engages a flange at one end of the member 175, while the marking member 172 is printed on the other end of the member 175. The length of member 175 corresponds to the distance from the proximal balloon end to the laying brush plus the length of the sphincter between the patient's stomach and esophagus. The indicator 172 is in a second position on the body 12 when the indicator flange 170 is positioned to engage the patient's dental arch. The physician need only adjust the position of the marking member 174 as needed to the third position on the body 12 before collecting the cells.

The marking member 174 shown in FIG. 7 is formed by a resilient rubbery O-ring that frictionally engages the body 12 and is movable along the body by the physician as desired. The body 12 carries a length indication 170 so that the physician can position the member 174 where it is desired to determine the stroke length of the brush.

Although not shown, the marker members may be formed of independent members, each of which is independently movable along the body 12 and defines first, second and third support positions, respectively. . The support indicator 140 can be used by a physician to measure the spacing between each member. Each member may be formed by a resilient O-ring or other suitable structure that is adjustably movable along the support.

The inflation signaling mechanism 162 signals the physician when the gastric sphincter positioning system is activated. The illustrated mechanism provides a visual indication as the balloon 40 expands or contracts. 8 and 9 show a mechanism 162 that includes a tubular housing 180 integrally formed with the check valve body 54a and an inflation indicating member 182 secured to the housing 180.

The illustrated housing 180 projects from the side of the check valve body 54a. The flow restricting vent hole 1 is provided while sealing the end of the housing proximal to the valve body to the valve body.
84 communicates the valve body 54a with the interior of the housing 180. Expansion display member 18
2 is fixed to the end of the housing spaced from the valve body 54a.

The inflatable indicator member 182 is illustrated as a thin, flexible plastic tube that communicates with the housing 180 and expands and contracts as the balloon 40 expands and contracts. The illustrated member 182 has an end proximal to the housing that is sealed around an opening in the distal housing end. The end of the member separated from the housing 180 is sealed and closed. The illustrated display member is constructed from a plastic film material that is sufficient but relatively inelastic as compared to the material forming the balloon 40.

When the balloon begins to inflate, the inflation air flows in through the vent hole 184 and enters the member 18.
Allow 2 to expand slowly. When fully inflated, the member 182 is straightened and upright, protruding from the housing 180 to provide a macroscopic indication of a balloon condition (FIG. 8).
Member 182 has a smaller internal volume compared to balloon 40, and the fill material from which it is made is less elastic than balloon material, so that both member 182 and balloon 40 are sufficiently inflated.

When the balloon begins to deflate, air is evacuated from member 182 via vent hole 184. Due to its softness, member 182 collapses and contracts, indicating that the balloon has deflated. In the illustrated device 10, the vent hole 184 is a member 18
The airflow to 2 is throttled, so that the balloon is fully inflated or deflated when the member signals a balloon condition.

Although several embodiments of the present invention have been illustrated and described in detail, the present invention is not limited to the disclosed configurations, and various modifications and uses will be apparent to those skilled in the art. Therefore, it will be understood that the present invention can be modified in various ways within the spirit and scope thereof.

[Brief description of drawings]

FIG. 1 is a front view of a cytology device implementing the present invention having each section shown in cross section.

[Fig. 2]   It is an expanded sectional view of the part of the device in FIG.

[Figure 3]   FIG. 3 is a cross-sectional view substantially seen from the plane indicated by line 3-3 in FIG. 2.

[Figure 4]   FIG. 3 is a drawing similar to FIG. 2 with parts in different operating states.

[Figure 5]   FIG. 5 is an enlarged view of a portion of the cytology device within line 5 of FIG. 1.

[Figure 6]   6 is a drawing showing a device inserted into a patient's stomach.

FIG. 7 is a view similar to FIG. 6 showing the device conditioned to collect cells for testing.

[Figure 8]   7 is a drawing similar to FIG. 6 showing a modification of the device of FIG. 1.

[Figure 9]   FIG. 9 is an enlarged view of a portion of the device of FIG. 8 with the components in the alternative position.

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Claims (19)

[Claims] 1. A distal end of a flexible support is inserted into a patient's stomach through the esophagus and mouth such that the proximal support end projects from the mouth. (C) expanding the distal support end and withdrawing the support until the expanded member engages the sphincter at the gastric entrance; (c) the patient when the expanded member engages the sphincter at the gastric entrance. Marking the position of the support at a predetermined distance from the dental arch; (d) retracting the expanded member and withdrawing the support so that the labeled position is adjacent to the patient's dental arch; (e) removing the support Withdrawing a second predetermined distance and marking the position of the second support adjacent the patient's dental arch; (f) laying the cell collection member from the distal end of the support to sphincter the cell collection member. (G) reciprocating the support over a second predetermined distance and constricting the esophagus within a predetermined distance from Laying a cell collecting member so that cells from the esophagus within a second predetermined distance from the muscle are deposited on the cell collecting member; (h) Conditioning the cell collecting member so that it does not engage with the esophageal wall; (i) A method for obtaining esophageal cells for diagnostic purposes, which comprises extracting a support from a patient. 2. A label on a support has first and second marking members, respectively.
And the method of claim 1 comprising frictionally fixing to the support at the second support position. 3. A support marking at the first support position further aligns with the patient's dental arch to frictionally secure the third marking member to the support when the balloon is positioned in the patient's sphincter. Together with the first marking member from the third marking member
The method of claim 1 comprising positioning at a predetermined distance. 4. The marking of the support at the second predetermined distance comprises frictionally fixing a third marking to the support at the second predetermined distance from the first marking. Method. 5. The method further comprises frictionally fixing the first and second marking members to the support, and further sliding the marking member along the support to the first and second support positions. Item 2. The method according to Item 2. 6. (a) having a distal end insertable through the esophagus into the patient's stomach and a proximal end protruding from the patient's mouth when the distal end is in the patient's esophagus. A flexible support; (b) a gastric sphincter positioning system comprising an expandable member attached to the support at the distal end and an expander system for controlling expansion of the expandable member; (c) distal support. A brush located at the end of the body, a brush actuator extending from the brush to the end of the proximal support, a retracted position connected to the brush actuator for placement of the brush within the support and a brush beyond the distal end and A cell collection system comprising a handle for axially moving the brush relative to the support relative to an adjacently placed laying position; and (d) a support between adjustment positions located between the ends of the support. Mounted on a support to move along Barrett cytology devices, comprising the first and second label member that is. 7. The expandable member comprises a balloon attached to the support at a distal end, the expander unit comprises an inflation system at the proximal support end, and an inflation channel comprises the balloon. 7. The device according to claim 6, wherein the device is in communication with the inflation system. 8. The device of claim 7, wherein the inflation channel is defined by a passage in a wall of the support. 9. An injector, wherein said inflation system supplies fluid for inflating said balloon, and said inflation channel connected to said syringe and for communicating inflation fluid from said syringe to said balloon through said inflation channel. 9. The device of claim 8 comprising a blunt needle extending to. 10. The inflation system comprises a check valve between the syringe and the blunt needle and a connecting structure for releasably securing the syringe to the check valve, the check valve being a syringe. 9. The device of claim 7, wherein the device is maintained open by the syringe when connecting the check valve to the check valve, the valve blocking communication with the balloon when the syringe is removed from the valve. 11. The device of claim 7, further comprising an inflation signal mechanism that provides a visual indication when the balloon is inflated. 12. The device of claim 11, wherein the inflation signal mechanism comprises a member that moves from a first position to a second position in response to inflation of the balloon. 13. The device of claim 6, further comprising a display mechanism that produces a signal in response to actuation of the gastric sphincter positioning system. 14. The method according to claim 6, wherein the first and second marking members are fixed to a common marking member slidably supported by the support member to move the respective members with respect to the support member. Device. 15. The third marking member fixed to the marking member, the first, second and third marking members marking respective positions on the support.
The device described in. 16. (a) having a distal end insertable through the esophagus into the patient's stomach and a proximal end protruding from the patient's mouth when the distal end is in the patient's esophagus. A flexible support; (b) a gastric sphincter positioning system consisting of a balloon attached to the support at the distal end and an inflation system for inflating and deflating the balloon; and (c) a distal support. A brush placed at the end, a brush actuator extending from the brush to the end of the proximal support, a retracted position connected to the brush actuator where the brush is placed in the support and the brush holds cells for cytological examination. Barrett cytology bullet, comprising a cell collection system consisting of a handle for axially moving the brush relative to the support between a laying position located beyond the distal end at the collecting position. . 17. The support is a tubular member having an open distal end through which the brush is laid from the retracted position by the brush actuator (the brush actuator being located within the support). The device of claim 16, wherein the device comprises: 18. The device of claim 17, further comprising a cell collection system connected to the proximal end of the support to generate a vacuum in the support as the brush retracts to the support. . 19. The device of claim 16, further comprising an inflation signal mechanism that provides a visual indication as the balloon inflates and deflates.