GB2423255A - Medico-surgical Apparatus for Indicating Penetration of a Body Cavity - Google Patents

Medico-surgical Apparatus for Indicating Penetration of a Body Cavity Download PDF

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Publication number
GB2423255A
GB2423255A GB0601560A GB0601560A GB2423255A GB 2423255 A GB2423255 A GB 2423255A GB 0601560 A GB0601560 A GB 0601560A GB 0601560 A GB0601560 A GB 0601560A GB 2423255 A GB2423255 A GB 2423255A
Authority
GB
United Kingdom
Prior art keywords
elongate member
tissue
display
along
needle
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Withdrawn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
GB0601560A
Other versions
GB0601560D0 (en
Inventor
John Edward Nash
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Smiths Group PLC
Original Assignee
Smiths Group PLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Smiths Group PLC filed Critical Smiths Group PLC
Publication of GB0601560D0 publication Critical patent/GB0601560D0/en
Publication of GB2423255A publication Critical patent/GB2423255A/en
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0465—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
    • A61M16/0472—Devices for performing a tracheostomy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3415—Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/46—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/061—Measuring instruments not otherwise provided for for measuring dimensions, e.g. length
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/062—Measuring instruments not otherwise provided for penetration depth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A61B2090/065—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension for measuring contact or contact pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/13—General characteristics of the apparatus with means for the detection of operative contact with patient, e.g. lip sensor

Abstract

An apparatus having an elongate member for indicating penetration of a body cavity with sensors to provide an output indicative of the location along the elongate member of contact with body tissue. In one embodiment a tracheostomy instrument has a needle 2 with a cutting tip 20 at the forward end of a metal shaft 22. Electrodes 24 are spaced along the length of the needle and insulated from the shaft 22 by a plastics layer 23. A handle 1 is mounted at the rear end of the needle and has an elongate bar graph 12 provided by a row of LED elements 13, one fir the tip 20 and each electrode 24. A processor 10 in the handle 1 receives outputs from the tip 20 and the electrodes 24, measures impedance and energises the LEDs 13 appropriately to provide a visual representation of the location of contact of the neck tissue 32 along the length of the needle 2.

Description

MEDICO-SURGICAL APPARATUS
This invention relates to medico-surgical apparatus.
The invention is more particularly concerned with apparatus for indicating the penetration of a body cavity, such as, for example the trachea.
Where a percutaneous or cricothyroid tracheostomy procedure is carried out it is important to know when the needle or the like has entered the trachea. One form of apparatus used for this purpose is described in GB2393398 and employs a needle with a spring-loaded rod projecting from the patient end of the needle. Entry of the trachea is detected by observing forward movement of the rod as the tip of the needle clears overlying tissue. Other techniques involve listening for the sound of air passing through a hollow needle or feeling loss of resistance to movement of a plunger in a syringe connected to a needle when the trachea is entered. There are other surgical procedures where an instrument is inserted through tissue into a body cavity and where it would be useful to indicate penetration of the cavity.
It is an object of the present invention to provide alternative apparatus for indicating penetration of a body cavity.
According to one aspect of the present invention there is provided apparatus for indicating penetration of a body cavity including an elongate member adapted for insertion through body tissue and having a first end adapted for insertion into a body cavity and a second end adapted for location externally of the cavity such that different parts along the length of the elongate member contact tissue during insertion, the elongate member being provided with sensing means adapted to provide an electrical output indicative of the location along the elongate member of contact with body tissue, and the apparatus including a visual display arranged to receive the electrical output and provide a display representation of the location along the elongate member of contact with body tissue.
The visual display is preferably elongate. The sensing means preferably includes a plurality of sensors disposed along the length of the elongate member. The sensors may include electrodes. The sensing means may be impedance sensing means.
The elongate member may include a metal shaft exposed at the first end of the elongate member, an outer electrically-insulative layer on the elongate member and a plurality of impedance electrodes spaced from one another along the elongate member and exposed to contact tissue during insertion. The exposed end of the metal shaft preferably has a pointed cutting tip for cutting tissue. The visual display preferably includes a plurality of electrically-energizable elements arranged along the display, such as LEDs. The sensor means preferably includes a plurality of sensors, each electrically-energizable element of the display having an associated sensor. The visual display is preferably mounted on the second end of the elongate member. The apparatus may be arranged additionally to produce an alarm signal when the body cavity is penetrated and or alternatively if the first end of the elongate member extends across the body cavity and contacts tissue on the opposite side of the cavity.
The alarm signal may include an audible alarm and or alternatively a visual alarm.
According to another aspect of the present invention there is provided tracheostomy apparatus according to the above one aspect of the invention, the length of the elongate member being sufficient to penetrate the trachea through neck tissue from the outside of the neck.
Apparatus for use in making a tracheostomy, according to the present invention, will now be described, by way of example, with reference to the accompanying drawings, in which: Figure 1 is a side elevation view of the apparatus; Figure 2 shows the apparatus in use at a preliminary position before entry into the trachea; Figure 3 shows the apparatus in use when its tip is located in the trachea; and Figure 4 shows the apparatus where the tip has been inserted too far and is in contact with the posterior wall of the trachea.
With reference first to Figure 1, the apparatus is a unitary, selfcontained, hand-held device comprising a combined handle and display 1 and a combined needle and sensing means 2 extending from the forward, patient end of the handle.
The handle 1 is generally rectangular and elongate containing a processing unit 10, battery 11 and a display panel 12. The processing unit 10 is powered by the battery 11 and receives signals via wires (not shown) from sensors 24 on the needle 2.
The output of the processing unit 10 drives the display panel 12, which is in the form of an elongate bar graph comprising a row of nine rectangular display elements 13 arranged side-by-side along the length of the panel 12. The display panel 12 and the display elements may be of any conventional form and could be light-emitting, such as LEDs, or reflective, such as LCDs. The operation of the display will be described in detail later.
The needle 2 is about 100mm long, of circular section with a pointed, cutting tip 20 at its patient end and having a bore 21 extending along it, which continues through the handle 1. The needle 2 has an inner metal shaft 22, such as of stainless steel, and an outer electricallyinsulative layer 23, such as a coating of plastics material. The metal shaft 22 protrudes at the patient end of the layer to provide the cutting tip 20. The needle supports a series of eight sensing electrodes 24 provided by metal bands mounted on the outer layer 23 and exposed externally. The electrodes 24 may be single electrodes or may be pairs of electrodes. The electrodes 24 connect with insulated wires (not shown) that pass between the outside of the metal shaft 22 and the inside of the outer layer 23 and extend to the processing unit 10 in the handle 1. The exposed tip 20 of the shaft 22 provides a ninth sensing electrode, the rear end of the shaft being electrically connected to the processing unit 10 so as to provide connection to the tip.
The apparatus is arranged to make the initial entry into the trachea 30. To do this, the clinician grips the apparatus and presses the cutting tip 20 against the skin 31 of the neck overlying the trachea 30. A preliminary scalpel cut may have been made.
He then pushes the apparatus inwardly so that the tip 20 cuts through the skin, as shown in Figure 2. As the apparatus is pushed in further it penetrates the underlying tissue 32, passes between the cartilages 33 overlying the trachea 30 and then enters the trachea 30. Once the trachea 30 has been penetrated, a guidewire (not shown) is inserted along the bore 21 of the apparatus sufficiently for its patient end to protrude from the tip 20 and locate in the trachea. The apparatus 1 is then removed, leaving the guidewire in place so that a dilator and tracheostomy tube can be inserted, in the usual way.
Initially, before the apparatus is inserted, the electrical impedance between the electrodes 24 and the tip 20 is high. When the tip 20 of the apparatus makes the initial penetration of the skin 31 of the neck, the tip and the first electrode 24 come into electrical contact with the tissue and thereby establish a low impedance path between the tip and first electrode. This fall in impedance is sensed by the processor 10, which produces an appropriate change in the display panel 12 by energizing the first two elements 13 so that they contrast with the other elements. Where the display elements 13 are LEDs, the first two elements would be bright and the remaining elements dark.
Further penetration of the neck tissue 32 brings additional electrodes 24 into contact with the tissue and hence alters the electrical impedance between them. This is represented by energizing additional elements 13 along the display 12 so that the increasing length of energized elements represents the increasing depth of penetration.
Where pairs of electrodes 24 are used, the impedance between the two electrodes of the pair can be measured to indicate whether the electrodes are contacting tissue or not. When the trachea 30 is entered, as shown in Figure 3, the impedance of the tip electrode 20 falls again and this causes the first element 13 along the display 12 to be de-energized. It may also cause some other indication to be given, such as an audible alarm or a visual alarm, such as a flashing light, or both an audible and visual alarm.
If the apparatus were inserted further, additional ones of the elements 13 at the forward end of the display panel 12 would be de-energized or darkened and the group of energized elements would be seen to move further rearwardly along the panel.
Figure 3 illustrates a position where the tip 20 and two forward electrodes 24 are exposed in the trachea 30, and where the three electrodes to the rear of those are located within the neck tissue 32. This produces a display of three energized, bright elements 13 spaced from the forward end of the display by three dark elements. If the apparatus were inserted far enough for the tip 20 to contact the posterior wall 34 of the trachea 30, as shown in Figure 4, this would cause its impedance to fall and would result in the first, forward element 13 of the display 12 being energized again. This could be arranged to produce another alarm signal to alert the user that the posterior wall 34 of the trachea 30 has been contacted. The pattern produced on the display 12 now appears as a single bright element 13, followed by a dark region of three elements representative of the trachea 30, followed by a series of three bright elements representative of the neck tissue 32, and followed by a dark region at the rear end of the display representative of that portion of the needle 2 remaining outside the trachea. The number of display elements 13 need not be the same as the number of electrodes 24, typically, there might be more display elements than electrodes.
By arranging for the shape of the display 12 to mimic the length of the needle 2 itself, the extent of penetration of the needle is readily apparent, even to an unskilled user.
Instead of using electrical impedance electrodes, as described above, various other forms of sensing means could be provided on the needle. For example, these could include capacitive electrodes, pressure-sensitive elements responsive to pressure exerted by tissue on the needle, acoustic means responsive to the change in acoustic impedance, and optical means responsive to the difference between the optical properties where the apparatus contacts tissue and where it does not contact tissue.
The sensors need not be equally spaced along the needle in the manner shown in the accompanying drawings, instead, the spacing could vary along the needle with, for example sensors more closely spaced towards the patient end. The display need not be mounted at the rear end of the needle but could be connected with it by a flexible wire so as to enable it to be positioned at a remote location.
The invention is not confined to use in the trachea but could be used in other body cavities. Where the cavity is fluid-filled, there may not be sufficient difference in electrical impedance between the tissue and the fluid to allow an impedance apparatus to function but other forms of sensing means could be effective.

Claims (18)

1. Apparatus for indicating penetration of a body cavity including an elongate member adapted for insertion through body tissue and having a first end adapted for insertion into a body cavity and a second end adapted for location externally of the cavity such that different parts along the length of the elongate member contact tissue during insertion, wherein the elongate member is provided with sensing means adapted to provide an electrical output indicative of the location along the elongate member of contact with body tissue, and wherein the apparatus includes a visual display arranged to receive the electrical output and provide a display representation of the location along the elongate member of contact with body tissue.
2. Apparatus according to Claim I, wherein the visual display is elongate.
3. Apparatus according to Claim 1 or 2, wherein the sensing means includes a plurality of sensors disposed along the length of the elongate member.
4. Apparatus according to Claim 3, wherein the sensors include electrodes.
5. Apparatus according to any one of the preceding claims, wherein the sensing means is impedance sensing means.
6. Apparatus according to Claim 5, wherein the elongate member includes a metal shaft exposed at the first end of the elongate member, an outer electrically-insulative layer on the elongate member and a plurality of impedance electrodes spaced from one another along the elongate member and exposed to contact tissue during insertion.
7. Apparatus according to Claim 6, wherein the exposed end of the metal shaft has a pointed cutting tip for cutting tissue.
8. Apparatus according to any one of the preceding claims, wherein the visual display includes a plurality of electrically-energizable elements arranged along the display.
9. Apparatus according to Claim 8, wherein the electrically-energizable elements are LEDs.
10. Apparatus according to Claim 8 or 9, wherein the sensor means includes a plurality of sensors and wherein each electrically-energizable element of the display has an associated sensor.
11. Apparatus according to any one of the preceding claims, wherein the visual display is mounted at the second end of the elongate member.
12. Apparatus according to any one of the preceding claims, wherein the apparatus is arranged additionally to produce an alarm signal when the body cavity is penetrated.
13. Apparatus according to any one of the preceding claims, wherein the apparatus is arranged additionally to produce an alanu signal if the first end of the elongate member extends across the body cavity and contacts tissue on the opposite side of the cavity.
14. Apparatus according to Claim 12 or 13, wherein the alarm signal includes an audible alarm.
15. Apparatus according to any one of Claims 12 to 14, wherein the alarm signal includes a visual alarm.
16. Tracheostomy apparatus according to any one of the preceding claims, wherein the length of the elongate member is sufficient to penetrate the trachea through neck tissue from the outside of the neck.
17. Tracheostomy apparatus substantially as hereinbefore described with reference to the accompanying drawings.
18. Any novel and inventive feature or combination of features as hereinbefore described.
GB0601560A 2005-02-04 2006-01-26 Medico-surgical Apparatus for Indicating Penetration of a Body Cavity Withdrawn GB2423255A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
GBGB0502302.3A GB0502302D0 (en) 2005-02-04 2005-02-04 Medico-surgical apparatus

Publications (2)

Publication Number Publication Date
GB0601560D0 GB0601560D0 (en) 2006-03-08
GB2423255A true GB2423255A (en) 2006-08-23

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GBGB0502302.3A Ceased GB0502302D0 (en) 2005-02-04 2005-02-04 Medico-surgical apparatus
GB0601560A Withdrawn GB2423255A (en) 2005-02-04 2006-01-26 Medico-surgical Apparatus for Indicating Penetration of a Body Cavity

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GBGB0502302.3A Ceased GB0502302D0 (en) 2005-02-04 2005-02-04 Medico-surgical apparatus

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2061393A1 (en) * 2006-09-12 2009-05-27 University of Florida Research Foundation, Incorporated Methods and devices for differentiating between tissue types
WO2009083651A1 (en) * 2007-12-31 2009-07-09 Katja Paassilta Determining the position of a needle
US11464485B2 (en) 2018-12-27 2022-10-11 Avent, Inc. Transducer-mounted needle assembly with improved electrical connection to power source
US11647980B2 (en) 2018-12-27 2023-05-16 Avent, Inc. Methods for needle identification on an ultrasound display screen by determining a meta-frame rate of the data signals

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4299230A (en) * 1979-05-09 1981-11-10 Olympus Optical Co., Ltd. Stabbing apparatus for diagnosis of living body
US5460182A (en) * 1992-09-14 1995-10-24 Sextant Medical Corporation Tissue penetrating apparatus and methods
US5630426A (en) * 1995-03-03 1997-05-20 Neovision Corporation Apparatus and method for characterization and treatment of tumors
EP1595496A2 (en) * 1994-10-24 2005-11-16 Mirabel Medical Systems Ltd. Impedance imaging devices and multi-element probe

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4299230A (en) * 1979-05-09 1981-11-10 Olympus Optical Co., Ltd. Stabbing apparatus for diagnosis of living body
US5460182A (en) * 1992-09-14 1995-10-24 Sextant Medical Corporation Tissue penetrating apparatus and methods
EP1595496A2 (en) * 1994-10-24 2005-11-16 Mirabel Medical Systems Ltd. Impedance imaging devices and multi-element probe
US5630426A (en) * 1995-03-03 1997-05-20 Neovision Corporation Apparatus and method for characterization and treatment of tumors

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2061393A1 (en) * 2006-09-12 2009-05-27 University of Florida Research Foundation, Incorporated Methods and devices for differentiating between tissue types
EP2061393A4 (en) * 2006-09-12 2009-09-16 Univ Florida Methods and devices for differentiating between tissue types
JP2010503477A (en) * 2006-09-12 2010-02-04 ユニバーシティ オブ フロリダ リサーチ ファンデーション インコーポレーティッド Method and apparatus for identifying tissue types
US8150506B2 (en) 2006-09-12 2012-04-03 University Of Florida Research Foundation, Inc. Methods and devices for differentiating between tissue types
WO2009083651A1 (en) * 2007-12-31 2009-07-09 Katja Paassilta Determining the position of a needle
US11464485B2 (en) 2018-12-27 2022-10-11 Avent, Inc. Transducer-mounted needle assembly with improved electrical connection to power source
US11647980B2 (en) 2018-12-27 2023-05-16 Avent, Inc. Methods for needle identification on an ultrasound display screen by determining a meta-frame rate of the data signals

Also Published As

Publication number Publication date
GB0502302D0 (en) 2005-03-16
GB0601560D0 (en) 2006-03-08

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