Medical instrument for therapy of hemorrhoidal lesions

• US 4,898,169 A
• Filed: 06/30/1988
• Issued: 02/06/1990
• Est. Priority Date: 05/08/1987
• Status: Expired due to Fees

• Current Assignee: Cabot Corporation
• Original Assignee: Boston Scientific Corporation
• Inventors: Norman, Daniel A., Nicholas, Glenn V., Onody, Stephen K., Newton, Ronald R., Bellofatto, Steven
• Primary Examiner(s): Jaworski, Francis
• Assistant Examiner(s): MANUEL, GEORGE C
• Application Number:
  US07/213,597
• Time in Patent Office: 586 Days
• Field of Search: 128/303.1, 128/303.13, 128/303.14, 128/303.15, 128/303.17, 128/419 R, 128/421
• US Class Current: 606/42
• CPC Class Codes: A61B 1/31 for the rectum, e.g. proctoscopes, sigmoidoscopes , colonoscopes
• CPC Class Codes: A61B 1/32 Devices for opening or enlarging the visual field, e.g. of a tube of the body dilators A61M29/00
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 2018/0066 without feedback, i.e. open loop control
• CPC Class Codes: A61B 2018/00928 by sending a signal to an external energy source
• CPC Class Codes: A61B 2018/1266 with DC current output

Abstract

An instrument for direct current electrical therapy of hemorrhoidal lesions or the like in a patient consists of a D.C. electric generator, a grounding pad, a probe with distal tip for penetration of a lesion, and a handpiece for support of the probe and control of the level of current. The probe has a base and at least one electrode terminating in the distal tip. The handpiece has a lower handle to be gripped by a physician. The probe base is coupled to the handpiece, with the probe axis at an obtuse angle to the lower handle axis, the angle selected to allow a physician to hold the instrument without extended abnormal wrist flexure. Disposed generally above the lower handle is a front panel visible to the physician when the probe tip is penetrated into a lesion. The front panel includes a display of conditions disposed generally the line of sight of a physician with the probe tip. Controls for the level of current are disposed to allow a physician to operate the controls with digits of a hand gripping the handle.

Claims

1. An instrument for direct current electrical therapy of hemorrhoidal lesions or the like in a patient comprises a D.C. electric generator means, a grounding pad for the patient, a monopolar probe having a distal tip for penetration of the hemorrhoidal lesion to act as a negative electrode, and an instrument handpiece for support of the probe and control of the level of direct current,

said probe comprising a base and, extending therefrom, at least one elongated probe electrode terminating in said distal tip adapted for electricity-conducting engagement with a hemorrhoidal lesion,

said instrument handpiece comprising:

a lower handle portion sized and constructed to be gripped by a physician,

cooperative means for coupling said probe base to said handpiece in electricity-conducting engagement with the axis of said probe at an obtuse angle to the axis of said lower handle portion, arrangement of said probe and said lower handle portion at said obtuse angle allowing a physician to hold said instrument handpiece during treatment of a hemorrhoidal lesion without extended abnormal flexure of the wrist,

a therapy-monitoring an control upper handle portion disposed generally above said lower handle portion and having a front panel visible to the physician when the probe distal tip is penetrated into a hemorrhoidal lesion,

said front panel comprising

means for display of status of treatment conditions of said instrument, said means for display and the distal tip of said probe disposed generally in the same line of sight of a physician holding said lower handle portion with said distal probe tip penetrated into a hemorrhoidal lesion, and

means for control of the level of direct current disposed adjacent said lower handle portion in a manner to allow a physician to operate said means for control with digits of a hand gripping said lower handle portion,

whereby a physician may simultaneously view a treatment site and observe conditions of treatment appearing on said means for display, while gripping the instrument and operating said means for control with one hand, leaving the other hand free as he conducts therapy on a hemorrhoidal lesion.

2. The instrument of claim 1 wherein said means for display of status of treatment conditions of said instrument includes means for display of elapsed time of treatment.

3. The instrument of claim 1 wherein said means for display of status of treatment conditions of said instrument includes means for display of direct current intensity of treatment.

4. The instrument of claim 1 wherein said means for display of status of treatment conditions of said instrument includes means for display of actuation status of said treatment.

5. The instrument of claim 1 wherein said means for control comprises first means for increasing the level of current, and second means for decreasing the level of current.

6. The instrument of claim 5 wherein said means for control further comprises third means for ceasing direct current.

7. The instrument of claim 6 wherein said third means is actuated by simultaneous actuation of said first means and said second means.

8. The instrument of claim 1 wherein said obtuse angle is of the order of about 120°

.

9. The instrument of claim 1 wherein said cooperative means comprises:

said probe base comprising a key of predetermined size and shape, and

said instrument handpiece defining a keyway adapted to receive said key therewithin in electricity-conducting coupled relationship.

10. The instrument of claim 9 wherein said key, taken in cross section, has the general form of a square with radiused corners of predetermined dimension corresponding to, but slightly less than, dimensions of said keyway.

11. The instrument of claim 1 or 9 wherein said probe comprises at least two elongated probe electrodes disposed in parallel array, and aid cooperative means for coupling said probe base to said handpiece is adapted for separation of a first said probe from said handpiece and engagement of a second said probe in coupled engagement with said handpiece.

12. The medical instrument of claim 11 wherein at least two distal tips of said elongated probe are longitudinally offset from each other.

13. An instrument for direct current electrical therapy of hemorrhoidal lesions or the like in a patient, employing a D.C. electric generator means, a grounding pad for the patient, a monopolar probe having a distal tip for penetration of the hemorrhoidal lesion to act as a negative electrode, and an instrument handpiece for support of the probe and control of the level of direct current,

said probe comprising a base and, extending therefrom, at least one elongated probe electrode terminating in said distal tip adapted for electricity-conducting engagement with hemorrhoidal lesion,

said instrument handpiece comprising:

a lower handle portion sized and constructed to be gripped by a physician,

cooperative means for coupling said probe base to said handpiece in electricity-conducting engagement, with the axis of said probe at an obtuse angle to the axis of said lower handle portion, arrangement of said probe and said lower handle portion at said obtuse angle allowing a physician to hold said instrument handpiece during treatment of a hemorrhoidal lesion without extended abnormal flexure of the wrist, said probe base comprising a key of predetermined size and shape, and said instrument handpiece defining a keyway adapted to receive said key therewithin in electricity-conducting coupled relationship, said key, taken in cross section, having the general form of a square with radiused corners of predetermined dimension corresponding to, but slightly less than, dimensions of said keyway,

a therapy-monitoring and control upper handle portion disposed generally above said lower handle portion and having a front panel visible to the physician when the probe distal tip is penetrated into a hemorrhoidal lesion,

said front panel comprising

means for display of status of treatment conditions of said instrument, comprising means for display of elapsed time of treatment, means for display of direct current intensity of treatment and means for display of actuation status of said treatment, said means for display and the distal tip of said probe being disposed generally in the same line of sight of a physician holding said lower handle portion with said distal probe tip penetrated into a hemorrhoidal lesion, and

means for control of the level of direct current disposed adjacent said lower handle portion in a manner to allow a physician to operate said means for control with digits of a hand gripping said lower handle portion, said means for control comprising at least a first means for increasing the level of current, and second means for decreasing the level of current,

whereby a physician may simultaneously view a treatment site and observe conditions of treatment appearing on said means for display, while gripping the instrument and operating said means for control with one hand, leaving the other hand free as he conducts therapy on a hemorrhoidal lesion.

14. A probe adapted for use with an instrument for direct current electrical therapy of hemorrhoidal lesions or the like in a patient, employing a D.C. electric generator means, a grounding pad for the patient, and an instrument handpiece for support of the probe and control of the level of direct current,

said probe comprising a base and, extending therefrom, at least one elongated monopolar probe electrode terminating in a distal tip adapted for electricity-conducting engagement with a hemorrhoidal lesion, and said probe further comprising cooperative means for coupling said probe base to the handpiece in electricity-conducting engagement, with the axis of said probe at an obtuse angle to the axis of the handpiece, arrangement of said probe and lower handle portion at said obtuse angle allowing a physician to hold said instrument during treatment of a hemorrhoidal lesion without extended abnormal flexure of the wrist, said probe base comprising a key of predetermined size and shape, and said instrument handpiece defining a keyway adapted to receive said key therewithin in electricity-conducting coupled relationship, said key, taken in cross section, having the general form of a square with radiused corners of predetermined dimension corresponding to, but slightly less than, dimensions of said keyway.