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Direct manual cardiac compression method    
United States Patent5484391   
Link to this pagehttp://www.wikipatents.com/5484391.html
Inventor(s)Buckman, Jr.; Robert F. (Radnor, PA); Badellino; Michael M. (Hatboro, PA)
AbstractMethods for employing a heart massager for substernal heart massage are disclosed. The heart massager comprises a heart-contacting member connected to a handle. The disclosed method comprises the following steps: making an incision in the skin in an intercostal space; surgically separating the intercostal space; inserting the heart massager through the intercostal space and guiding heart-contacting member of the massager onto the ventricular region of the heart; and periodically pressing and releasing the handle so that the heart's ventricles are compressed and allowed to return to their non-compressed condition.
   














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Drawing from US Patent 5484391
Direct manual cardiac compression method - US Patent 5484391 Drawing
Direct manual cardiac compression method
Inventor     Buckman, Jr.; Robert F. (Radnor, PA); Badellino; Michael M. (Hatboro, PA)
Owner/Assignee    
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Publication Date     January 16, 1996
Application Number     08/182,906
PAIR File History     Application Data   Transaction History
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Litigation
Filing Date     January 14, 1994
US Classification    
Int'l Classification    
Examiner     Hafer; Robert A.
Assistant Examiner     Kenealy; David J.
Attorney/Law Firm     Seidel Gonda Lavorgna & Monaco
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Parent Case     This is a divisional of application Ser. No. 07/922,714 filed on Jul. 30, 1992 abandoned.
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Patent Tags     direct manual cardiac compression
   
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What we claim is:

1. A method of heart massage, the method comprising the steps of employing a heart massager having a heart-contacting member with a heart-contacting surface which is at least partially concave, said heart-contacting member being connected to a handle, the heart-contacting member having a plane tangential to the member's concave surface in a region the handle is attached to the heart-contacting member, the handle being substantially upright with respect to the plane;

(a) making an incision in the skin in an intercostal space;

(b) surgically separating said intercostal space;

(c) inserting said heart massager through said intercostal space and guiding the heart-contacting member onto the ventricular region of said heart; and

(d) periodically depressing and releasing the handle so that the heart's ventricles are alternately compressed and allowed to return to their non-compressed condition, the substantially upright handle imparting downward forces to the heart-contacting member during the periodic depressions.

2. A method of heart massage according to claim 1, wherein said incision is made in the fourth intercostal space.

3. A method of heart massage according to claim 1, wherein said incision is made in the intercostal space between the left nipple and the lateral border of the sternum.

4. A method of heart massage, the method comprising the steps of: employing a heart massager having a heart-contacting member with a heart-contacting surface which is at least partially concave and cushioning means comprising deformable material on said surface, said heart-contacting member being connected to a handle, the heart-contacting member having a plane tangential to at least a portion of the member's concave surface in a region where the handle is attached to the heart-contacting member, the handle being substantially upright with respect to the plane;

(a) making an incision in the skin in an intercostal space;

(b) surgically separating said intercosial space;

(c) inserting said heart massager through said intercostal space and guiding the heart-contacting member onto the ventricular region of said heart; and

(d) periodically depressing and releasing the handle so that the heart's ventricles are alternately compressed and allowed to return to their non-compressed condition, the cushioning means providing a cushioning action for the heart as the substantially upright handle is depressed, the substantially upright handle imparting downward forces to the heart-contacting member during the periodic depressions.

5. A method of heart massage, the method comprising the steps of: employing a heart massager having a heart-contacting member with a heart-contacting surface which is at least partially concave, said heart-contacting member comprising a generally curved plate, said heart-contacting member being connected to a handle, the heart-contacting member having a plane tangential to the member's concave surface in a region where the handle is attached to the heart-contacting member, the handle being substantially upright with respect to the plane;

(a) making an incision in the skin in an intercostal space;

(b) surgically separating said intercostal space;

(c) inserting said heart massager through said intercostal space and guiding the heart-contacting member onto the ventricular region of said heart, the curved plate conforming to the surface of the heart's ventricular region; and

(d) periodically depressing and releasing the handle so that the heart's ventricles are alternately compressed and allowed to return to their non-compressed condition, the substantially upright handle imparting downward forces to the heart-contacting member during the periodic depressions.

6. A method of heart massage, the method comprising the steps of: employing a heart massager having a heart-contacting member connected to a handle, the heart-contacting member having a heart-contacting surface and a circumferential sidewall supporting the surface, the sidewall being expandable and compressible, the heart-contacting surface and sidewall defining a substantially enclosed volume, the volume being less when the sidewall is compressed than when the sidewall is expanded, the handle being substantially rigid and having a longitudinal axis extending along its length;

(a) making an incision in the skin in an intercostal space;

(b) surgically separating said intercostal space;

(c) locating the ventricular region of the heart relative to said intercostal space;

(d) inserting the heart massager through said intercostal space and guiding the heart-contacting member in its compressed condition onto the ventricular region;

(e) expanding said sidewall of said heart-contacting member; and

(f) periodically translating the rigid handle in a direction substantially along its longitudinal axis, the translation of the handle causing corresponding translation of the heart-contacting surface toward and away from the heart's surface so that the heart's ventricles are alternately compressed and allowed to return to their non-compressed condition, the translation of the handle imparting downward forces to the heart-contacting member through the circumferential sidewall.

7. A method of heart massage according to claim 6, wherein said incision is made in the fourth intercostal space.

8. A method of heart massage according to claim 6, wherein said incision is made in the intercostal space between the left nipple and the lateral border of the sternum.

9. A method of heart massage, the method comprising the steps of: employing a heart massager having a heart-contacting member connected to a handle, the heart-contacting member having a heart-contacting surface and a circumferential sidewall supporting the surface and extending longitudinally towards the handle, the sidewall being radially expandable and compressible, said sidewall having an outer diameter which is less than about one inch when the member is in a compressed state, said circumferential sidewall having a longitudinal axis, the handle being substantially rigid and having a longitudinal axis extending along its length, the longitudinal axis of the handle lying substantially along the axis of the circumferential sidewall;

(a) making an incision in the skin in an intercostal space;

(b) surgically separating said intercostal space;

(c) inserting said heart massager in its compressed condition through said intercostal space and guiding the heart-contacting member onto the ventricular region of said heart;

(d) radially expanding said sidewall of said heart-contacting member, the radially expanded sidewall being substantially bisected by the longitudinal axis of the handle; and

(e) periodically translating the rigid handle in a direction substantially along its longitudinal axis, the translation of the handle causing corresponding translation of the heart-contacting surface toward and away from the heart's surface so that the heart's ventricles are alternately compressed and then allowed to return to its non-compressed condition, the translation of the handle imparting downward forces to the heart-contacting member through the radially expanded sidewall.

10. A method of heart massage according to claim 9, wherein said incision is made in the fourth intercostal space and is about one inch in length.

11. A method of heart massage according to claim 9, wherein said incision is made in the intercostal space between the left nipple and the lateral border of the sternum.

12. A method of heart massage, the method comprising the steps of: employing a heart massager having a heart-contacting member with a heart-contacting surface which is at least partially concave, said heart-contacting member being connected to a handle, the heart-contacting member having a plane tangential to the member's concave surface in a region where the handle is attached to the heart-contacting member, the handle being substantially upright with respect to the plane, the heart contacting surface having at least one electrode thereon in communication with an external heart monitoring device through an electrical connection path in the handle;

(a) making an incision in the skin in an intercostal space;

(b) surgically separating said intercostal space;

(c) inserting said heart massager through said intercostal space and guiding said heart-contacting member onto the ventricular region of said heart;

(d) periodically pressing and releasing the handle so that the heart's ventricles are alternately compressed and then allowed to return to their non-compressed condition, the substantially upright handle imparting downward forces to the heart-contacting member during the periodic depressions; and

(e) transmitting electrical signals between the electrode and the external heart monitoring device through the electrical connection path in the handle while the surface of the heart-contacting member is contacting the heart.

13. A method of heart massage according to claim 12, wherein said incision is made in the fourth intercostal space.

14. A method of heart massage according to claim 12, wherein said incision is made in the intercostal space between the left nipple and the lateral border of the sternum.

15. A method of heart massage, the method comprising the steps of: employing a heart massager having a heart-contacting member with a heart-contacting surface which is at least partially concave, said heart-contacting member being connected to a handle which is substantially upright with respect to the surface of the heart-contacting member, the heart-contacting surface having an endoscope with a light source associated therewith and means for directing the light source to said heart-contacting member;

(a) making an incision in the skin in an intercostal space;

(b) surgically separating said intercostal space;

(c) inserting said heart massager through said intercostal space, and then, using said endoscope to guide said heart-contacting member onto the ventricular region of said heart; and

(d) periodically pressing and releasing said handle so that the heart's ventricles are alternately compressed and allowed to return to their non-compressed condition, the substantially upright handle imparting downward forces to the heart-contacting member during the periodic depressions.

16. A method of heart massage according to claim 1, further comprising the step of monitoring the blood pressure of the heart during said pressing and releasing of said handle, said heart-contacting member being positioned during said pressing and releasing in a manner to increase said monitored blood pressure.

17. A method of heart massage according to claim 15, wherein said incision is made in the intercostal space between left nipple and the lateral border of the sternum.

18. A method of heart massage according to claim 12, wherein the heart contacting surface has an electrical signal sensor thereon and the electrical heart monitoring or controlling device is an electrocardiograph,

step (e) comprising receiving electrocardiographic signals from the sensor.

19. A method of heart massage according to claim 12, wherein the heart contacting surface has an electrode thereon and the electrical heart monitoring or controlling device is a cardiac pacing device,

step (e) comprising transmitting electrical signals from the device to the electrode.

20. A method of heart massage according to claim 12, wherein the heart contacting surface has electrodes thereon and the electrical heart monitoring or controlling device is a defibrillator,

step (e) comprising transmitting electrical signals from the defibrillator to the electrodes.

21. A method of heart massage according to claim 12, wherein the heart contacting surface has a pressure sensor thereon and the electrical heart monitoring and controlling device is a compression pressure warning device,

step (e) comprising receiving pressure signals from the sensor.

22. A method of heart massage, the method comprising the steps of: employing a heart massager having a heart-contacting member with a heart-contacting surface having an edge, said heart-contacting member being connected to a rigid handle, the handle having a longitudinal axis extending along its length, the longitudinal axis of the handle intersecting the heart-contacting surface at an angle substantially upright with respect to the contacting surface and at a location spaced from the edge;

(a) making an incision in the skin in an intercostal space;

(b) surgically separating said intercostal space;

(c) inserting said heart massager through said intercostal space and guiding the heart-contacting member onto the ventricular region of said heart; and

(d) periodically translating the handle in a direction substantially along its longitudinal axis, the translation of the handle causing corresponding translation of the heart-contacting surface toward and away from the heart's surface so that the heart's ventricles are alternately compressed and allowed to return to their non-compressed condition.

23. A method of heart massage according to claim 22, wherein said incision is made in the fourth intercostal space.

24. A method of heart massage according to claim 22, wherein said incision is made in the intercostal space between the left nipple and the lateral border of the sternum.

25. A method of heart massage according to claim 22, further comprising the step of monitoring the blood pressure of the heart during said pressing and releasing of said handle, said heart-contacting member being positioned during said pressing and releasing in a manner to increase said monitored blood pressure.

26. A method of heart massage according to claim 22, wherein the heart-contacting member has a heart-contacting surface which is at least partially concave and includes cushioning means comprising deformable material on said surface, and during step (d), the cushioning means provides a cushioning action for the heart as the handle is depressed.

27. A method of heart massage according to claim 22, wherein the heart contacting member comprises a generally curved plate, and during step (c), the curved plate conforms to the surface of the heart's ventricular region.

28. A method of heart massage according to claim 22, wherein the heart-contacting member has a heart-contacting surface, said heart-contacting surface having at least one electrode thereon in communication with an external heart monitoring device through an electrical connection path in the handle, the method further comprising the step of:

(e) transmitting electrical signals between the electrode and the external heart monitoring device through the electrical connection path in the handle while the surface of the heart-contacting member is contacting the heart.

29. A method of heart massage according to claim 28, wherein the heart contacting surface has an electrical signal sensor thereon and the electrical heart monitoring or controlling device is an electrocardiograph,

step (e) comprising receiving electrocardiographic signals from the sensor.

30. A method of heart massage according to claim 28, wherein the heart contacting surface has an electrode thereon and the electrical heart monitoring or controlling device is a cardiac pacing device,

step (e) comprising transmitting electrical signals from the device to the electrode.

31. A method of heart massage according to claim 28, wherein the heart contacting surface has electrodes thereon and the electrical heart monitoring or controlling device is a defibrillator,

step (e) comprising transmitting electrical signals from the defibrillator to the electrodes.

32. A method of heart massage according to claim 28, wherein the heart contacting surface has a pressure sensor thereon and the electrical heart monitoring and controlling device is a compression pressure warning device,

step (e) comprising receiving pressure signals from the sensor.

33. A method of heart massage according to claim 22, wherein the heart-contacting member has an endoscope with a light source associated therewith and means for directing the light source to said heart-contacting member, step (c) further comprising using said endoscope to guide said heart-contacting member onto the ventricular region of said heart.

34. A method of heart massage, the method comprising the steps of: employing a heart massager having a heart-contacting member connected to a handle, the heart-contacting member having a heart-contacting surface and a circumferential sidewall supporting the surface, the sidewall being expandable and compressible, the heart-contacting surface and the sidewall defining a substantially enclosed voluble, the volume being less when the sidewall is compressed than when the sidewall is expanded;

(a) making an incision in the skin in an intercostal space;

(b) surgically separating said intercostal space;

(c) locating the ventricular region of the heart relative to said intercostal space;

(d) inserting the heart massager through said intercostal space and guiding the heart-contacting member in its compressed condition onto the ventricular region of said heart;

(e) expanding said sidewall of said heart-contacting member; and

(f) periodically depressing and releasing the handle so that the heart's ventricles are alternately compressed and allowed to return to their non-compressed condition, the depression of the handle imparting downward forces to the heart-contacting member through the circumferential sidewall.

35. A method of heart massage according to claim 34, wherein said incision is made in the fourth intercostal space.

36. A method of heart massage according to claim 34, wherein said incision is made in the intercostal space between the left nipple and the lateral border of the sternum.

37. A method of heart massage, the method comprising the steps of: employing a heart massager having a heart-contacting member connected to a handle, the heart-contacting member having a heart-contacting surface and a circumferential sidewall supporting the surface, the sidewall being radially expandable and compressible, said sidewall having an outer diameter which is less than about one inch when the member is in a compressed state;

(a) making an incision in the skin in an intercostal space;

(b) surgically separating said intercostal space;

(c) inserting said heart massager in its compressed condition through said intercostal space and guiding the heart-contacting member onto the ventricular region of said heart;

(d) radially expanding said sidewall of said heart-contacting member; and

(e) periodically depressing and releasing the handle so that the heart's ventricles are alternately compressed and then allowed to return to its non-compressed condition, the depression of the handle imparting downward forces to the heart-contacting member through the radially expanded sidewall.

38. A method of heart massage according to claim 37, wherein said incision is made in the fourth intercostal space and is about one inch in length.

39. A method of heart massage according to claim 37, wherein said incision is made in the intercostal space between the left nipple and the lateral border of the sternum.

40. A method of heart massage according to claims 1, 4, 5, 6, 9, 12, 15, 22, 34 and 37 wherein the pericardium remains intact when performing the steps of the method and the step of guiding the heart contacting member onto the ventricular region of the heart includes guiding the heart contacting member onto the outer surface of the pericardium.
 Description Submit all comments and votes
 


FIELD OF THE INVENTION

The present invention relates to heart massagers and a method of use thereof and, more particularly, to various heart massagers each of which is introduced through a relatively small surgical incision made in the chest wall so that the massagers may be positioned to directly massage the heart during cardiac arrest.

BACKGROUND OF THE INVENTION

In the medical profession it is recognized that it is necessary, in the event of a cardiac arrest, to assist the heart in its pumping function until effective spontaneous cardiac contraction can restore normal blood circulation. During cardiac arrest, the pumping action of the heart ceases and blood flow stops. If blood flow or circulation is not sustained or reinstituted, either by restoration of spontaneous cardiac activity or by some other provision of artificial circulatory support, irreversible vital organ damage and clinical death will ensue.

Currently, several method are employed to sustain circulation during cardiac arrest. These methods include closed chest external and open chest internal cardio-pulmonary resuscitation (CPR) techniques. All of the external CPR techniques, as well as the devices which are used therewith, rely on depressing the sternum producing a generalized increase in intrathoracic pressure. This produces a low level of blood flow to the organs of the body. However, none of these external CPR devices nor their related techniques, develop enough direct mechanical compression of the ventricular chambers of the heart to produce physiologically significant blood flow. Open-chest, bi-manual cardiac compression, in which the heart is directly compressed by the hands of the operator, produces far more blood flow than any method of closed chest CPR. It is capable of supplying vital organs with more blood and produces a higher probability of survival than any method of closed chest CPR. During open-chest, internal CPR, an anterior-lateral chest incision is commonly used with the surgical incision being large enough to accommodate introduction into the chest cavity of both hands of an operator, so that a manual compression of the heart muscle may take place.

Both the external (closed chest) CPR and open chest techniques can be performed manually or with the aid of mechanical devices. With either technique, the goal is to maintain artificial circulation, including circulation through the heart itself, until spontaneous cardiac activity can be restored. This restoration almost always involves electrical defibrillation of the heart in which a direct current shock is administered to the heart muscle to restore its spontaneous contraction.

A method of performing internal CPR is described in U.S. Pat. No. 3,496,932 of Prisk et al. issued Feb. 24, 1970. This described method uses a small surgical incision, about one (1) inch, to accommodate the placement of a direct mechanical compression device on the heart muscle. The compression device comprises a generally cone-shaped plastic film serving as an inflatable and deflatable bladder which is connected to an air supplying stem which, in turn, is attached to an external pneumatic apparatus.

In the method of the '932 patent, a surgical incision is made in the upper abdomen below the lower tip (xiphoid) of the sternum for the purpose of introducing the device which is placed behind the sternum onto the heart. Before such an introduction, a trocar carrying a large tube and having a pointed tip is inserted into the incision, in an upward manner, into the space between the sternum and the anterior aspect of the pericardium, or alternatively into the pericardial sac itself. Entrance of this device carrying a sharp tip between the posterior aspect of the sternum and anterior aspect of the heart involves risk of accidently wounding the heart. After insertion, the tip of the trocar is moved until the desired location for the later placement of the inflatable/deflatable bladder on the heart is reached. Then, the trocar is withdrawn but the large tube carried by the trocar remains, allowing for the bladder to be inserted through the tube and onto the heart ready for periodic pneumatic inflation and deflation cycles of the bladder. These cycles are accomplished with the assistance of a mechanical pump apparatus to produce corresponding compression/relaxation cycles of the heart muscle to produce an artificial circulation during cardiac arrest.

Although the '932 patent may advantageously accomplish mechanical compression/relaxation of the heart by means of a small surgical incision so as to avoid an open-chest procedure, it is desired that such compression/relaxation be accomplished by a self-contained heart massager device having no reliance on any external mechanical device. Moreover, it is desired that a heart massager be positioned on the heart without the need for any sharp probing tip that might damage contacting elements of the body because of inadvertent contact therewith. Further, it is desired that the heart massager not only be devoid of a pointed tip but also have relatively small dimensions for insertion into the chest and a contoured surface for mating with the heart. Still further, it is desired that a heart massager be provided having collapsible features so as to minimize the size of the surgical incision needed for the introduction of the massager into the chest.

It is further desired that a method for inserting the heart massager be provided so that a surgical incision is not made through the abdomen.

It is still further desired, that means be provided to allow the heart massager to be guided to not only its most desirable/optimum position on the heart, but also be monitored and maintained at such a position during the direct mechanical compression of the heart muscle. Moreover, it is desired that the heart massager be provided with means to allow the massager to be re-positioned during use so that an optimum hemodynamic compression of the heart muscle and maximal blood flow to vital organs may be obtained during the massage and until spontaneous cardiac action can be restored.

Further, it is desired that the heart massager have provisions to accommodate direct cardiac defibrillation, detection of any abnormal electrocardiograph rhythm that might occur during the heart massage, and means for stabilizing any irregular heartbeats that might occur during the cardiac arrest condition.

Accordingly, it is an object of the present invention to provide a massager having no reliance on any external mechanical device apart from the massager per se to accomplish a direct massage of the heart muscle.

Another object of the present invention is to provide a heart massage that is not only devoid of a sharp tip that may unnecessarily and inadvertently damage body elements but also has relatively small dimensions and a contoured surface for mating with the heart.

It is a further object of the present invention to provide a massager having collapsible features so as to hold to a minimum the size of the surgical incision needed for the subcutaneous introduction of the massager onto the heart.

Still further it is an object of the present invention to provide a device having provisions for endoscopic (optical) guidance means so as to allow the massager to be initial positioned on the heart as desired to perform the massage, to be maintained at that initial position or to be repositioned during the massage so as to accomplish hemodynamically optimal compression of the heart.

Further still, it is an object of the present invention to provide a device having provisions to accomplish cardiac defibrillation, while at the same time allowing for the detection of abnormal electrocardiograph rhythms, or if needed, provisions for stabilizing the heartbeats during cardiac arrest by electrical cardiac pacing.

SUMMARY OF THE INVENTION

The present invention is directed to a massager and a method both to be used to accomplish internal cardio-pulmonary resuscitation (CPR). The massager is a manually operated cardiac compressor that is used to sustain the blood flow of the body during periods of cardiac arrest, and has various embodiments each of which allows for a minimal thoracic incision for the massager's safe, intrathoracic introduction and positioning.

The direct, intrathoracic heart massager comprises a heart-contacting member having a surface which is at least partially concave for contacting the heart, a handle means attached to the heart-contacting member for manually manipulating the massager, and, preferably, cushioning means on the surface of the contacting member.

The method for performing the heart massage comprises the following steps: providing a heart massager having a heart-contacting member connected to a handle and which member is at least partially concave for contacting the heart; making an incision into the skin at the intercostal space, preferably in the fourth intercostal space, between the left nipple and the lateral border of the sternum; surgically separating the intercostal space; inserting the heart massager through the intercostal space and onto the apex region of the heart; and then, periodically and manually pressing and releasing the handle so that the heart is alternately compressed and allowed to return to its non-compressed state.

Other objects, advantages and novel features of the present invention will become apparent in the following detailed description of the invention when considered in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

For the purpose of illustrating the invention, there is shown in the drawings a form which is presently preferred; it being understood, however, that this invention is not limited to the precise arrangements and instrumentalities shown.

FIG. 1 illustrates a heart massager in accordance with one embodiment of the present invention.

FIG. 2 is a