U.S. patent application number 11/936282 was filed with the patent office on 2008-03-06 for central nervous system administration of medications by means of pelvic venous catheterization and reversal of batson's plexus.
This patent application is currently assigned to SERENE MEDICAL, INC.. Invention is credited to Gilbert R. Gonzales.
Application Number | 20080058768 11/936282 |
Document ID | / |
Family ID | 34377065 |
Filed Date | 2008-03-06 |
United States Patent
Application |
20080058768 |
Kind Code |
A1 |
Gonzales; Gilbert R. |
March 6, 2008 |
Central Nervous System Administration of Medications by Means of
Pelvic Venous Catheterization and Reversal of Batson's Plexus
Abstract
An infusor system for administering medications to a venous
blood vessel in the body of a patient. The infusor system includes
a flexible, elongated delivery tube having opposite ends. One of
the ends is couplable to a supply of liquid medication, which is
remote from the venous blood vessel. The system further includes a
delivery component coupled to the other end of the delivery tube.
This delivery component is adaptable to be placed in confronting
relationship with the venous blood vessel so that medication from
said supply may be introduced directly into the venous blood vessel
and distributed in the body of the patient. The infusor system
further includes a pressure-altering device used for increasing
intraabdominal pressure in the body of the patient.
Inventors: |
Gonzales; Gilbert R.; (New
York, NY) |
Correspondence
Address: |
WOOD, HERRON & EVANS, LLP
2700 CAREW TOWER
441 VINE STREET
CINCINNATI
OH
45202
US
|
Assignee: |
SERENE MEDICAL, INC.
420 Lexington Avenue Suite 300
New York
NY
10170
|
Family ID: |
34377065 |
Appl. No.: |
11/936282 |
Filed: |
November 7, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10675147 |
Sep 30, 2003 |
|
|
|
11936282 |
Nov 7, 2007 |
|
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Current U.S.
Class: |
604/523 |
Current CPC
Class: |
A61P 25/04 20180101;
A61M 5/14 20130101; A61M 2005/1405 20130101; A61M 2005/1404
20130101; A61M 5/142 20130101 |
Class at
Publication: |
604/523 |
International
Class: |
A61M 25/00 20060101
A61M025/00 |
Claims
1. An infusor system for administering medications to a venous
blood vessel in the: body of a patient comprising: a flexible,
elongated delivery tube having opposite ends, one of said ends
couplable to a supply of liquid medication, said supply being
remote from a venous blood vessel chosen from a pudic vein, an
internal pudic vein, and an external pudic vein; a delivery
component coupled to the other of said ends, said delivery
component adaptable to be placed in confronting relationship with
said venous blood vessel so that medication from said supply may be
introduced directly into said venous blood vessel and distributed
in the body of the patient; and a pressure-altering device, the
pressure-altering device being positionable on the patient body for
increasing pressure within the body of the patient to cause
reversal of blood flow in Batson's Plexus to thereby delivery
medication via said reversal of blood flow.
2. The infusor system of claim 1, wherein said delivery component
is selected from the group consisting of a venous needle and an
indwelling venous catheter.
3. The infusor system of claim 1, wherein said delivery component
is adapted to be placed in confronting relationship with a venous
blood vessel of the superficial or sacral venous system of the
human body.
4. The infusor system of claim 3, wherein said venous blood vessel
is selected from the group consisting of a femoral vein, a deep
epigastric vein, a deep circumflex iliac vein, an internal iliac
vein, an internal pubic vein, a common iliac vein, a spermatic
vein, a dorsal vein of the penis, an inguinal vein, a pudendal
vein, a pubic vein, and a genitofemoral vein.
5. The infusor system of claim 1, wherein said supply of liquid
medication further includes an apparatus adapted to store said
supply of liquid medication and/or deliver said supply of liquid
medication to said tube, the apparatus being selected from the
group consisting of an IV bag and a pump.
6. The infusor system of claim 1, further comprising an injection
site operatively connected to said tube for receiving a syringe for
injecting bolus dosages of medication into said tube.
7. The infusor system of claim 1, wherein said tube further
includes a valve for allowing flow of said liquid medication in
only one direction in said tube from said supply of liquid
medication to said delivery component.
8. The infusor system of claim 1, wherein said liquid medication is
selected from the group consisting of chemotherapeutic medications,
steroids, anesthetics, opioids, narcotic analgesics, and
non-narcotic analgesics.
9. The infusor system of claim 1, wherein said pressure to be
increased in the patient body is intraabdominal pressure.
10. The infusor system of claim 9, wherein said pressure-altering
device is selected from the group consisting of an abdominal binder
and an abdominal restraint.
11. The infusor system of claim 9, wherein said intraabdominal
pressure is increased to at least 30 mmHg.
12. The infusor system of claim 9, wherein said intraabdominal
pressure is in a range of about 15 mm Hg to about 90 mmHg.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a division of, and claims the benefit
of, the filing date of U.S. patent application Ser. No. 10/675,147,
filed Sep. 30, 2003, the disclosure of which is incorporated by
reference herein in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to the
administration of medications to patients, and specifically, to the
administration of medications through the venous system of a
patient, and more specifically, through the superficial to sacral
venous system of a patient.
BACKGROUND OF THE INVENTION
[0003] The effective administration of medications for the
treatment of disease symptoms and for the alleviation of pain,
i.e., pain management, is an important aspect to the overall
treatment of patients for both curable diseases and terminal
illnesses. Particularly, the effective administration of
medications in patients experiencing chronic pain associated with a
terminal illness is particularly important, because such pain
management requires constant administration of medication over
prolonged periods of time. As a result, the management of pain for
terminally ill patients, such as terminal cancer and those
afflicted with HIV, has come to the forefront as the medical
profession seeks to alleviate pain to allow the patient to
comfortably pass away.
[0004] Oral administration has been widely utilized in the past for
dispensing pain medications such as narcotic and non-narcotic
analgesics. However, oral administration is oftentimes not possible
due to an obstruction blocking the oral and gastrointestinal tract,
or due to severe nausea/vomiting by the patient. Such
gastrointestinal problems are often experienced by terminally ill
patients whose bodies are slowly deteriorating.
[0005] Parenteral administration, or, administration outside of the
intestine, such as through bolus injections or slow infusions are
also widely utilized. Intravenous (IV) drips are particularly
popular for long-term administration of a medication in controlled
dosages. However, parenteral administration is invasive and usually
painful to the patient. Undesirable local reactions can occur at
the site of the injection or infusion, and wheal, or skin
elevation, occurs due to the injections or infusions which involve
a needle and are subcutaneous, or beneath the skin. Furthermore,
parenteral administration of medications may not be possible if
there is a lack of peripheral vasculature and blood flow cannot
move to certain areas of the body. Also, some terminally ill
patients may refuse parenteral administration of medications.
[0006] Parenteral administration of medications is also not
practical for long-term patient care due to the requirement that
proper sites must be utilized for effective administration.
Terminally ill patients may not have the physical capability of
performing an injection procedure, and if physically able, may not
have the knowledge to properly choose an injection site and
administer the medication. Thus, while parenteral administration
may be effective, a properly trained healthcare provider is usually
necessary for administration. When long-term patient care must be
provided by an untrained person, injection techniques may become
impossible to implement, requiring a patient to stay in a hospital
or other medical facility indefinitely.
[0007] Rectal administration of medication is widely used for
administering a number of different medications, including
non-narcotic and narcotic analgesics for pain management,
antinausea medications, and steroids. However, currently available
rectal administration techniques involve the use of suppositories,
which contain a fixed dosing of medication. The suppositories are
placed within the rectum for one-time, slow, and continuous
absorption. Therefore, there is generally no control over the
administration rate except that provided by the fixed breakdown of
the suppository and the absorption rate of the rectal mucous
membrane. As such, suppositories do not provide the needed
flexibility in the management of pain, which often requires quick
bolus administrations to combat acute pain and acute worsening of
pain. Furthermore, since suppositories are generally single dose
elements, extended care may require the continual insertion of
single dose suppositories for continuous pain management. Such
continuous monitoring is expensive and often requires a skilled
caregiver when the patient is either unable or unwilling to insert
the suppository.
[0008] For pain management, the intraspinal administration of
non-narcotic and narcotic analgesics is important in alleviating
acute and chronic pain. Approaches have been developed for
delivering high concentrations of medications into the spinal cord;
however, all such techniques are invasive and have associated risks
related to the use of a catheter or pump for the injection or
infusion. Furthermore, most of these techniques are generally
expensive, as they require administration and monitoring by skilled
medical personnel.
[0009] Therefore, alterative methods of administration that are
less complex, demanding, and expensive, are desirable.
[0010] Recently, the use of the reversal of blood flow in the
vertebral venous system or Batson's Plexus for rectal or
intravenous administration of medications into selected pelvic
region veins has shown promise as a method of administering
analgesics and anesthetics at high concentration directly into the
intraspinal areas. Reversal of flow in the Batson's Plexus refers
to the physical phenomenon of reversal of blood flow in the veins
of the vertebral structures when intraabdominal pressure is
applied. Normally, the vertebral venous plexus in the pelvis,
sacrum and lumbar spine assist in carrying the venous blood from
the meningorrhachidian veins of the vertebral structures, including
the spinal cord, to the sacrum and sacral plexus, the iliac veins
and ultimately to the inferior vena cava and to the heart. However,
the vertebral venous plexus or Batson's Plexus is valveless so
blood is free to flow in any direction. The Batson effect occurs
upon increased intraabdominal pressure, which causes reversal of
pelvic and lumbar venous flow such that venous flow occurs from the
sacral venous plexus and inferior vena cava into the
meningorrhachidian blood vessels. In short, normal blood flow
occurs from the spinal column toward the heart, but under Batson's
described effect, blood flow can occur in the opposite direction,
providing blood flow back to the spinal area. Using Batson's Plexus
reverse flow by increased intraabdominal pressure, in conjunction
with the administration of analgesics using venous needle or
indwelling venous catheter delivery of opioids, anesthetics or
other medications into pelvic region veins that drain into the
sacral plexus and Batson's Plexus, the analgesic or other
medication might be more efficiently and effectively administered
at high concentrations to the spinal cord to alleviate pain without
infusions.
[0011] Therefore, it is an objective of the present invention to
administer medications to patients without the various drawbacks
associated with traditional oral, rectal, and parenteral methods of
administration discussed hereinabove. Furthermore, it is an
objective to administer medication intravenously (IV) with greater
flexibility and with central nervous system specific delivery than
provided with currently available techniques.
[0012] Particularly, it is an objective of the present invention to
administer non-narcotic and narcotic analgesics to continuous care
and terminal patients for the management of acute and chronic
pain.
[0013] It is a further objective of the present invention to
administer medications in a nonpainful, noninvasive and safe way
without incurring the large expense associated with procedures
involving administration and continual monitoring by large numbers
of skilled caretakers, such as physicians and nurses. Safe,
effective and inexpensive pain management in economically
depressed, third world countries is particularly important, as
these countries often have large numbers of terminally ill patients
without the requisite medical staff available.
[0014] It is a further objective of the present invention to
provide greater flexibility in the administration of medications,
both continuously and in bolus dosages and to provide for easy
initiation and termination of the dispensing process.
[0015] It is a further objective of the present invention to
administer medications so that the medications are rapidly and
efficiently absorbed into the necessary areas of the body to
alleviate the medical condition or the pain associated
therewith.
[0016] It is also an objective of the present invention to more
efficiently and effectively administer medications into the
intraspinal area and particularly to administer anesthetics and
analgesics into that area for pain management purposes.
[0017] It is also an objective of the present invention to more
efficiently and effectively administer medications into the
intraspinal and systemic circulation of multiple different
pharmacologic agents for many different medical reasons. Medication
that can be delivered by pelvic region veins and directed into the
intraspinal area include any therapeutic or diagnostic agent that
can be delivered by IV in any other area of the body. These include
steroids, nonsteroidal anti-inflammatory agents, anti-infectives,
oncolytics, immune therapies, antibleeding agents, anti-epileptic
agents, fluid replacement, radiopaque x-ray imaging agents and
magnetic resonance imaging agents, such as gadolinium, and
radioactive diagnostic and radioactive therapeutic agents and
experimental drugs (such as ziconotide, large molecules, nonpolar
molecules, hormones, and immune modulating agents and other
compounds, that may not or only poorly cross the blood-brain
barrier, or that are poorly or nonabsorbed through the oral or
rectal route) that may be useful to treat pain conditions, or
hypothermia or hyperthermia therapy of the pelvic venous blood flow
for therapeutic purposes.
SUMMARY OF THE INVENTION
[0018] The above-discussed objectives are addressed in the present
invention which comprises an infusor system for administering
medications to a patient through a venous needle or indwelling
venous catheter. In a preferred embodiment of the invention, the
infusor system is designed for use within the superficial to sacral
venous system of a patient for administering medications into the
body of the patient.
[0019] In a preferred embodiment, the infusor system comprises a
needle or indwelling catheter that is placed into a superficial
vein or veins of the pelvis or inguinal region including but not
limited to the femoral vein, deep epigastric veins, deep circumflex
iliac vein, internal iliac vein, internal pubic vein, common iliac
vein, spermatic vein, dorsal vein of the penis, inguinal vein,
pudendal vein, pubic veins, or genitofemoral vein. The system
further comprises a delivery tube coupled at one end to a supply of
liquid medication and at an opposite end to the venous needle or
indwelling catheter.
[0020] The supply of medication is delivered into the tube and to
the IV needle or indwelling catheter either continuously through an
IV drip bag or a pump apparatus, or in a bolus dosage. To that end,
the infusor system includes apparatus for coupling the IV needle or
indwelling catheter to an IV bag or to a pump and also includes a
bolus injection site. The infusor system further comprises a
one-way valve in the delivery tube for allowing medication flow in
only one direction, from the supply to the IV needle or indwelling
catheter.
[0021] The infusor system eliminates the large expenses associated
with other procedures which involve administration and continual
monitoring by professional medical personnel. The IV needle or
indwelling catheter of the infusor system may be inserted into the
superficial vein or veins of the pelvis or inguinal region
including, but not limited to, the femoral vein, deep epigastric
veins, deep circumflex iliac vein, internal iliac vein, internal
pubic vein, common iliac vein, spermatic vein, dorsal vein of the
penis, inguinal vein, pudendal vein, pubic veins, or genitofemoral
vein and left therein while medication is supplied. Furthermore,
medication administration can be easily initiated and terminated by
simply starting or stopping the flow of medication to the delivery
IV needle or indwelling catheter. The infusor system provides safe,
effective and inexpensive pain management and is particularly
useful in economically depressed third-world countries which have
large numbers of terminally ill patients who do not have the
monetary resources to afford continuous attention by medical
professionals, even if such professionals are available. The
medications dispensed through the infusor system are rapidly and
efficiently absorbed into the necessary areas of the body for
alleviation of the medical condition or the pain associated
therewith. Furthermore, a large number of medications, such as
chemotherapy medications and some anesthetics, may be introduced
through the superficial vein or veins of the pelvis or inguinal
region including but not limited to the femoral vein, deep
epigastric veins, deep circumflex iliac vein, internal iliac vein,
internal pubic vein, common iliac vein, spermatic vein, dorsal vein
of the penis, inguinal vein, pudendal vein, pubic veins, or
genitofemoral vein. An IV method of use of the infusor system is
particularly effective for the efficient administration of
medications directly into the intraspinal area for pain
management.
[0022] In an embodiment of the method of the present invention, the
IV or indwelling catheter is placed within the superficial vein or
veins of the pelvis or inguinal region including but not limited to
the femoral vein, deep epigastric veins, deep circumflex iliac
vein, internal iliac vein, internal pubic vein, common iliac vein,
spermatic vein, dorsal vein of the penis, inguinal vein, pudendal
vein, pubic veins, or genitofemoral vein, and medication is
dispensed. Intraabdominal pressure is then increased by any number
of different available methods, such as by utilizing an abdominal
restraint or binder. The blood flow in the vertebral venous plexus
is reversed and the dispensed medication is delivered from the
rectal and sacral veins directly into the vertebral bones, the
epidural and intrathecal space, and the spinal cord. By maintaining
the increase in the intraabdominal pressure long enough, cranial
structures will also receive the vertebral venous flow of
medication.
[0023] Therefore, the infusor system of the present invention
provides a more direct infusion of medication, either continuously
or in bolus dosages, into the spinal cord and other vertebral
structures, as compared to oral or parenteral administration, for
more effective pain management. As such, analgesic medication, such
as morphine, can be delivered in relatively higher concentrations
to the spinal cord before circulating throughout the body and
before significant dilution. Furthermore, the bypassing of liver
metabolism provides a greater concentration of available medication
to the necessary targeted areas. Since there are lower
concentrations of the analgesics dispensed systemically within the
body, side effects such as sedation, respiratory depression,
nausea, and vomiting are reduced. Still further, utilizing the
inventive method of the present invention, more costly injection
procedures requiring skilled professionals are avoided when
introducing medications within the epidural and intrathecal spaces
of the spinal column.
[0024] These advantages and other advantages of the present
invention will become more readily apparent below from the Brief
Description of the Drawings and the Detailed Description of the
Invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] The accompanying drawings, which are incorporated in and
constitute a part of the specification, illustrate embodiments of
the invention and, together with a general description of the
invention given above, and the detailed description of the
embodiments given below, serve to explain the principles of the
invention.
[0026] FIG. 1 is a schematic view of an embodiment of the infusor
system of the present invention;
[0027] FIG. 1A is an enlarged view, in partial cross-section, of a
venous needle as used in accordance with the principles of the
present invention;
[0028] FIG. 1B is an enlarged view, in partial cross-section, of an
indwelling venous catheter used in accordance with the principles
of the present invention;
[0029] FIG. 1C is an enlarged view, partly in cross-section, of an
indwelling venous catheter inserted in a vein in accordance with
the principles of the present invention;
[0030] FIG. 2 is an enlarged view, partly in cross-section, showing
a venipuncture needle in position in a vein and the catheter used
in accordance with the principles of the present invention about to
be inserted through the needle into the vein;
[0031] FIG. 3 is a side view, in partial cross-section, of a
patient body illustrating the infusor system used within the
superficial to sacral venous system of the patient;
[0032] FIG. 4A is a front view of a pressure-altering device, such
as an abdominal binder, of the infusor system to be utilized with
the tube and catheter of the present invention; and
[0033] FIG. 4B is a side view of a patient's body, in partial
cross-section, of a patient body, showing the pressure-altering
device of the infusor system of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0034] FIG. 1 is a schematic view of one embodiment of the infusor
system 10 of the present invention. The infusor system 10 includes
a medication delivery tube 12 which is coupled to a supply of
medication 14 to be dispensed therethrough. The tube 12 may be made
of PVC material or of a biodegradable material for more
environmentally safe disposal. The delivery tube 12 is coupled to a
delivery component 18 for dispensing medication 16 delivered
thereto by the tube 12. Such a delivery component 18 may include,
but is not limited to, a venous needle 20 or an indwelling venous
catheter 22. As discussed further hereinbelow, the delivery
component 18, such as the venous needle 20 or indwelling venous
catheter 22, is operable to direct medication 16 from the tube 12
to a venous system 24 of the patient. In one embodiment, the venous
system 24 may be the superficial to sacral venous system of a
patient, and in particular, the medication 16 may be directed into
the superficial vein or veins 26 of the pelvis 28 or inguinal
region 30 of a patient.
[0035] FIGS. 1A through 1C show a venous needle 20 (FIG. 1A) and an
indwelling venous catheter 22 (FIGS. 1B and 1C) that may be used in
the infusor system 10 of the present invention. Referring to FIG.
1A, a venous needle 20 is typically inserted into a patient with
the needle 20 puncturing and protruding through the skin 32 and
into the vein 26 of the patient following preparation and
sterilization of the insertion site 34. Thereafter, the venous
needle 20 may be held in place by a plurality of tapes 36 which
hold the venous needle 20 to the insertion site 34. Referring to
FIGS. 1B and 1C, an indwelling venous catheter 22 may be inserted
into a vein 26 beneath the skin 32 of a patient. In particular, a
venipuncture needle 38 is inserted through the skin 32 and into a
vein 26, and the catheter 22 is inserted into the vein 26 through
the venipuncture needle 38. Once the catheter 22 has been inserted
into the vein 26, the venipuncture needle 38 used for the catheter
insertion is removed, leaving the catheter 22 in the patient's vein
26.
[0036] Referring now to FIGS. 2 and 3, then delivery component 18,
being an indwelling venous catheter 22 in the illustrated
embodiment, is shown inserted into a portion of the superficial to
sacral venous system 24 of a patient body 39. Within this venous
system 24, the indwelling venous catheter 22 is able to deliver
medication 16 through the tube 12 to a contact point 40. This
contact point 40 may be a superficial vein or veins 26 of the
pelvis 28 or inguinal region 30, including, but not limited to, the
femoral vein, deep epigastric veins, deep circumflex iliac vein,
internal iliac vein, internal pudic vein, common iliac vein,
spermatic vein, dorsal vein of the penis, inguinal vein, pudendal
vein, pubic veins, or genitofemoral vein. It will be recognized by
those of skill in the art that the contact point 40 may be in other
veins 26 of the patient body 39.
[0037] As illustrated in FIG. 1, the delivery tube 12 is coupled to
a supply of medication 14 and delivers medication 16 to the venous
needle 20 or indwelling venous catheter 22 from the supply 14. For
example, a first end 42 of the delivery tube 12, being the end
opposite the venous needle 20 or indwelling venous catheter 22, may
be coupled to an IV drip bag 44 for continuously dispensing
medications 16 at a controlled drip rate into the tube 12.
Alternatively, the first end 42 of the tube 12 may be connected to
a pump device 46, such as a Patient Controlled Analgesia, or PCA,
pump for injecting medication 16 into the tube 12 at a
predetermined pumping rate. Infusion rates and doses may be
determined by a physician.
[0038] The tube 12 of the infusor system 10 of the present
invention may also include a bolus injection dock 48 for receiving
a syringe 50 to rapidly inject bolus dosages of medication 16 to be
dispensed through the delivery component 18, such as a venous
needle 20 or indwelling venous catheter 22. This may be used to
alleviate acute pain or acute worsening of pain experienced by a
patient utilizing the infusor system 10. If a patient is using a
home infusion pump, a preset "rescue" or bolus dose is set for
every time the patient or caregiver presses an extra dose/rescue
button, as with other infusion pumps, as is known to those skilled
in the art. A one-way valve 52 ensures that medication 16 flows in
the proper direction to the venous needle 20 or indwelling venous
catheter 22.
[0039] The embodiments of the infusor system 10 illustrated herein
utilize venous needles 20 or indwelling venous catheters 22 which
are designed and configured to be positioned within the veins 26 of
the pelvis 28 or inguinal region 30. However, the infusor system 10
might also be utilized with other venous systems 24 of the body 39
which are proximal to areas requiring medication 16. For example,
Batson's Plexus extends up to the cervical (neck) region. Thus, a
very long catheter, such as a cardiac catheter, could be extended
up through the superficial pelvic veins and into the vertebrovenous
and meningorrhachidian vasculature (i.e. around the spinal canal
and spinal cord and structures) and up to the base of the skull.
This would allow for focal delivery and site directed delivery of
medications into the higher central nervous system (CNS).
[0040] Although including an orifice 54 to direct liquid medicine
from the tube 12 to the contact point 40, namely, the superficial
or sacral venous system 24 of a patient, the material utilized to
form the venous needle 20 or indwelling venous catheter 22 should
not absorb and hold the medication 16 away from the venous system
24. Furthermore, the material should preferably not foster the
growth of microfluora. While the infusor system 10 of the present
invention utilizes a venous needle 20 or indwelling venous catheter
22 which is configured for remaining within a venous blood vessel
26, it may be useful to precede the insertion of the venous needle
20 or indwelling venous catheter 22 with an anesthetic to prevent
reaction to the venous needle 20 or indwelling venous catheter 22
as a foreign body.
[0041] Vein catheterization, in the method of the present
invention, is performed by medical professionals. Likewise, a
pressure-altering device 56, such as an abdominal binder 58 (FIGS.
4A and 4B), may be applied to a patient and removed from a patient
by medical personnel. In some situations, the patient may be able
to remove and apply the binder 58 by himself after receiving
training. Additionally, in the embodiment of the present invention
wherein an IV may be attached to a home infusion pump 46, such a
pump 46 may also be turned on and off and bolus injections may be
given by the patient, as with home infusion pumps 46 and diabetic
pumps. Such pumps are commercially available from Deltec, Inc. of
St. Paul, Minn. and Pharmacia of Kalamazoo, Mich. When using an
abdominal binder 58 to affect reversal of flow through Batson's
Plexus, the pressure applied to the binder 58 is controlled with a
sphygmomanometer device. Continuous abdominal pressures to induce
reversal of flow through Batson's Plexus may range from about 15 mm
Hg to about 90 mm Hg.
[0042] As described previously, the delivery component 18 of the
infusor system 10 may include a venous needle 20 or indwelling
venous catheter 22. The venous needle 20 or indwelling venous
catheter 22 preferably ranges from very small needles measuring
about 25 gauge to very large needles and catheters measuring 18
gauge or larger. The delivery component 18 should sustain a flow
rate of medication suitable for the application being utilized. In
general, infusion rates may be as slow as "TKO", or "to keep open"
rate such as 10 cc/hour (kept open by using an infusion pump), or
may be relatively rapid rates of 100 cc/hr. Rapid rates may often
be used in applications involving delivery of medication 16 to the
central nervous system. Faster rates could be instilled depending
on the medication 16 used and the need. As other examples, for
morphine usage, a sustained flow rate of about 15-20 cc/hr at a
morphine concentration of 5 mg/cc may be desired. Furthermore, the
venous needle 20 or indwelling venous catheter 22 may have the
capability of providing bolus dosage delivery of 10-20 cc/hr,
either as a single dose or in multiple fractions of 20 cc/hour.
[0043] A standard intravenous catheter, such as an Angiocath.RTM.,
may be used as a delivery component 18 in one particular embodiment
of the present invention. This type of catheter is flexible and has
a more rigid guide wire for insertion that is removed after
insertion. Angiocath.RTM. catheters are commercially available from
Becton, Dickinson and Company. In use, an angiocatheter, such as an
Angiocath.RTM., would be placed subcutaneously into a pelvic vein,
such as a vein selected from the group described previously.
Following placement of the angiocatheter, the sheath or guide wire
is removed. Alternatively, a simple straight infusion needle could
also be inserted into the most superficial of pelvic veins. These
needles or catheters are then taped down or stitched down in the
case of deep angiocatheters.
[0044] The elements of the infusor system 10 should preferably be
able to withstand gamma radiation for the purpose of pre-use
sterilization. Furthermore, the materials are preferably safe to
use in the presence of medical diagnostic systems such as magnetic
resonance imaging (MRI), x-ray, or computerized tomography (CT)
scan.
[0045] Medication 16 dispensed through the venous needle 20 or
indwelling venous catheter 22 is directed into the venous system 24
and distributed throughout the body 39 to address a targeted
symptom or to alleviate pain experienced by the patient. Since the
infusor system 10 of the invention is utilized within a venous
system 24, it is noninvasive and generally nonpainful. Since no
injection is involved, use of the infusor system 10 of the
invention is not accompanied by the various drawbacks and side
effects experienced with parenteral administration. Furthermore,
the infusor system 10 may be utilized with patients who cannot
tolerate orally administered medications. The infusor system 10
provides great flexibility in the dispensing of medication 16
through IV bags 44 and pumps 46. A bolus dosage of medication 16,
such as a dosage of morphine for a patient suffering acute pain,
can be administered through the bolus dock and received directly
into blood vessels.
[0046] The infusor system 10 is safe and inexpensive. Not only will
the infusor system 10 be generally inexpensive to manufacture, but
it is also generally inexpensive to utilize. Once the venous needle
20 or indwelling venous catheter 22 has been properly placed, it
can be left therein to provide continuous medication 16 without the
need for constant medical attention, which is often associated with
parenteral administered medication. Furthermore, the infusor system
10 provides continuous dispensing, unlike individual pills or
suppositories that the patient or medical professional must
remember to administer at predetermined intervals.
[0047] A large number of medications, such as chemotherapy,
steroids, anesthetics, opioids, and other narcotic and non-narcotic
analgesics may be administered using the infusor system 10 of the
present invention. During operation of the infusor system 10, it is
easy to initiate the administration of medication 16 simply by
providing medication flow through the tube 12 and into the venous
needle 20 or indwelling venous catheter 22. Similarly, stopping the
medication flow will terminate the administration, whereupon it can
simply be reinitiated by again beginning flow through the delivery
tube 12.
[0048] In accordance with one inventive method for utilizing the
infusor system 10, use of the infusor system 10 is combined with
intraabdominal pressure to infuse medication 16 directly into the
spinal structure 60 and the cavities surrounding the spinal
structure 60. The administration of medication 16 directly into the
intraspinal area, and particularly, the administration of opioids
and other analgesics, is very useful for pain management. For
effective intraspinal administration in accordance with the
principles of the present invention, the venous needle 20 or
indwelling venous catheter 22 is positioned within the superficial
vein or veins 26 of the pelvis 28 or inguinal region 30 to deliver
medication 16 into the superficial or sacral venous system 24.
Intraabdominal pressure is then increased to create a reversal of
blood flow within the vertebral venous plexus, or Batson's Plexus.
The intraabdominal pressure may be applied by using an abdominal
restraint 62 or binder 58 or any other medically suitable method
for creating intraabdominal pressure. The intraabdominal pressure
may be set for each patient and is generally not altered after the
optimal pressure for full reversal of Batson's Plexus flow is
determined. Determining the optimal pressure may generally be a
relatively low pressure of around 30 mm Hg, but with obese persons,
the pressure may be higher. The Batson's Plexus is valveless, and
blood is free to flow in the reverse direction when intraabdominal
pressure is applied. Normally, the vertebral venous plexus in the
pelvis, sacrum, and lumbar spine assist in carrying the venous
blood from the meningorrhachidian veins of vertebral structures,
including the spinal cord, to the sacrum and sacral plexus, the
iliac veins, and ultimately, to the inferior vena cava and to the
heart. However, upon reversal of pelvic, sacral, and lumbar venous
flow, the venous flow occurs from the sacral venous plexus and into
the meningorrhachidian blood vessels. That is, the normal blood
flow that occurs from the spinal column toward the heart reverses
in the reversal of flow in the Batson's Plexus such that blood flow
occurs back into the spinal area. Therefore, using Batson's Plexus
reverse flow with the infusor system 10 in accordance with the
principles of the present invention, medications 16 are delivered
directly into venous blood vessels 26 and more effectively and
efficiently administered to the spinal cord, such as to alleviate
pain. For example, morphine administered utilizing the infusor
system 10 with increased intraabdominal pressure, is delivered in
high concentrations to the spinal cord and other vertebral
structures.
[0049] Minimal systemic dosing of morphine or other medication 16
occurs utilizing the inventive method, and thus, provides a number
of distinct advantages. Concentrated medications 16, such as
analgesics, are delivered into the spinal cord and other vertebral
structures before circulating throughout the body 39 and before
significant dilution occurs. Furthermore, the medications 16 are
directly delivered into the vertebral structures 60 before liver
metabolism of the medication 16 occurs. With a greater
concentration of the medication 16 directed to the vertebral
structures 60 instead of systemically throughout the body 39, side
effects such as sedation, respiratory depression, nausea, and
vomiting are reduced because there are lower concentrations of the
medication 16 to the brain and brainstem. Furthermore, utilizing
the inventive method, the delivery of medications 16 can be given
intermittently, if desired, into the vertebral venous plexus using
intermittent intraabdominal pressure, and then a systemic delivery
may be initiated simply by removing the intraabdominal pressure.
Therefore, high concentrations of an analgesic might be infused
intraspinally to manage acute pain, and then systemically for
continuous management of less acute, chronic pain. A further
advantage of the inventive method is that medication 16 may be
administered epidurally, that is, outside of the covering of the
spinal cord, and intrathecally, that is, within the spinal fluid
surrounding the spinal cord without the use of injections, which
are generally costly and usually require administration by a
trained anesthesiologist due to potential risks, and also require
continuous monitoring by trained personnel. Therefore, the cost and
the risks of effective pain management are reduced.
[0050] While the present invention has been disclosed by reference
to the details of preferred embodiments of the invention, it is to
be understood that the disclosure is intended in an illustrative
rather than in a limiting sense, as it is contemplated that
modifications will readily occur to those skilled in the art,
within the spirit of the invention and the scope of the appended
claims.
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